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&D awards. Those products, plus the rest of our portfolio, are what enable us at Boston Scientific to improve the lives of 30 million patients each year and what drive us each and every day. My name is Susie Lisa. I'm the Vice President of Investor Relations. 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. 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-K, which have 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. I have two 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. Our financial guidance will continue to exclude the impact of BTG given that it has yet to close. 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 five and a half hours with us.
We'll start with a strategic overview by our CEO and chairman, Mike Mahoney. We'll get right into our business unit, starting with MedSurg, where we'll be kicked off with Urology and Pelvic Health, where President of MedSurg and UroPH, David Pierce, will be joined by our General Manager of the UroPH franchise, Meghan Scanlon, who I think will be new to many of you. We look forward to Meghan's deep dive on that franchise. 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, Dr. Brian Dunkin, who's our VP of Medical Affairs and the Chief Medical Officer for Endoscopy. We'll 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, Dr. Ken Stein, will lead the conversation there, going through our cardiac rhythm management and electrophysiology businesses. We'll then turn to Neuromodulation, where Maulik Nanavaty will lead the conversation, President of Neuromod, he'll be joined by Milad Girgis, whom 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&A with the entire Rhythm and Neuro team, then we'll give you a break before we conclude the afternoon, turning to our cardiovascular segments, where Jeffrey Mirviss, who leads our peripheral interventions business, will kick off the second half of the program. He'll be joined by Catherine Jennings, our vice president of new business development and commercial marketing for PI.
Then we'll conclude the business segments with Interventional Cardiology, where Kevin Ballinger, the president of IC, will be joined by our chief medical officer globally, Dr. Ian Meredith, as well as the general manager for Structural Heart, Shawn McCarthy. We'll then turn to do a deep dive on our emerging markets business, we're really pleased that June Chang, our general manager and vice president for Greater China, has come all the way to share insights into how she runs her business and the opportunities there. Then Dan Brennan, executive vice president and our chief financial officer, will conclude with the long-term financial outlook. We'll then have one final Q&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.
All of our speakers will still be here and are happy to answer any questions that weren't answered in the prior Q&A sessions. Hopefully that arrangement agrees with everybody, we'll look to wrap promptly at 1:00 P.M. 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. The swim, bike, run, three sections with breaks in between, when you get home, you can tell your friends and partners you ran a triathlon at Boston Scientific. It's great to be here. Thank you for showing up. Many familiar faces. This is an important day for us. We do this every other year, it's, I think, a great time to showcase all of the things that Boston Scientific does, primarily focused on innovation. 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.
You're going to meet 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. You're going to see a lot of that today. You're going to see quite a bit of our portfolio of innovation that will help drive the company over the next chapter. With that, ultimately, one reason you're here is to create shareholder value. We have tremendous confidence in the company and the business and where we're headed over the next three years. We have very clear plans in place, but we also have the ability to have some agility along the way here.
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, or I believe as, or an investor in Boston Scientific.
You're going to hear a lot about products today and our portfolio, because at the end of the day, I think about two things every day, the people and the culture of the company, and innovation. If you can do those two things right, we're going to do well. That's what we focus on, are our culture and our portfolio. Then with motivated, empowered people, you can do great things. Lots of companies have slides like this. You saw our video. We talk about advancing science for life. We oftentimes bring the patient experience right to our employees.
The reason we do that is we know employee engagement is everything. A small uptick in employee engagement gives you a small uptick in performance. It's the right thing to do to show our employees what their impact on patients is, but it's also good for our business. 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, we really bring these to life, despite the companies and businesses have slightly different strategies and tactics, this connects all of Boston Scientific employees together, it's ultimately about the patient. We focus on patients, our employees, the communities, drive meaningful innovation. We'll focus on high performance and a winning spirit. 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 our geographies. How we're organized, we essentially have three reporting segments, cardiovascular, rhythm and neuro, and MedSurg, that's how the triathlon's set up over the course of the day.
You see the operating business units that associate with those reporting units. I think the most striking thing on this slide to me is most of our businesses have grown over the past, call it five years, continue to grow faster than our peer group in our core businesses. We have lots of adjacencies we can talk to. Not every single business, every single quarter, but for the most part, most of our businesses grow faster than the market. You see the widening and strengthening of many of these businesses, like Peripheral Interventions, especially with the pending acquisition of BTG, Endoscopy, Urology, Neuromodulation. 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., but you 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, that's very encouraged because that's where most of our new products are launched first. To me, it gives you indication of the future. You're going to see about 8,000 slides today. 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. I think you want to start with the people. The second thing is what's the track record of delivering? I think this is our third or fourth investor day, Susie, since I've been here. The good news is we don't provide aspirational plans at our investor day. We actually show you plans that we've actually delivered or beat consistently over this time period. These are LRPs that are interesting. They're LRPs that we actually aim to beat, at least meet. Track record. Secondly, the third point is our focus on category leadership. You're going to see this across the board of the businesses.
