Good morning, everyone. We hope that you found that video half as inspiring as we do. We actually produce that annually for our internal R and D awards. And those products, plus the rest of our portfolio are what enable us at Boston Scientific to improve the lives of 30,000,000 patients each year and what drive us each and every day. My name is Susie Lisa.
I'm the Vice President of Investor Relations. And on behalf of the entire IR team, we're very grateful that you chose to spend your June morning in New York with us here today and those virtually with us on the web. Thank you very much and we'll do our very best to lay out a really exciting day of our growth prospects and pipeline and our people and why we're excited for the long term outlook. Before we get into it, I do have some housekeeping items to go through. First, the usual Safe Harbor and risk factors apply.
We encourage you to consult our latest SEC filings and 10 Q and 10 ks, which have a discussion a full discussion of all the risk factors that applies. We will be making forward looking statements. Secondly, we will be spending a lot of time on our product pipeline. So I have 2 pages of regulatory disclaimers here as many of these products are not yet approved in all jurisdictions around the globe. With respect to financial disclaimers, please note that within most of our business unit presentations, we will be discussing operational growth unless it's otherwise noted.
That is a non GAAP measure that excludes the impact of foreign currency, but includes acquisitions. Whereas in our strategy and financial sections, we'll be discussing organic growth, which excludes both foreign currency impact as well as the impact from acquisitions. I'd also note too that with respect to BTG, our proposed acquisition, we remain on track for a midyear closing, but our financial guidance will continue to exclude the impact of BTG given that it has yet to close. But when we discuss our market opportunities, BTG will be included there given it brings us many very exciting adjacent markets. Now to get to the agenda.
Again, thanks for spending 5.5 hours with us. We'll start with a strategic overview by our CEO and Chairman, Mike Mahoney, and then we'll get right into our business units, starting with MedSurg, where we'll be kicked off with Urology and Pelvic Health, where President of MedSurg and UroPH, Dave Pearce, will be joined by our General Manager of the UroPH franchise, Megan Scanlon, who I think will be new to many of you, and we look forward to Megan's deep dive on that franchise. Then we'll turn to endoscopy, where Art Butcher, who runs that business, will lead the conversation and be joined by a relatively recent addition to Boston Scientific, Doctor. Brian Duncan, who's our VP of Medical Affairs and the Chief Medical Officer for Endoscopy. We'll then take a break and have 20 minutes for your questions before transitioning to our Rhythm and Neuro businesses.
Joe Fitzgerald and our Chief Medical Officer for Rhythm, Doctor. Ken Stein, will lead the conversation there going through our cardiac rhythm management and electrophysiology businesses. We'll then turn to neuromodulation where Malik Nadabadi will lead the conversation, President of neuromod, and he'll be joined by Milad Girgis, who some of you may have met at NANS in prior years and runs our BRAIN franchise. We'll then break again for 15 minutes of Q and A with the entire Rhythm and Neuro team. And then we'll give you a break before we conclude the afternoon, turning to our cardiovascular segments where Jeff Mervis, who leads our Peripheral Interventions business, will kick off the second half of the program along he'll be joined by Kat Jennings, our Vice President of New Business Development and Commercial Marketing for PI.
And then we'll conclude the business segments with interventional cardiology. We're Kevin Ballinger, the President of IC. We'll be joined by our Chief Medical Officer globally, Doctor. Ian Meredith as well as the General Manager for Structural Heart, Sean McCarthy. We'll then turn to do a deep dive on our emerging markets business and we're really pleased that June Chang, our General Manager and Vice President for Greater China will has come all the way to share insights into how she runs her business and the opportunities there.
And then Dan Brannen, Executive Vice President and our Chief Financial Officer, will conclude with a long term financial outlook. We'll then have one final Q and A session designed to have Mike come back up and talk strategy, financials, emerging markets and Ian will join as well for that to focus on clinical. But all of our speakers will still be here and are happy to answer any questions that weren't answered in the prior Q and A sessions. So hopefully, that arrangement agrees with everybody and we'll look to wrap promptly at 1. So without further ado, it's my great pleasure to introduce Mike Mahoney, our CEO and Chairman.
Mike?
Thanks, Susie.
Appreciate it. Thank you for setting this up, Susie, and the team. Good morning, everyone. That agenda feels a bit like a triathlon. Swim, bike, run, 3 sections with breaks in between.
So when you get home, you can tell your friends and partners you ran a triathlon at Basel Scientific. It's great to be here. Thank you for showing up so many familiar faces. This is an important day for us. We do this every other year.
And it's, I think, a great time to showcase all of the things that Boston Scientific does primarily focus on innovation. And if you think about some of the big takeaways for me will be for this meeting. First of all is, I think one thing that really differentiates Boston is the depth of our global leadership team. And you're going to meet most of our all of our BU leaders, many of our General Managers today. And the depth of the pipeline that we have in the company and their knowledge of the business and agility, I think, really helps Boston Scientific significantly.
So you're going to see a lot of that today. You can see quite a bit of our portfolio innovation that will help drive the company over the next chapter. And with that, ultimately, one reason you're here is to create shareholder value. So we have tremendous confidence in the company, in the business and where we're headed over the next 3 years. We have very clear plans in place, but we also have the ability to have some agility along the way here.
So, extremely excited about the company, feel blessed to work here and to help lead the company with the group over here. And there's never been a better time to be at Boston, where I believe we're an investor in Boston Scientific. So you're going to hear a lot about products today in our portfolio because at the end of the day, I think about 2 things every day, the people and the culture of the company and innovation. If you do those two things right, we're going to do well. And that's what we focus on, our culture and our portfolio.
And then with a motivated, empowered people, you can do great things. But lots of companies have slides like this. You saw our video. We talk about advancing science for life. So we oftentimes bring the patient experience right to our employees.
And the reason we do that is we know employee engagement is everything. And a small uptick in employee engagement gives you a small uptick in performance. So it's the right thing to do to show our employees what their impact to patients is, but it's also good for our business. So we talk about Advancing Science for Life. We have these values across the slide.
Lots of companies has values like these. We take them very seriously. We have a decentralized company, over 30,000 employees. The cultures can be a bit different in the different divisions or regions, but at the end of the day, these values below knit us all together. I won't go through each one of them, but we really bring these to life despite the companies and businesses have slightly different strategies and tactics, but this connects all of Boston Scientific employees together.
It's ultimately about the patient. We focus on patients, our employees and communities, drive meaningful innovation. We'll focus on high performance and our winning spirit. So some of you know the company super well, some maybe less well. This is a bit of a review for those who have been tracking us closely.
This is Boston Scientific year end 2018. A quick snapshot on the left of our business unit segments and the right on the our geographies. So how we're organized? We essentially have 3 reporting segments: Cardiovascular, rhythm and neuro and med surg and that's how the triathlon set up over the course of the day. And then you see the operating business units that associate with those continue to grow faster than our peer group and our core business.
And I think and continue to grow faster than our peer group and our core businesses. And then we have lots of adjacencies we can talk to. So not every single business every single quarter, But for the most part, most of our businesses grow faster than the market. And you see the widening and strengthening of many of these businesses like peripheral interventions, especially with the pending acquisition of BTG, endoscopy, urology, neuromodulation. So many of these other businesses have become much weightier for Boston.
On the right, you see really nice geographic balance. We do have over 50% of our sales in the U. S, We see strong growth across the regions. I like to call it the growth in Europe. What is typically a very difficult slow market with tremendous pricing pressure continues to be one of the fastest growing regions for Boston, and that's very encouraged because that's where most of our new products are launched first.
So it kind of, to me, gives you an indication of the future. You're going to see about 8,000 slides today, but if you want to just have one to use with your handy little notebook that we gave you, this is the one page takeaway if you look at Boston Scientific over the next chapter that you can look at as an investor. The first one is employee engagement, inclusion and our leadership bench. We really have a focus on all three of those and an excellent leadership bench and a team that's highly motivated to differentiate the company. So I think you want to start with the people.
The second thing is what's the track record of delivering? And this is I think this is our 3rd or 4th Investor Day, Susie, since I've been here. And the good news is we don't provide aspirational plans at our Investor Day. We actually deliver show you plans that we've actually delivered or beat consistently over this time period. So these are not LRP's that are interesting, they're LRP's that we actually aim to beat, at least meet, so track record.
Secondly, the third point is our focus on category leadership. You're going to see this across the board in the businesses. We think being a clear category leader is helpful to pursue service lines and to partner with customers closely. And at the same time, while we do that, importantly, you'll see us move into $22,000,000,000 of new markets with products that we're launching in the near term if they haven't launched already. We've got a very strong pipeline.
You're going to see that across the board. Dan will highlight a little bit of our venture activity. We have about 40 active investments in companies, 4 of which we've acquired in 2018. And this provides some additional fuel for our growth. And at the bottom line, you add all that together, we expect to deliver top tier revenue growth over the next 3 years, continue to drive margin expansion, deliver double EPS and our strong cash flow with less liabilities is significant.
You've seen this slide in the past. I think that what's nice is we actually deliver against this, and we customize our strategic plans and our priorities each year by division, by region, so it's not a fixed document. But essentially, we focus on driving our core business growing faster than peers, widening our growth profile, which you'll see in a minute, driving global expansion, driving productivity in the company and always focusing on new capabilities for the future. You'll see a lot in digital health today. We have some risk sharing programs, commercial excellence, globalization, so lots of capabilities in the company that we actually share and leverage quite a bit.
I think this is obviously a really important one. This shows the performance track record, which we also believe is a good indicator for the future. So years ago, we were kind of a turnaround story. In 'fourteen through 'sixteen, we moved to what was at that point likely above market growth over those 3 years. 'seventeen and 'eighteen, 'nineteen, so the 'nineteen number shows the midpoint of our full year guidance in 'nineteen, but it shows the 3 year CAGR of a +7 percent organic CAGR.
This is all organic, not operational. You would add M and A on top of that. In the next 3 years, we're providing organic guidance of plus 6% to 9%. Plus 6% to 9%. So our aim and our goal would be 2 years from now at Investor Day that we've accelerated our organic growth profile in this 3 year period versus 2017, 2018 and 2019.
So we should be consistent with what we've done over the past few years, and we feel like this is a healthy organic range for 2020 through 'twenty two is 6% to 9%, which would show a our aim would be an acceleration for the current over the previous 3 years. So similar to our financial brand, which has grown at the high end of our peer group, the second one is improved margins and delivered double digit EPS growth. And we believe we have a lot of confidence in ability to continue to deliver this like we have in the past few years. And you see a nice ramp up in operating margin improvement over the past years. And we'll call out a tip of what we've said in the past, a 50 to 100 basis point margin improvement over these 3 years.
And with that, we're able to invest at the high end R and D about plus 10% and deliver strong growth and consistently improve margins. And if you're a long term investor, there's still room in the tank where even at these levels, we're under a few of our peers. So we have quite a bit of room here. Dan will talk about it. We want to do it in a smart way that enables us to fuel all the innovation that we have because we have more good ideas and deliver that financial brand to you.
With that, we delivered double digit earnings per share growth in the 'twenty to 'twenty two period. Again, 'nineteen is at the midpoint of the guidance. So this business really is about our people and innovation. And on the left side are is Dan Brennan with all of our 7 business units wrapped around them. And on the right side are kind of the sources of our innovation.
And so on the left, we talk about this category leadership. And so maybe just a few points here. You take like urology, pelvic health, or we can go through each one of them. And consistently over the past 4 or 5 years, you've seen us move from a maybe defined as kind of a sleepy stone company to a company that has disrupted the stone business through our lithoView platform and now enhancements from there. And added to that 2 BPH properties with a laser and a MIH property, men's health implants, stress urinary incontinence and then recently in oncology cancer space with a prostate with Augmenix.
So that is a great example of creating category leadership within the urology group, which is a global fast growing market now and having really portfolio differentiation. And we really have a similar story of that type of strategy across our businesses, and you're going to hear that today. So one is category leadership while taking share in our core and growing in these new adjacencies. On the right is the fuel that gives us all this. And we're pretty good about figuring out what do we want to do organically.
The bulk of our revenue comes from organic R and D. Many of our divisions do very few acquisitions, it's all internal. But we're pretty good at figuring out what we want to do organically, what we want to acquire and what we want to invest in for a VC standpoint to mitigate risk or to have more shots on goal. So we do that pretty thoughtfully. Our R and D programs are more now more global, many engineers in India and China and Costa Rica for sustaining business.
We expect over 10%. We have a culture of innovation with our ImagineIF program where we incentivize our employees to come up with new innovation ideas whether you're in legal, finance, HR, supply chain. So it doesn't have to be a product. We've done a number of tuck in acquisitions in 2018. Doing a nice job of integrating those in 2019 and BTG deal is pending.
I touched on our BC portfolio. We've also done some nice work on build to buy opportunities and spinouts to have create more shots on goal. So I think our innovation cadence and our strategy works pretty well, but it's not fixed. We create new capabilities and globalize our R and D teams. I think I'm probably most proud of this because this is a direct result of the strategy that we've had in place for many years.
And essentially what we've decided to do is how in the world do we get into faster growth markets and win in those faster growth markets. And this is the scorecard of that execution. And it will continue as you look at 2022 and it will continue 2 years from now when we show 2024, 2025 where the numbers will be smaller and bigger. The low growth will be smaller, the moderate will be bigger and the high growth will be bigger again. So kudos to our team for basically essentially in the bottom slide, bottom row, moving our served market growth CAGR from what used to be a negative one, where we were all about DES and CRM, essentially nothing else.
Well, the good news well, very little else, I should say. The good news is we actually are for the most part, take share in those businesses, but the company has really continued to morph into a higher growth TAM. And you see 20% of our businesses I'm sorry, in 2019, 30% of our businesses are in the lower growth markets. We call out moderate growth of 3% to 7% CAGR, which is pretty good. And we think about 45% of our business is in that category now.
And 25% from what used to be 10% is now in the high growth greater than 8% in many of those markets in the teens. And in 2022 based on what you'll see, you're going to see this continue to accelerate. The low growth goes down, moderate, say, is about the same and high growth increases. You increase our served market, we grow faster than the market, you accelerate your organic growth profile. So this is the other page I would recommend if you want to steal a few that you would tuck in your shirt or whatever.
This is our essentially all the businesses are going to be covering the things on the right side. And this is exciting for us. So as we continue to win in our core business and stabilize that foundation, you have all these new growth branches coming off these different divisions. And this is really the summary of what you're going to be hearing about today. And each business has a number of new growth platforms, new adjacencies where we have core competencies and core capabilities that support that organic profile that I discussed despite always having political uncertainty, despite market changes.
We feel like the diversification of the company and the breadth of these offerings allows us to take a few shots to absorb some issues occasionally because we have so much diversification and strength in the company to balance that out to grow faster than peers. But you're going to hear a lot about that on the right side. Essentially what this means is in 2022, we anticipate competing in markets that have a value of $22,000,000,000 where today we have just under $1,000,000,000 of revenue today. So we see this as a big opportunity for us. Another thing that's I think is pretty neat, if you look at our focus on interventional oncology.
And so historically, if you look at the far left of the slide, Boston Scientific Interventional Oncology was really done by our peripheral interventions business that had about $250,000,000 in sales or so and some products within endoscopy. So we looked at this and we said besides our core businesses and adjacency that makes sense for us from a call point perspective and from an R and D perspective and an ops perspective is let's get bigger and let's drive category leadership in this category. It's less crowded, it grows quickly and it's a bit under the radar. And so over the last 2018 2019, we acquired a few companies. We acquired Augmenix and urology, you'll hear about EndoChoice and endoscopy and BTG, which is pending, which is really our anchor asset for the strategy for our PI business and interventional oncology.
And with that, we see we serve the prostate, pancreas, colon and liver. So what's really exciting in the 2019 that will deliver over $1,500,000,000 that clump of assets within interventional oncology. But as you look forward, where Boston is most unique, and I think Jeff and Cat will talk about this, is the delivery tools that we have, the coils that we have, the visualization capabilities, the ability to get access to therapeutic areas that probably no other company can and see those and now have the ability to deliver a therapeutic agent directly to that organ, whether it be RF, cryo, Y90, drug beads, bland beads, whatever the case may be is really unique opportunity. And with that, we think we can expand indications beyond what we're looking at in 2019 in the future and leverage capabilities across the company. So in '21, we expect over $2,000,000,000 in this category growing faster than the company.
We've got a big pipeline. We have not shared all of our product launches in this for obvious reasons, for competitive reasons and for various other reasons. But here's a healthy list of our product cadence over this 3 year category, over this 3 year time period, and a lot of this will be highlighted here. So I do want to kind of end my little start up here with where I started. This really is about creating a culture where employees are proud to work at Boston Scientific.
They're engaged, they can be developed, they've got a strong supervisor and when they go home to speak with their friends or the partners of the family, they're proud of what the company does and they also want the stock to improve, but oftentimes that's not the big motivator for our employees. This is what motivates our employees. So in our carrying value, we talk about caring for patients, well over 35,000,000 patients helped annually. We do a lot in the close of the gap community to focus on underserved populations and drive inclusiveness. Our diversity and inclusion efforts, you never are completely satisfied here, but I can tell you there's never been a bigger focus in the company than there is right now to continue to strengthen this area because it's not only the right thing to do for our employees and the right thing to do period, but it's also great for our business.
So a lot of efforts in these areas and also our employees spend a lot of time giving back to the communities. We also do the right thing for the environment. Kudos to our supply chain operations team as the primary driver for this. We have specific environmental footprint goals. We've decreased water consumption by 30%.
We expect to be carbon neutral by 2,030. And we've set a goal of 100% renewable energy electricity by 2024. So some ambitious targets, but many plans and investments have put in place and see the new facility that we have in Malaysia, which is ramping up right now with Lotus Valve and some other products. Lastly, you do good things, you get some nice awards and we're really proud of many of these, focusing our innovation, focusing our culture, working mother and best places to work. So I think these types of things are nice to see.
It's kind of just an output of what the company culture is. And I'll just wrap up saying that I'm just very honored to be part of the company. We've got extremely bright future, and I'm way over indexed in Boston Scientific stock. So I hope that you are as well. Thank you for coming and I'll turn it over to Doctor.
David Pierce to he's not a doctor, but and Megan Scanlon, who lead our urology business.
Good morning. I'm happy to be here to kick off, I guess, the swim leg of our who'll present Endoscopy and then we'll take Q and A. The Urology and Pelvic Health division has become an important component of Boston Scientific. We've delivered consistent growth and have scaled to over $1,000,000,000 in revenue through a combination of internal innovation and thoughtful acquisitions. We've established category leadership in this space and see continued growth with significant market expansion opportunities as well.
The division revenue margins in OI are accretive to Boston Scientific, and we're targeting $2,000,000,000 in revenue by 2022. In 2018, we achieved $1,200,000,000 in revenue in markets we value at $3,300,000,000 Our growth was 11%, driven by our broad portfolio, increasing market access and therapy development, along with strategic globalization. And this was nearly double the solid market growth in these spaces at 6%. We characterize our business in 3 verticals. The first is stone disease, which is our largest market nearing $1,500,000,000 with solid mid single digit growth.
We see continued prevalence in this market as obesity increases because we know that high BMI increases the risk of stone disease. The Men's Health segment is approaching $1,000,000,000 and includes prostate health and prosthetic urology. The prostate health segment shows strong double digit growth, driven by the emergence of less invasive therapies to treat the massive population impacted by benign prosthetic hyperplasia or BPH. Along with prostate cancer sufferers who elect radiation therapy as their treatment of choice. The as well as erectile dysfunction.
And lastly, our women's health markets are at 1,000,000,000, serving a large population of women ovarian cancer diagnosis. We strive for broad category leadership as all the Boston Scientific businesses do. In stone, the key drivers of our success are innovation, evidence and global education. For prostate, execution with our Spacor and Rezum acquisitions is critical. And for prosthetic urology, innovation, training and patient outreach will support continued growth.
In Women's Health, we will focus on the important SUI segment and in developing the Cytuity diagnostic from our Envision acquisition. We also see significant adjacencies in OAB and urologic cancer. We estimate our addressable markets will grow to $5,600,000,000 in 2022. I'll now ask Megan to provide further detail on our Stone and Men's Health plans. Megan?
Thanks, Dave. As mentioned, I'm a new face at Investor Relations Day, and I welcome the opportunity to take you through a deeper dive in some of our priority franchises. So first, I'm going to start with Stone. As Dave mentioned, Stone is a large and growing market, valued at around $1,400,000,000 today. We have clear category leadership in this space with the broadest stone device portfolio in the world.
We continue to strengthen this portfolio with the highest investments in clinical education, clinical research and the continued pursuit of meaningful innovations to address a wide array and a high level of clinical needs. So, one of the most notable examples of this innovation, Mike mentioned this, is litho view. LithoVu was a homegrown R and D effort that was the first of its kind in the market. This is a disposable, flexible ureteroscope that since its launch in 2016 has been used now in close to 100,000 flexible ureteroscopy procedures in over 2,500 centers across the globe. So this has been an incredible success for EuroPH and for Boston Scientific.
But we also showcase this today because we believe that this serves as an example of one of the important cornerstones of what strengthens our broader EuroPH portfolio, but it also serves as a really beautiful proof point for the capabilities being developed at BSC around the disposable scope landscape. And Art Butcher, when he talks about endoscopy, is going to talk a lot about some exciting innovations to build out a portfolio in disposable therapeutic imaging. So we look forward to reviewing that with you. Now in STONE, there remains a huge need for clinical innovation here. The rate at which stones are occurring in the marketplace, right, the prevalence of stone disease is increasing at a rate 2 times the rate at which procedures are increasing.
So what does this mean? This means there's an emerging and critical bottleneck in patient care and the healthcare ecosystem. This important and widening capacity gap is what motivates us to try to redefine the way flexible ureteroscopy is done to be able to treat more patients and improve patient outcomes. So, you're going to start hearing us talk a lot about StoneSmart. Let me define what that is.
StoneSmart is the name of a comprehensive, flexible ureteroscopy ecosystem that's being developed organically at Boston Scientific. This aims to reinvent ureteroscopy with differentiated energy sources that are important relative to delivering efficient fast lithotripsy, which is the largest source of frustration and variability in flexible ureoscopy procedures, to bring next generation disposable visualization with a number of new highly differentiated capabilities, as well as an integrated fluid management system. Yes. So now while these three components, right, energy, visualization and fluid management can work independently, solving important procedural needs. Where the magic happens is when the ecosystem is integrated together to drive streamlined procedures with better speed, better predictability and improved patient outcomes.
So we're excited about what the investment in StoneSmart can mean for Boston Scientific in the years to come. So turning now to prostate health. This is under our Men's Health business, right? This is an exciting and rapidly growing franchise for Boston Scientific, which was given critical mass last year with the 2 important acquisitions that Mike talked about, with SpaceOar getting us into the prostate cancer arena, as well as with Rezum increasing and broadening our portfolio in BPH. So I'm going to start with prostate cancer and the Spasor Hydrogel.
This has been a really remarkable innovation for men who choose radiation therapy to treat their prostate cancer. It's a big market opportunity, target market opportunity estimated at about $750,000,000 Now, for those of you who aren't familiar with what SpaceSor does, SpaceSor is an important hydrogel shown in this infographic that in essence pushes the prostate I mean pushes the rectum away from the prostate during radiation therapy. It basically pushes the prostate, I mean the rectum out of the radiation zone. Importantly, eliminating the commonly seen GI toxicity issues in men undergoing radiation therapy. We hear repeatedly from radiation oncologists how much this little bit of space feels like a football field's length.
It gives them a lot of extra degrees of freedom to plan their radiation protocol and to think more aggressively about their dosing approach. Now the enthusiasm that we hear from our customers, combined with some really strong commercial execution in the United States, Europe and Asia has us on track to deliver approximately $100,000,000 this year, which is ahead of the initial expectations that we've shared publicly. So the benefits seen in spacing for prostate cancer gives us confidence in 2 important expansion opportunities. 1st, the continued pursuit of bringing this value to more men around the world undergoing radiation therapy in prostate cancer. We believe the clinical and economic value proposition of SpaceOAR is going to give us a lot of fuel to prove compelling to global health care systems around the world.
So we still have a lot of global runway to bring space or across global markets. But also we're seeing a lot of meaningful interest from radiation oncologists because the degrees of freedom that spacing affords them in the prostate is as important a need for some of the other radiation therapy protocols in pancreas, breast, head and neck, thyroid.
So we have
a number of small pilot trials underway to see which of these indications we are going to pursue next. Next, under our prostate health franchise is Rezum, an important innovation in the minimally invasive treatment of benign prosthetic hyperplasia. I mean, looking at the demographics in this room, likely something that will be relevant for some of you at some point in your life. We know this is a big and rapidly growing market. And we love this technology.
Because notably, it is a natural water vapor based solution that importantly eliminates the problematic adenoma tissue in the prostate. And as importantly for men, without unwanted sexual side effects. This important mechanism of action, again, the removal of the adenoma tissue, was reinforced earlier this year when we published our 4 year clinical data showing the impressive durability. Now at 4 years, men being treated with Rezum required an additional surgical re intervention rate of only 4.4%, compared to a 14% actually slightly over 14% surgical retreatment rate with competitive technologies. Now later this year, our 5 year data will be published, and we expect to see this sustained durability advantage for Rezum.
Our Category 1 code went live at the start of this year. And we are seeing improved coverage with both the Medicare regional payers and private payers as the year rolls on. We continue to ramp up our efforts in digital patient activation with our Treat My BPH campaign and increasing our investment in physician and patient education to bring Rezum to more markets around the globe. We're confident in the long term prospects to help these millions of men who need help with their BPH symptoms. And so now I'd like to pivot to a short video done where Doctor.
Neal Shore, who is a thought leader in BPH. He's also the past president of LUGPA. LUGPA is the large urology group practice association. He's a high volume surgeon located out of Myrtle Beach, South Carolina, and he's going to share his view with us on why Rezum is his treatment of choice in minimally invasive BPH.
The way I look at it is I want to do what's in the best interest of my patient, what's going to give them the best result most safely and most durable. So that's why I picked Rezum Water Vapor Therapy. Quite honestly, it's such a really holistic approach. Steam energy, water vapor therapy, as we understand with just convection heat, basically a really nice defect or a lesion within the prostate adenoma or the area of the prostate that is causing the obstruction. The immune system is able to absorb that tissue.