We think being a clear category leader is helpful to pursue service lines and to partner with customers closely. At the same time while we do that, importantly, you'll see us move into $22 billion 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, four of which we've acquired in 2018. This provides some additional fuel for our growth. At the bottom line, you add all that together, we expect to deliver top-tier revenue growth over the next three years, continue to drive margin expansion, deliver double-digit 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. 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. 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. Years ago, we were kind of a turnaround story.
In 2014 through 2016, we moved to what was, at that point, likely above-market growth over those three years. 2017 and 2018, 2019, the 2019 number shows the midpoint of our full-year guidance in 2019, but it shows the three-year CAGR of a +7% organic CAGR. This is all organic, not operational. You would add M&A on top of that. In the next three years, we're providing organic guidance of +6% to +9%. +6% to +9%. Our aim and our goal will be, two years from now at Investor Day, that we've accelerated our organic growth profile in this three-year period versus 2017, 2018, and 2019.
Which would 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 2022 is 6% to 9%, which would show our aim would be an acceleration over the previous three years. Similar to our financial brand, which is grow at the high end of our peer group. The second one is improve margins and deliver double-digit EPS growth. We believe we have a lot of confidence in our ability to continue to deliver this like we have in the past few years. You'll see a nice ramp up in operating margin improvement over the past years. We'll call out a, what we've said in the past, a 50 to 100 basis point margin improvement over these three years.
With that, we're able to invest at the high end R&D at about +10%, and deliver strong growth and consistently improve margins. 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.
We have quite a bit of room here. Dan will talk about it, but 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 deliver double-digit earnings per share growth, in the 2020 to 2022 period. Again, 2019 is at the midpoint of the guidance. This business really is about our people and innovation. On the left side is Daniel Brennan, with all of our seven business units wrapped around him.
On the right side are the sources of our innovation. On the left, we talk about this category leadership. Maybe just a few points here. You take Urology Pelvic Health, and we can go through each one of them. Consistently over the past four or five 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 LithoVue platform, and now enhancements from there. Added to that, two BPH properties with a laser and an MIH property, men's health implants, stress urinary incontinence, and then recently in oncology cancer space with the prostate with Augmenix. 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.
We really have a similar story of that type of strategy across our businesses, and you're going to hear that today. 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&D. Many of our divisions do very few acquisitions.
It's all internal. 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 from a VC standpoint to mitigate risk or to have more shots on goal. We do that pretty thoughtfully. Our R&D programs are now more global. Many engineers in India and China and Costa Rica for our sustaining business.
We expect over 10%. We have a culture of innovation with our Imagine If program, where we incentivize our employees to come up with new innovation ideas, whether you're in legal, finance, HR, supply chain. It doesn't have to be a product. We've done a number of tuck-in acquisitions in 2018.
We're doing a nice job of integrating those in 2019, and the BTG deal is pending. I touched on our VC portfolio, and we've also done some nice work on build to buy opportunities and spin-outs to create more shots on goal. I think our innovation cadence and our strategy works pretty well. It's not fixed. We create new capabilities and globalize our R&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.
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? This is the scorecard of that execution, and it will continue as you look at 2022, and it will continue two years from now when we show 2024 or 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. 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, very little else, I should say. The good news is we actually are, for the most part, take share in those businesses.
The company has really continued to morph into a higher growth TAM. 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%-7% CAGR, which is pretty good, and we think about 45% of our business is in that category now. 25% from what used to be 10% is now in the high growth, greater than eight in many of those markets in the teens. In 2022, based on what you'll see, you're going to see this continue to accelerate. The low growth goes down, moderate stays about the same, and high growth increases. You increase our served market, we grow faster than the market, you accelerate your organic growth profile.
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 slide. This is exciting for us. 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. This is really the summary of what you're going to be hearing about today. 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. 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 billion, where today we have just under $1 billion of revenue today. We see this as a big opportunity for us. Another thing that I think is pretty neat, if you look at our focus on interventional oncology.
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 million in sales or so, and some products within Endoscopy. We looked at this and we said, besides our core businesses, an adjacency that makes sense for us from a call point perspective and from an R&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. Over the last 2018 and 2019, we acquired a few companies. We acquired Augmenix in Urology you'll hear about, EndoChoice in Endoscopy, and BTG, which is pending, which is really our anchor asset for the strategy for our PI business and interventional oncology.
With that, we serve the prostate, pancreas, colon, and liver. What's really exciting, in 2019, that'll deliver over $1.5 billion, that clump of assets within interventional oncology. As you look forward, where Boston's most unique, and I think Jeffrey 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, Y-90, drug beads, bland beads, whatever the case may be is really a unique opportunity. 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.
In 2021, we expect over $2 billion 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. Here's a healthy list of our product cadence over this three-year category, over this three-year time period, and a lot of this will be highlighted here. I do want to 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 or 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. In our caring value, we talk about caring for patients. Well over 35 million patients helped annually. We do a lot in the close-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. 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 2030, and we've set a goal of 100% renewable energy electricity by 2024.
Some ambitious targets, many plans and investments have put in place. You can 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, we're really proud of many of these, focus in our innovation, focus in our culture, Working Mother, and Best Places to Work. I think these types of things are nice to see. It's kind of just an output of what the company culture is. I'll just wrap up saying that I'm just very honored to be part of the company. We've got an extremely bright future, I'm way over-indexed in Boston Scientific stock, I hope that you are as well.
Thank you for coming. I'll turn it over to David Pierce. He's not a doctor. Meghan Scanlon, who lead our urology business.
Thanks, Mike. Appreciate it. Morning. I'm happy to be here to kick off, I guess, the swim leg of our triathlon, the MedSurg business. Joining me on stage is Meghan Scanlon. She is the GM of our urology business. We'll be followed by Art Butcher and Brian Dunkin, who will present endoscopy, then we'll take Q&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 billion 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 and OI are accretive to Boston Scientific, we're targeting $2 billion in revenue by 2022. In 2018, we achieved $1.2 billion in revenue in markets we value at $3.3 billion.
Our growth was 11%, driven by our broad portfolio, increasing market access, and therapy development, along with strategic globalization. This was nearly double the solid market growth in these spaces at 6%. We characterize our business in three verticals. The first is stone disease, which is our largest market, nearing $1.5 billion 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 billion 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 prostatic hyperplasia, or BPH, along with prostate cancer sufferers who elect radiation therapy as their treatment of choice.
The prosthetic urology segment will grow mid to high single digits, driven by the large population of men impacted by urinary incontinence as well as erectile dysfunction. Lastly, our women's health markets are at $1 billion, serving a large population of women impacted by stress urinary incontinence, or SUI, and aiming to meet the significant unmet need in 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 SpaceOAR and Rezūm acquisitions is critical. 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 nVision acquisition. We also see significant adjacencies in OAB and urologic cancer.
We estimate our addressable markets will grow to $5.6 billion in 2022. I'll now ask Meghan to provide further detail on our stone and men's health plans. Meghan?
Thanks, David. As mentioned, I'm a new face at Investor Relations Day, I welcome the opportunity to take you through a deeper dive in some of our priority franchises. First, I'm going to start with stone. As David mentioned, stone is a large and growing market valued at around $1.4 billion 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. One of the most notable examples of this innovation, Mike mentioned this, is LithoVue. LithoVue was a homegrown R&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. This has been an incredible success for UroPH and for Boston Scientific. 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 UroPH portfolio. It also serves as a really beautiful proof point for the capabilities being developed at BSC around the disposable scope landscape. 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. We look forward to reviewing that with you. In stone, there remains a huge need for clinical innovation here.
The rate at which stones are occurring in the marketplace, the prevalence of stone disease, is increasing at a rate two times the rate at which procedures are increasing. 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. 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 ureteroscopy procedures.
To bring next-generation disposable visualization with a number of new, highly differentiated capabilities, as well as an integrated fluid management system. While these three components, 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. We're excited about what the investment in StoneSmart can mean for Boston Scientific in the years to come. Turning now to prostate health, this is under our men's health business. This is an exciting and rapidly growing franchise for Boston Scientific, which was given critical mass last year with the two important acquisitions that Mike talked about, with SpaceOAR getting us into the prostate cancer arena, as well as with Rezūm, increasing and broadening our portfolio in BPH.
I'm going to start with prostate cancer and the SpaceOAR 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 million. For those of you who aren't familiar with what SpaceOAR does, SpaceOAR is an important hydrogel shown in this infographic that, in essence, pushes the rectum away from the prostate during radiation therapy.
It basically pushes 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.
The enthusiasm that we hear from our customers, combined with some really strong commercial execution in the U.S., Europe, and Asia, has us on track to deliver approximately $100 million this year, which is ahead of the initial expectations that we've shared publicly. The benefits seen in spacing for prostate cancer gives us confidence in two important expansion opportunities. First, the continued pursuit of bringing this value to more men around the world undergoing radiation therapy and 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 healthcare systems around the world. We still have a lot of global runway to bring SpaceOAR across global markets.