It's so well tolerated and safe and now has 4 year proven effectiveness. Long term is quite remarkable. And of course, they have no change in their sexual function. They've got improved flow, less hesitancy, good strong stream, better emptying of their bladder and they're sleeping better through the night. It's also particularly traffic because you can do it in your clinic.
It creates incredible efficiencies for me. Every urologist knows how to do rigid endoscopy. The procedure takes 2.5 minutes. If I were looking at a long term strategy of a value based model, the Rezum is head and shoulders the best model for de obstructing the prostate in a cost effective way.
Okay. So listen, I believe that Doctor. Shore conveys pretty compellingly and clearly the clinical and economic benefit of the Rezum system and why it's positioned for long term success. So last from me, shifting now to the last component of our men's health business is prosthetic urology, which notably was brought to Boston Scientific in 2015 under the AMS acquisition. And this portfolio has been a big part of the growth story of Euro PH over the last few years.
This too is a large and growing market, with millions of men who still suffer from erectile dysfunction and or urinary incontinence. And while we're proud of the substantial market leadership position that we have earned and sustained, we still remain very dissatisfied that there aren't more men choosing solutions to these oftentimes life changing and embarrassing conditions. So we have the broadest portfolio and we have recent new product launches in both ED and incontinence, which will be further strengthened by a very robust and substantive investment in our pipeline to bring future meaningful innovations to men who need them. So together, these will serve to strengthen and sustain our layer on top of that increasing investments in digital and in person patient outreach and activation. We aim to continue to increase the number of men who choose to seek solutions to these important issues in their personal lives.
With that, I'm going to turn it back to Dave.
Thank you, Megan. We mentioned our compelling adjacencies earlier. We're executing on market development efforts for our Cytuity technology, which came to us through our Envision acquisition. This will be a vital diagnostic option for women at high risk of developing ovarian cancer. Applications that we're considering include endometriosis and infection diagnostics as well as fertility.
We know that the OAB market is large at over $1,000,000,000 and growing. We have multiple venture investments in our portfolio that we feel will mature and allow us to take meaningful share in this space. And lastly, the number of procedures relating to urologic venture investments in this area as well. In closing, I would like to reiterate that the Urology and Pelvic Health division has been and will continue to be a significant component of the BSC story. We will outpace our markets, which are strong and growing.
Our financials will be accretive to BSC, and we are aiming for $2,000,000,000 in revenue in 2022. And with that, I'll now ask Art and Brian to come up and present the compelling endoscopy story.
Thanks, Dave. Thanks, Megan. Good morning, everyone. Thank you all again for coming. It is a pleasure to be here with you.
And I'm joined by my colleague, Doctor. Brian Duncan, to give you an overview of our endoscopy story. By way of introduction, I'd like to introduce Brian because he's relatively new to the team. Brian joined us in February of this year and he's leaving 22 years of advanced clinical practice. He comes to us from Houston Methodist Medical Center, where he was a professor of surgery.
And as a surgeon endoscopist, he's been a close collaborator with us for many years in the development of new technologies and education. He was director of the MITEI Center, focused on innovation, technology and education at Houston Methodist Hospital. And he's also a past president of the SAGES Society, which many of you are familiar with, which is surgeons that are focused on endoscopic procedures. So we're thrilled to have Brian joining our endoscopy team and he's been a great addition to our management board. So our endoscopy story continues to be a very compelling one and that is based on the strength of our global leadership position, the strength of our P and L, which is truly exemplary, and also the incredibly rich technology pipeline that is unfolding new opportunities for growth in endoscopy around the world.
For over 3 decades, the endoscopy business has been a strong contributor and growth engine for the Boston Scientific Business, delivering high performance and outpacing our markets consistently. On top of our exciting core growth businesses, we're actively engaged in branching out into high growth adjacencies and several of those initiatives are multiple years running already. So we're really gaining traction and excited to share those with you today. We have a clear number 1 global leadership position in endoscopy based on the depth and breadth of our portfolio and our strong commercial presence globally. From a financial perspective, very interesting, our top line growth rates as well as operating margin profitability rates are accretive to Boston Scientific.
And when I stood here at this meeting 2 years ago with most of you, I outlined an aggressive plan to get us to $2,000,000,000 by 2020. And here in 2019, I'm happy to report, as Mike said, we lay out plans at this meeting that we aim to achieve and to beat. We are on track to beat that target and deliver over $2,000,000,000 next year in 2020. So we've set a new aggressive goal for ourselves to be a $3,000,000,000 division for Boston Scientific within the next 5 years by 2024. So that will be a 50% growth within the next 5 years and Brian and I are excited to share with you our plans to do that this morning.
So let's look at some of the numbers. In 2018, we were a $1,800,000,000 player in a $5,000,000,000 global endoscopy market, strong number 1 market leader position. We delivered 8% growth and again record revenue for the division and we're continuing that momentum into 2019. In fact, in Q1, we reported operational growth of 9% for the endoscopy division. And if you look at average daily sales versus the prior year, we were actually at 10% growth.
And that momentum and acceleration is being driven by our pipeline that has really produced beautifully over the last 18 months. In fact, over the last 18 months, we have delivered 15 new products in the endoscopy division. And some of them are small and some of them are quite meaningful, like SpyGlass DS2 or ORISE Gel for endoluminal surgery or our ORCA pod system or Jaguar Revolution. And we're going to talk about all of those today. Going forward, we expect our core markets, not inclusive of therapeutic imaging, to grow by 5%.
And as we execute on our high growth adjacency strategy, we anticipate being able to beat our core market growth rates by an additional 4% to 5%. So we think we're in an excellent position to drive accelerating growth. So how do we define endoscopy at Boston Scientific? And this is important because a lot of people ask me this question and it's key that we define what market segments we're actually talking about. People ask me, do you compete with other big companies that have endo in the name, like Stryker Endoscopy or Ethicon Endosurgery.
And the answer is no, we don't. We don't compete with those companies at all in this space. The way we define endoscopy is a large set of very specialized flexible devices that go through the working channels of endoscopes to allow physicians to reach deep into the anatomy and do procedures in a targeted area. So these are devices like balloons, baskets, stents, guide wires, biopsy forceps and they are used in procedures like ERCP, which is a procedure to look up inside the bile duct and the pancreas, colonoscopy, upper GI scoping, endoscopic ultrasound. Those are the procedures where we compete.
And in those spaces, we develop toolbox approaches to procedures, allowing physicians to do them more rapidly, less invasively and with better outcomes for patients. And in those segments, we are pretty much the undisputed worldwide leader. And what we do is we take one procedure after the next and develop out those toolboxes, building foundations so that by now over 30 years into this endeavor, we have the broadest and deepest portfolio in the endoscopy market. So with that definition, these are the disease state market segments where we play. Pancreatic procedure that I just mentioned lives, GI cancers, GI bleeding, infection prevention and pulmonary disease.
These are huge patient populations with many unmet needs, plenty of opportunity left for innovation and for us to continue to differentiate ourselves in the marketplace. So let's take GI cancers, for example. GI cancers are responsible for over 50% of patient deaths from cancer each year globally. So this is a gigantic patient population. And we already lead in this space from a device standpoint with biopsy forceps and snares for resection.
In the future, we expect this market to continue to grow as more and more procedures that are done open today become endoscopic procedures in the future. If we can resect GI cancers endoscopically, this market will explode. And so we are investing heavily in a suite of devices to allow physicians to perform endoluminal surgery and Brian will go into greater detail about that. Or GI bleeding, GI bleeds actually have a 10% mortality rate in upper GI and lower GI bleed scenarios. These are emergent cases that are highly stressful for physicians because the stakes are high.
Already today, we lead with our Resolution 360 Hemostasis Forceps. But in the future, because of this urgent need, you can imagine there's a lot of opportunity for innovation to solve that mortality rate. We have a strong pipeline of devices to reduce that mortality rate and make these procedures more, shall we say, less stressful for the physicians. Interestingly, across this entire category of disease state franchises, our therapeutic imaging initiative will play in each and every one of these categories, elevating the growth rates of the device markets for years to come.
Here
you can see our strategy of expanding our markets unfolding. So for several years, Boston Scientific has been exercising or executing on a 2 part strategy. 1, category leadership and expanding our leadership in the places where we have long legacy leadership businesses and 2, expanding into high growth adjacencies. In endoscopy, we have been executing on that exact strategy. So by 2018, you can see already we expanded our headroom from our $3,300,000,000 accessible market in places where we lead like biliary procedures and GI therapeutics.
And we added pathology and infection prevention to create a $5,000,000,000 addressable market. Going forward, as we go into therapeutic imaging and endoluminal surgery and activating our surgeon call point, we expect to be playing in a $7,700,000,000 market by 2022. So the opportunities for growth are continuing to accelerate in the endoscopy space. Here you can see again the markets where we play and exactly where that growth is going to come from as well as the key Boston Scientific accelerators during the period. For example, pancreatic biliary disease, which we've talked a lot about already, will become a $2,000,000,000 market and Boston Scientific has the opportunity to take substantial share and lead with differentiated launches like our SpyGlass Discover, 1st of its kind single use cholidoscope, which will launch next year and Brian will talk about that one.
And that will accelerate pancreaticobiliary procedures for surgeons or also our breakthrough device that we launched in 2015, the Axios intraluminal stent system that Brian will also talk about has the opportunity to gain multiple new indications during the period and we're pursuing those. Or infection prevention. Infection prevention is one of the fastest growing segments in the endoscopy field. And already, we lead with our EndoChoice portfolio. But going forward, as disposable as single use air and water suction valves become the standard of care, we're positioned well to have explosive growth with our Orca Pod product, which we launched in Q4.
And coincidentally, I will share with you, we just finished the completion of a radical capacity expansion at our Ireland plant in Cork, Ireland. So we can now service up to 8,000,000 units per year. And by next year, we'll be able to service 16,000,000 units of OrcaPod into the market. And we see that the opportunity for single use air and water suction valves will just continue to grow as there are over 50,000,000 endoscopic procedures where these will be applicable performed in the United States each year. So now let's talk about some of the new accelerators that we're most excited about over the next few years.
First, I'd like to talk about our category leadership play in pancreaticobiliary disease. And again, the core procedure in pancreaticobiliary disease is the ERCP procedure, which is where physicians go inside the bile duct and the pancreatic duct searching for cancer or stones or strictures and seek to resolve those issues or take stent to alleviate some of the symptoms. Boston Scientific has a tremendous history of leadership and differentiation in this space. Over 30 years of innovation in ERCP is the backbone of the endoscopy division. So we are a 60% share player in a global market worth $1,400,000,000 We grow 10% where that market grows 5% even as the number one market share leader.
How do we do that? It's by consistently innovating. And what you see here is a long history of game changing devices that we have launched over the past few decades. And what I would want you to really consider about this list of products is the longevity of these products. So if you look at products like CRE Balloons or WallFlex Stents, these are products that have been market leaders for 1 decade, 2 decades or more.
And we continue to refresh them to make them current and to make them better. But that longevity allows us to build a true foundation of leadership in the space. And each time we launch another highly differentiated product in the space, it increases our customers' desire to partner with us. So last year was no different. We had multiple key launches with the Habib probe for ablation in the bile duct, which came from our Emsision acquisition, SpyGlass DS2, which I'll talk about in just a minute, and the Epic biliary stent, which is specifically designed for the hiler region.
All of these are differentiated products that excite our customers. This year, we've just launched the Jaguar Revolution Guidewire. The Jaguar Revolution is a high performance, low profile, highly steerable guide wire and it's really taking off beautifully in the marketplace right now. Let's take a look at its performance with this video. So the beauty of the Jaguar revolution is its low profile and its steerability.
So what we did was we took our market leading Jaguar and we made it smaller, but we kept the core strength so that its use as a monorail is just as good in a low profile. You see how well it navigates a tough structure there. And now you're going to see the beauty of the steerability. In this case, they're using a straight tip wire, but they need to go into a different duct. So they substitute an angled tip, which gives the physician the ability with his or her hand to rotate the wire steering the angled tip into the duct of choice wherever the suspicious tissue or stone may be.
And once you get into that space, you can then drive other devices like sphincter tones or balloons over the wire. But the wire is the key. The wire is the first device that is used in an ERCP and it is the thing that may determine success or failure of the entire procedure because whether or not you gain access can be everything in the ERCP procedure. So let's look at SpyGlass, another device that has been a huge growth driver for us in the pancreatic, obiliary space further establishing our leadership is SpyGlass. SpyGlass was the first well is the first and only single use single operator digital cholangioscope.
It's used in the ERCP procedure through a duodenoscope to look deep inside the bile duct or the pancreatic duct. And SpyGlass has truly revolutionized complex ERCP. Why is that? The reason is that SpyGlass gives the physician real time high quality video footage deep inside the bile ducts so they can see if suspicious tissue looks like it's cancer or a benign stricture, take a biopsy. They can see if a filling defect is a stone or a stricture and they can take the appropriate action.
That might sound simple, but before spyglass, physicians had to look at an image like the one on the far left, which is essentially an x-ray image, right, 2 dimensional, trying to determine if it's stone or structure. And now we have pictures like the ones that you see there. So the physician in real time can make a decision that leads to a better outcome for patients. It's a big deal. And what originally we thought was going to be a niche product is now over $100,000,000 franchise annually for Boston Scientific.
In the last 6 months, we launched SpyGlass DS2, which is our 3rd generation of the SpyGlass technology with even further enhanced imaging and a whole suite of accessories to increase the utility of this device. We launched baskets, snares and EHL probe to break up stones and also we're launching an improved biopsy forceps so you can get better tissue. All of those things together are making SpyGlass more and more useful. So our utilization has increased by twofold in the last 3 years. It's a really, really exciting time for SpyGlass.
So at this point, I'd like to invite Brian to come and talk about some of our new high growth adjacencies. Brian?
Thank you, Arden. Good morning to everyone. It's a pleasure to be here. I want to talk to you about Axios as a growth driver in the endoscopy area and then 3 high growth adjacencies and give you a little bit more insight into each of those. Axios is a stent technology that Boston Scientific acquired in 2014 from ex lumina.
And I really think it is a good example of combining the legacy strength of Boston Scientific as a world leading stent manufacturer with a smart acquisition and using that to change the endoscopy space. Axios is a unique stent. It is the 1st stent designed to have one end inside the lumen of the GI tract and the other end outside the lumen of the GI tract. And what that allows us to do is essentially to connect the intestinal tract to some other structure. Now work using this stent has begun in peripancreatic fluid collections.
A patient has a bad episode of pancreatitis, the digestive enzymes in that pancreas collect around it. Those collections are typically right behind the wall of the stomach. And we can use Axios to gain access to that fluid collection through the stomach and drain that fluid back inside the GI tract where it belongs. This used to be a very complicated problem managed with surgery. Now we have an endoscopic alternative to do that.
We can even use the stent as a portal to drive an endoscope into the area where that fluid collection is and to debride away dead tissue. Outside the U. S, Axios is also being used to connect the intestinal tract to the biliary system and allow us to either do drainage or gain access to that system as well. But that's just the beginning. If you look at Axios and think about it as this connecting technology, it is essentially a way to endoscopically create an anastomosis to connect 2 structures together.
And if we think of it as that kind of platform, now we can get into some exciting areas. And one of them is in metabolic disease. If you look at the far right of that screen and you see the stomach with the A and the B, we can use Axios to connect the stomach directly to the intestine downstream. Why is that important? Well, we know in surgery that if we connect the stomach to the intestine downstream, we can dramatically affect metabolic diseases like Type 2 diabetes, essentially cure that disease.
This now provides a platform to endoscopically create that connection. We can use it also for bypassing blockages in the GI tract as well. So we're just getting started on advancing a technology like Axios into the endoscopic space really to accomplish endoluminal surgery. Now a few high growth adjacencies that I'd like to talk about. The first is the surgical endoscopist.
Art mentioned a little bit about my background in the beginning. I am a surgical endoscopist, a surgeon who gained additional training to do endoscopy in order to leverage those things to take care of diseases in the GI tract. I think when most people think about endoscopy, they think about a gastroenterologist. That's a medically trained person who has gained additional fellowship training in order to learn how to use an endoscope in the GI space. And what they might not realize is that surgeons have a long
legacy in the endoscopy space.
In fact, almost every therapeutic surgeon. And that legacy continues. We have over 13,000 surgeons doing the endoscopy on a daily basis in this country alone. And that's translating into nearly 2,000,000 procedures per year. The interesting thing is that the medical device world in endoscopy has not served this segment of clinicians specifically in the past.
In fact, even Boston Scientific, if I were here last year having a discussion like this with you, I would have been able to tell you that Boston Scientific has 5 people working in the area of surgical endoscopy. Today, we have nearly 70. And so this is an area of high growth adjacency. Not only is it already a busy clinical area with these physicians, but it's growing. So if you look at the natural progression of surgery, it really is to evolve into a less invasive, more accurate procedure.
And in the GI space, this is definitely the case. We've moved from open surgery to laparoscopic surgery and now to endoluminal surgery. And the surgical world is recognizing that advance and embracing it. In fact, the American Board of Surgery has changed the requirements for training general surgery to general surgery residents. They now must go through a 5 year specific curriculum in flexible endoscopy.
What does that mean? That means in July of 2018, when that mandate matured and took effect, we had 1200 newly minted general surgeons entering the workforce, every one of which is capable of picking up an endoscope and using it. And that is going to segment that is So this is a growing segment and it is a segment that is perfectly suited to embrace the world of endoluminal surgery. The first device that Boston Scientific is going to deliver to this group of surgical endoscopists that's specifically made for them is SpyGlass Discover. And SpyGlass Discover is an endoscope, a mini endoscope that we can put inside the bile duct at the time of surgery.
It's basically a takeoff of the SpyGlass DS platform. Over 800,000 gallbladder operations are done per year in this country alone. Many of those cases have bile duct diseases that need to be managed. SpyGlass Discover is going to help us manage that. Now another high growth adjacency is endoluminal surgery.
We've kind of been talking about that already with Axios and with Discover. And Art mentioned the disease burden of GI cancer in the world. 3,400,000 new cases of GI cancer per year, that's 20% of all new cancers in the world. We have an opportunity to change the paradigm and how we manage GI cancer. It's already moved from open to laparoscopic.
We want to move it from laparoscopic to endoluminal. And there's some low hanging fruit in this area.
If you look
at benign diseases alone in the GI tract, last year in this country, 23,000 patients, excuse me, 23,000 patients went to surgery and had a segment of their colon removed for a benign disease. Every one of those is a potential candidate to have an endoluminal procedure. So Boston Scientific is making a toolbox of surgical type devices to do these procedures endoluminal. We have traction devices that can help us lift and separate, lifting agents that do tissue dissection like ARISE gel and cutting and suturing technology. So let me show you a little video vignette of how this might work or actually how it does work.
The whole thing. This is a Ryze gel, a tissue dissecting gel that lifts that inner lining of the GI tract away from the underlying muscle, so we can remove this lesion safely. A traction device to stabilize the area and lift the tissue and then a cutting device to cut that away from the underlying muscle and resect the lesion. Cutting, tissue dissection, retraction, removal and then closure of the resultant defect with these clips, those are surgical principles and that is endoluminal surgery. Now last I want to talk about another high growth adjacency and that's infection prevention.
As a clinician, 3 years ago, I never heard the term infection prevention applied to the GI suite. And then unfortunately in 2016, we had some high profile outbreaks of infections in GI suites both in the U. S. And outside. And when an investigation was undertaken to look at why those were happening, it became evident that we were vulnerable to tracking antibiotic resistant bacteria from one case to another, basically contaminated one case to another.
That was the birth of the infection prevention movement. In 2016, Boston Scientific acquired a company called EndoChoice, which was making a suite of products that could be brought to each endoscopic procedure to minimize the chance of infection transmission. And it's basically everything you need to do an endoscopic procedure, buttons for the endoscope, even gowns, gloves, gauze, lubrication that I need to do the procedure and the devices used to clean the scope. There's even a bag that packages everything up at the end of the procedure and allows you to transport those things cleanly to the processing room. There are over 50,000,000 endoscopic procedures performed each year in the U.
S. Alone. Every one of them needs an infection prevention strategy. And this suite of projects is products is helping to drive that. You heard Art talk about the increased capability of manufacturing these products.
And so we feel that we're just getting started in entering this workspace and meeting the needs of clinicians. In fact, that's reflected that in less than 2 years, we've already doubled the sales in this market alone.
So I'm going
to turn it back over to Art now to talk about Exalt D, which I think is an example of the ultimate extension of the infection prevention strategy.
Thanks very much, Brian. So I'm excited to wrap up our section by talking about single use endoscopy. And I'm going to start with the most highly anticipated project in Boston Scientific Endoscopy's history and that is the Exalt Model D. We see single use duodenoscopy as a $1,000,000,000 market opportunity and we expect to be pending FDA clearance. We expect to be first to market by the end of this year and we expect to be alone in this market for potentially a year and potentially longer.
So how did this start? Well, years ago, we saw a need for infection prevention in the ERCP procedure and we set out to create solutions. And as we've been working on the Exalt Model D, the need for infection prevention in ERCP procedures has become greater and greater as the awareness from study after study has shown that duodenoscopes even after high grade disinfection in some cases still carry multidrug resistant bacteria. And this is a big deal because these of scopes after disinfection were still carrying multidrug resistant bacteria. So a solution must be found for this problem so that we can protect the safety and integrity of these life saving ERCP procedures.
So as you can imagine, as we've been working on this, caregivers and regulators are taking a greater and greater interest in finding a solution to this important problem. And the Exalt Model D for us brings together 3 important strategies inside Boston Scientific. First, our continued focus on pancreaticobiliary leadership. Second, our commitment to infection prevention in all endoscopic procedures and third, on top of building on the shoulders of lithoview and SpyGlass, our commitment to developing therapeutic imaging solutions in endoscopic procedures. So we feel like it is right in our wheelhouse.
And as I mentioned, we have an established sales force globally that we can leverage to roll out this device. Boston Scientific Endoscopy has over a 1,000 sales reps focused on GI around the world already. And this is not a sales force that we need to build. They're tenured, they're trained, they have relationships with these physicians and they're expert in these procedures. So we believe that a fully single use duodenoscope is the only full proof solution for this problem.
It's the only way that you can know 100% that your device is sterile. And this solution is resonating as more and more physicians and hospitals are hearing about the solution. So we're really excited about it. Now where are we in the development? The design is complete.
After years of careful study, trying to meticulously reproduce the physician experience of a reusable duodenoscope because the difficulty of getting up inside the bile duct with a duodenoscope is such that any compromise in the performance of that device could lead to reduced patient outcomes and that is completely unacceptable. So we did more than 10 animal labs with this procedure, dozens and dozens of bench top studies and we've just completed a clinical trial with 60 patients and we're moving to publish that very soon. Our 510 application has been submitted in late April and we're ramping up our manufacturing capability and expect to be in the market before the end of the year. And we see this as a game changer in the space. We're very excited about it.
But beyond EXALT, we're developing a robust capacity and capability in single use endoscopy in general. So we see opportunities in bronchoscopy, in upper GI endoscopy. Certainly, we talked about SpyGlass Discover already. And in the coming years, we will roll out an entire family of single use endoscopes. And the market created by single use endoscopy over the next 5 years, we expect to be as big as $2,000,000,000 This is a greenfield opportunity and Boston Scientific is in the best position to lead.
So I want to close by asking you to really think about the implication of single use endoscopy. We see it as a truly disruptive and revolutionary force in the way endoscopic procedures will be done. And infection prevention is just one piece of the pie. As we move forward, and we've seen this with lithoVu and with SpyGlass, infection prevention is just one reason that people will adopt single use endoscopes. The convenience in the hospital, the ability to not have to have an entire reprocessing capability within your medical center or community hospital will be very empowering and liberating.
Think about the ability to customize single use endoscopes in ways that you can't do for reusable devices. Left handed, right handed, small handle, big handle, we have the ability with single use endoscopy to really create convenience and effectiveness of devices that is not possible today. And beyond that, think about the access to care. We have the ability to have portable endoscopy. You don't have to have a whole scope tower to move the gastroscope up to any room in the hospital, a patient's room or even a physician's office.
Think about the ability in rural settings or in developing countries where access to care is not available. The ability to quickly transport a single use endoscope into some of those places will radically increase access to endoscopy and improve patient care. We see single use endoscopy as something that will be lifesaving and market expanding and Boston Scientific intends to lead the way. So in closing, I hope you see endoscopy as a consistent growth engine for Boston Scientific with very bright prospects and a clear path to $3,000,000,000 in revenue by 2024. Thank you very much for your attention.
And now I think we'll take questions.
We'll take questions. Yes. Thank you very much. Before we start, we are aware of and recognize and apologize that there is an issue with the webcast and the quality coming in and out. We have a full team working on it.
We'll be posting our slides fully at 1 p. M. At the conclusion of today. So thanks. With that, really excited to take your questions.
We'll start right in the
middle of David.
David Lewis, Morgan Stanley. So two questions. I'll start with kind of it's ALT and then maybe one question over Zoom. But for Aart and Brian, the market size for ALTI that everyone is very, very large. And the key question that we've been struggling with in diligence is what is the rate of the curve?
How quickly is this adoption going to happen? The FDA has created kind of an acute issue, but that curve is hard. Is this the kind of dynamic where your 5% to 10% penetration in that $1,000,000,000 is that the type of thing we should expect in 1 to 2 years or is it going to take 3 to 5 years? And I wonder, Brian, your thoughts on at Houston Methodist, how much of a pain point is this going to be critical need and how much of a pain point is it to drive the transition?
And then
a quick one for Megan.
Sure. Thanks for the question, David. So, of course, we have to acknowledge that this device has never existed before. So the curve is impossible to accurately predict. But of course, we also have a notion of how we think it will play out.
So I would I believe that a 50% adoption in the space within 5 years is reasonable, especially in a U. S. Market. And beyond that, it's hard to predict because there will be other solutions. This is a high profile problem.
And there will be other competitors, there will be other solutions put forward. It will also be regulated by capacity to service And so to service 50% of the U. S. Market takes quite a manufacturing capacity. We're ramping to that, but it will take us time to get there.
Does that
Yes. I think it numbers it, Steve. I think that's very clear.
Yes. Well, I think I mean, there are a couple of things from the clinical side to think about. One is in this kind of transition period, how do we make decisions about who to apply the technology to? And each clinician is going to have to make that decision individually, but there are a couple of categories, right? One is looking at patients that are what I would call vulnerable patients, patients that cannot tolerate being exposed transplant or from cancer therapy.