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. 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 Rezūm, an important innovation in the minimally invasive treatment of benign prostatic hyperplasia. In 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, we love this technology, because notably, it is a natural water vapor-based solution that importantly eliminates the problematic adenoma tissue in the prostate, 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. At four years, men being treated with Rezūm required an additional surgical reintervention rate of only 4.4%, compared to a 14%, so actually slightly over 14% surgical retreatment rate with competitive technologies. Later this year, our 5-year data will be published, and we expect to see this sustained durability advantage for Rezūm.
Our Category 1 code went live at the start of this year. 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, increasing our investment in physician and patient education to bring Rezūm 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. Now I'd like to pivot to a short video done with Dr. 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, he's going to share his view with us on why Rezūm 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. That's why I picked Rezūm 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 creates 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 four-year proven effectiveness. Long-term is quite remarkable. 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 attractive 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 two and a half minutes. If I were looking at a long-term strategy of a value-based model, the Rezūm is head and shoulders the best model for de-obstructing the prostate in a cost-effective way.
Okay, this music goes on for a while. I apologize. Okay. Listen, I believe that Dr. Shore conveys pretty compellingly and clearly the clinical and economic benefit of the Rezūm system and why it's positioned for long-term success. 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.
This portfolio has been a big part of the growth story of UroPH 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. 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.
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. Together, these will serve to strengthen and sustain our category leadership for years to come. Layer on top of that, so strong portfolio today, strong pipeline. 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 David.
Thank you, Meghan. We mentioned our compelling adjacencies earlier. We're executing on market development efforts for our Cytuity technology, which came to us through our nVision acquisition. This will be a vital diagnostic option for women at high risk of developing ovarian cancer, and other 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 billion 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. Lastly, the number of procedures relating to urologic cancers is high, and we have both internal activities and 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 billion in revenue in 2022. With that, I'll now ask Art and Brian to come up and present the compelling endoscopy story.
Thanks, David. Thanks, Meghan. 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, Dr. Brian Dunkin, 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. 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 MITIE Center, focused on innovation, technology, and education at Houston Methodist Hospital.
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. We're thrilled to have Brian joining our endoscopy team, and he's been a great addition to our management board. 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&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 three 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. We're really gaining traction and excited to share those with you today. We have a clear number one 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. When I stood here at this meeting two years ago with most of you, I outlined an aggressive plan to get us to $2 billion by 2020. 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 billion next year in 2020. We've set a new aggressive goal for ourselves to be a $3 billion division for Boston Scientific within the next five years by 2024. That'll be a 50% growth within the next five years, and Brian and I are excited to share with you our plans to do that this morning.
Let's look at some of the numbers. In 2018, we were a $1.8 billion player in a $5 billion global endoscopy market. Strong number one 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. If you look at average daily sales versus the prior year, we were actually at 10% growth.
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 DS II or ORISE Gel for endoluminal surgery or our ORCA Pod System or Jagwire 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%. As we execute on our high-growth adjacency strategy, we anticipate being able to beat our core market growth rates by an additional 4%-5%. We think we're in an excellent position to drive accelerating growth. How do we define endoscopy at Boston Scientific?
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 Endo-Surgery?" 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. These are devices like balloons, baskets, stents, guidewires, 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.
In those spaces, we develop toolbox approaches to procedures, allowing physicians to do them more rapidly, less invasively, and with better outcomes for patients. In those segments, we are pretty much the undisputed worldwide leader. 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. With that definition, these are the disease state market segments where we play. Pancreaticobiliary disease, that's where the ERCP 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. Let's take GI cancers, for example.
GI cancers are responsible for over 50% of patient deaths from cancer each year globally. 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, 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. 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.
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. For several years, Boston Scientific has been executing on a 2-part strategy. 1, category leadership and expanding our leadership in the places where we have long legacy leadership businesses. 2, expanding into high-growth adjacencies. In endoscopy, we have been executing on that exact strategy.
By 2018, you can see already we expanded our headroom from our $3.3 billion accessible market in places where we lead, like biliary procedures and GI therapeutics, and we added pathology and infection prevention to create a $5 billion 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 $7.7 billion market by 2022. 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, pancreaticobiliary disease, which we've talked a lot about already, will become a $2 billion market, and Boston Scientific has the opportunity to take substantial share and lead with differentiated launches like our SpyGlass Discover, first of its kind single-use choledochoscope, which we'll launch next year, and Brian will talk about that one. 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. Already we lead with our EndoChoice portfolio, but going forward as disposable, single-use air and water suction valves become the standard of care, we're positioned well to have explosive growth with our OrcaPod 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. We can now service up to 8 million units per year, and by next year, we'll be able to service 16 million units of OrcaPod into the market. We see that the opportunity for single-use air and water suction valves will just continue to grow as there are over 50 million endoscopic procedures where these will be applicable performed in the U.S. each year.
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. 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 a biopsy or place a 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. We are a 60% share player in a global market worth $1.4 billion. 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. What I would want you to really consider about this list of products is the longevity of these products. If you look at products like CRE balloons or WallFlex stents, these are products that have been market leaders for one decade, two 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. Last year was no different.
We had multiple key launches with the Habib probe for ablation in the bile duct, which came from our EMcision acquisition, SpyGlass DS II, which I'll talk about in just a minute, and the Epic biliary stent, which is specifically designed for the hilar region. All of these are differentiated products that excite our customers.
This year, we've just launched the Jagwire Revolution guidewire. The Jagwire Revolution is a high-performance, low-profile, highly steerable guidewire, and it's really taking off beautifully in the marketplace right now. Let's take a look at its performance with this video. The beauty of the Jagwire Revolution is its low profile and its steerability. What we did was we took our market-leading Jagwire 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 stricture there? 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. 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.
Once you get into that space, you can then drive other devices like sphincterotomes or balloons over the wire. 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. Let's look at SpyGlass.
Another device that has been a huge growth driver for us in the pancreaticobiliary 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. 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 duct 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.
Two-dimensional, trying to determine if it's stone or stricture, now we have pictures like the ones that you see there. 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 a $100 million franchise annually for Boston Scientific.
In the last six months, we launched SpyGlass DS II, which is our third 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, an EHL probe to break up stones, 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, our utilization has increased by twofold in the last three years.
It's a really exciting time for SpyGlass. At this point, I'd like to invite Brian to come and talk about some of our new high-growth adjacencies. Brian?
Thank you, Art, 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, then three 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 Xlumena, 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 first stent designed to have one end inside the lumen of the GI tract and the other end outside the lumen of the GI tract. 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. 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 two structures together. 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.
We're just getting started on advancing a technology like AXIOS into the endoscopic space, really to accomplish endoluminal surgery. 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. What they might not realize is that surgeons have a long legacy in the endoscopy space.
In fact, almost every therapeutic endoscopic procedure we do today was first done and described by a surgeon, and that legacy continues. We have over 13,000 surgeons doing endoscopy on a daily basis in this country alone, and that's translating into nearly 2 million 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 five people working in the area of surgical endoscopy. Today, we have nearly 70. This is an area of high growth adjacency. Not only is it already a busy clinical area with these physicians, but it's growing.
If you look at the natural progression of surgery, it really is to evolve into a less invasive, more accurate procedure. In the GI space, this is definitely the case. We've moved from open surgery to laparoscopic surgery, and now to endoluminal surgery. 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 residents. They now must go through a five-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 1,200 newly minted general surgeons entering the workforce, every one of which is capable of picking up an endoscope and using it. That is going to happen every July forward.
If you want to compare that in the GI world, that's more than double the number of gastroenterologists entering the workforce. 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. 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. Another high-growth adjacency is endoluminal surgery.
We've kind of been talking about that already with AXIOS and with Discover. Art mentioned the disease burden of GI cancer in the world. 3.4 million 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 in how we manage GI cancer. It's already moved from open to laparoscopic. We want to move it from laparoscopic to endoluminal. 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 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. 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 ORISE Gel, and cutting and suturing technology. Let me show you a little video vignette of how this might work, or actually how it does work. Clicking, and I'll try it one more time. There we go. This is a lesion that we want to remove. We mark our surgical margins first to make sure we get the whole thing. This is ORISE 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. Last, I want to talk about another high-growth adjacency, and that's infection prevention. As a clinician, three years ago, I never heard the term infection prevention applied to the GI suite. Then, unfortunately, in 2016, we had some high-profile outbreaks of infections in GI suites, both in the U.S. and outside. 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 contaminating 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. 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 million endoscopic procedures performed each year in the U.S. alone. Every one of them needs an infection prevention strategy, and this suite of products is helping to drive that.
You heard Art talk about the increased capability of manufacturing these products. 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 two years, we've already doubled the sales in this market alone. 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. I'm excited to wrap up our section by talking about single-use endoscopy. 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 billion market opportunity. We expect to be pending FDA clearance. We expect to be first to market by the end of this year. We expect to be alone in this market for potentially a year and potentially longer. How did this start? Well, years ago, we saw a need for infection prevention in the ERCP procedure. We set out to create solutions.