There may be some subgroups in there that we want to have special consideration around pediatric group or obstetrics type thing. So that's one group that we got to make a decision about. I think that's where you're going to see it applied immediately. The other group is somebody is coming into my ENDO unit and I know they have an infection. And I don't want to expose my reusable platform to that infection and then risk having that transmit something to another patient.
So that if we're going to sub segment, that's where I think we see the start. I will add to that that I hear lot of discussion around price and cost and that kind of stuff. One of the things that I see from a clinical side in the community is the beginning actually more than beginning, an understanding now, particularly as we get more and more requirements for reprocessing of the burden of trying to reprocess reusable scopes and the cost of that burden, not just in the endo unit, but storage, all that kind of thing. So I think people are starting to realize that, and they're starting to realize that they're investing in a flawed solution. That despite applying the best reprocessing technology that we have to offer, we still have a 5.4% rate of antibiotic resistant organisms on that scope.
So I think if I were left to my own devices in clinical practice, I'd want to be at 100% adoption and I would have to be thoughtful about how I manage this transition time.
The issue on adoption near term has been reimbursement. So what are the plans to expand Rezum reimbursement and sort of site of service and total aggregate reimbursement? And what enhances our plan for the system in 2020? Thanks so much.
Yes. So, we continue to do a lot of work and have made a lot of headway this year with reimbursement. All 7 of the regional Medicare plans are now covering and paying for Rezum. We're in about 4 now 4 of the top 10 payers, private payers are covering Rezum. We still have some work to do to improve our reimbursement in the ASC landscape and we have our Health Economics and Market Access team really pointed towards resolving that gap and disparity.
Sorry, that was the first piece of your question and the second?
Enhancements.
Oh, the enhancements. So, I'm not going to get into specifics on the enhancements other than just to share that we're investing considerably and continuing to improve the system itself. And you'll see system enhancements that occur over the course of the coming years. Jason?
Thanks, Susie. Jason Mills, Canaccord Genuity. I have a question on growth that I'd like Dave and Art both to comment on respectively for the 2 divisions. The growth curves that you gave or the growth estimates you gave for your respective businesses differ a little bit both in terms of the pace of the comp and annual growth over the forecasted period and the forecasted period itself. Art, you gave a little longer period, Dave, a little shorter period.
Could you talk about the slopes of those curves juxtaposed to your product launches over the time periods from 2022, Dave, and 2020 4 for Art? And then also maybe talk about the combination of organic growth and M and A that's factored into those expectations?
3 years and obviously want to put plans in place that will extend that far beyond that as well. So we feel like we have a nice combination of internal innovation, legacy products, good markets as well as executing on things like Rezum and Augmenix. And that combination will give us the opportunity to give nice double digit growth throughout the next 3 and hopefully many more years
after
that, really also delivering strong operating income to Boston Scientific as well. So that's what our target is and that's what our intent is.
Yes. It's a similar story in endoscopy. We just chose the 2024 because that's when we get to the $3,000,000,000 nice round number. But we expect to have consistent growth through the period. Near term, we're fueled by the 15 new product launches that I mentioned over the last 18 months, which is giving us a lot of growth energy right now.
And then as Exalt and SpyGlass Discover and the rest of the scope portfolio kicks in. Even as we get to be a bigger business, we think we can continue to deliver that 9% to 10% goal consistent through the period.
Consistent, yes. Bob, you have a question?
Yes. Thank you. Bob Hopkins from Bank of America. Two quick questions back on Xalt D. First of all, on the economic side, do the economics to either the doctor or the hospital change much with the disposable product?
And then the second part of the question is probably more important, just big picture. Going up against these established competitors in the reusable market has been brutal historically. There's been a lot of resistance to change in this particular marketplace. And I feel like I've watched several technologies try and fail in this area. What is it specifically about right now that gives you the confidence that we're at sort of a tipping point to give those pretty aggressive projections about potential for 50% penetration within 5 years?
Thank you.
Yes, sure. So in terms of economics, I think there's adequate reimbursement within the procedures to absorb the cost. And then there are also substantial reductions in cost that counterbalance a lot of any incremental cost. The cost to reprocess endoscopes is not insignificant. And then you're also removing the risk profile associated with reprocessing the scopes.
So from an economic standpoint, the feedback that we have gotten is that no one expected the price point to be lower than a spyglass, which is in that same $2,500 to $3,000 range. Of course, everyone wishes it could be $500 but the technology that is built into this scope to deliver the kind of performance that's expected with a reusable device just doesn't allow that. So there's, I think, considerable interest at that price point. And then what was the what how do we think in this disruptive or we can disrupt? This is a very disruptive technology.
This is not aiming to necessarily completely replace your scope tower. So the entry point, the switching costs are nominal. You don't have to switch completely away from any of the reusable manufacturers. This can be plugged in side by side and integrated with the existing unit. So I think its ability to gain access into the vast majority of hospitals that do ERCPs is not it won't be hindered.
And the acquisition cost of the capital is truly nominal. So there's not a lot of resistance there. And I hope that answers your question. Maybe Brian, you could comment.
Yes. I might add a few factors to that. So I think your comment was that what's going to make this kind of stick in the marketplace versus some other things that have been tried in the flexible endoscopy market that might not have. And to me, there are 3 factors. So first of all, we have a problem that's bigger than we expected with this contamination rate at 5.4%.
That was thought to be they thought that was going to come out at 0.4%. So we have a problem that's much bigger than expected. We don't have a solution to it. It was in the beginning when we heard discussion about this, it's like, well, it's the tip of the endoscope that's a problem. So we'll make a reusable tip or a sleeve or something like this.
This is not a tip problem. It's a scope problem, which means the tip is vulnerable, the entire working channel is
vulnerable and the buttons are vulnerable as well.
And so any solution that doesn't right the right solution. And then I think ERCP is also the right procedure. When you it's the one that's at highest risk for this problem, but also the demands of the endoscope are different. So getting that endoscope in position and getting visualization to that papilla is key in making that feel like the reusable scope. But from then on, it's a platform that we're working with.
I'm not navigating churns using alternative visualization, light forms and that kind of stuff like you might see in colonoscopy. So I think as a place to start for our reusable platform, it's just got the right marriage. It's a problem, and the demands are right in the marriage. And for that problem and the demands are right in the marriage. And when you layer on top of it, it's a box this big goes on your tower and some more supplies in the supply room as far as what's required to do that, then I think all those things line up.
Could you also mention too the regulatory backdrop?
The regulatory backdrop To
help fuel this change
as well?
Yes. I think that there's because of the urgency of the situation, as Brian mentioned, there's so much interest in every stakeholding body, right? So the FDA is very interested in solutions for this problem. They want to protect the safety of ERCP. Every hospital wants to avoid having an outbreak at their hospital.
Physicians worry about the of doing harm while trying to do good because they can't see whether a device is sterile or not. They have to have faith that the reprocessing department nailed it and the scope is bug free. So every single stakeholder, not to mention the patient, of course, is most interested in having a device that has not been used on hundreds of other patients. So, there's a lot of of this technology as well. There's really no one who's saying except maybe some of the reusable scope manufacturers that this is a bad idea.
Right. And ARIKXALD study is probably our fastest enrollment ever. Is that fair to
say that?
That's true. I'll just a quick anecdote. The physicians who ran the study, when you do a clinical study, you have to get patient consent to participate in the study. And the physicians that did our study told us that they had the highest percentage of yes, I will participate among the patients that they asked. Over 90% of patients asked, will you participate in this clinical study to have a single use scope instead of a reusable scope used on you today?
Over 90% said, I'm in, right? So it's a powerful force.
Chris?
Chris Pasquale, Guggenheim. Just one follow-up on Exalt D and then one on Space OAR. So the high risk populations that you laid out that you would view as low hanging fruit or the obvious candidates for first adoption, sense of how what percentage of the population that represents?
Yes. It's a good I don't know if
I have that percentage off the top of my head.
We've been discussing around 15, but it's hard to nobody has that number exactly. And every institution may have a slightly different algorithm of what they say is the group that they want to allocate these scopes to.
I will say that if you combine that group with the group of coming in with infection, I mean, coming in with infection, that's a patient with cholangitis, that's a case that's a common indication for doing ERCP that it's going to be over that 15% range.
And then for SpaceOAR, curious what you think the gating factors are in prostate adoption from the progress you've made thus far to get it up to more of a standard of care level and opportunities outside of prostate that you think are compelling for being able to shift vulnerable organs away from the target?
Yes. So, real quick on the last piece. I think we highlighted that. So, pancreas, gynecological, so cervical cancers, head and neck are some of the ones that are bubbling up, having a lot of interest. In terms what did you say?
Oh, in breast. Thank you. In terms of the gating factor to drive faster adoption, so the reimbursement on that went live last year. And so, we're actually starting to see a much faster rate of adoption in the urologist community. So, prior to that reimbursement, the vast majority of the appliers were radiation oncologists who were skilled in brachytherapy, right?
So, they these are radiation oncologists who are comfortable with touching patients and delivering brachytherapy seeds or fiducial markers on their own. Once the reimbursement gating component was alleviated, we're starting to see a much more rapid adoption of this in the urology community, about 40% of our players now being urologists. And that's been changing at a pretty rapid pace. That candidly is probably the most significant driver is just our ability to train and reach these urologists as we scale up our commercial infrastructure to make that happen. We are confident that the continued benefits of this device are going to ultimately render it as a method of choice for men undergoing radiation therapy.
Yes. And just to add on, we'll continue to do the clinical work, attempt to get it in the guidelines for as a standard of care. And there's a lot of opportunity to potentially work to look at more aggressive radiation protocols because of the protection you have with the space source. So there's additional clinical work that we'll do because we feel like it's there's a fantastic opportunity.
Yes.
An important dynamic to layer on top of that is, so we're seeing is these hyperfractionation protocols, right, delivering higher doses and fewer visits, which is good health economics and good for the patient. The challenge is that extra dose can put the rectum at significant risk. And so we believe that SpaceAware can have a really compelling value proposition,
1st in Rhythm and Neuro Q and A, sorry. Vijay?
Vijay Kumar from Evercore ISI. Just one on Exarti and one on endoluminal. Exalti, I think you mentioned a price point of $2,500 that's the list price. 1 of your competitors from Europe has spoken about a sub-one thousand dollars price point. Do you think the market can support 2 different devices at different price points?
Are there any technological differences in the device itself which would make a case for a premium price point? And aluminum, is this are you running up against robotic surgery in that space? Or is this a completely different market you're targeting? Thank you.
You want to go with endoluminal first? Yes, sure. I can so I don't know if running up against robotics is kind of the way I would put it. In my mind, advancing into endoluminal surgery requires enabling technology. And I think that that enabling technology can come from a lot of places.
The basic concept is I need to work in a confined space remote from where I am standing and addressing the patient. Today, there is no robotic solution to do that. In the future, maybe, and there's a constant scanning that landscape to take a look at that. What we're seeing more is more sophisticated ways to do remote manipulation and more sophisticated end effectors. And that's certainly where I think Boston Scientific leads the way.
So I don't know if that helps kind of give you my take on it, but I think it's all about the enabling technology. It's not about a robot that's pulling cables and doing these kinds of things. It allows me to do the things I need to do that look like surgery in a confined space distance from where I'm standing.
And then regarding price, I don't want to comment too much about competitors' strategies, but I can tell you our that is largely based on the requirements are very on this, the requirements are very exacting for the performance of this device. It has to have a certain feel in the way the physician can access the papilla. You have to navigate through the esophagus, through the stomach, into the duodenum and then do all of that with only a camera on the side of your scope. And then there's a device at the end of the scope called an elevator, which has to give you precise deflection of your guide wire to go up into the papilla, which is going to be on the side wall to access the bile duct. It's a difficult technological achievement to build a scope that is single use that performs as close as possible to a reusable duodenoscope.
So in our experience, the technology and the testing required to do that leads to a price point where we've put it. And I think the market values performance over price. Period.
Just for emphasis. There you go. All right, MedSurg team, thank you, Brian, Dave and Megan. And with that, we'll transition
to become
a neuro. I'd like to ask Joe Fitzgerald and Doctor. Kent Stein to join me on stage. Thanks, sir.
So good morning. I think Doctor. Stein just got a new objective now that endoscopy has set the market 90% success rate with patient consents. All of our clinical timelines are probably not going to be accurate in this slide. So just kidding.
So let's jump into Ribbon Management. Obviously, this is our core CRM and Electrophysiology business. And let's start with CRM. So we have built over the last couple of several years a consistent track record of beating market in our core CRM space that has varied, but it has really been consistently beating in the high voltage space. We had a phenomenal pacemaker MRI launch several years ago, hit our highest global mark in pacers.
We've given a little bit of that back, but literally have went from a distant 3rd place in global high voltage. That's all things ICDs and CRTDs. And we've now created the clear number 2 position for BSC globally in high voltage. And most importantly, a shout out to our U. S.
Commercial capability. We have now achieved the clear number 2 overall position in CRM in the United States of America, which represents at least 50% of the global market. How do we do that? Obviously, SICD and our success with that over the past 7 years has played a huge role. Our battery longevity has played a huge role.
HeartLogic, which was introduced about 7 quarters ago with our introduction of our Resonate platform in Q4 of 2017 has played a huge role. And as we've talked about in multiple meetings, our replacement headwinds, given our extreme battery longevity, have now turned in to tailwinds on both CRTD and ICD. So again, winning in CRM, moving from a number 3 to a number 2 has really funded the journey for everything we've done in other key growth markets that I'll talk about next. So if you look about where we go next, we're going to enter 2 new growth markets in the rhythm management space. First of all, and I'll detail these on later slides.
So we will enter the single shot therapy market in EP. Today, that's about a $700,000,000 market. Most of that is controlled by a single competitor. And if you take Europe as an example, we'll enter with 2 different technologies attacking the single shot market close to the end of 2019 with full launches in 2020. Secondly, you'll hear us talk about in the implantable cardiac monitor space, that's another $700,000,000 market dominated by 1 or 2 players.
We will enter that market in 2020. So you look at those 2 as combined to be about $1,400,000,000 in new market opportunities, where today we have $0 of sales. And we will enter those between late '19 and we'll give you these details when we show you the slides for 2020. The second the third area that I want to talk about is an area that we talk about a lot. It's the EP space that is defined by advanced mapping, navigation and advanced ablation.
That is nearly a $3,000,000,000 segment within the EP space. So you think about EP, EP the market $5,000,000,000 I'll show you some detailed slides, but about $3,000,000,000 of that $5,000,000,000 is high growth, advanced napping, advanced navigation, advanced ablation. We entered that space. Our first full year of launch was 2016 when we introduced RHYTHMIA. That was our 1st full year of launch.
And we'll show you some data that shows how we have outpaced significantly market growth in that segment. We're still the startup in this space. We still have relatively low share, but we have an enormous opportunity to continue to take share and grow at multiples of the market growth rate in that $3,000,000,000 market segment. So overall, both CRM and EP, we show or we project and anticipate that we'll grow faster than market and we'll sort of scale that as we get in. And then as we've talked about for multiple investor presentations, we continue to really focus on growing the profitability in the RM and now what is called the RM and neuro divisions.
And we'll give you more detail on that in terms of how we accomplish that as well. So overall, we participate in a $15,000,000,000 market, 9 plus of that is in CRM and about 5 of the rest of that $15,000,000,000 market is EP. When we look at the go forward CAGR, I would see I would think about CRM as a relatively flat at best marketplace. And I would look at EP as being in the low teens growth and the advanced mapping, navigation, etcetera segment of that being above that level, okay? And then the $700,000,000 market that is ICM, which has grown double digits for several years, will probably through the next 3 years get into that mid to high single digit sustained growth from a market perspective.
And again, looking at 2018, how do we drive our success? I've already said several of these, but we continue to grow RHYTHMIA growth well above market. And in certain geographies, I'll give you some examples, we've grown at multiples of the market growth rate. And again, 2018, when you look at that year, that was our 6th year of SICD launch. We continue to grow that well ahead of ICD market growth across the world.
HeartLogic and our battery longevity continues to drive de novo share growth in high voltage. And again, we're now just about finishing what's about our 7th or 8th quarter of that launch. And then again, I'm glad I don't ever have to say again or talk to you about the headwinds of having great battery longevity. So both CRTDs and ICDs have now normalized to tailwinds for Boston Scientific. If you look at our market segments, first, let's start on the left.
EP again is a $5,000,000,000 category. I'll show you some details in terms of how the market is sort of paraded out in terms of size of those markets. But if you think about EP, you have about $1,500,000,000 that is core legacy EP stuff that is probably growing low single digits. You have the advanced mapping and navigation segment, which is almost $3,000,000,000 that's growing well into the teens. And then you have single shot, which is now about $700,000,000 and that has been growing well north of that fast growing advanced mapping and navigation, probably in the high teens, low 20s over the past 3 to 4 years.
So that is a tremendous market opportunity for us and we put multiple building blocks in to get after winning and taking share in that space. And then in the middle, you have core CRM, that's a $9 plus 1,000,000,000 market. Obviously, the high voltage segment is larger than the low voltage segment. And we predict probably flat growth in that market. And again, I'm sure we'll get into this in Q and A, but you look at low single unit volume growth and then ASP growth that is in that same trajectory, but to the negative.
So we're calling that flat to low single digit negative as a market, and we clearly have been and plan on continuing to beat those market numbers. Then I've already talked about the implantable cardiac monitor market $700,000,000 today. We project that will continue to grow mid single digits and sustain that growth rate for several years into the future. I've shown this slide, I think every Investor Day, 3 or 4 past ones, but our strategy has been really simple. If an EP is doing it and it's important to him or her, right, we want to be the innovators in that space.
So a combination, Mike said this earlier, a combination of increasing the efficiency and the productivity of our internal R and D and then selectively making acquisitions. And we can talk about WATCHMAN, Cameron Health, Rythmia, Bard, 2 recent single shot technologies. These are all aimed at surrounding DEP with highly innovative solutions from Boston Scientific. We believe that both take share in those segments and it also increases our brand perception in terms of who EPs globally want to work with. Most importantly, BSC and Gaiden has had a rich history and this is really kudos to Ken of driving really market leading, market creating clinical science.
And whether you look at what we've done with the SICD, the multiple studies we've we're up to 2 randomized studies completed, 2 large continued access registries with WATCHMAN, the first ever randomized ablation plus WATCHMAN option study. Those are just good examples how when we invest in R and D or we invest in a startup, we complement that with phenomenal clinical science. So that's kind of our strategy on the page, surround the EP, high focus on innovation and drive clinical science, which drives reimbursement, share shifting and therapy adoption. I'm going to turn it to Ken now. We're going to go through sort of what are the growth drivers that will allow us in the CRM, the modular CRM and the diagnostic space and then we'll switch to EP.
Ken?
Okay. Thanks a lot, Joe. And so again, I'm going to begin, take walk you through the differentiated portfolio and pipeline within our core CRM first. And I think we've got to begin by talking about HeartLogic. HeartLogic is still unique.
It is the first and still the only FDA approved alerting algorithm that gives physicians and patients early warning prior to a heart failure hospitalization. It actually is able to predict 70% of heart failure events and gives patients and physicians weeks to months of warning before an event. And I'll say a little bit more about heart logic in a moment, but I don't want you to think that we're starting and stopping with HeartLogic. In addition, in the future, we're bringing out a set family of sheets to enable physicians to do site selective pacing, whether that's his bundle pacing or left bundle branch pacing for patients who need bradycardia pacing an evolution of our Ingevity Brady lead to enhance the implant experience for physicians, next generation of our algorithms for optimization of cardiac resynchronization therapy, the one that's actually of most personal interest to me right now is where we're going in terms of patient apps. So actually my dad just got one of our devices a week ago.
And I can now go online and see that his battery status is normal, see when his next scheduled clinic transmission is, see that his attitude connection is working appropriately. So that's available today. You can download it from the App Store on iTunes if you want. But what we intend to do is to fast iterate this, continue bringing out new types of data that we can provide to patients and, in my case, to caregivers to increase their level of engagement, their knowledge, reduce the burden for our technical services team, reduce the burden for device clinics. And eventually, the goal is not just to bring information about device specific function, but also to provide diagnostic information directly to patients so they can start to see things like heart logic and become much more able, empowered, invested in their own care.
Let me say a few words about the heart logic. I think you all know that heart failure today is the single largest DRG counting for medical expenditures in Medicare patients in the United States. And there's a huge need not just to improve patient outcomes, but to improve the efficiency of care delivery in a value based care world. We do have a risk share program for clinics that are using HeartLogic that's been greeted really enthusiastically. We're now seeing our first clinical trials of HeartLogic.
And speaking about clinical trials, I can't claim that we're going to get 90% of patients to agree to enroll in our trials. But we have finished enrollment in the first phase of MANAGE HF, which is our trial aimed at actually substantiating the magnitude of the benefit that you see with cart logic. And we will begin enrollment next year in the 2nd phase of MANAGE HF, which is a large scale, global, randomized clinical trial to quantitate the exact amount of benefit that patients see and the economic benefit to health care systems from the use of HeartLogic.
Ken, if I could add a small anecdote. A couple of days ago here in Manhattan at a very large hospital, I asked one of the implanting EPs like how are you implementing HeartLogic? And it was very interesting because our sales force not only calls on EPs, but they also call on the heart failure referring and management sort of physicians. And he said, well, it's very interesting. He goes, your team has done a great job educating the heart failure docs.
So what I'm getting now are prescriptions. This patient needs a CRTD, go ahead and
put any device you want. I just need that HeartLogic algorithm and that HeartLogic alert. So that kind of shows you the power of the branding of this intuitive preemptive alert for hospitalization. Yes. Absolutely.
Again, this is something that's unique in the industry. And if you're a patient with heart failure, why in the world wouldn't you want to have access to this kind of physiologic data? I want to turn now to where we are with our modular CRM franchise. Again, the subcutaneous ICD is the first and only and for years will continue to be the only defibrillator that can be implanted without needing to touch the heart, without needing to invade the thorax. We continue to iterate off that platform.
Already, our Emblem SICD now has projected longevity that is roughly equivalent to what competitive transvenous ICDs can offer. We'll be bringing out enhancements to our SmartPass technology, reduce the risk of inappropriate therapies with the device, enhancements to the SICD electrode to make the implant an easier, quicker process for implanters. One thing I do think is exciting that people may not recognize. With what we've learned about defibrillation thresholds with the SICD, with more optimal modern implant techniques, we do see a possibility to develop a downsized SICD that would be no larger than our competitors' transvenous ICDs are today. But I think frankly, all that's exciting, but what's most exciting is where we're going on the right hand side of this screen.
And that's the development of our legalist pacemaker, I'm going to call it Empower. And the thing that is really revolutionary about Empower is that while it can function just like our competitors' legalist pacemaker as a simple run of the mill single chamber pacemaker, the revolutionary aspect is that our device is also designed to be able to communicate with today's emblem SICDs and coordinate as a system so that patients with an SICD can get brady pacing, but can also get antitachycardia pacing if they develop that need after their SICD implant. We're in discussion with FDA today about our IDE trials and are intending to start our IDE clinical trials in the United States and globally in 2020. Joe, I'm going to turn it back to you now to talk about our implantable cardiac monitor.
Thanks, Ken. Just as one anecdote, and Ken mentioned it, but when we first purchased Cameron Health, that was in 2012, we obviously had purchased and inherited the 1st generation. So we really kind of moved heaven and earth to get this Emblem product sort of designed and out. And our goal back then was, let's do that in under 3 years, so that we beat anybody else that could possibly get to the European market. So our goal there was, hey, they might get there by 20 15.
And back to what Ken said, in terms of a purely subcutaneous that's as minimally invasive as SICD, we don't see a single product from a single competitor in development or in clinical studies anywhere. So as Ken focused on, the first and only for quite a number of years into the future is a really important point. So let's talk about our ICM. So our ICM brand name is LuxDx. If you look at the left side of the slide, we have an extremely competitive implant and set of implant tools.
So think of it as a sub-two-1.3cc device, good longevity, super minimally invasive implant. So put a check mark there. We will offer both through a patient smartphone or through a smartphone lockdown smartphone provided by BSC connectivity to the cloud and therefore connectivity to Latitude. Most importantly is that we have we think we've been extremely innovative in how we help clinics and physicians manage data via the Latitude Clarity application. And if you go out and you survey 50 or 100 or 1000 doctors or clinics, their biggest complaint is I'm getting a mountain of data off of these devices and I can't manage it.
So we have spent an inordinate amount of time getting to what we think is a market leading data management, cloud based management solution. We previewed this at several meetings over the past few quarters, and we're getting rave reviews on what we've done on the data management side. So that will be sort of LuxDx Gen 1 should launch mid year HRS timeframe 2020. So importantly, we're not just stopping there. So we're going to take this micro implantable and this cloud based sort of data management platform.
And what we're working on now is to turn that micro implantable into a chronic monitor of heart failure conditions. And most specifically for the HFpEF, the heart failure patients with preserved ejection fraction, I mean, think about that. That's a 3,000,000 sort of target addressable market patient population. Think about the ASPs and you start to get into a multibillion dollar opportunity where there is essentially nothing that physicians can do to monitor ambulatory in an ambulatory fashion what's happening. So is that available today?
No. Is it in Gen 1? No. But we have done probably more work than you or our competitors know about in terms of taking the parameters that drive heart logic and replicating those on this super small micro implantable. So that's LuxDx version 2 and beyond, and we're very active in that.
Obviously, it will take us a couple of years to get that work done, that preclinical work done and then to run the clinical trials to prove it. But that could open up just an enormous sort of new market. Ken, you want to make a comment on that?
Yes. And I just because I think this is something that's fallen a bit under the radar. I just want to reiterate what Joe said, right? The heart failure preserved EF population is as big as the heart failure with reduced EF population. These are just about the most frustrating and difficult patients there are for cardiologists to manage today.
Mainstay of therapy is water pills, diuretics, but they're very sensitive based on their physiology. So there's a huge opportunity to improve the care of these patients if we can get HeartLogic onto the monitor. And as Joe said, while we have to do the clinical trial work to prove that we can pour HeartLogic over into this, right now, based on what we know about the sensors and the physiology, we have a high degree of confidence that we're going to be able to do this.