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 multi-drug resistant bacteria. This is a big deal because these procedures are necessary and they are life-saving.
The most recent study from FDA showed that 5.4% of scopes after disinfection were still carrying multi-drug resistant bacteria. A solution must be found for this problem so that we can protect the safety and integrity of these life-saving ERCP procedures. 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. The EXALT Model D, for us, brings together three important strategies inside Boston Scientific.
First, our continued focus on pancreaticobiliary leadership. Second, our commitment to infection prevention in all endoscopic procedures. Third, on top of building on the shoulders of LithoVue and SpyGlass, our commitment to developing therapeutic imaging solutions in endoscopic procedures. We feel like it is right in our wheelhouse. As I mentioned, we have an established sales force globally that we can leverage to roll out this device. Boston Scientific Endoscopy has over 1,000 sales reps focused on GI around the world already. 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. We believe that a fully single-use duodenoscope is the only foolproof solution for this problem. It's the only way that you can know 100% that your device is sterile.
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. We did more than 10 animal labs with this procedure, dozens and dozens of benchtop 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. Beyond EXALT, we're developing a robust capacity and capability in single-use endoscopy in general.
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. The market created by single-use endoscopy, over the next five years, we expect to be as big as $2 billion. This is a greenfield opportunity, and Boston Scientific is in the best position to lead. 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 LithoVue 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. 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 life-saving and market expanding, and Boston Scientific intends to lead the way. 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 billion in revenue by 2024. Thank you very much for your attention. Now I think we'll take questions.
We'll take questions. Yep. Thank you very much. Before we start, we are aware of and recognize and apologize that there's 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 1:00 P.M. at the conclusion of today. Thanks. With that, really excited to take your questions. We'll start here in the middle with David. Thanks, Julie.
Thank you.
Hi. David Lewis, Morgan Stanley. Thank you. Two questions I'll start with kind of EXALT D and then maybe I have one question on Rezūm. But for Art and Brian, the market size for EXALT D everyone's very aware is 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%-10% penetration, that $1 billion, is that the type of thing we should expect in 1-2 years, or is it going to take 3-5 years?
I wonder, Brian, your thoughts on, at Houston Methodist, how much of a pain point is this going to be a critical need, and how much a pain point is it to drive the transition? A quick one for Megan.
Sure. Thanks for the question, David. Of course, we have to acknowledge that this device has never existed before, so the curve is impossible to accurately predict. Of course, we also have a notion of how we think it'll play out. I believe that a 50% adoption in the space within five years is reasonable, especially in a U.S. market. 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 the market. There's 700,000 ERCPs in the U.S. alone, about 1.5 million globally. To service 50% of the U.S. market takes quite a manufacturing capacity. We're ramping to that, but it'll take us time to get there. Does that
Yeah, I think the numbers, that's good. I think that's very clear.
Well, I think, 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? 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 that cannot tolerate being exposed to an antibiotic-resistant organism. Those typically are patients that have some type of immunosuppression, whether from 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. That's one group that we have to make a decision about. I think that's where you're going to see it applied immediately.
The other group is somebody who's 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. That if we're going to sub-segment, that's where I think we see this start. I will add to that I hear a 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.
I think people are starting to realize that, 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. I think if I were left 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.
Thank you, very helpful. Meghan, just for you on Rezūm, the three- and four-year achievement rates are very impressive. The issue on adoption near term has been reimbursement. What are the plans to expand Rezūm reimbursement and sort of site of service and total aggregate reimbursement? What enhances our plan for the system in 2020? Thanks so much.
Yeah. We continue to do a lot of work and have made a lot of headway this year with reimbursement. All seven of the regional Medicare plans are now covering and paying for Rezūm. We're in about now four of the top 10 payers, private payers, are covering Rezūm. We still have some work to do to improve our reimbursement in the ASC landscape, we have our health economics and market access team really pointed towards resolving that gap in disparity. Sorry, that was the first piece of your question.
Enhancements.
Oh, the enhancements. I'm not going to get into specifics on the enhancements other than just to share that we're investing considerably in continuing to improve the system itself. 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 David and Art both to comment on respectively for the two 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 compounded annual growth over the forecasted period and the forecasted period itself. Art, you gave a little longer period, David, a little shorter period. Could you talk about the slopes of those curves, juxtaposed to your product launches, over the time periods from 2022, David, and 2024 for Art? Also, maybe talk about the combination of organic growth and M&A that's factored into those expectations. Thank you.