Yes. We also get to benefit from 20 years of research, 13 clinical studies that led to the approval of HeartLogic. So I think we think we've got a substantial sort of lead on most people in terms of heart logic and the ability to sense impending heart failure decompensations. Okay. To keep on time, I'm going to transition now to EP.
We did some disclosures at our HRS meeting that I just want to kind of expand upon. So if you look at the EP market on the left hand of this slide, 2 thirds of the market is in mid to high teens to high teens growth. And that is essentially, if you're not color blind like Mike, the light blue and the gray, that's 2 thirds of the market. Was that a HIPAA violation?
I'm sorry.
Strike that from the webcast. 2 thirds of the EP market, extremely attractive high growth. You do have the legacy business down there in the 1.5% part of the market that is low probably low single digits. What we disclosed at HRS is that right now we look like the inverse of the market. So 2 thirds of our business is in legacy diagnostics, single tip non NAV type of ablation catheters.
So we've done a what I would say a respectable job of creating a new segment, which is a third of our business today in the with the RHYTHMIA launch over the past 3 plus years, okay? When you look futuristically and we're going to show you in a couple of slides here how we're going to do that. We're going to invert our business in the next 3 years. So by the time we exit 2022, we'll go from 2 thirds of our EP business in the low growth segments to 2 thirds of our EP business, which will grow well north of market and will then become the dominant sort of segment that we're selling, right? So it's going to be a really fun time.
It's driven by the technologies that Ken is going to talk about next. But before we go there, I think Art did a great job about talking how they can leverage the global footprint that they have in endoscopy. Well, interestingly, and kudos to our CRM success because that has really funded this investment case. But if you think about it, we started our RHYTHMIA launch 3 years ago. Well, we have been building the commercial infrastructure and the commercial capability to attack the EP very attractive, very large, very high growth market.
So when you look at the blue on the right side of that, we now have infrastructure. Think of that as hundreds of people, whether they be clinicians, technicians or sales reps that are selling RHYTHMIA and our legacy EP portfolio. So all of the things you're going to hear from Ken will launch into a well established commercial pipeline that we've already forward invested in. And just a couple of callouts, that team in 3 short years, 3 plus short years has gotten RHYTHMIA installed and adopted in nearly 600 centers. We've done greater than 40,000 cases.
And with the help of Ken's team, we produced 50 articles, peer reviewed articles on the innovation behind RHYTHMIA, high density mapping and automatic annotation. So with that, I'll have Ken lead the discussion on what technologies will drive our expected above market growth.
Yes. Thanks, Jeff. And so I want to talk about the pipeline. I'm going to get to the single shot technologies. But I think you need to recognize that even with single shot, there's always going to be a need for advanced mapping, advanced point RF ablation catheter technologies.
Very pleased with the launch to date of our LumaPoint software module. We sell this as a license. We've already sold more than 120 licenses, have over 2,000 procedures completed with LumaPoint. And to give you the quick explanation of what LumaPoint is, since it's at HRS, Joe said I couldn't do this. It's our first foray into augmented intelligence to help physicians quickly assimilate and interpret complex information during a procedure.
I think the best analogy, it's like the yellow line that you see in a telecast of an NFL football game, tells you where the next down marker is. I mean, you could figure that out if you were paying intense attention to the game all along and weren't paying attention to all the other stuff. But this gets you to where the critical information is quickly and immediately improves the efficiency of procedures, we hope improves the outcome of procedures. Second thing I want to talk about is our direct sense ablation platform. This is our IntelliNav MiFi OI ablation catheter for point RF ablation.
This is already approved in Europe. And it's one of the reasons why in Europe today, we are growing an EP faster than market. What DirectSense enables you to do is measure local tissue impedance, the tip of the ablation catheter. It tells you proximity to tissue, but I think what folks are really interested in is it enables ablationists to
measure the
electrical changes in tissue as the revolutionary will be the introduction of our IntelliNav stable point catheter. And this will be the first and the only ablation catheter on the market that combines the ability to measure mechanical force. So mechanical coupling with tissue as well as direct sense local impedance, which tells you electrical coupling of tissue because both mechanical coupling and electrical coupling are what are necessary to actually create a transmural ablation lesion.
And Ken, just to add, if you you don't need to go back. But if you look at Europe right now, Europe for several months has had LumaPoint, for 18 months has had DirectSense. Our RHYTHMIA segment, not the core legacy BSE EP, is growing at multiples of that mapping and navigation segment. So that kind of is the prologue to what's going to happen when we get that approved in 2020 in the U. S.
But that's not a guess. That's based on 18 months now of experience of how physicians react to the RHYTHMIA, RHYTHMIA software, the catheters and the actual direct sense software and LumaPoint. So we think we have a really good prediction for what we'll do in other markets as we get just those 2 of the 3 critical things across the goal line.
Great. I want to close with our 2 single shot technologies. It's like my 2 daughters. They're both very different. I love them both equally.
So you all know we acquired our cryoablation platform with the purchase of criterion, the trade name PolarX. This is an evolutionary cryoablation platform. There's one single competitor out there today. We believe that PolarX offers some very important differentiated advantages to patients and to electrophysiologists. The one that I'm going to focus on for you here today, given constraints at time, it's one that I think is the most important.
You probably don't realize this. The competitive system that's out there, you inflate the balloon to a certain size, make sure that you've occluded the pulmonary vein is to do pulmonary vein isolation for ablation of atrial fibrillation. And then when you go to actually freeze the tissue, the balloon expands in size, tends to pop back, you lose the position that you're at or the physician has to actually push the balloon forward to try to keep it engaged. And the major difference in our system is that our balloon stays at the exact same size and the exact same pressure once it's deployed throughout every phase of the freeze thaw cycle. There are a number of other advantages to this technology.
We've seen a lot of interest already through from physician customers both in the United States, Europe and globally. We are targeting getting CE Mark for Polarex in Europe in the Q4 of this year and also intend to start our U. S. IDE trial Q4 of this year. And then depending on pace of enrollment and the results, anticipate U.
S. Launch in 2022. And then our other single shot technology, again, everyone's aware our acquisition of Apama. This is Lumineze. This is a truly revolutionary technology.
This is a RF balloon catheter, again, for fast single shot isolation of the pulmonary veins. What you can see in the picture on the left side of that slide is the catheter itself when the balloon is inflated, sort of hockey puck size, that's very Minnesota centric viewpoint. It's got a series of ablation electrodes along the periphery as well as on the distal face. And it enables physicians to be very discreet and titrate where you want to deliver power and how much power you want to deliver across the pulmonary vein. But what's really unique and revolutionary here is what you see on the right.
You know what, my friend Ryan Duncan, as a surgeon, is used to be able to see what he's doing. We haven't had that opportunity in electrophysiology. But this balloon has endoscopic visualization. But you see on the right actually in an ablation that you can see exact where you are in the pulmonary vein, see your level of contact and again choose the therapy pathway that you're delivering across those multiple electrodes with precision and personalization. Joe?
Yes. And I think we're looking at this. It's a little bit behind just from a design verification, development, etcetera. So we're expecting both CE Mark and US ID start in the first half of twenty twenty. But I love the way that you described that as revolutionary to what people are doing.
Thanks, Ken. So just quickly in closing, we've already talked about many of the things on this slide. You should expect our goal is to grow faster than market in CRM, to grow substantially faster than market in EP as we deliver these technologies and invert our business from 2 thirds legacy low growth stuff to 2 thirds high growth market leading stuff. And then again, you should expect us to continue on our journey just as we've done since the last Investor Day to continue to focus on growing profitability, not only in Rhythm and the Rhythm and Neuro segment. So with that, why don't we transition to our neuromodulation, spinal cord stim and DBS business.
I'll ask Malik and Milad to come on up.
All right. Thank you, Joe. Good morning, everyone. So I'll talk through for the neuromod to start out and then Melad will go through our DBS franchise who has been leading this for a number of years. Overall, as a neuromod business, so this is really an exciting space.
And as a field, this is still probably an early innovation curve, and there's a lot of more knowledge to be built as we understand how do you use electricity and how do you dose electricity to a nervous system. There's a very low awareness from the patient side. Interestingly, even now, when you go and talk to any of the pain patients, every time they come and you have a chance to talk to them in the clinic, a lot of times they say, how come I never heard about this? I went through 2, 3, 4 surgeries and then I found out that this alternative exists. Or even for the DBS patients.
They go through a number of clinical studies and after that they find out on their own or through another physician, the DBS procedure probably is an ideal procedure for them. It's one of the patients Mlad will talk about later. For the pain therapy for us, the focus really is on true category leadership. And we focus on 2 dimensions. 1 is on technology advancement, driving innovation and outcomes, especially from a point of view of longevity of the therapy.
If we want to move up on the therapy continuum, that becomes really important on a longer run. On top of that, providing multiple innovative options that you are able to personalize the therapy for that patient for that particular time. This pain is something very unique. It's not that there's a clear biomarker. It's not something you can see.
The only biomarker you have is you ask the patient how do you feel. And then pain is something that evolves over time. So multiple modalities are very, very important going forward. On the brain side, simply transforming the therapy. This therapy has been existing for DBS, has been existing for 20 plus years.
The innovation that we're bringing, one of the most innovative platform, we're the first to introduce the Cartesian directional we introduced at 4 years ago in Europe, thousands of patient experience before even coming to U. S, allowing us to make this into a global franchise going forward. The early reception has been very, very positive. A lot of good experience and positive outcomes for the patients. It's a very exciting time for us.
But it's also a platform as we look at it in the future because what this does is our knowledge of building understanding of the NeuroStep On top of that, understanding of the technology is really future unlocking the treatments for the neurological disorders. We have investments in treatment for stroke, some early clinical work going on, as well as investment in Alzheimer's. They have started a large clinical study, pivotal study for treatment of Alzheimer's. So these are exciting markets where no other therapy options available and we look forward to the future. So as a market, when we look in the category leadership, number 1 in U.
S. Position coming out from 2018 as well as building up the number 2 position for DBS with the momentum that we have in U. S. Introduction. Dollars 3,500,000,000 market at the same when you look at the composite growth, including everything from DBS as well as all the pain therapy options, Look at about 10% growth as a market 2019 to 2022.
We have seen a clear transient slowness in the SCS market. Everyone has been talking about it. We see that continuing. But at the same time, we see that there is no fundamental change taking place in the reimbursement. There is no therapy change.
We go and talk to the physician, they consider SCS to be one of the most innovative therapy as well as something that can truly help the patient. Also, we see that the new product introductions coming in towards the end of the year with a number of companies coming in. Also, the new product data clinical data coming out should help to support and bring the momentum back. And in the longer run, we see indication expansion to drive this market growth. At the same time, patient awareness continues to be an important factor for going forward in the growth.
From a business focus point of view, from 2018, we had a strong growth coming out of the WayRyder, superior outcomes. And some of the best outcomes, we continue to see that. We presented some of the data at INS and talk about it a little bit later. At the same time, also the Cartesia system U. S.
Launch and then the strong international growth. A few years ago, we started to expand our platform internationally, and it continues to provide a strong growth going forward. On the pain therapy side, when we look at breaking down the market, we're the only player with 3 therapy options, innovative product options. On the spinal cord side, as I mentioned, 7% to 10% growth we expect in the longer run. There are 3 factors that drive that.
1 is technology outcomes and having clinical data showing longevity of the therapy. 2nd is indication expansion, assuring that in the longer run, where can you really provide the therapy outcomes. And then the third is awareness. And all those combined, as you move up on the pain continuum, you're able to provide much more therapy option. But the key really remains is that you do need to show longevity of the therapy going forward.
RF ablation, 10 plus percent growth, it's a versatile, fast, effective and safe procedure. We believe this is going to be very helpful, especially in treatment of joint pains. Vertiflex, very excited about the acquisition. We feel that this is a space where 6,000,000 moderate lumbar stenosis patients. This is a fast growing innovative minimal invasive procedure and really excellent outcomes with 5 year clinical data, one of the only one in this space.
And we believe that this can provide a really a missing link in terms of providing therapy solutions for the pain patients. On top of that, the brain modulation finally having a global franchise, which is introduction of a platform, this expect us to be of a 10 plus percent growth, 1,200,000 Parkinson's patient in U. S. Only. Technology outcomes, therapy awareness and future indication expansion, all those will factor into the growth as a DBS platform in movement disorder as well as in the future indication.
So in terms of the pipeline, when we look at the portfolio of how we see this in neuropathic pain and SCS, We see this we expect a combo RCT data coming out, interim analysis data coming out towards the end of the year, a full platform system enhancement tool of our WaveWriter platform by before end of this year, and then a next generation system in 2021 as well as in the future indication expansion. We're very, very methodical in looking at how we want to be able to expand an indication. It's important that we get very strong data in patients' long term outcomes before we move on to indication expansion. What we don't want to do is have excellent data for the 1st 1 or 2 years and then you see a number of explants coming out. So the longevity of the data really matters.
You want to be able to make sure that you have a very clear idea how you're going to maximize the benefit for the patient before you expand into other indication. On top of that, for the joint pain, especially for RF, expanding for the unique probes that we have to be able to add clinical data as well as international expansion, probably one of the most interesting platform, especially for emerging markets where you do not need a lot of infrastructure and a support care necessary. And then for the S with the WordFlex platform, we expect additional clinical investments to drive the clinical outcomes on top of the 5 year RCT data that is there as well as in the future, international expansion as we look at the markets in the future because Vertiflex has been purely focused on U. S. Introduction until now.
So a little bit about VERTIFLEX, very excited to talk about it. This is truly a unique platform and it advances our category leadership as well as a unique procedure building a treatment gap for moderate stenosis. There's a strong call point overlap of 90% of the call point for where we serve for their primary users are SCS implanters. This really fits in with how we see this as a treatment offering for the patients as well as for the physician as one more thing to offer in the portfolio. Strong 5 year clinical RCT data, 84% experienced clinical success, 90% patient satisfaction.
And especially over 5 years, 85% decrease in opioids. This is something very unique and we probably see this one of the few players in the marketplace and continue to drive future growth. And for our ability to bring in some of the capabilities from everything from physician education, patient education and to be able to provide infrastructure at the same time remaining focused and assuring that we drive long term success of this therapy, we're very excited about the opportunity. It is also medically Medicare reimbursed Category 1 and also expect it to reach about $60,000,000 revenue in full year 2019. We expect the opportunity to accelerate in the future.
At the same time, right now, just after the closing, we're excited about having Vertiflex as a family addition to neuromod portfolio. So just a little bit about WaveWriter. We just produced and presented this data at INS. What is interesting is this is the first and only system that delivers stimulation, paresthesia as well as subparasthesia waveform. This is a work that's been going on for us.
Almost 6 years of research went into this. So when you look at our real world data and this is what was presented, what is interesting is these are patients in 5 centers, consecutive patients coming in. So there's no cherry picking because what's important is you want to be able to provide therapy outcomes for the patient that are everyday walking into the clinic, not just in clinical studies. When you look at this 80% responder rate after 1 year, on a 2.5% in terms of the pain scale, significant drop. What is most interesting is 23% of the patient reported pain free and 66% are showing minimal pain 1 to 2.
So it's a very strong data set. And on top of this, our RCT data will start coming up. We expect similar results, mid term data coming out by end of this year and the full data set, 100 and 40 to 150 patients by middle of next year. So this should add and substantially the value of what we see as a wave router. We continue to see that as a future platform going forward.
With that, I'm going to turn over to Milak Girgis to talk a little bit about DBS. Thanks, Malak.
Thanks, Malak. Good morning again. It's great to be here with you. My name is Milat Gurgis, and I've had the privilege of leading our Brain Modulation franchise really since the beginning. Next week marks our 7 year anniversary.
We launched in Europe 7 years ago. And last year, we became much more global as we launched our product in the United States. Today, our product is available in 40 plus countries around the world. And like Malik said, we're changing the lives of thousands of patients. The other exciting milestone was in the Q1 of this year, we released our precise Gevia, our precise PC and our Cartesia systems, our directional systems that the market was eagerly anticipating, and we're starting to see that impact.
We'll show you a patient video later of how that impact is transforming lives. Change the slide. Like Malik said, Parkinson's in the U. S, we estimate there's about 1,000,000 patients that are diagnosed with Parkinson's disease. Of those, 240,000 would benefit from DBS therapy.
But there's only about 12,000 implants in the U. S, about 5% penetration. And then the other 5% are replacements. So this market really is severely underpenetrated. So Parkinson's is a chronic debilitating disease, and patients and caregivers are seeking treatments.
Much of that is pharma. They're going to general neurologists, but really our goal and what we believe is that innovation, technology and ease of use of a system can help facilitate patients to their care continuum to get them to the movement disorder specialist and make the procedure easier so more and more can treat the patients with our technology. For brain modulation, really there are 2 goals. It's to place the lead in the right location. And once the lead is there, to stimulate and to maintain therapy so that you can elicit the right therapy and not have side effects.
Because the brain is much like Manhattan real estate. It's like walking through Times Square last night and there's people everywhere. And so the wrong stimulation will lead to the wrong side effects. So with that, we took on a little different DNA. We came from a neuroprosthetic.
We came from a cochlear implant. And we used that DNA of a neuroprosthetic to create this technology called multi independent current control. The acronym is M ICC. Think of it as a dimmer switch for every one of those 8 contexts. It's something no one else can do.
And with that, we looked at it clinically. We looked at our Intrepid U. S. Clinical study. It's the only randomized, double blind with a sham controlled study for DBS.
We now have 2 years of data that was released in the Q2 of that study. And you can see here on the left hand side of the screen, for 2 years now, we're seeing 50% motor score improvement. Compared to previous literature with legacy devices, it's almost double the improvement. And that's with our 1st generation system. What's even then more exciting is on the right hand side is a picture of our STIM V programmer.
That's the programmer that's behind our directional capability. We're seeing again in studies and continued studies our DIRECT study, which was a multicenter randomized study in Europe, looking at directional versus non directional capabilities that again in the blinded phase, 11 of 12 patients selected those directional settings. And we're continuing also with a registry that now has over 400 patients across 40 sites, and we'll be looking at over up to 1,000 patients in 70 worldwide sites to see the real world long term capability of what this system can provide. So that's a lot of the engineering and the science. And what we thought it would be important is to share again a real patient experience.
The patient that you're going to see was diagnosed with Parkinson's disease in his 30s. It can really be any one of us standing here. He went into several pharma studies, almost 11. One of those turned his eyes black. And he connected with a patient ambassador of ours.
And now in his early 40s, he received a RECISE Gevia system. You'll notice something interesting in the video about his voice, and we'll talk about that after the video.
I am a movement disorder neurologist and director of the movement disorder program based at a university hospital, this patient was implanted with the Boston Scientific Directional DBS system. With stimulation off, the patient exhibits prominent tremor symptoms. Using the controls, I can move stimulation up and down the lead and in 360 degrees around the lead to pinpoint exactly where I want to stimulate. This is something that only the Boston Scientific Directional Systems can do. With other directional leads, you are limited to only the mechanical contacts that you have.
At this level, the patient has good tremor control. Small changes in directional settings can lead to big impacts in patient outcomes. Currently, I have the stimulation directed 100% on one contact. Are your symptoms resolved yet?
No, not yet. Okay, good.
We're going to shift the stimulations so that it is split between directional contacts. Do you feel any tingling, any muscle contraction, any pulling? No. Can you repeat after me? Today is a sunny day.
Today is a sunny day.
Well, as you can see in this setting, the patient is experiencing severe speech side effects. I'll now rotate the stimulation. Can you repeat after me now? Today is a sunny day in Miami.
Today is a sunny day
in Miami.
You'll notice that by making even the slightest adjustments in directional settings with this system, I'm able to reduce side effects with a precision that I never had before. For this patient, there was no trade off in treatment and side effect. And that's a great option to have.
We hid his face just for to protect his privacy. Did you notice his voice and how it changed? If you notice that, it was with a setting that was 25%, 75%. Small changes again in that stimulation resulted in big changes in his outcome. Because what we hear from patients is often this voice side effect is one of the most troubling of DBS therapy, voice, balance.
And this is where we get excited about expanding the continuum, where we're not treating just the motor, the ability to walk, which DBS therapy has been shown to do, but can we now also help in their quality of life longer term? And this is what excites us about the product that we have today. It's a true directional system. The full system together, software, hardware, electronics working together to make this easy and again to show results just like we saw in this video. And that's what's available today and we're launching that again in the U.
S. We're continuing our launch and around the world. What we're excited about also is going into next year, a theme this morning has been around visualization. And in Brain Modulation, we partnered with Brainlab. And what we're doing there is taking a patient specific MRI, taking that and bringing it to our software.
So a neurologist today who's programming without any information, they're just looking at the patient almost playing Battleship to program, can see that patient specific MRI, see where the lead is and see where the stimulation field is interacting with that MRI. Again, to make it easier so that we can expand this therapy outside the specialist centers to more and more centers with the highest quality. And again, that's the goal. Some of this is available in Europe today and we'll be further integrating this. Beyond that, in 2021 2022, we look to have more connected, smarter systems again that expand the therapy, make it a lot easier for neurologists and neurosurgeons to connect together with the goal really of making this procedure a lot faster, taking it from the niche that it is today to the mainstream by making it cost effective and efficient.
Finally, this really unlocks the keys for the indications that Malik mentioned, Alzheimer's and strokes, other debilitating diseases that we believe with this technology that we can help expand using this platform.
Turn it
back to you, Malek.
All right. Thanks, Malte. So as Malte mentioned, it's really exciting times for us. DBS has been a long journey for us, almost 10 years of work. We're Finally able to see that coming into the market is very exciting times.
Overall, we see this existing exciting marketplace in underpenetrated, underserved markets. But the key is for us to continue to focus on science driven approach. Understanding of mechanism of action and waveform advancement will drive outcomes, but more importantly also longevity of the therapy. Driving awareness and combine that with patient access is probably the best way to move up the patient continuum and at the same time to be able to offer multiple therapies, especially in the pain side becoming a category leadership. On the brain side, this is a starting point, but at the same time, we believe in fast innovation, especially you see some of the patient experience of the video that you saw is unique to what we can do in impacting the patients' lives, as well as ability to change how therapy is given by the physicians.
And overall, leading with technology and the clinical insights that we're learning from both pain as well as on the brain side will allow us to unlock new treatments going forward in disorders, especially neurological disorders. And we are taking a very, very methodical approach for all of this to be able to go after new targets, to be able to go with new modalities, to be able to provide the precision and directionality visualization, all those will enhance the chance of success for treatment such as Alzheimer's, for treatment such as stroke, as well as indication expansion for pain. So very excited to have a high growth opportunity to contribute to the success of Boston Scientific. With that, I'm going to end this. Thank you.
And Milad and Joe and Ken. And now we have about 15 minutes for Q and A, and I promise Rick could be first. Should I could you or Mike? Thanks. Go ahead, Rick.
Thanks. I have a couple of questions. I'm going to focus on the Rhythm and the CRM and EP side. There's a million questions, obviously. Maybe, Joe, just start off with just I'd be curious to stay here expanding your thoughts on the leadless PACER potential.
I mean, obviously, your 2 main competitors have been visible leaders well ahead of you. How do we think about your potential to win in the space longer term? And just curious, does Emblem or your SICD experience tie into that in some way that we should understand that you really are going to be a viable serious winner here as you are everywhere else?
Yes. Let me I'll try to talk about some of the market dynamics and then what Ken to weigh in on sort of the clinical side. So what we get to watch right now, obviously, one of the competitors stumbled very quickly during their European launch. So it's been a little bit of a storied past here driven by that. But we get really good insight right now in markets like Japan and the United States, where one of our competitors has approval and good reimbursement in both of those markets.
And we get fairly accurate sort of assessments for what kind of penetration. Now it's in a fairly small market. So single chamber pacemakers are really 15% of the total global pacemaker market. But we get really good insight and we see sort of the share uptake that that has achieved in markets that have good reimbursement. We also get to see what happens in markets broadly speaking like the EU where there is not preferential reimbursement and that penetration is dramatically lower than what we see, for instance, in Japan and the United States.
I think when you look at the promise of things that are leadless, brady pacing, defibrillation without putting anything in or on the heart, right? We're kind of chasing that same vision. And although it may not be material in the next few years, we look at it as a space we have to be active in. And honestly, today, if you say, hey, let's count everything from leadless pacemakers to leadless SICDs that don't touch the heart. We're the clear market leader in that.
So we're uniquely positioned to sort of innovate in that space. And I think Ken hit it really well. We will be the we are the 1st and only company with a subcu ICD. We are going to be the 1st and only company that has figured out the communication scheme and sort of the collaboration between an SICD and a leadless pacemaker. Ken, you want to tell you about
it from a clinical? Yes. I'll expand on 2 points. I think first, frankly, one of the luxuries in going after the competitors is we've seen what are some of the issues with their systems. And even when we just look at Empower as a standalone single chamber pacemaker, we believe that we have learned quite a bit from the experience with the other devices.
And the intent is to come out with a delivery system and a retrieval system that is easier to use for implanters and that will enhance the safety of the procedure relative to what we've seen with published data with the competitors out there. The other thing that I think is important is when you look at the combined system, so the modular CRM system, we're really trying to change the paradigm when we talk about modular approach to therapy, right? I mean, today, if you look at the folks who haven't made the switch to SICD for primary prevention patients, why haven't they done it? They're not because they've got some residual concern that down the road, patients may develop a need for pacing or may exhibit a need for anti tachycardia pacing. And it just doesn't make sense that you should give everyone the Swiss Army knife that can do everything, but that has the risks that you have with being inside the heart and being inside the thorax.
With the availability of modular CRM and EMPOWUR, right, physicians can feel confident, start with the SICD for that broad swath of primary prevention patients. And then if down the road they develop a need for pacing, develop a need for antotachycardia pacing, they have the option of just getting an EMPOWUR device. They stay leadless. You maintain all the advantages, all right? And giving them that security, it's our belief, actually then unlocks a big portion of patients who haven't yet been considered to be candidates for SICT.
And just turning to the arrhythmia AF side of things. It sounds like you're very excited about the potential for arrhythmia in the U. S. And just maybe remind us the number of centers potential briefly, but more specifically, is there any common thread you're looking for in terms of adoption like there are already BSX accounts? That's where your opportunities are.
But even more important, the upcoming capital launches like DirectSense and Telenav, is this catch you up or put you ahead of others? And so we should be a lot more optimistic or how would you frame how we should feel about the potential for RHYTHMIA adoption over the next 2 or 3 years versus it's been good, but is this the inflection point now? I'm just not sure I'm clear about all that.
Yes, there's a lot packed in.
I know, sorry.
So we're targeting everyone. Now obviously and we've shown, if you look at the markets we've entered, the regions we've entered, getting to 600 as we've built the portfolio, we think is quite an accomplishment. But there are thousands more labs of labs that we can target. And I think to answer your question in as succinct a way as possible, it's we have really good experience and outstanding feedback for how our NAV MiFi OI catheter, which is our latest, combined with DirectSense software, what that has done in the European market. And that continues to accelerate and build momentum.
So I'm not going to get into specific numbers. But think about Europe with current generation RHYTHMIA HTX, our latest catheter, not our final catheter, but our latest catheter and our latest software growing at multiples of the market growth rate. And that and again, we're still very early in that launch. And I won't get into how penetrated we are, but even with partial penetration, even into our user base, right, we're growing at multiples of the market. Now we still have the issue in every market.
Our old legacy stuff doesn't is not really growing. So we're still fighting that headwind. But man, that's why we get so excited because we can look at Europe and the momentum that keeps accelerating as we deliver things like NAV, MIFIOI and DirectSense. Ken, you want to add anything to that?
I mean, the only thing I'd add is, I mean, this is a tough market because the competitors aren't standing still either and we know that. And that's why we're at the long range strategy isn't to focus on just one segment of what it takes to win an ablation, right? But it's to provide the complete toolbox, single shot with cryo, single shot with an RF balloon, advanced mapping navigation with with Direct Sense and then with Stable Point. And I think ultimately, it takes having that complete portfolio to win.
Jason?
Jason Bedford, Raymond James. Just to follow-up on Rick's question. BP Growth, low teens market, your goal is to grow faster than that. What's the time line on that? Is that 2020?
Is it 2021?
It is dependent on when we deliver those technologies. So go back to my Europe statement, 2 thirds of what you saw and this is let's split this from a single shot statement to what's happening in that advanced mapping and navigation category. So with only 2 thirds of what we think are the major sort of accelerators, we're growing at multiples of the EU market. And we think that will accelerate when we bring the last barstool leg, which is StablePoint Force Sensing catheter. I mean, if you look at Force Sensing alone, Force Sensing catheters make up almost $1,000,000,000 of the $5,000,000,000 market.
We don't have a product in that category. So 2 thirds of those things that Ken talked about on that slide are already in Europe. We're really happy with what they're doing with that. The 3rd leg of that stool comes in 2020 and opens up another sort of $1,000,000,000 global opportunity as we launch a 4th sensing catheter that's specifically designed to leverage everything we do with RHYTHMIA and the RHYTHMIA software.
Okay. Okay. Maybe for Malek on SCS growth. You mentioned the slowdown is transient. Any further thoughts?
I feel like it's a bit of a redundant question here, but any further thoughts on the slowdown in SCS growth? And you mentioned awareness is needed for greater awareness is needed for further adoption. Given the slowdown, what are you guys doing differently to raise adoption outside of additional clinical data?
I think a couple of things. One is when you go and ask the physicians, they haven't seen a fundamental change. There's no change in policy, health care policy, anything like that. They also believe strongly in SES being one of the best alternative for the pain treatment. So we see that with the new introduction of new platforms coming out towards the clinical data coming out, we see the momentum starting to pick up after that.
Sorry. Patient awareness?
I think that's just given. I mean, at the end of the day, when you look at the number of patients that are in the field and treated with SCS, you're looking at all the players combined, you're looking at about 60000 to 70000 patients getting treated. Number of patients coming into the pool every year, 1,000,000 back surgeries, 30% failure rate, so you about 300,000 patients coming in every year. On top of that, additional neuropathic additional pain patients coming in. So you're combining that and you're looking at about 500,000 patients, new patients coming in on top of the pool that is there.
So I think that as we go forward, longevity of the data will support an interest from the patients. And there is no decline in terms of the patient referral coming into the pain patients and pain physicians. So it's a matter of time till you see that momentum pick up.
Okay. We're running a little bit behind, so I think we're going to cut there. Happy to take additional questions for these guys at our wrap up session. And we'll ask that we'll take just a 10 minute break and we'll start promptly at 10:30. Thank you.
Okay. Thank you very much, everyone, for your flexibility in that quick break. And recognize there's still a queue for some of the facilities, but we're going to plow right ahead and really excited to turn now to our cardiovascular segment, where as I mentioned, we'll start with peripheral intervention. Super exciting time for this business. And with that, I'm happy to turn it over to Jeff Mervis, our Senior Vice President and President for Peripheral as well as Kat Jennings, our VP for Marketing and New Business Development.
Jeff?
Okay, great. Thank you, Susie. It's great to be here. Hopefully, you had a few minutes to stretch your legs. We can't have anyone thrown off a DVT as a result of our Investor Day.
So we wanted to get your blood moving, get you going here. And if you do, we have a great portfolio to help you out. So we're going to be talking about that in our presentation here about our category leadership strategy on Venus. So overall, I'd say peripheral has been a really strong growth sector, and we see many new catalysts for growth as we look at the future. And we believe that BFC is extremely well positioned to continue the above market growth that we've been enjoying here for the past couple of years.
And over the next 25 minutes or so, Cat and I will cover the following key points in this presentation. So this is sort of our high level summary for you. So first and foremost, we serve very large and underpenetrated disease states. And we see that there are many, many unmet clinical needs that we can help patients with. And as the global population ages, patients are entering the period of life where these peripheral diseases are becoming more prevalent.
And probably most importantly, these large and underpenetrated markets provide us at Boston Scientific Peripheral with a lot of room to continue to deliver meaningful innovations to help our customers treat more and more patients with cost effectively cost effective minimally invasive solutions. 2nd, we see that BSC has highly differentiated portfolio of drug eluting solutions for above the knee and below the knee disease and that we believe this provides us with a long term sustainable competitive advantage. Now we're the only company to offer a safe and effective DES and DCB, and we're the only company that's investing in comparative evidence, so that our customers can practice evidence based medicine. And our category leadership strategy is working, and it's bolstered by the BTG acquisition, which will accelerate our position in both venous and interventional oncology.
And we believe that both
of these franchises will continue to be strong growth contributors and that Boston Scientific is uniquely positioned to extend our leadership position. We've got several adjacencies with both new organic product launches and market expansion opportunities in new disease states that will help us drive above market growth. And what you'll see in this presentation is how we plan to expand into new spaces where we can leverage our Boston Scientific capabilities. And finally, there are many international markets where we can expand the penetration of our broad portfolio, especially in the emerging markets and then of course with DPG products. And there's a significant number of countries where we have yet to reach our full potential as a peripheral business.
So looking at the market, we see the total addressable market in peripheral at over $6,000,000,000 last year. And we estimate that our market will continue to grow around mid single digits in the next 3 to 5 years. And this growth is well balanced across our 3 franchises, which is arterial, venous and interventional oncology, as well as from a geographic perspective. And in particular, we see really good strong growth coming from the Asia Pacific region as we look forward over the next several years. And last year, BSEPI organically grew 9% to reach $1,200,000,000 in global revenue, which was accretive both to the market as well as to the BSE enterprise average.
And our goal is to continue to drive this high single digit growth over the next several years as we expand into new adjacencies and launch the many new products that you'll hear about in this presentation, both in our served markets and in new adjacencies. And so this slide highlights the significant amount of unmet clinical needs across the 3 franchises we're focused on. And in arterial, we have a category leading position in PAD, where there's over 200,000,000 patients around the world who suffer from the disease and less than 1% receive an intervention. And we've expanded our investments to patients with critical limb ischemia, which is the most severe form of PAD. And nearly a quarter 1000000 of these patients receive an amputation each year in the U.
S. And Western Europe alone. So we see a ton of room to improve the care of these patients and also importantly take costs out of the healthcare system as a result of that treatment. And we've built a strong portfolio of products to serve this market and we're uniquely positioned to provide physicians and hospital systems around the world with a full toolbox of solutions to treat patients. And on the venous side, we see this market approaching $2,000,000,000 in 5 years as it continues to grow in the high single digit range.
And we've been focused on deep venous disease, where there's millions of patients every year that develop a deep vein thrombosis, half of which will go on to develop post thrombotic syndrome. And we'll also be uniquely positioned in the DVT space as the only company with a full portfolio of products. And we're investing in new clinical trials to ensure that our innovations are supported by the most contemporary clinical evidence. And then we're now expanding our portfolio into pulmonary embolism, which actually causes more deaths in the U. S.
Every year than breast cancer and AIDS combined. So it's a pretty large and difficult market for patients. And we believe that a minimally invasive approach to treatment can not only help patients, it can be more cost effective to healthcare system. And there's lots of data that supports that earlier diagnosis and treatment can significantly reduce these high mortality rates. And in terms of interventional oncology, this market is also growing high single digits, where nearly a 1000000 patients every year are diagnosed with liver cancer.
And while technology has improved dramatically in liver cancer, survival rates continue to be very poor with the 2nd lowest overall cancer survival rate at 5 years. And so we aim to change this and we're making investments in both new innovations as well as clinical data to help improve these low survival rates. And we see opportunities to improve the outcomes of patients with other solid tumors and you can see that listed on the bottom right of this slide, the other solid tumors. And interventional radiologists treat some of these cancers today. And we know that a very localized treatment approach can improve outcomes for many of these patients with cancer.
So we're excited about closing the BTG acquisition, which you heard earlier that we're still on track for mid year and we'll update you as soon as we have more precise information, we see this as a very strong strategic fit to accelerate our category leadership strategy in both venous and interventional oncology. At BSCPI, we're a global leader with strong commercial engine in countries around the world. We do business in over 100 of those countries and we built a category leading portfolio to better serve our customers. And we've experienced above market growth over the last several years. And on the other hand, BTG has a differentiated portfolio that's focused on higher growth adjacencies that I mentioned on the previous slide.
And they've consistently grown double digits and their innovations are a perfect complement to our current portfolio. And upon close, BTG will provide BSC peripheral an entry into a greater than $1,000,000,000 of new adjacent markets. And so we're stronger together and we'll accomplish more as one team than either company would have accomplished on their own. And together, we'll accelerate a category leading peripheral business that's focused on helping our customers treat more and more patients with today's most challenging lesions and diseases. From a financial perspective, we expect to achieve strong synergies and cash flows and have developed a very good capabilities at integrating companies.
So we see this as like right in our execution sweet spot. The combined DSC and BTG teams have been hard at work over the last several months, planning for integration and getting prepared to begin execution upon close. So we feel like we're ready and we're ready to go. And we're reiterating our expectations that this acquisition will have a really strong ROIC, approaching double digits at year 5. So we're excited and we really look forward to welcoming the BTG employees to the Boston Scientific family in the next couple of months.
In our future combined category leading portfolio across arterial and venous and interventional oncology, it's an impressive blend of meaningful innovations and growth drivers. We'll be able to provide our customers with a broad array of innovative solutions that has unparalleled clinical evidence. That's all supported by a large local team that's trained and focused on very specific disease states. We'll have some of the market's leading premier brands, when you just think about this across the franchises. In Arterial, Eluvia, Ranger and the SAVAL DES for BTK lesions.
In venous, think about the angiogen, Vici stent and ECOS. And in interventional oncology, think about TheraSPHERE Y90, the glial cryoablation and of course our leading delivery and embolization portfolio, a portfolio combined of premier leading brands in the market. And we feel this is a unique portfolio that can help advance the care of patients, enable geographic expansion, and of course continue to drive above market growth. And there is so much on this slide that I could talk about, but let me just cover 2 innovations from BTG that we believe will provide a differentiated option for our customers and their patients. So the first one in the middle on the bottom is the Sentry vena cava filter that's used to prevent life threatening pulmonary embolism, is a blood clot that breaks off and travels to the lungs.
You may be aware that Boston Scientific actually created the market for the very first endovascular vena cava filter placement nearly 30 years ago. And the Sentry filter is the world's 1st bio convertible filter and provides protection from pulmonary embolism without the need to remove the filter. In fact, up to 40% of retrievable filters today actually don't get properly removed, which can cause patient adverse events. And so this Sensory filter was designed to solve this problem and has demonstrated excellent safety and efficacy with 2 year data that was reported at Veeva last fall. So the Sentry filter expands our total addressable market by roughly $250,000,000 and will be an opportunity for us as a combined BTG and BHCP now to change the current paradigm of retrievable filters.
And the other innovation I'd like to touch on is the TheraSPHERE Y-ninety product, which is a localized radiation that's used currently in the treatment of liver cancer for both primary liver cancer and metastatic colorectal cancer. And we view the TheraSPHERE product as a platform technology that can be leveraged into other radiation sensitive tumors. And TheraSPHERE works by delivering a high dose of radiation right directly into the tumor. And this is in contrast to external beam radiation, which requires patients to have daily trips to the hospital over a several week period and it can be quite difficult for many patients. And TheraSPHERE offers a single treatment and it's convenient and cost effective for patients that have liver cancer.
And it also has some advantages over the other Y90 option that's available in the market. Because TheraSPHERE is made from glass, which allows for a higher dose of radiation to be delivered directly right into the tumor. In fact, it has 50 times the dose per beat than the other Y90 option, which is a meaningful difference. And TheraSPHERE will be supported by new clinical evidence, which we anticipate will read out over the next 12 months or so. And we're assuming that the market continues to grow at this high single digit growth rate.
So positive data from these trials could be a nice meaningful growth driver in this market in particular to TheraSPHERE. And so additional upside from that would be to expand into new cancers that I touched on earlier, such as lung or maybe brain or prostate, as well as any other type of geographic expansion such as bringing TheraSPHERE into China. And each TheraSPHERE case utilizes a number of delivery tools such as a catheter or a guide wire, which previously wasn't part of the BTG portfolio. So now when we come together, we'll see this complete portfolio be a really nice revenue synergy and a way for us to serve our customers in a much more effective and efficient manner. So with that, let me turn it over to Cat, who's going to now touch on paclitaxel, as well as some more specifics around some of our future growth drivers.
Great. Thank you, Jeff, and it's a real pleasure to be here with you. My name is Kat Jennings, and I'm the Global Vice President of Marketing and New Business Development for the PI division. As many of you know, last week, the FDA held a special panel meeting of the Circulatory System Device Advisory Panel following the report of increased mortality with paclitaxel devices. Boston Scientific has over 20 years of experience working with paclitaxel eluded through a polymer.
Our Eluvia stent utilizes the same design principles used in coronary drug eluting stents, namely a drug embedded in a polymer that allows for controlled sustained release. Because of their similar design, we believe that the coronary data with Texas can be leveraged when looking at safety data for Eluvia. Texas SIS data in almost 2,800 patients randomized versus bare metal stents showed no difference in mortality at 5 years. This data set has 3 times the number of patients that were included in the CASANOS, FDA and VIVA meta analysis. And these randomized trials were designed to be pooled.
This stent design has been used in over 6,000,000 patients worldwide and we believe that if the signal existed with this controlled delivery mechanism, we would have seen it in the coronaries. Last week, we laid out why we believe drug eluting stent is unique, safe and effective. Our unique polymer based design allows for 2 key attributes. 1 is the lowest paclitaxel dose of any product on the market, in some cases up to 20 times lower than DCBs. And 2, the lowest particulate burden compared to other paclitaxel devices.
We have seen no safety signal with Eluvia and Eluvia was not a part of any of the meta analysis showing a safety signal either performed by Doctor. Katsanos, the FDA or the VIVA Group. We have 5 year data on almost 2,800 patients with Ataxa stent, which has the identical design principles with no safety signal. We also presented brand new 2 year data on Eluvia at the panel, including a statistically significant reinterventions at 2 years versus our control arm, ZILBR PTX, the only other drug eluting stent available on the market. In terms of number needed to treat, we showed that you only need to treat 7 patients to avoid a revascularization at 2 years versus the PTA control arm and the FDA meta analysis, really demonstrating the unique benefits of this differentiated technology.
I wanted to share some of our perspectives from the panel. 1st, while the panel did say that they see a signal from the various meta analysis, which as a reminder, Eluvia was not a part of, they did say that it was difficult to understand the magnitude, the clinical significance and the cause of that signal. However, when speaking about the benefit of these devices, the panel was very clear that they've reduced revascularization and that physicians and patients should continue to have access to these technologies. I thought one panel member summarized it particularly well when he said that the known clear benefits of these devices outweigh the potential risks, especially when looking at the totality of the data. We won't know more until the FDA issues its updated guidance, but we are encouraged by the constructive conversation at the panel.
Eluvia is an important growth driver for peripheral interventions in the U. S. We continue to open new accounts and we just started our unrestricted launch with full supply in Japan. And we continue to be optimistic about China approval in 2020. We would be the only drug eluting stent in that market.
The RANGER program, which is our drug coated balloon, also continues to progress well, and we recently submitted several modules to the FDA and are completing follow-up on our clinical trial as we speak. We anticipate that our COMPARE data, which takes RANGER head to head against Medtronic's impact balloon will be available in Q1 of 2022. That's a 414 patients randomized across those two products. And we have heard from physicians and healthcare systems that this type of comparative data is really valued by them, and we continue to expect that RANGER will be approved in 2020 in the United States, followed by Japan and China. Finally, our SAVAL program takes the best attributes of Eluvia and modifies them for use below the knee for critical limb ischemia.
As Jeff mentioned, critical limb ischemia is a large and underserved market with significant unmet clinical need. We are the only company bringing a drug eluting stent to this challenging calcified vascular bed, where we hope to see the same differentiated results we've seen with Eluvia. SAVAL received FDA breakthrough designation, the first in the peripheral branch and our trial is over 1 third enrolled. Once approved, we believe TAVAL could become a frontline therapy for the millions of patients that suffer from critical limb ischemia. To summarize, we're currently modeling a drug eluting market that is $700,000,000 in 2022.
As the market recovers, assuming the FDA does not further limit the use of paclitaxel technology, we believe our differentiated DE portfolio with Eluvia, Ranger and Saval position us for leadership in this important segment. I'm going to now switch to our venous franchise. As Jeff mentioned, venous disease is a large underserved market and we're building a best in class portfolio to treat that disease. On the left hand side of the slide, we have an armamentarium of venous stents with our recently launched VICI stent, which is being well received in the market. We also have Angiojet, our mechanical thrombectomy system, IVUS catheters and an high pressure ultra high pressure balloon in development, representing a $1,000,000,000 market by 2022.
Importantly, we'll be the only company that can offer this full portfolio of devices that a physician may use in a treatment for either deep vein thrombosis or deep venous obstruction. Through the BTG acquisition, we'll double that addressable market by entering into pulmonary embolism and venous insufficiency. The ECOS device has the largest data set in PE with hundreds of patients in clinical trials and a commanding leadership position in the interventional PE space. Jeff touched on SENTRI and the opportunity to reenter the vena cava filter market. And the last product from BTG that I would like to touch on is in Venus is Verathena.
Verathena is a strong competitor in the fast growing non thermal, non tumescent segment of the over $400,000,000 superficial venous insufficiency market, commonly known as varicose stains, where it competes with Medtronic's VenaSeal. We continue to hear physicians share their positive experience with product and with strong reimbursement in place in the United States, we continue to see significant growth in that category. We also continue to place bets on new and innovative technology like Intervene to help us continue to build out our portfolio for future growth. Similarly, in interventional oncology, we added to our market leading portfolio of delivery and embolic products with best in class therapeutic offerings. And similarly to our strategy in Venus, we continue to place small bets in interventional approaches to treat hard to treat cancers like Renovo Rx for pancreatic cancer.
As Jeff outlined, BTG's TheraSPHERE and cryoablation product lines build on our category leadership strategy. They're viewed as highly differentiated and enjoy market share leading positions in their respective categories. Cerosphere is commonly chosen because its unique glass bead design allows for a greater radiation load and potentially more effective treatments. KOLs in this space repeatedly tout its unique therapeutic effect. While the cryoablation system is easier to use with less cumbersome setup, thinner needles allowing for easier placement for physicians who are for physicians and are designed to provide a better kill zone.
There are 2 XEROSURE trials, as Jeff mentioned, that we expect to read out within the next year, STOP HCC and EPOCH. Positive results from either of those trials would represent upside to our current projections. In addition, BTG has a microwave ablation system in development that's on track to launch next year, which would complete our portfolio of therapeutic offerings in interventional oncology. BTG enables our entry into a greater than $1,000,000,000 market by 2022 for local regional therapies to treat tumors, with these technologies that have earned market leading positions in the U. S.
Boston Scientific would be the only company to offer a best in class delivery embolization portfolio with our coils, microcatheters and guide wires, as well as a best in class therapeutic offering with TheraSPHERE beads and cryoablation. Thanks, please. These platform technologies and as we learn more about BTD's research activities, we see additional applications for these unique therapies to treat some of the most challenging cancers, including lung, prostate, liver, pancreas and kidney. These cancers affect 5,000,000 patients annually. Tumors that have historically responded well to radiation therapy and where we can get a catheter our potential target for TheraSPHERE.
And this technology is able to deliver a much larger radiation dose than external beam radiation. Additionally, an opportunity for local regional therapy to complement and potentially enhance the efficacy of immunotherapy is an extremely exciting opportunity. Because TheraSPHERE and cryoablation help debulk tumors and break up tumor fragments, they help they may help patients respond to immunotherapies more effectively, making these therapies synergistic instead of competitive. These indication expansion opportunities would be above and beyond our current assumptions for BTG and would be another growth catalyst for PI. And in the near to medium term, we have a great opportunity with global expansion.
BTG's revenues are highly concentrated in the U. S. Market and we see a tremendous opportunity to bring these breakthrough technologies to patients around the world, expanding their global reach by putting these products through our commercial engine where approved and where we have consistently delivered double digit growth. And using our regulatory capabilities in places like China Japan to bring these products to those markets faster than BTG may have been able to on their own. Asia Pacific continues to be a critical growth driver for the division and there also represents some of the largest opportunities for BTG products.
Half of the world's primary liver cancer patients are in China and China represents a great opportunity to bring these new technologies to help these treat these patients in a less burdensome way. And last but not least, Japan represents the 2nd largest market for drug eluting technology, where we continue to see fantastic excitement around Eluvia and our entire drug eluting pipeline. So to summarize, we operate in large underpenetrated disease states where our highly differentiated product positions as well for sustained above market growth based on our category leadership strategy, which is only accelerated by our acquisition of BTG, creating a PI division that's engineered for growth. With that, I'd like to welcome Kevin, Sean and Ian up on stage.
Good morning, guys. Good morning. Hi, Mike. So this is the last leg in our Triathlon of Business. Hopefully, it feels like an Olympic distance Triathlon and not a test of survival Ironman.
So let's jump right into it. We've got a lot of compelling opportunities in our interventional cardiology business. So I'm excited to tell you about those and I appreciate you being here today. So this continues to be a very exciting time for the field of cardiology and our division is fueled by numerous possibilities. Each day our teams focus on delivering results while diversifying and also growing our business and we built a large profitable coronary therapies business that's very stable and it's foundational to the overall company.
Now the success of this business has also enabled us to reinvest and develop a top tier structural heart portfolio, where we can leverage our global commercial experience to drive growth in this market and the investments we've made uniquely position us to accelerate and strengthen our category leadership position within interventional cardiology. We compete in large and compelling markets, markets that are changing the foundation of how we deliver care to cardiac patients. And our focus is on developing less invasive approaches in cardiology to improve and in some case even save the lives of patients around the world. When we start out as a coronary focused business, we've now since translated that deep expertise into developing minimally invasive approaches in the structural heart arena. So last year, our interventional cardiology division delivered $2,600,000,000 in revenue and we grew 7%.
Now contributing to that, our structural heart franchise grew 50% and we're just getting started with the global impact of our TAVR portfolio. The overall cardiology market continues to gain global significance, and we expect it will grow around 6% annually over the next few years, led by double digit growth in structural heart. And we believe there are many more patients that can benefit from the technology and innovation that these markets inspire. We built a team and we built a breadth of portfolio that we believe uniquely positions us to capitalize on these markets and be a preferred partner to our physicians. The coronary market is large and stable.
It's an $8,000,000,000 segment. It serves as our foundation. And we expect the combined structural heart market will reach a similar $8,000,000,000 size over the next few years, enabling BSC in our space to compete in a $16,000,000,000 global market. And our broad portfolio that we believe is the most comprehensive in the industry will make us a formidable competitor. Strong markets, deep expertise and laser focused execution have enabled us to deliver consistent growth.
And we anticipate the potential for acceleration in the future as we solidify our coronary leadership and establish ourselves as a very strong structural heart competitor. The recent launches of LOTUS Edge as well as SENTINEL's have gained good early momentum and our ACURATE system continues to be the fastest growing valve in Europe. With the success and also with the success of WATCHMAN, our LAC business continues to grow impressively, and we expect to be the only player in the U. S. Market for the next 18 to 24 months.
So over the past several years, we focused our R and D investment portfolio on growth and diversification. And this diversification strategy has been intentional. It's the result of significant and thoughtful choices on investment in our portfolio and in our commercial organization. Category leadership in this broad field required us to lessen our reliance on a single product category like DES, which we all know was a high concentration of our revenue mix several years ago. So complex PCI has taken a much more prominent role in our coronary portfolio.
And in 2019, we expect structural heart to represent over 25% of our revenue mix, up from 10% a few years ago, and we anticipate that approaching 40% in the next few years. We recognize that our path to sustained IC leadership really requires strong execution across 3 fronts. So first, protecting our position in stents second, extending our leadership in complex PCI and third, disrupting the fast growing structural heart market. So while diversification will maximize our growth, protecting and enhancing our market leading coronary therapies franchise remains a critical pillar in the strength of our overall business. The coronary therapies market, which includes stents, complex PCI and PCI G or imaging is a substantial $8,000,000,000 segment that encompasses over 5,000,000 PCI procedures on a global basis annually.
And for over 2 decades, Boston Scientific has focused on building expertise in this market and has become foundational for our division and for our company. We set out with a vision to pioneer meaningful technology and bring that to physicians, and we've been rewarded as the market leader in coronary since we launched our first drug eluting stent in the U. S. Way back in 2004. Innovation and a global focus have enabled us to create a highly diversified business.