Thanks, Jason. We are targeting to be a consistent double-digit growth throughout the next three years, obviously want to put plans in place that will extend that far beyond that as well. We feel like we have a nice combination of internal innovation, legacy products, good markets, as well as executing on things like Rezūm and Augmenix. That combination will give us the opportunity to give nice double-digit growth throughout the next three, and hopefully many more years after that. Really also delivering strong operating income to Boston Scientific as well. That's what our target is, and that's what our intent is.
It's a similar story in endoscopy. We just chose the 2024 because that's when we get to the $3 billion nice round number. 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. 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.
Through.
Consistent through the period.
Consistent, yep. Bob, you have a question?
Thank you. Bob Hopkins from Bank of America. Two quick questions back on EXALT-D. First of all, on the economic side, do the economics to either the doctor or the hospital change much with the disposable product? 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 five years? Thank you.
Sure. In terms of the economics, I think there's adequate reimbursement within the procedures to absorb the cost. There are also substantial reductions in cost that counterbalance a lot of any incremental cost. The cost to reprocess endoscopes is not insignificant. You're also removing the risk profile associated with reprocessing the scopes. 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-$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. There's I think considerable interest at that price point. 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. The entry point, the switching costs are nominal. You don't have to switch completely away from any of the reusable scope manufacturers. This can be plugged in side by side and integrated with the existing unit. I think its ability to gain access into the vast majority of hospitals that do ERCPs, it won't be hindered. The acquisition cost of the capital is truly nominal, so there's not a lot of resistance there. I hope that answers your question. Maybe Brian, you can comment.
I might add a few factors to that. 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. To me, there are three factors. First of all, we have a problem that's bigger than we expected
With this contamination rate at 5.4%. They thought that was going to come out at 0.4%. We have a problem that's much bigger than expected. We don't have a solution to it. In the beginning when we heard discussion about this, it was like, "It's the tip of the endoscope that's the problem.
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. Any solution that doesn't address all of those, I think is only a partial solution. The technology is the right solution. I think ERCP is also the right procedure. It's the one that's at highest risk for this problem, but also the demands of the endoscope are different.
Getting that endoscope in position and getting visualization to that papilla is key in making that feel like the reusable scope. From then on, it's a platform that we're working with. I'm not navigating turns, using alternative visualization, light forms, and that kind of stuff like you might see in colonoscopy. I think as a place to start for our reusable platform, it's just got the right marriage. It's a problem that doesn't have a solution, it's the right technological solution for that problem, and the demands are right in the marriage. When you layer on top of it's a box this big that 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.
Eric, could you also mention too the regulatory backdrop?
The regulatory backdrop.
To help fuel this change as well.
Yeah, I think that because of the urgency of the situation, as Brian mentioned, there's so much interest in every stakeholding body. Right? 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 potential 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. 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. There's a lot of alignment that is driving interest, and the physician societies are supportive 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. Eric, EXALT-D study is probably our fastest enrollment ever. Is that fair to say? Yeah.
That's true. I'll just tell 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. 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. It's a powerful force.
Okay. Chris?
Thanks. Chris Pasquale, Guggenheim. Just one follow-up on EXALT-D and then one on SpaceOAR. 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 what % of the population that represents?
Yeah, I don't know if I have that % off the top of my head.
We've been discussing around 15, 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. Yeah.
Thanks. 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.
Yeah. Real quick on the last piece, I think we highlighted that. Pancreas, gynecological, cervical cancers, head and neck are some of the ones that are bubbling up, having a lot of interest.
Breasts.
What'd you say? Oh, breasts. Thank you. In terms of the gating factor to drive faster adoption. The reimbursement on that went live last year, we're actually starting to see a much faster rate of adoption in the urologist community. Prior to that reimbursement, the vast majority of the appliers were radiation oncologists who were skilled in brachytherapy, right? 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, with about 40% of appliers 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 choice for men undergoing radiation therapy.
Yeah, just to add on, we'll continue to do the clinical work, attempt to get it in the guidelines as a standard of care.
Yeah.
There's a lot of opportunity to potentially look at more aggressive radiation protocols because of the protection you have with the SpaceOAR. There's additional clinical work that we'll do because we feel like there's a fantastic opportunity here.
Yeah. An important dynamic to layer on top of that is, what we're seeing is these hypofractionation protocols, right? Delivering higher doses in 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. We believe that SpaceOAR can have a really compelling value proposition, particularly across the globe, as many healthcare ecosystems are looking to move towards these hypofractionation regimens.
Great. One last one from Vijay, and Rick, you can be first in rhythm and neuro Q&A. Sorry. Vijay?
Thanks, Susie. Vijay Kumar from Evercore ISI. One on EXALT and one on endoluminal. EXALT, I think you mentioned a price point of $2,500. That's the list price. One of your competitors from Europe has spoken about a sub-$1,000 price point. Do you think the market can support two 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? Endoluminal, 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?