And in 2019, we expect that more than 50 percent of our coronary revenue will come from our non DES business and more than 60% of our revenue will come from international markets. In fact, next year, we expect Asia Pacific will be our largest contributing revenue region in the coronary portfolio. So we've been shaping this market for years, but we remain just as committed and focused on its continued success and to the patients that will benefit from it. We continue to invest in clinical science. We've got more than 50 active clinical trials, which will enable us to bring new therapies and new indications to our physicians and their patients.
And in any given year, what you should expect from our coronary team is to bring between 510 new products to physicians around the globe. Our leadership in this space in coronary is the result of intense focus on diversification even within this segment. So we talk a lot about diversification of the overall interventional cardiology business. Even within coronary, we've got over 20 distinct product families. And so we're uniquely positioned to look at the full PCI procedure that we've been developing and investing in a full portfolio of devices to treat the most complex and challenging cases.
So in the past, many of these cases had to go to surgery, but through innovation, through physician training, through improved workflow, we're now able to help physicians treat the most complex cases with less invasive procedures. And as a result, our complex PCI business has been growing double digits in the recent past. In fact, we expect our non DES coronary business to reach more than $1,000,000,000 this year and be larger than our stent business. So our team in coronary has the broadest portfolio of any player in the market, and we continue to invest in meaningful technology to expand that leadership position. Through our global network, we continuously find new product opportunities.
For instance, we're focused on improvements for the treatment of calcium with our recent launch of RotaPro and we're working on ways to simplify that procedure further with an electric version of Rota. So both of these technologies are expected to grow the overall calcium market by making them accessible to more physicians. Additionally, we want to use technology to improve PCI decision making through improved FFR and IBIS tools. High value complex PCI tools create a unique portfolio advantage for us. We're also continuing to iterate our ship synergy product line, which includes expanding the size matrix, creating a dedicated large vessel spend and developing a new extra deliverable catheter.
Additionally, we ran a large clinical study, EVOLVE SHORT DAP, to assess the shortened DAP duration in high bleeding risk patients. And we believe the mechanism of synergy with its unique early healing benefits is particularly well suited for this patient population. And we anticipate the results of that study will be presented later this year. So through meaningful innovation, through consistent execution, we expect to maintain our position in stents and extend our leadership in complex PCI. And then that will enable in the coming years for us to maintain growth at or above the levels of the overall coronary market.
Now, I'd like to turn to what I believe is one of the most innovative and fastest growing areas in medtech, our WATCHMAN LAC franchise. Approximately 33,000,000 people around the globe suffer from AFib. And WATCHMAN, as you know, is a left atrial appendage closure device that offers patients with non valvular AFib a one time implant that provides a lifetime of protection from stroke. In this quote from Marjorie, who is one of our patients who had challenges with being on blood thinners, describes succinctly how many WATCHMAN patients feel after receiving the implant. At our last Investor Day meeting in 2017, we had treated approximately 30,000 patients at that time, patients like Marjorie with WATCHMAN, and we anticipated doubling that number within 18 months.
Now 2 years later, as we stand here today, we've exceeded those expectations. We've actually tripled that number and estimate that we've now treated more than 90,000 patients cumulatively. But importantly, during that time, we also laid a strong foundation for continued global growth. We've seen an approximate 50% increase in U. S.
Reimbursement since FDA approval, making the procedure more economically viable for the majority of the 550 plus hospitals across the nation performing WATCHMAN. And we also reestablished our market leadership position in Europe earlier this year and anticipate expanding our position with WATCHMAN Flex in Europe, which received CE Mark in Q1. And in China, the adoption of LAAC with Watchmen has been outstanding, and we've more than tripled that business since the last time we met. In fact, we expect China to treat more than 15,000 patients in the next 2 years. We're just scratching the surface on local reimbursement.
Japan is another key global market with great potential for us, and we're going to learn more about that opportunity once reimbursement is established this fall. So together, these opportunities give us confidence and continued strong performance from this franchise. Now we've been innovators across the board when it comes to this category. One of the most critical areas that we've talked about in the past, but a critical area of focus is on reaching the patient. Given the elective nature of the WATCHMAN procedure, we believe educated and motivated patients play an absolute key role in driving consideration for this therapy.
So beginning in 2017, we piloted a patient awareness campaign in select markets to learn how to identify and engage with these patients. And using highly targeted digital approach overlaid with selective cable TV buys, we connected the right patient population and drove implant growth. But what surprised us the most during this campaign were the tens of thousands of patients that took proactive steps wanting to learn more about this alternative therapy. So results from those pilot markets gave us confidence to expand the campaign nationally. And through the power of a multi channel approach, we expect to reach the majority of Afib patients in the U.
S, exposing them to this potential therapy option. And we found that connecting with patients via TV, online and in office at the same time is much more powerful than any single channel alone. Once the patient is engaged, their journey is not over. So we've also invested in significant patient nurturing programs to help them through the entire course of their journey in determining if WATCHMAN is right for them. We've obviously also made very significant financial investments in engineering investments in product innovation to build on that leadership and outcomes, workflow and ease of use.
And I honestly couldn't be more excited about our next generation watchband device called Flex. And to tell you more about that product, our portfolio as well as our clinical portfolio, I'd like to now introduce Ian.
Thanks very much, Kevin. It's a great pleasure. Good morning, everyone.
So it's my pleasure to talk about
the WATCHMAN Flex device. Now you've seen on the previous slides, the Watchmen's original device was a parachute shaped device. So it was open ended. And you can see here very clearly Watchmen Flex is enclosed. It's rhomboid in the structure.
It has 18 laser cut paired struts, which make it very conformable and 18 specifically designed anchors to allow it to seal very well. Now the benefit of this device, the WATCHMAN Flex, is that it will be able to treat more anatomies, more different shaped anatomies and therefore reach more patients. And the way that the device has been designed allows much more control during delivery. In fact, actually, you can lead with the device ahead of the sheet. That's very important.
The left atrial appendage is a very thin walled structure and being able to lead with the device and land gently, particularly in shallow left atrial appendages, is going to make a great deal of comfort for the physicians being able to do it in a traumatic fashion. And of course, because it's more conformable and it feels better and because the screw in section of the valve is actually being flattened off. We believe there's optimal healing capabilities here and less likelihood of having a leak. Now thus far, we have substantial data already. Patients in the clinical FLEX review U.
S. IDE trial, record recruitment speed. We're now in follow-up phase for that. And because of the European rollout, we have more than 1,000 patients who've had experience with Botulinflex so far. And the physician feedback from that experience, both in the Pinnacle Flex trial and the European rollout has been very good.
Now to attest to that, we have a video here from some leading physicians who can speak to some of these features and validate some of these design features that I've spoken to.
So the first time I had the Flex device, I had 2 reactions. 1, when I looked at the device, I saw that it closed back on itself. Just based on that, you know that's going to be a very traumatic dose, less challenging complications that you maneuver in that in the last The three words that would use to describe Flex would be atraumatic control and precision. The most important thing for me is the atraumatic nature of deployment for the Flex. Watchman Flex has really changed my perception because even I've always said the lobe and disc because it's better sealage.
Once you use a bunch of flex with 18 struts, it comes from so well with the artificial appendage, it feels it almost perfectly. The criteria for Flex really requires an appendage that's only half as deep as it is wide. Suddenly, more patients are eligible that would not have been eligible with the previous WATCHMAN device. The previous advantage I find with WATCHMAN Flex, especially for new users, is that you can completely recapture the device and use the kit. I think Watchmen Flex is going to be a game changer.
It's going to improve the safety of the procedure. It's going to
improve the effectiveness of the
validation. I think the words you've heard there, atraumatic. You've heard ease of use. You heard simplicity. You heard good feeling and game changers.
So we're very excited about this technology, and we do believe that this will actually suffice the vast majority of patients who need left atrial appendage closure. But it's not just simply a question of the technology. You have to expand the evidence base as well. Now we believe there is an enormous opportunity to grow robust evidence to broaden the patient population that we can treat. Now currently, we're focusing our evidence on the penetration into high bleeding risk patients, educating physicians about what we have learned from the PROTECT and PREVAIL trials, very important approval studies.
And now, of course, we're conducting the ASAP2 trial in truly contraindicated patients. But moving forward, there is a real opportunity to expand this to lower and moderate bleeding risk patients. And of course, our first foray here is with the Option trial, 1600 patients, 130 sites patients who have undergone pulmonary vein isolation for the treatment of atrial fibrillation are being randomized 1 to 1, WATCHMAN versus DOAC. This will provide us very important insights into this low risk population about the benefits of left atrial appendage occlusion as opposed to DOAC in the post ablation patients. We're also planning and evaluating the option of a true head to head trial against DOACs in all comer patient populations with the eye on whether this could be ultimately a first line therapy obviating the need for long term anticoagulant therapy.
So we're incredibly excited about this option. I'll hand back to Kevin. Thank you.
Great. Thank you, Ian. So hopefully you can tell why we're so excited about this novel and differentiated technology with WATCHMAN. It's really a key component to our structural heart portfolio and it's helped us develop a lot of new capabilities that we can apply to other areas. So the other key piece of our structural heart business that's a key component obviously centers around our valve portfolio.
And with the recent commercial launch of LOTUS Edge, this is a very busy and very exciting time for us in this space. And to tell you more about this business, I'd like to turn it over to Sean McCarthy, he's our General Manager for Structural Heart Valves.
Thanks, Kevin. Well, Structural Heart Valves continues to be one of the largest and fastest growing segments in medical device. And in TAVR, it's going to continue. This is continually going to expand globally. We're already only in about 15% of sales generated outside of the U.
S. And Europe. So you think about global expansion is going to be tremendous, as well as broadening of indications. We're seeing lower risk patients being treated, TAVR now becoming the percutaneous standard. So for sure, TAVR continues to grow.
And in mitral, I'd suggest that we're probably starting to step out of the emerging market status and maybe more of a growth mode, where we're starting to see more evidence supporting, especially in the repair category, the future growth that we expect out of these businesses. So in essence, we have called what we're expecting to be a $9,000,000,000 market by 2024, vast majority, roughly $6,000,000,000 of that in the TAVR landscape and close to $3,000,000,000 of that in mitral therapies, again, primarily in the repair segment. And we believe we are uniquely positioned. You think about our 40 year history with cardiologists who are the primary physicians involved in these procedures, both aortic and mitral. So in terms of the landscape that we see and being able to disrupt the established players, we're well positioned.
Because as we look forward to how do we make our investments, we think about meaningful innovation supported by compelling clinical evidence surrounded by the world class service that you know Boston Scientific has already generated across the business units you've already seen today, we do the same thing and the same commitment happens in structural heart valves. Our patient centered approach to innovation drives the portfolio that you see here. As a matter of fact, if we were to go back to the last Investor Day, can anybody tell me how many of these devices were actually on the board and we were actually selling? And to cut to the chase, one of them. One of these devices is the safari wire.
So in a reasonable short period of time, we have established a portfolio that's incredibly impressive to our physicians most importantly and the patients that they serve. So how is it that we drive innovation? It's all about the patient. So if we think about in the TAVR landscape by example, what matters most to them in terms of the best outcomes, right, limiting mortality, driving the greatest benefits that happens when we reduce paravallvular leakage, when we prevent stroke, when we improve pressure gradients and lower pacemaker rates, and then of course, we lower vascular complications. Well, the beauty is our portfolio uniquely addresses all of those things.
So when you think about LOTUS Edge, it's designed to offer the best in class PTL. When we look at the proprietary SENTINEL device that we acquired, we're preventing stroke. It's a protected TAVR procedure. It's a proprietary landscape that we own, 1st and only to that market so far. Accurate is designed to give us those optimal low gradients and also lowest pacemaker rates, as well as iSleep, which is our expandable sheet that allows us to access smaller anatomies and reduce vascular complications.
In mitral, we recognize a toolkit of solutions will be required and we're extremely proud about our investment we made and Kevin mentioned closed earlier this year, a foundational investment, which mimics the cornerstone in mitral surgery. Is exactly what the surgeon starts with. Protect the annulus first, make sure you leave all options open for the future, and that's exactly what we do. You could even argue we enable future interventions with the way we first take care of the annulus. Our dual valve portfolio, we're incredibly proud of this portfolio.
It's essential to us being uniquely positioned in disrupting the landscape. Basically, each of these valves on their own can be a workhorse valve, but each of them also have unique characteristics that will separate them from others on size of these cases. For example, if you look towards the middle, you can see that we are in a unique position, the only company to have a intraannular and supraannular valve. So why is that important? Well, you could think about the early cases that have already been done with intraannular devices.
As those patients come back, it's hard to put a valve inside of a valve without limiting your grade you start to put pressure on your gradients, you start to reduce flow, you're acting like a stenosis that you're actually fighting against, might you consider and physicians do starting intraannular and then you follow-up a superannular. So the ability for a single company to provide all of those options to physicians, we believe is incredibly powerful. So beyond the Workhorse elements, you can see the devices on their own also have unique benefits to important markets, some of those identified in the middle section. So if we think about the bicuspid valve arena, 1 obviously we're studying right now with LOTUS Edge, we see that about 15% to 20% of all TAVR procedures worldwide are bicuspid valves and about half of the cases in China, fifty percent of TAVR procedures. So that's an important market as well as heavily calcified native valves.
And both of those segments important, those heavily calcified native valves also by 15% to 20% of the market. So you put those pieces together and those are really well suited for the design intents that we laid out with MODIS Edge. But then let's also think about more tortious anatomies, small annulus, we think about horizontal aortas, these are also challenges, 15% to 20% of the market there, wonderfully suited for the accurate valve and the optimization of a top down deploying valve that's very easy and straightforward to deliver. LOTUS Edge, we're extremely excited about our launch, obviously selling both in Europe and the U. S.
And we believe we're offering unmatched control and predictability. It's designed to give physicians what they want on the table acutely, but also give patients what they need over time, the chronic long term solutions. We have designed LOTUS Edge to deliver the best in class PDL outcomes to nail your delivery exactly where you want it, never have a mouth position, having superior stroke rates as seen in their study in REPRISE 3 and also competitive pacemaker rates. And as you know, we're commercializing both in Europe and
in the U. S. As we speak.
Our launch plans are controlled and measured. They're basically focused certainly early on on the REPRISE 3 centers or centers that have had experience with us, but we've got a great distribution, large, medium and small and whether it's academic or otherwise, it represents the market in our early days of launch and it's going extremely well. Our focus is to drive sticky adoption, right, to make sure as this product is different than original LOTUS and it's unique because it's the only repositionable and retrievable valve on the planet. So of course, we want to make sure we're doing the exact work we will as a world class organization to train physicians to use and reuse the technology. So our focus will be to launch in roughly 150 accounts within the 1st 12 months of launch and then soon after we'll start to increase the rate of new customers.
Early indications I would suggest are very positive. We can share with you some anecdotes and some quotes. Some of you were at the TBT Conference in Chicago just a couple of weeks ago, but if I could share a couple of those key quotes with leading physicians in our marketplace, one of them suggested with LOTUS perfection is normal, We're normalizing perfection and nothing else feels like LOTUS Edge. So those are impressive comments. At TBT, we had cases done in Bonn, Germany and also at Columbia Presbyterian, just north of us up here in New York, where the physicians and the panelists said, it's great to see your results before you release the valve.
Talk about the confidence that you give to physicians and the entire cath lab. And maybe I could even ask Professor Meredith, who was in one of the top TAVR volume centers on the planet just earlier this week, doing some cases. And maybe, Ian, a couple of thoughts on this edge?
Yes. Thanks, Sean. So on Monday, I was assisted in 2 cases in California, 2 incredibly difficult cases. The first patient had severe annular calcification and subannular calcification, which is always the risk of annular rupture when you do balloon dilatation or balloon expandable stent. Person also had critical coronary artery disease and they were worried about paravalvalvular leak from the severe annulus calcification.
We deployed an appropriately sized LOTUS valve in under 10 minutes. We did that with no paravalvalvular leak, no pacemaker, no other complications. Most importantly, we were able to reposition the valve once just to obliterate the paravalvalve for the leak, and that was all done without either pre or post balloon dilatation. The second patient was a patient, very overweight patient, severe bicuspid valve disease, gross calcification. This is the most challenging cases for our all valves.
Again, we did it under 10 minutes. No parabolic leak, no pacemaker, no complications, case done.
Thank you, Ian. So we're going to continue also enrolling in the REPRISE IV. This is the intermediate risk study that started earlier this year. It has a bicuspid cohort and component. So exciting to say that we continue to drive our pathway to broadening out our indications.
But in addition to the dedication and efforts by so many Boston Scientific employees with a winning spirit to bring back LOTUS Edge to the market, we've also been moving forward. So behind the scenes, never anything other than a relentless effort to drive innovation forward. And you can see that the next generation valve we're focused on is Lotus Mantra. This is a next generation valve designed to offer a shorter frame height, which will improve coronary access. It has an open cell design at the top of the valve, which you can see there, which will also help to reduce the risk of any intraannular valve thrombosis, and it also generates the optimal radial force inside of the LVOT, which will also help us to further drive down rates of pace maker.
So our initial focus will be to bring the LOTUS NACHA valve out in the 29 millimeter size that will come out in our current delivery system and that allows us to broaden out the size matrix and basically participate in the larger currently available market. Next, we'll offer Lotus Mantra across all sizes in addition to putting it on a new motorized electronic delivery system. The idea of a time that delivery system is to provide additional superior ease of use, also acute performance, but it also allows for self centering of the valve, which will also help to drive down pacemaker rates even further. We expect the LOTUS Mantra 29 on our current delivery system to be in worldwide clinical trials in the first half of next year and then in 2021 for the remaining sizes plus the motorized electronic delivery system. Excitingly, Acurate Neo is a self expanding superannular valve that remains the fastest growing valve in Europe as it's become widely appreciated for its ease of use and allows physicians in a top down deployment to provide outstanding clinical results.
And we saw those earlier in our SABITF1000 patient registry, which was the basis for our European approval. In that data set, ACCURATE NEO was shown to have a 98.7 procedural success rate, a low single digit moderate and mild PDL rate. It had a single digit pacemaker rate. It had a 6.5 minute average device usage time and it had 0 coronary obstructions. So in essence, that's been a huge driver of why we've been able to maintain our ASPs while tripling market growth in countries where we've launched.
And we've recently received approval also in France, one of the largest markets in Europe. So not only approval, but reimbursement, we're excited to drive further penetration as we're opening up many accounts as we speak. I'd also like to share some very exciting new news for all of you. First time publicly shared that in fact the ACURATE IDE has initiated its enrollment. So we're very excited to kick that trial off.
This is a 500 patient randomized control trial that will also be supported by data already generated in Europe. Recall the SCOPE 1 and SCOPE 2 studies, randomized trials, roughly 1500 patients. So we'll combine those European data with the US500 patients, will serve as the basis of our PMA submission and FDA approval. But with LOTUS, we continue to invest in accurate futures as well. So never anything other than a relentless pursuit of meaningful innovation here.
Next generation would be the Neo 2 valve. Neo 2 basically carries all the great attributes of the original Neo, but it has an extended an elongated external skirt, which continues to drive down the rates of PBL, while maintaining these great pacemaker rates. We expect that to reduce leakage by an additional 50%, tremendous move in that neo2 valve. Then ACTRATE NEO Prime has enhanced radial strength throughout all sizes and expands also to include an extra small and an extra large size range. Accurate Prime will be the first out in this product family to be launched
in the U. S. And then
of course, NextGen Acura, don't stop there. The NextGen is a lower profile valve to support improved delivery accuracy and a smaller vessel size indication and also reduce PDL even further. We have a bit of a revolutionary ceiling system we're not ready to share just yet with you folks, but we're going to do all of those things while maintaining best in class pacemaker rates. So we expect the ACURATE IDE enroll the U. S.
Randomized trial enrollment to conclude early next year, okay. So then the basis of that would be a U. S. Approval estimated in 2021, followed by approvals in Japan and China in 2022. So there's more to TAVR than simply the valve itself clearly, and it's an entire procedure and I talked a lot about those patient benefits that we need to ensure like low PBL rates and one of the items brought up there also was their stroke rate.
And to make sure that we are going with the grain for patients, it's the right thing to do. If you ask physicians, would they choose to use a SENTINEL device or a protection on their family member or their friends and every hand gets raised. So to that end, we're proud to have a product like SENTINEL in our portfolio. We've introduced the technology to roughly 200 accounts in the United States and those that have adopted the technology are using it roughly 65% of their procedures. So that ends up being about a 15% of TAVR penetration, 50% of TAVRs in the U.
S. Are receiving SENTINEL at the same time. That's both with our technology obviously and without as we're just launching LOTUS Edge, which is exciting news because you think about the future growth that's available to us, We're just getting started because that would mean we're roughly in less than 20% of roughly about 20% of the accounts and yet we're having all that growth in front of us. Importantly, CMS has also come back and proposed that the NCAP, the new technology add on payment that was put in place specifically for SENTINEL, it's only 1 of 9 devices CMS actually has this NTAP code for, we basically have been allowed to continue that NTAP through 2020 and actually have an increase. They're going to be raising the level of reimbursement for sites that do qualify by about $400 if that goes into effect that would happen in October.
So we also see the benefits of providing direct and referring physician education and our customers that use SENTINEL value the ability to reach out to physicians and market their ability to offer protected TAVR. We see that geographically where a physician would start and then use Sentinel at a high rate and then the other hospitals follow because those patients and the referring physicians understand the value of a protected TAVR procedure. So as we go a little bit deeper into the clinical program, I'd ask Ian to talk about why this technology is so important.
Thanks very much, Sean. So as with any medical device that is used in the treatment of a significant condition, there are 3 Ps that matter: the patient, the prosthesis and the procedure. And we can iterate the prosthesis as much as we like. We can't really change the patient, but we can do a lot about improving the procedural outcomes. And this is where the Sentinel device plays in.
From the very outset of Tabby, we knew that there were 3 powerful predictors of mortality: vascular complications, paravalfil leak and stroke. And stroke is perhaps the worst of these, is dehumanizing. It is debilitating and people never recover fully from a stroke. You live with the consequence of that forever. Now it's true to say that the rate of stroke is underestimated.
I think we all know that. And more importantly, who is going to have a stroke during a procedure is entirely unpredictable. Data that has been established thus far hasn't shown any relationship to physician volume or center volume nor to any specific TAVR device. And if you look at the totality of the large trials, 15 plus trials of, in recent times, more than 8,000 patients, the average stroke rate is around 4%, and about half of those are disabling dehumanizing major strokes. In trials where stroke ascertainment is much more thorough and a more meticulous approach to assessment of the patients before and after by a neurologist with imaging shows that the rates can be as high as 9%.
And there's a cost to this. And there's a significant cost of stroke, not just in patient morbidity and the suffering that the patient actually has, but in the length of stay, in the hospital costs and the 30 day readmission rates. All of these things add a significant impost on the system. Sentinel actually works. We know that there is a 3% to 4% absolute reduction absolute reduction in the risk of periprazedial stroke at 72 hours.
So the number needed to treat is around 25 in order to prevent a major event. We also know that there's about a 60% to 80% relative risk reduction from the number of large registries in the rate of stroke in the 1st 72 hours. This is supported by significant body of evidence showing that captured and removed material in the embolic filter is around 99%. 99% of the filters are containing material that would be trash emboli to the brain. So all of this actually points to an important role for protected TAVR by supporting the patients from one of the most devastating complications, namely stroke.
Finally, to finish this session, last but certainly not least, it's important to say a few words about our martial program. Now you can't be a category leader or a true success in structural heart disease without having a role in mitral valve disease and indeed tricuspid valve disease. Why mitral first? We're an aging population. The main problem with aging is the development of heart failure.
And functional mitral regurgitation is a critical element of age related heart failure. As we speak, there are more than 53,000,000 people on the planet with severe functional mitral regurgitation, 53,000,000. By 2,030, that number will be in excess of 84,000,000 people. And if you take the entire population of 2,030, that's nearly 380,000,000 people with mild, moderate or severe functional mitral regurgitation. Now as you all know, functional mitral regurgitation, the leaflets are actually normal.
It's just the annulus that's being pulled apart. And so the primary approach should be repair first. The leaflets are normal. There's nothing wrong with them. You don't need to deal with them.
You just need to get them to collapse and bring them back together. And as Sean said before, the market for mitral valve repair is large. As you all know, we acquired the Millipede device earlier this year. This is a percutaneous transvenous transseptal complete semi rigid annuloplasty ring. It is a foundational commitment to any mitral toolbox.
Now we understand that the mitral valve has a number of different ways to fail, particularly early and late in the disease process, And no one single therapy is going to be ideal. But it all begins with treating the most common cause of functional mitral regurgitation, annular dilatation. And as any surgeon would know, it's about the annuloplasty to get the leaflets to co opt. So a little bit on Millipede. As we said, it is a transvenous, transseptal, semi rigid annuloplasty.
It's the cornerstone of our toolbox. It is predicated on what we know from surgery. It is fully customizable. It's fully repositionable and it's fully retrievable up until the time that you uncouple it. Now when a surgeon does the mitral valve repair, they do that with the heart cardiopledged with the circulation through an extracorporeal system.
So the heart isn't beating, it isn't pumping. So you can't tell how well the mitral valve repair is until you actually reestablish the circulation. The absolute beauty of this device is that you're actually creating your endoplasty in a beating heart and you can actually see the integrity of the co action of the leaflets under a fully pressurized normal situation, something that surgeons can't do and something that surgeons immediately appreciate when you explain it to them. The best part about this device is that it leaves options open for future therapies. You're not interfering with the leaflets.
You're using the predicate and you're leaving options open. So perhaps I could just show you a little bit from this video of how the device actually works. This is a cartoon, but it is a good representation for how the device actually works. Again, as I said before, transvenous, transseptal. So this is a surgical view looking down on the mitral annulus from the left atrium from above.
The device steers very much like a mitral clip. You land the device on the annulus and then you anchor it. Now we've got over the anchoring issues because we've got an integrated intra cardiac ultrasound that allows you to see the tissue integrity circumferentially around the annulus as you're screwing it in. That's critical because now you can avoid hitting the circumflex or the coronary sinus. Once you've anchored it, then it's a case of just manipulating these sliders to cinch the annulusine to the desired level to get the coaption.
If that's adequate, then you simply uncouple the device and remove the delivery catheter. If it's not, you don't uncouple it, you simply take it out. So this really is a foundational tool for mitral valve repair in the largest valve market there is. That's mitral. That's nearly 300,000,000 people by 2,030.
Very exciting time.
Perfect. Thank you. So also to put a specific date to it, as some of you may have seen in the bottom of the chart, we do expect to be with Millipede in an early feasibility study next year. So progressing this category forward to drive a continued waves on a PEACH growth strategy for the structural heart valves business, both aortic and mitral at Boston Scientific. So I would just maybe end this segment with who better to bring structural heart and cardiovascular innovation to life than accompanied with this 40 year history.
And you think about the relationships we have obviously with physicians, but also with the hospitals themselves. To give you a sense, most of the TAVR centers in the world are doing business with us at some level, but more specifically in the U. S, about a third of the TAVR hospitals buy more than half of their volume, more than half of their cardiovascular volume from our coronary therapies division. Additionally, TAVR centers also, those that are out there, about 80% of them are already doing WATCHMAN procedures. So you take that, you combine it with the 200 plus centers I talked to you about with regard to Sentinel adoption, you have another 300 customers with that leading wire we talked about previously, Safari wire.
It gives a great conduit to bring new innovation forward like LOTUS Edge. We have the relationships in place and we're proud of those relationships and we know that a big part of our future is going to be delivering on their expectations of a world class organization like us that they've seen historically carry that forward into the field of structural heart. So we're going to continue to invest in our sales force. The interventional cardiology group has a lot of responsibility to support these sites. So you know we have a very large presence and a commitment to developing this technology and to introducing it the right way and surrounding our physicians the highest level of customer service that they've grown to expect from Boston Scientific.
Kevin?
Great. Thank you. Thanks, Sean and Ian. So just one last slide here, kind of a teaser slide as we move to Q and A. So you can see with what's been presented so far, we've got a really exciting chapter ahead in interventional cardiology and I am confident that we're just getting started.
But beyond the sizable opportunities we described, there's also a long runway of meaningful innovation in adjacent markets that in my mind will be driven primarily by interventional cardiologists. So these include areas such as tricuspid valve repair and entire suite of interventional heart failure tools in the important area of circulatory support. And we, BSC, have got several investments, many venture investments as well as some in some cases internal programs aimed at these significant markets. So we look forward to highlighting those more in detail at future events as those opportunities mature. So with that, I'll hand it back to Susie for Q
and A. Great. Now I'd like to have Cat and Jeff join us again and questions for our cardiovascular team. Go to Larry here in the front.
Thank you. Larry Biegelsen, Wells Fargo. One for Jeff, one for Ian. So Jeff, the $700,000,000 in 2023, if I have the number right, for drug coated technology in the peripheral. What do you think the run rate is right now?
My guess is about $300,000,000 or so. What gives you the confidence that we can get to that $700,000,000 based on the panel last week? And Ian, this first head to head study comparing WATCHMAN to novel anticoagulant, PROG 17 of late breaker at ESC, is that an opportunity or a threat for WATCHMAN? How should we think about that? Thank you.
Yes. So coming out of the panel, our view is that the dialogue at the conclusion of the panel was very constructive. And just yesterday, the FDA posted answers to the 12 questions. So if you haven't seen that, I would encourage you to take a look at it and look at question number 8, which is around the risk benefit ratio. And I think that sort of points us in the direction that in our view, the FDA will likely come out with a statement similar to what the first letter is that these devices indeed have a very strong benefit and that physicians should educate patients around the potential risks.
We think the FDA will do this in the next month or 2. And if that's the case, then our view is that the market begins to recover here in the back half of this year and then grows heading into 2020, could be double digit growth to get to this roughly $700,000,000 in the next 3 to 4 years. And we're modeling this somewhat off of the coronary DES because this is what we experienced over a decade ago is, takes a little while for the market to sort of digest it and then move on. And of course, we believe that we have a differentiated position with Eluvia. And so in a lot of these patients that are at high risk of restenosis, this is where Eluvia shines.
And I'm sure you've seen that data. And then on top of that, we'll have Ranger coming next year. So we think that the market will begin to recover sort of beginning next year, and then we'll have a decent shot at having a good chunk of that market
growth. Ian, on next?
Yes. Thanks, Larry. So short answer to that is we don't see it as a threat. We see it as a potential opportunity. A small study.
If we are really going to test non inferiority to DOAC therapy and shows, say, perhaps the leading advantage, the trial will need to be many thousands of patients, not that small. So I think it will provide us insights. There are methodological differences with the PRIZE17 trial. We see it as an opportunity not a threat.
Our mic please.
Hi, Matt Hanksick from Credit Suisse. Thank you. So question on the long term market for structural heart. Numbers have come up since the last time you presented. You've gone out a year.
If you could talk maybe a little bit about some of those elements that have changed between your $6,500,000,000 2021 estimate, your $8,000,000,000 2022 estimate. What are the components of that? And I have one follow-up.
Yes, I can take that. Thanks, Matt. Yes, I don't know how much they've changed necessarily, but I think it's important to just kind of ground on kind of the buildup up to that market. So if you say structural art now at a growing in 2022 to about $8,000,000,000 market, it would be roughly that's the timeframe we're talking about the LAC market roughly approaching $1,000,000,000 plus or minus. You've got mitral that in that time is probably $1,500,000,000 on its way to $3,000,000,000 by 2024.
So that puts TAVR being the balance at 5.5 ish or upper fives by that time period. And that I think that's fairly comparable to the competitive calls. It might be just slightly under one competitor, but I think we're all in the same kind of ballpark.
Okay. That's helpful. And then on the rollout LOTUS and then clinical strategy for ACURATE, You mentioned you're going to go to sort of existing clinical experience with LOTUS first. And you have a set of clinical centers enrolling or beginning to enroll now for ACURATE. If you could give us some sense maybe over the next year, year and a half, how many U.
S. Centers do you think you'll have running clinical studies for TAVR, various trials for various devices?
Yes. I'll let Sean expand. I mean, I would just say in general, a lot of these bigger studies are 40 plus centers. So when we run intermediate risk trials, when we run an accurate IDE, you might be talking about 40 to 60 centers. And so I think that if we've got multiple trials going on at the same time around the same patient population, we tend to not want to overlap centers having them enrolled and compete with themselves for patients with their own devices.
So if we've got unique clinical trials, you might get upwards of 70 ish centers going at any one time if there's overlap. And we've got a lot of trial activity planned, obviously, in both products over the coming years. So I don't know if you want to expand any more on Just to
add that of the 40 to 50 that are in each of those studies, as mentioned previously, we expect from a LOTUS U. S. LOTUS launch to be in roughly at about 150 accounts in the 1st 12 months. So the balance obviously being outside of those 50.
Thanks so much. Thanks. Let's go to Matt Taylor there. Matt Cruz to your right there, white shirt and beard.
Thanks, Susie. Matt Taylor from UBS. So I wanted to ask a follow-up question on panel commentary. I guess, two things. One is, could you help us understand what you think still kind
of needs to be ironed
out from an FDA perspective or just their communication to clinicians to help everyone sort of understand that right risk benefit? And then following that, what do you think the right kind of patients or the typical patients are going to be who will be treated with these drug eluting technologies? And could you comment on your own mix? How much Ranger versus Eluvia do you see kind of growing in your forecast?
Yes. So I think there is a perception amongst physicians and healthcare systems around the medical legal issue. And I think that if the FDA comes out and makes a statement similar to their first letter that indeed the benefits outweigh the risks, I think that will lift a lot of the uncertainty for physicians and healthcare systems, especially here in the U. S. There is we estimate up to 40% of hospitals don't even have paclitaxel devices on their shelf.
So the use is 0. So if the FDA makes a statement similar to the first letter and then they reintroduce products back on the shelf, that will provide a meaningful growth catalyst for the market. And I think our view what will happen is the FDA will ask for labeling changes, which I think is entirely appropriate. I think they will ask for some sort of trial, whether that be a registry or some other type of trial. I think Eluvia is in a unique position because we have a very large randomized trial going on right now in Europe, studying Eluvia against bare metal stents.
So the FDA is very interested in the outcome from that trial. So I think Eluvia is well positioned. And we obviously believe in the benefits of Eluvia and so we think kind of unbalanced that Eluvia will carry the bigger growth for our drug eluting franchise, especially as we launch it in new markets such as China next year. And the beauty about what we're doing is we're offering physicians choice and we're sort of in that unique position where whatever they believe is best for their patient, it's like we've got the tool for them. And so I think as we introduce Ranger, we can support them in any way, shape and form, both at the hospital system level, also within the lab.
Great.
Thanks for that answer. I just had one follow-up question, if I could. Just want to ask Kevin one on LOTUS versus ACURATE. Could you just comment on how the reintroduction is doing in Europe? And what you might expect the mix to be there?
And if it would be different than what we would see in the U. S. And why?
Yes. Thanks, Mike. Good question. And I'll Sean, you can expand if you'd like because you're in the field every single day. But I would say in Europe specifically, it's a little different situation obviously in the U.
S. Our European team has enjoyed a great product like Accurate for the last couple of years. So they've got momentum with Accurate. Having said that, about half of our accounts that we've launched thus far with LOTUS are in Europe. And so there is enthusiasm.
I think you started to sense that at PCR, and that's built since. I would say the predominance of the mix in Europe going forward for a while will be inaccurate. I think there's momentum there. I think in terms of where we want to focus, primarily right now, the U. S.
Market is a great opportunity for us because we're starting from nothing there. So I think long term, we'll see how the mix plays out. If you fast forward a couple of years when we've got both products approved in any given market, We'll see how the mix played out. I think Sean represented nicely intraannular, superannular. Some physicians are more comfortable with the self expanding valve, some like a mechanical valve and some appreciate different kind of clinical features of each valve.
So I think we'll be relatively agnostic over the long term. In terms of that mix, we're committed to having pipelines in both. And the market frankly will tell us a lot. I mean, I think this next 6 months, the back half of the year is going to be pretty informative to us as well in terms of the adoption. But we're encouraged thus far.
It's early innings with LOTUS. But I think the one thing I'm confident on with LOTUS is that this valve has a role in the market. It brings something different to the table. So I'm not leaning forward giving predictions on share uptake, but I know that it's got a clinical role and our physicians are making that clear. So long term, we'll see how that mix plays out, but Europe will be a little more heavily tilted toward ACURATE for the foreseeable future.
I probably said it was impossible to say.
We'll go in the middle here please to Danielle.
Hi, good morning. Danielle Antofy with SVB Leerink. One question for you, Jeff, and one for you, Kevin. On the follow-up on the panel from last week. And just curious how you're thinking about how FDA will approach new product approval.
So it sounds like you're confident that Ranger will come to market next year. What gives you that confidence? Are you hearing something from FDA as to
how they're thinking about products that
haven't yet come to market?
Yes. So I'll give you 2 data points that give us confidence. I think the first was the discussion at the panel about future products and future clinical trial endpoints. And they reaffirmed that a 12 month endpoint was appropriate and following the patients out to a full 5 years, which is what we were already doing with RANGER. And then second, we have continued to file modules with the FDA and enroll patients in our trials.
None of that has changed and everything is going according to how it would normally go if the panel wasn't taking place. So both of those things give us confidence that things will move forward.
Okay, helpful. And then, as it relates to LOTUS, so it feels like one of the overhangs still a little bit out there on the market is the PACER rate. When will we see any updated data just specifically to LOTUS Edge and potentially lower PACER rate?
Sure. Great. I'm going to kick that to Sean, get him back in the Q and A game here.
For sure. And I would just start by saying, recall that the changes that we had made to the technology from original Classic Lotus to what is currently Lotus Edge, it is a different product and a lot of those design improvements were driving down pacemaker rate from the original rates of 30% that you might have heard early on in the technology, all the way down to 12% in the latest clinical data set. So technology helps, procedure evolution for sure helps, training and education helps. I would just say this, we'll have to see how the data plays out here, right, over the next several months. But the idea is we're incredibly confident in what we're seeing right now in the technology.
We do have additional studies that are ongoing right now, so REPRISE 4, the intermediate risk study, as well as the nested registry, which was part of our FDA submission, our capturing data points. And what we'd like to do and we expect to do is probably see something later this year. So we won't wait obviously for those large studies to be done. The market would expect an answer sooner. There's also independent studies that are happening for sure.
And so I would say between now and end of year, you'll see more waves of data coming out on LOTUS Edge. And again, we expect to be very competitive.
Joanne? Joanne Wuensch from BMO Capital Markets. Two questions. The first one is, where do you stand on thinking about competition entering the market for WATCHMAN? You've really developed this market and had a great runway.
How do you think about that?
And then I'll quickly ask my second one. Can you discuss the Millipede clinical trial design that you expect to start in 2020? And we're hearing more and more about sort of annuloplasty and clipping types of procedures being done at the same time. How do you think about integrating that?
Great. I'll start. Thanks, Joanne. Great question. So our preference would be competition doesn't enter the market for LAC, but that's probably wishful thinking.
So I think the short answer to this is, we've had we launched first in the U. S. In 2015 and the U. S. Market for LHC is the predominant market right now.
And that will over time international markets will come more on board. But I think we've had the benefit of trailblazing the market, learning about these patients, really helping establish centers and patient referrals and patient flow. WATCHMAN Flex is one of these products as well that I grew up in engineering. So I've got a lot of experience in product development. I would say over that time period, every once in a while a product comes along that potentially will weigh exceed your expectations.
And for me, this feels like we've got that type of product on our hands with WATCHMAN FLX. Now we got more to do. We have to prove it, but I think WATCHMAN FLX is going to put further distance between us and competition, along with just a very rich set of clinical data. So those coming behind us need to kind of establish that same level of clinical comfort. And so there's a whole ecosystem beyond product and clinical in terms of the how we're engaging with the centers and making workflow more simple and things like that, that I think are all very helpful.
But our goal is just to be the act like a market leader and continue to try to stay 3 steps ahead. So competition is inevitable. We understand that, but we feel pretty good about our standing.
I can deal with the second 2 part question. I'll deal with the second part of your So there's a long history outside the U. S. Of doing that sort of procedure with direct and indirect annuloplasty devices is to bring the leaflets to closer to co option so that you could actually click. So those procedures exist.
The truth is that if you could actually do an adequate annuloplasty and get the appropriate degree of coaptation, you may not need martial valve replacement or Cortal Repair. So, mitral valve replacement or caudal repair. So yes, you can do those procedures, yes, they will happen. But the ideal would be to have the best possible annuloplasty first and then there is no need for a clip because you've got the right degree of coaptation of the leaflets. To deal with the first part of your question, which was asking about the CEE study in the U.
S. And if things go well, that would roll out to a CE Mark trial. Obviously, we have to establish the efficacy and safety of the procedure in the centers in the U. S. And develop the outcomes and understand the outcomes before moving to an IDE based trial.
Maybe to add on real briefly, I think the COABT trial was obviously great for patients and for the field. And so that opens up some degrees of freedom potentially. And we're not that far along with FDA discussions, but it opens up some degrees of freedom to have reasonableness in trial designs in terms of whether it's not inferiority trials, device versus device, but more work to do there, but I think that really was a helpful trial for many reasons.
I should add that, as I said last year at one of the meetings at DCT, the COAPT trial is a foundational moment in history because it's the first significant trial to show that treating functional mitral regurgitation can save lives and reduce hospitalization. For the 40 years prior to that, it was merely speculation. So we have to pay credit where credit is due. But is that the right technology necessarily for the treatment of functional mitral regurgitation? Well, perhaps not.
Okay. I think with that, actually, we'll move on to our final two speakers, Jeff, Kat, Kevin, Sean and Ian. Thank you very much. Our final two speakers are spotlight on emerging markets, and we'll wrap up with Dan and the financial outlook. So it's my great pleasure to introduce June Chang, who is our Vice President and Managing Director for Greater China.
Thank you, June.
Thanks, Susie. Great, great to be here. I think this is a very exciting time to be part of the Boston Scientific Emerging Market story. It's actually also good to see a couple of familiar faces from the investor events we had last week in Shanghai. Emerging market having a steady growth driver for this company over the last few years.
It has a nice growth of 20% in 2018 and reached over $1,000,000,000 in revenue. Countries like China, Russia, Brazil continue to execute on its local strategy and we anticipate that growth trajectory will continue about 15% over the next few years. Our long runway remains for our business to improve patient outcomes in those regions and that would contribute about 150 basis points to our overall company growth. Now, when we look at our emerging market, our success is driven by both portfolio and the capability expansion. Portfolio expansion has been particularly focused on endoscopy, urology, peripheral intervention and the complex PCI.
Many of our products have been able to enable developing markets to transition more towards minimum invasive technique, which ultimately we believe improve the quality of care as well as lower the overall cost of care. And that's why you see us leading in those regions because of the significant investment in physician education. And we know in order for us to reach as many patients as possible in those markets, Emerging market demand an incredible amount of flexibility and our willingness to adapt for different business models for those regions and for those markets. At the same time, we're also working very hard to increase our presence, R and D presence and manufacturing. We now have R and D presence in China, in India and we have manufacturing facility in Malaysia as mentioned earlier.
Now let me switch gear and dive deeper on China. China medtech market remains to be one of the most attractive and high growth markets globally. Boston Scientific China today placing a total addressable market of RMB 3,500,000,000 growing at a 15% CAGR and we expect it to reach about $5,000,000,000 market size by 2022. The growth is highly supported by strong fundamentals, aging demographics, unmet patient needs. We talked about AFib, there's about 10,000,000 patients AFib patients in China, 4,500,000 patients have failure.
PCI procedure volume will exceed the case volume in U. S. For the first time in 2019. And there's a tremendous opportunity in those underserved markets in lower tier cities and lower tier hospitals. Now there was tremendous runway from a commercial opportunity standpoint, we do know China market is dynamic and complex.
The U. S.-China trade war has created a lot of uncertainties, A few words on the tariff impact, we don't have any manufacturing facility in China, but we do import a lot of finished goods from outside the U. S. So the cost impact on our China financial so far has been very manageable and limited. Now there are growing concerns over other aspects in terms of market access and hospital listing.
So far, we haven't really seen any major, major large scale retaliatory treatment. Now we're all looking forward to the G20 meeting between the 2 presidents in the upcoming weekend in Osaka. We don't anticipate a quick lift on tariff, but we can see how the whole trade war plays out. The second big headwind certainly is about the price erosion. Now China tender system has been extraordinarily comminatory, very complex, the tendering at a hospital level, at a provincial level, at a central government level.
There's a lot of talk about the national tender on DES. We know the magnitude if that scenario occurs, the magnitude of the price cuts on standard business will be significant, probably much bigger than what we've ever seen in the past couple of years. Having said that, on the other side, there will be tremendous volume upside to compensate for the price reduction as what we have witnessed on the farm side. Now we know China has also been having a very, very complex market access system to get product registered in China has been very, very tough and challenging. And certainly local competition has escalated to a different level.
A lot of local playlists, we see them started to reach scale because of the international expansion. And we do see local products are getting more and more sophisticated. They're no longer me too And they were able to claim first in market status. So how are we doing in China for Boston Scientific China? We actually have been doing quite well.
We delivered a very, very strong track record of high double digit growth from both top and the bottom line. We've been outpacing our competition, gaining market share, specifically in our whole portfolio IC and PI. At the same time, we've been able to diversify by bringing new products to the market and growing our business in WATCHMAN and mass search. Today, on the right hand side, you're going to see we have a very well diversified portfolio and we believe we're in a very, very strong position to compete and capture opportunities in fast growth segments as we continuously reduce our revenue reliance to the DES. So how are we going to sustain such high rate of growth looking to future?
Our strategy is actually quite straightforward. We're going to be focusing on 4 pillars portfolio strength, innovative channel expansion, local partnership and talent development. Specific to portfolio strength, a prime example for us is our Watchmen business. We're very fortunate to be the 1st in marketing China, our WATCHMAN got CFDA approval way ahead of the U. S.
Approval. And to promote the therapy awareness, the China team actually orchestrated the world's first 72 hour live pace broadcast, which covered about 19 centers across the U. S, Germany and China with total case volume of 79. So at any time during that 72 hours, a physician could log on to the stream and view live cases. As Kevin mentioned earlier, we've completed about 8,000 watchmen cases in China already.
Despite the tough local competition, we remain to be the market leader in that space. And we know how important it is to transition in China. Boston Scientific China is one of the very first few companies that have established the dedicated training facilities. We have the most number of training facilities, 1 in Beijing, 1 in Shanghai, couple of co founded with large hospitals and we're about to open another one in Chengdu sometime this fall. So as I said earlier, innovative approach to channel expansion has served us very well in the last few years.
When we look at the landscape of the go to market strategy, go to market model in China, majority of the business is still very much on the distributor model. And over the years, Boston Scientific China has built a very, very strong IT infrastructure and some innovative programs to allow us to activate, segment, train and empower our dealers, which has allowed us to significantly expand our footprint and increase our hospital coverage. We just announced a strategic partnership with a local platform dealer, which we're going to specifically target lower tier hospitals. By the way, this is very, very consistent with Chinese government's goal to shift more healthcare resources to improve the patient access in those lower tiers. So with those kind of new and cost efficient models, we're expecting to double our coverage in the next couple of years.
Today, Boston Scientific China, we don't just sell device, We are actually a very active participant in the healthcare ecosystem. Last year, we launched a T3 engine, which is an innovation acceleratorincubator partnering with Tsinghua University. It is an open platform that is designed to attract the healthcare talent and to allow us to have access to more local startups. We're in our year 4 of a partnership deal with a top tier cardiologist led group to accelerate and support more local research and product development. And we're going to continue to do more of those partnerships with various stakeholders in the ecosystem and to expand our presence in China.
Now, a few last comments on our culture, as I truly believe this is one of the differentiating factor for us to play in the market. As we accelerate our business in China, we're now able to provide a much more dynamic platform to grow our employees. As you can see, we have a very young and diversified workforce, average age is about 33 and almost 50% of our managers are actually female leaders. At the same time, we also have perhaps one of the most seasoned commercial team and the market access team in the industry. Our strong execution capability has allowed us to bring many of our innovative ideas to fruition in the marketplace.
So let me just do a quick wrap up here. We know we have some tough headwinds in China. We believe Boston Scientific China is in a very strong position to succeed. We're excited about our short pipeline. And we know we have the best team on the ground to run those operations.
With that, let me turn over to Dan for financials.
Thanks, Jun.
No doubt, a lot of exciting opportunities in the emerging markets, particularly in China, but as well in other emerging markets. We're in the home stretch. So I changed the horseracing, I guess, from the triathlon analogy. But last section, finance, then we'll get to Q and A. So hopefully, over the last 5 hours, you've heard Mike and the team and you have a sense of renewed confidence in what we can do as a team over the next 3 years and beyond from our perspective.
We're showing you through 2022 today, but we run the company for the next 5 to 10 years. So you have that relative to our revenue outlook. My job over the next 15 minutes is we give you that same level of confidence in our financials. So I like showing this slide at each Investor Day. It's pretty simple in its purpose.
Take what we said we were going to do 2 years ago and compare it to what we actually did. So we showed this slide in June of 2017 at our Investor Day for what we said for 2017 2018 and a review of that compares quite favorably to our predictions. Organic revenue, we grew 7%. Operational revenue, we grew 8%, both exceeding the high end of what we had talked about. Adjusted operating margin, we got to 25.5% in 2018.
Adjusted earnings per share, 15% growth over the 2 year timeframe. Importantly, years 5 6 on a journey of 6 straight years of double digit adjusted earnings per share growth. And really, almost one of the most important things, adjusted free cash flow, we added almost $450,000,000 $448,000,000 of adjusted free cash flow in 2 years. So as I look at our report card and we'll show you this again in 2 years at our next Investor Day, as I look at our report card, I give us good marks for the global team for what we were able to achieve over the last 2 years.
So going forward, this is a nice look of
what we have for the last 3 years and the 3 years going forward with this year kind of in the middle. So, 1st column on the left, 2019 guidance. I think most people are familiar with this. Organic revenue, this is full year current guidance. Organic revenue, 7% to 8% operational revenue 110 basis points, so 8.1% to 9.1 percent adjusted operating margin 50 basis points to 100 basis points on top of last year's 25.5%, so 26% to 26.5%.
Importantly, this year, our impact from FX is said to be neutral. That's pretty important as the last few years, that's been a headwind we've had to overcome. So it's nice to see for us. Adjusted EPS growth 10% to 13%. That does include the $0.07 one time tax benefit that we had last year in that 10% to 13%.
If that were to happen, that would be year 7 in a row of double digit adjusted earnings per share growth for the company and a target of adjusted free cash flow of $2,200,000,000 So you put that all together as a composite for the last 3 years and you take the midpoint of guidance for 2019, so how did the company do the last 3 years? Organic revenue, 7% operational, 8% adjusted operating margin, we added 125 basis points over those 3 years. The FX impact was clearly a headwind, 2019 neutral, but 2017 2018 a clear headwind, so a net headwind over that period. Adjusted EPS growth of 11% and free cash flow growth of 13%. So very proud and very solid performance of 2017 to 2019.
Mike touched a little bit on these goals here for 2020 to 2022 and what we think we can do. It would largely be an acceleration from what we've done the last 3 years. That's our goal. So 2020 to 2022 next 3 years, 6% to 9% CAGR in organic revenue, midpoint 7.5%, that would be acceleration what we did the last 3 years. Adjusted operating margin 50 basis points to 100 basis points improvement annually in each of those years.
Some years may be closer to 50 basis points, some years may be closer
to 100 basis points. We'll see
how that all plays out. Estimated FX impact to EPS, neutral. Where the rates are today, we look and we say, we think we can keep that neutral. Again, that'd be a great thing because that has not been the case for the last 5 to 6 years. But where we sit today, we would say neutral and we'll obviously keep you informed as rates move over time.
Adjusted earnings per share growth, double digit growth. So 2020 would be our 8th year, 2021 would be our 9th year and 2022 would be our 10th year in a row if we're able to achieve these guidance range, these goals that we've established. And then free cash flow growth of 10%, in line with the rest of that. So as we look at 2017 to 2019, proud as a team of what we've been able to accomplish. We've moved on.
We're now into finishing 2019 and heading out to 2020 to 2022 and we're focused on the execution to deliver that. So next three slides, let me give you a sense of how we think we can continue to grow and expand our adjusted operating margin, gross margin, SG and A, R and D, gross margin. So you look at the slide and there's a nice round 73 on the slide. I think we'd like to think we can beat that number over time. Our team has been and this only shows starting at 2015, we were in the mid-60s in 2011 and 12.
The team has done an awesome job of really driving improvements in gross margin. So like to think we could beat that. How do we do that? Reduce product costs. This is the bread and butter of what this team does every year.
Take 5% to 10% of standard cost out. Optimize the plant network, that's pretty simply, make sure you're making the right products in the right plants. Improve the portfolio mix, sounds simple, Dan, right? Just get into higher gross margin markets and get into higher growth markets, right? But it's been a big part of our recent success and something we're keenly focused on continuing going forward.
And then the playbook approach for integration with our acquisitions, as you know, a lot of acquisition integrations ongoing today. To boil it down, when we acquire these companies, these tremendously innovative novel technologies, they're generally sized for lower volume, which tends to mean higher cost. What our team does goes in and transforms that to really increase the level of volume and capacity that they would have and as a result reduce cost. So it's a play we've run many times in the past. We're running it currently on the acquisitions that we have in the portfolio today and we'd look to continue that.
So gross margin should contribute on our journey over the next 3 years. SG and A, we've probably said very often that this is the area that has the most opportunity for us for many reasons. One being, it's where we lag our peers, when you look at us as a percentage of sales. 2, it just fundamentally as you look at what we have internally and the opportunities that we have, it provides the most opportunity for us to continue to advance against our goals. So how do we do that?
Optimization of global facilities footprint, again, that's pretty simple. It's lower cost of facilities, less facilities optimize those, less facilities, less plus dollars. The efficiencies in distribution and customer service, we've done some nice work outside the United States. I'd say the U. S.
Is almost a greenfield for us right now. A lot of work we continue to do in the U. S. Around that front. Leveraging the commercial sales and marketing, that's really in a couple of areas.
One being acquisitions. So when we acquire new technologies, the vast majority of those go right into the existing sales bags. And so as we have these acquisitions that are in our portfolio today, and we layer those into the bag, that's a natural leverage opportunity that we have for external for acquisitions, but we also have that for internal adjacencies that we've done. Think Lotus, think PVS, think Exalt, all those things will generate leverage as we go through and launch those technologies. A lot of great work going on in business process streamlining, robotic process automation, RPA, all the rage, I'm sure you've heard of it.
Actually, I'm proud finance is really leading the way in Boston Scientific with RPA, particularly in the area of tax. So think of tax return preparation. Yes, tax return preparation. It's we've been able to eliminate 1,000, literally 1,000 of hours of routine tedious processes for our tax professionals and set them loose on more higher value activities like forecasting and planning, better job satisfaction, better work life balance, and it also allows tax and finance overall and then in the G and A of the company to better leverage against the sales growth that we have. So RPA is something that we're really looking to broaden throughout the entire G and A platform or services.
Expanding Global Business Services, I would say that we have harvested the lowest hanging fruit there, but there's a lot of room we still have as as Mike talked about earlier, a tougher environment where they grow revenue much higher than the market, but they also are able to eliminate a lot of costs, set up centers of excellence, drop some of that to the bottom line and then also reinvest some of that in commercial facing resources. So it's a model that they've perfected and we're looking to share that across the company. And then a lean culture, that's simply getting all 32,000 team members at Boston Scientific all focused on that lean mentality, eliminating waste, eliminating non value add activities, non value add spend and making sure the spend we do goes towards helping the company achieve its objectives. So as we go through the next 3 years and our next stop on the journey here in our Investor Day in a couple of years, you should see SG and A lower on that path to 33.5%
by 2021.
R and D. R and D is really about efficiencies. It's not about reducing the amount of R and D we're doing. We actually think if we do the efficiencies right, we can actually do more R and D projects over time. This will contribute, I'd say, somewhat.
You see the numbers here, 10.5% by 2021. We're down from the high of 11.4% in 2015. It will contribute somewhat in the short term, but this is more of a long term. We talk about our 30% longer term goal. This will contribute more meaningfully on the way to that 30%.
How do we do that? Leverage and expand our R and D centers of excellence across the sites. We can continue to make better use of our global footprint in our India, China and Costa Rica sites. And as you've seen today, we have a lot of clinical trial activity as a company. That's a great thing.
It's going to continue. And what Doctor. Meredith and his team are doing is really looking to do it as efficiently as we can across the company, so that we can look to potentially over time drive that 10.5% down. As a growing company over time, I don't think we need to be at 10.5%. We can drive that down, still fuel the top line and just do
it more efficiently.
So that all adds up to this slide here, operating margin. You look back to 2015, 22.3%, again, proud that in 2018, we were 25.5%, so we had added 3 20 basis points. That's good performance. If you look at 'nineteen, 'twenty, 'twenty one, adding 50 to 100 basis points per year during that timeframe. And with a durably consistent growing top line, a continuous focus on improvement of those margins and a culture, frankly, where margin improvement is ingrained in that culture, we see no real reason why we can't get to that 30% plus and beyond.
Cash flow for Boston Scientific is strong and I think it's often overlooked. People tend to focus on the P and L and have kind of missed the strong story we have from a cash flow perspective. Obviously, operating margin and operating margin expansion and sales growth are kind of the life's blood of cash flow, but working capital management is a big piece of that as well. So if you look here, we've converted over 100% of our adjusted net income over the last 5 years to adjusted free cash flow. We plan to continue that trend.
And then when you look at accounts receivable, we've reduced our DSO and we've done opportunistic factoring where we can to help on the receivables front. On the payables front, we have implemented some very creative supply chain vendor financing initiatives, which have been very effective. On inventory, I wouldn't give us high marks. I wouldn't give the industry high marks and I wouldn't give us high marks. There's still too much inventory that we have in the system and we're working to kind of kick that curve and have less inventory relative to our sales growth.
And that's something that I would say we have not done yet and that's a big piece of the chapter over the next 3 to 5 years we're going to get after. Our capital structure, a great time and really an inflection point for our capital structure as well. It's amazing to think that over the last 4 years, 2015 to 2018, 2 thirds of our cash went to satisfy existing and contingent liabilities. So one would argue very non strategic uses of the cash. So we only had a third of that cash left to really help fuel the business and be put to a much more strategic use.
Look at the chart for 2019 2020, that's exciting. 95% of the cash in 2019 2020 and hopefully 2021 with what's on the balance sheet today and what we know can go to actually more strategic uses helping to grow the business, M and A, those types of activities. This would also include the $1,000,000,000 of debt pay now we have associated with the BTG acquisition. That's a strategic use, obviously, to bring BTG into the fold. So this is a really exciting time for us, because I think we've done well as a company, but we've kind of done that with one arm tied behind our back with only a third of our cash being available for those more strategic uses.
While I'm on capital structure, we always get a lot of questions on below the line expenses. So for us, below the line is our interest expense, the equity method dilution from our DC portfolio and the cost of executing our FX hedging program. This year, recall that guidance is $325,000,000 to $350,000,000 $325,000,000 That includes the make whole call that we had on the bonds that we issued in February. So as I look forward and think of the next 3 years, I think 325 is probably a good proxy for that number as we go forward. That obviously excludes any BTG related interest.
We will we talk about that once the deal is closed. But I think if you use 325 for below the line going forward, I think that's a reasonable estimate. M and A. So the traditional M and A is at the top of this slide and our venture capital portfolio at the bottom. The M and A is actually shown, it's not just a scatterplot, it's actually shown relative to when the meaningful revenue contribution should hit from each of those deals, right?
So a lot of deals up there, that's a great thing. We're excited about each of them. They cover most of the divisions. They cover a great kind of cadence of time. So you have some deals that were contributing meaningful revenue in 2018, some in 2019, some come in 2020, some will come in 2021, 2022, 2023.
We haven't done some deals, obviously, we'll do over time that will show up on the slide. So really exciting for us to be able to look at what we have from a traditional M and A perspective. And our VC portfolio, I would tell you, I think has done exactly what we wanted it to do. We set out to create
a portfolio
of novel technologies, novel companies, get in early, Series A sometimes in these companies and really drive new learnings about new markets, all with the goal when it comes time for those companies to exit, assuming they're successful, of being a well informed potential buyer. It doesn't mean we're going to buy any of them, it doesn't mean we're going to buy all of them. But when you get to the table, having been with a company for 5 years, maybe you had a Board observer seat, maybe you had some other type of strategic rights, you're just in an advantage position when you get there. We've seen it. We actually acquired we've acquired 5 of them.
Mike mentioned earlier, we acquired 4 in and 18 and we acquired Millipede in the beginning of 2019. So we've acquired 5 of these companies over the last 18 months, which has been a nice fuel for our and a pool for our M and A activity. So I will close these are really the 3 pillars of our financial brand. If you think of what do you want a company to do, if you're going to invest in a company, what do I want that company to do? Well, certainly, they call it revenue is the top line and it's the first line in P and L for a reason.
You need durable revenue growth. We've shown that over the past 6 years, but it's certainly for the last 3 years, 7% organic, 8% operational cater for 2017 to 2019, again at the midpoint of our goal for '20 to 'twenty two, that would be acceleration versus that. 2nd one, you want a company that consistently delivers adjusted operating margin expansion. I think this has been again, as cash flow has been, this has been kind of the hallmark of the company. We've done this extremely well as a global team over the last 6 or 7 years.
We don't plan on stopping now. Again, 3 20 basis points since 2015 and a goal to put 50 or 100 more on each year over the next 3 years. And again, with that long term opportunity to get to 30% plus. And then lastly, double digit adjusted earnings growth, 11% CAGR, 2017% to 2019%. It's a target we always have.
And if we're successful, as I said, in 2020, we will have done it for 10 years in a row. And that's a goal that we all hold as a management team. It's one of the reasons why I'm so excited about the financial future of Boston Scientific, and I hope you are too.
With that,
I'll turn it back to Susie.
Thank you, Dan. I would like to ask Mike and June and Ian to come back and join us on the podium here. We have just under half an hour for final round of Q and A. As they come up, I would just like to extend a heartfelt thanks to some folks who are behind the scenes today. First, our IR team, Miriam Marces gives a special shout out for the slides, Lauren Tengler, Matt Cruz and Robin Foreman.
Also huge thanks to logistics to Joanne DiFlaminio and to our partners in accounting, legal and Corp Com. So with that, I'll come with Raj first. Go ahead, Raj.
Thank you. Raj Denhoy from Jefferies. I wanted to understand the messaging around the revenue growth outlook. The guidance for this year implies about 7.5% at the midpoint. The guidance for the next 3 years is about 7.5% at the midpoint.
Yet from all the commentary up on the stage today, it does sound like you're pretty excited about the pipeline and potential for accelerating growth. And so I guess I'm curious how to reconcile those two things. And then also the follow-up to that is you're not giving us anything for BTG yet. And how should we think about the trajectory over the
next 3 years if that falls in as well? Thanks, Raj. A couple of things on there. One is, as I laid out at the very beginning, we like to actually hit our commitments and deliver on, hopefully exceed them like we've done in the last few Investor Days and we tend that trend to continue. If you look at that 6% to 9%, even at that 6 to 9 range, it's a wide range.
There's many variables that could lead to the upside and some variables that could lead to the downside. But I think if you look at the diversity of the portfolio and the volume of growth drivers that we have, there's not one single product that can make it. But if you look at the volume of activity we have, the portfolio we have, we get very, very comfortable with that range and the opportunity to obviously do well within that range. I think even at 6% to 9%, you're at the high end of the peer group. And our goal, as I laid out in the very beginning, is to accelerate our growth over the next 3 years versus the past 3 years.
So, at the midpoint, 7.5%, we've got many growth drivers that can improve that. And our goal would be 2 years from now to report out that we've delivered accelerated growth rate over the past 3 years.
It's helpful. And then maybe just one question on
the tax rate over the next 3 years as well. How does
that play into the double digit earnings growth you've outlined? Yes, I would see the tax rate being somewhat similar to where it is this year. So this year, it's 11% before stock comp, it's 10% after. I think a range of 11% to 12% over the next 3 years is a very reasonable pre stock comp. So 11% to 12% versus the 11% this year is a good range.
Sorry, here to let's go to David and then David.
David, this morning. Just a couple for me. Dan or Mike, just kind of a structural observation about the guidance this year versus 2 years ago. You're effectively saying top line is going to grow faster, earnings is going to grow kind of the same, right? So accelerating upper single digit top line, double digit earnings growth.
How should investors sort of think about that? Is that because that's conservatism as the top line grows faster? Or are you finding you have to just invest more to sustain these higher levels of growth?
As Dan said, we look at we showed a 3 year picture here. We're not showing a lot of the initiatives we actually have in place for the next three years. So when we look at it, we're always making trade offs. We have actually more good ideas that we could invest in. But we want to provide we want to deliver high end of our peer group on the revenue side and improve operating margins consistently.
And so we could if we wanted to deliver that high end of operating margin each year and potentially leave some on the table on the growth side for future years. So we think that 50 to 100 basis points of margin improvement is the proper mix that enables us to provide differentiated top line growth. And so as I said, we're very comfortable with that 6% to 9% range. There's lots of opportunity for upside based on BTG synergies there, clinical readouts, EXALT V, that significant structural heart portfolio that we have. I won't go through everything.
But you see the growth drivers that we have, but we're consistently balancing how do we be a top tier organic revenue growth driver, but also knowing we have room to improve margins, but we're not hastily trying to drive significant operating margin improvement quickly, as quickly as we could because we don't want to sacrifice the many ideas that we have. A lot of our spend is in clinical, about a third of R and D is clinical. They take a number of years. We're building out and strengthening our sophisticated commercial teams. So we think it's the right mix for BSE and Investors to enable top tier revenue growth.
That 50 to 100 is more differentiated than most of our peer group as well. So we think we are differentiated in top line and margin improvement and a consistent tax rate and a free balance sheet. So I think all that works. I think the key is we're just not playing for the next we're not playing to 2022. And so, we have many investments in number of categories that are in play that you didn't hear about that will impact kind of 23% to 25%.
And then
Dan just BTC in Jeff's presentation, he didn't reiterate the low single digit accretion for 2019. So can you still reiterate the BTT accretion targets for 2019? And as return thresholds have provided the kind of the ROIC at 9% to 10%, is that even assuming FTC driven or antitrust driven divestitures or strategic divestiture of the Pharmaceutical business, can you still hit those objectives if those things occur in the near term? Yes. I think unfortunately with BTG, we're going to have to wait until we close update anything there.
We're kind of limited with
what we can say.
Let's go VJ, Larry, then Rick. And just do one question now if you're on your 2nd round, so we can squeeze everybody in.
Vijay Kumar from Evercore. Thanks for taking my question. Mike, maybe on the revenue front. This year, the guidance is 78 organic and you had a number of headwinds, right? TBM got pulled off.
The way I look at the 69 outlook, the comps get easier for next year. Revenue should be in the solidly in the upper half of the 6% to 9%. What would cause you to and when you look at the product pipeline, it seems to sustain this momentum, right? What would cause you to come in at the bottom half of that range?
So, obviously, if we look at guidance for 2020 at the proper time here, we thought that was the right range for a 3 year period given all the uncertainties in the market. We didn't expect spinal cord stim to slow down a bit in the first half. And we didn't expect the paclitaxel piece and we didn't expect some of the China headwinds. But based on the strength company, we're able to offset some of those things and still deliver above pure growth and you see all these future platforms that come through. So I think it's a responsible guidance to give, 1st of all, so you can count on it and know we're going to hit it or beat it rather than miss that.
What would have to go wrong? You have to have a lot of things go wrong, we believe to hit at that lower end. You'd have to have lack of momentum in our structural heart business. You'd have to have paclitaxel kind of fall off the map. You'd have to have a bad case scenario in China.
You basically have to be in the kind of negative side of many things that we have, which we don't think that's the case. And so that's why you can that's why we provide that range. And again, I think it's a durable portfolio of assets with a lot of unique innovation. And most of it are in cases where we have depth of commercial presence. But you could just go through every piece and say, okay, what's the bad scenario and that's why we have a range and what potentially is
a good scenario, maybe there's upside there. Some pretty onerous assumptions to get to the low end. That's helpful. Just maybe one on China. June, you mentioned the national tender.
How confident are you of hitting the 20% growth in China, assuming that tender happens? And I think you guys sounded pretty excited about BTG opportunity in China. How long it's going to take for you to register those products? And maybe give us a sense of how big BTG could be in China? Thank you.
So I'm going to do the Yiwi Wang first. On the BTG, I think the time line is quite far out and probably not going to be the next one to 2 years. It's probably going to be 3 years out. In terms of the national tender, as I mentioned earlier, when you look at our portfolio today, our revenue exposure to DES has consistently been declining. Thanks to our global pipeline of innovation allow us to diversify in many of the faster growth segments.
Now, how are we confident in terms of national tender? As a matter of fact, I think the whole timeline of national tender and how the government will eventually administer that national tender, there are a lot of questions around that. As we'll be seeing from the pharma side, there's a lot of petition right now from the industry side to lobby, to petition the government. So we believe that the government will take a more cautious sort of approach to assess the whole mechanism. And the other wrinkle to that is the local players, their profit exposure to the DS market is actually very, very high.
So if that national tender occurs, it will affect a lot of the profit situation in terms of local med device company. And that is some a significant part of the implication that Zeko Domingo had to take into account. So there are a lot of moving pieces. And we have like I said, we have very, very strong HIGA team, tender team. We're working very, very closely with the administrators to figure out the details and specifics.
We're going to see how plays out next year.
Just a
couple of the points.
One, the Synergy stem, which does quite well, is unique with the spirozorb polymer. So we think that provides some unique characteristics in the tender. The other reason why we gave you a transparency to the China number was 5 or 6 years ago, it was drug resistant stents. Now I think it showed 17% or 8% 17% of that pie in China is DES, complex coronary is bigger. And so there's some exposure there, but the other parts of the business are getting so large in China.
And hopefully, we do well in the national tender given some of the unique characteristics. But much like the rest of the company, it's so balancing its other growth areas. So the reason we shared it, we did knowing there's some uncertainty in the tender. It's a small piece of our global business and a smaller piece within China. Thanks.
One question. Larry, I think it's the most part. But one question for Mike and perhaps Ian. One thing that was new strategically today
is the focus on oncology.
So what about the tax piece with RPA that Dan talked about? That was new. So Mike, can you talk about your vision for oncology? Do you see this as a standalone business with Boston Scientific at some point? The slides one of the slides talked about accelerating acquisitions in this area.
What are some of the gaps you have now in your on comp? Yes. So we don't see it as a standalone separate business within Boston. So what we have are beautiful platforms that fit businesses that we have now. And Jeff and Cat did a nice job of talking about BTG with liver cancer and all the rounding of the portfolio and Biola will be uniquely strong with interventional radiologists in that category.
But they also spoke about the one slide that Cat showed of the adjacent therapies that are of interest to us. And for example, one of those is in lung. So guess what, we've got a great capability in endoscopy with our pulmonary capability. So you won't see us create a separate oncology commercial group because they fit ideally within one of our business units. But what we'll do is we'll develop capabilities working together.
So we also have a tech team. So, we have a decentralized R and D group, but we have a very efficient tech group that doesn't look at a specific business unit and looks at therapies. And so, Jeff and Art will partner together on how do we bring lung interventional oncology to life, leveraging capabilities we have across the company, but the commercial model would fit better in Arch Group. Similarly, we have the same thing in urology. So, I don't expect this whole separate division.
That's more leveraging the R and D capabilities that we have. We have mechanisms to do that where we don't look at it by you, we look at BU, we look at it by platform. And then, we'll leverage our commercial teams when we widen out new indications, leveraging capabilities that we have and then bringing that to HVAC.
Rick Wise, Stifel. Just one question. Obviously, Dan and his team have done an amazing job on the balance sheet and the cash flow balance sheet relatively unencumbered to use your favorite phrase, Dan. But maybe if you reflect that cash free cash flow is going to, gosh, approach exceed $8,000,000,000 over the next 3 years based on your numbers. Clearly, M and A is a priority, but maybe talk to us, Mike, if you would, where else
is this cash going to go?
How are you thinking about it maybe these next 3 years relative to the past when the balance sheet was encumbered, you had a
lot of other challenges? And maybe as part
of that, explain to us when you're going to double the Investor Relations budget and thanks for all the excellent work. I think that's how Susie wanted me to say. Yes, I could start.
Great question.
Mike is really filling in the back end except for the IR part. It's a high class problem to have, right? We're super excited to be at the kind of the inflection point of a capital allocation perspective. So as you look, I won't pick a number, but a lot of billions of cash over the next years that we can deploy, we look at the ability to deploy that in smart tuck in M and A, kind of run the same play we've run, right? That's been successful for us for the last 6 years, continue that play going forward.
And then filling on the back of that with returning cash to shareholders over time. So it's a great place to be. There's really a tremendous amount of opportunity on the M and A front for us over the next call it through 2022. And it's an exciting time for us to continue to grow organically internally and augment that with some really smart deals from an M and A perspective, continue to invest in the VC portfolio and take those from seed to harvest over time. So I'm super excited for the next 3 years of that journey.
Steve? Thank you. Steve Lichtman, Oppenheimer. June, you had encouraging comments, I think, that tariffs on end market performance in China isn't significant. Can you expand a little bit more about what you're seeing as to how the tariff issues are staying siloed from demand dynamics and your outlook as to whether that changes or not, if this current tariff environment continues on for an extended period?
Thanks.
As I highlighted earlier, so far, the tariff on our financials have been very limited. As I said, about over 70% of our products actually imported outside the U. S, so from Europe to Costa Rica. Now how this trade war again going to escalate? I don't think anybody here knows exactly where it's going to stay at.
We do know we do anticipate, I don't want to speculate, but we don't anticipate that in our scenario, financial modeling, we don't anticipate that tariff are going to be lifted anytime soon. We actually did provide some stats about the cost impact on those tariffs. But we are working with our supply chain folks to look at optimize our supply chain network to shift even more of our products from U. S. Based to Europe, Costa Rica or even Malaysia.
And that would help us further mitigate our exposure to increase the tariff for China.
Just one big picture question. It's been a great 2 years for Boston Scientific. It's been a great 2 years for the medical device industry and there's now a lot of people invested in this space and one of the most successful in all of the S and P 500. So I guess, Mike, I'd love to get your perspective on just how you see the broader operating environment for MedTech today versus 2 years ago during your Analyst Day? What are the if there are any, what are some of the risks that you would point out kind of as we look forward for the next 2 years?
Just want to kind of compare the operating environment a little bit.
Yes. I'll start because I'm higher shop terms. I'll start with the positive. It's really amazing, the innovation opportunity. I think you always come to investors here about innovation.
If I look at the innovation opportunity in med tech and more importantly to us, the innovation we're embarking on over a couple of the next 5 years is really amazing. If you look at all the pieces that Art and the team talked about, how do you completely disrupt a very large market and pull through. If you look at the metabolic capabilities with diabetes and obesity with Axios, I'm just kind of picking on endo. If you look at what we have in structural heart, we didn't really talk much about it. Our other investments that we have in neuromodulation, partnering with rhythm management neuromodulation for these smart devices that are getting smaller and smaller and our AI capabilities and how do you whether it be rheumatoid arthritis, overactive bladder, we've got really encouraging clinical work going on in stroke and Alzheimer's.
So across the board, I think the innovation cycle that we see happening now over the next 5 years to me is uniquely strong versus legacy. And I think also specifically with Boston Scientific, you can take other companies that are in mature markets and they haven't found ways to innovate and grow in new adjacencies like this company has. And so, I think you have a DNA with Boston who consistently grow their core, but always finds new therapeutic opportunities and growth platforms. You saw it across each business. So I think you have a culture here that finds growth in these healthy markets and we change our portfolio mix and you combine that with a, I think, a really a nice wave of new innovation that's coming and you have a lot of positive there on the growth side.
And again, I think on the category leadership there, our customers know us really well and they trust us. I think that's all good. On the downside, I think you always start with price, but we model in price as you know declines each year in terms of our base operating plans. We tend to beat those plans. And as our exposure becomes lower and lower in drug eluting stent in CRM, that's actually a potential positive.
But you have the China tender risk issue. So we kind of bake in price, but we see some of that price actually improving as our profile of our mix changes. 2nd thing we always worry about is quality. We invest a lot of money in quality. We have excellent post market support in our quality and capabilities and systems.
And so you just can't afford a major hiccup in quality or things go right pretty quickly. The other thing that's more difficult now than industry last 2 years ago is the regulatory environment. Clearly, the European changes with the regulatory requirements in Europe are a significant investment for the company in terms of clinical demands, regulatory demands and also internal resources to bring those products to Europe and to have the right clinical data to support the MBR. That's a big I would say that's a pretty significant burden and a requirement for most companies. I think the bigger companies quite frankly will be able to handle that maybe a little easier than smaller companies.
But I think the regulatory environment is very fluid right now with a heavier impact in the EU and you saw some recent activities going on in the U. S. I think the more and more demands for clinical data, which is kind of in our wheelhouse, on the contrary, the FDA has been actually quite supportive of new breakthrough technology. I think the regulatory environment is probably more dynamic now than it was 2 years ago. I think the pricing environment is always there, but our portfolio mix is changing.
I think our innovation that BSE specifically is in is uniquely good.
Awesome. That's a good list in there. Time maybe for 1 or 2 more. Anybody else? Matt?
Matt, go ahead.
Hi, thanks. Matt, next to Chris. Just on that outlook and sort of innovation and what is pluses and minuses of growth over the next couple of years. I guess, I know Mike you mentioned earlier we're not giving fiscal 2020 guidance today, but I'd love to understand what some of the big moving parts are, where you're most confident, where you're less certain, what things you'll know more, say, in the next 6 months in order to sketch out what 2020 will bring?
Yes. We'll give a lot more details going forward. I think the area is probably the most question was the 25 questions that Jeff had on that paclitaxel panel. So lots of questions on that. So that one's a bit and Jeff gave you our answer, which he thinks is kind of a slowing and then an uptick.
And good news, we're seeing good things
in Japan. So I think that's a question going into 'twenty a little bit, but we're seeing strong momentum in our structural heart business. Art and team talked about the EXALT launches, which will be significant for us. I won't go through all the portfolio, but I just think we have a strong balance of positive things that can help offset unplanned or potential circumstances of the downside to deliver that 6% to 9% and we'll give you more guidance as we get closer to 20
percent. I think we've exhausted everybody.
All right.
Okay. Thank you very, very much for your kind and diligent attention. Appreciate it and Thanks, Ken.
Let's give it up for Susie Elisa here. Thank you very much.