Yeah, sure. I don't know if running up against robotics is the way I would put it. In my mind, advancing into endoluminal surgery requires enabling technology. I think 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, there's a constant scanning of 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, that's certainly where I think Boston Scientific leads the way. I don't know if that helps to 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, distant from where I'm standing.
Regarding price, I don't want to comment too much about competitors' strategies, I can tell you our experience. The price point that we've laid out is between $2,500-$3,000, that is largely based on the technology that is in this scope. As I mentioned before, the requirements, and Brian, maybe you can comment 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.
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. In our experience, the technology and the testing required to do that leads to a price point where we've put it, I think the market values performance over price, period.
Was that like a mic drop?
Just ramp this. There you go.
Yeah.
All right. MedSurg team, thank you.
Okay.
Art, Brian, David, and Meghan. With that, we'll transition to.
Thanks, everyone.
Rhythm and Neuro. I'd like to ask Joe Fitzgerald and Dr. Ken Stein to join me on stage. Thanks, guys.
Thanks, Susie.
You're welcome, Thank you.
Good morning. I think Dr. Stein just got a new objective now that Endoscopy has set the mark at 90% success rate with patient consents. All of our clinical timelines are probably not going to be accurate in this slide, just kidding. Let's jump into Rhythm Management. Obviously, this is our core CRM and electrophysiology business, let's start with CRM. 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, literally have went from a distant third place in global high voltage, that's all things ICDs and CRT-Ds, we've now created the clear number 2 position for BSC globally in high voltage. 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 did we do that? Obviously, S-ICD 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. As we've talked about in multiple meetings, our replacement headwinds, given our extreme battery longevity, have now turned into tailwinds on both CRT-D and ICD. 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. 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, I'll detail these on later slides. We will enter the single-shot therapy market in EP. Today, that's about a $700 million market. Most of that is controlled by a single competitor.
If you take Europe as an example, we'll enter with two 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 million market, dominated by one or two players.
We will enter that market in 2020. You look at those two as combined to be about $1.4 billion in new market opportunities, where today we have $0 of sales, and we will enter those between late 2019, and we'll give you these details when we show you the slides, or 2020. The third area 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 billion segment within the EP space.
You think about EP, the market, $5 billion. I'll show you some detailed slides. About three of that five is high growth, advanced mapping, advanced navigation, advanced ablation. We entered that space, our first full year of launch was 2016 when we introduced RHYTHMIA. That was our first full year of launch. We'll show you some data that shows how we have outpaced significantly market growth in that segment. We're still the startup in the 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 billion market segment. Overall, both CRM and EP, we project and anticipate that we'll grow faster than market, and we'll sort of scale that as we get in.
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. We'll give you more detail on that, in terms of how we accomplish that as well. Overall, we participate in a $15 billion market, nine plus of that is in CRM, and about five of the rest of that $15 billion market is EP. When we look at the go forward CAGR, 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, et cetera, segment of that being above that level. Okay?
The $700 million market that is ICM, which has grown double digits for several years, will probably through the next three years get into that mid to high single digit sustained growth from a market perspective. Looking at 2018, how did we drive our success? I've already said several of these, but we continue to grow RHYTHMIA growth well above market. In certain geographies, I'll give you some examples, we've grown at multiples of the market growth rate. 2018, when you look at that year, that was our sixth year of S-ICD launch. We continue to grow that well ahead of ICD market growth across the world. HeartLogic and our battery longevity continues to drive denovo share growth, in high voltage. We're now just about finishing what's about our seventh or eighth quarter of that launch.
I'm glad I don't ever have to say again or talk to you about the headwinds of having great battery longevity. 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 billion category. I'll show you some details in terms of how the market is sort of played out in terms of size of those markets. If you think about EP, you have about $1.5 billion 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 billion. That's growing well into the teens.
You have single shot, which is now about $700 million, 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 three to four years. 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. In the middle, you have core CRM. That's a $9-plus billion market. Obviously, the high voltage segment is larger than the low voltage segment, and we predict probably flat growth in that market. Again, I'm sure we'll get into this in Q&A, but you look at low single-unit volume growth and then ASP growth that is in that same trajectory, but to the negative.
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. I've already talked about the implantable cardiac monitor market, $700 million today. We project that'll 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, three or four past ones, but our strategy has been really simple. If an EP is doing it and it's important to him or her, we want to be the innovators in that space. A combination, Mike said this earlier, a combination of increasing the efficiency and the productivity of our internal R&D, and then selectively making acquisitions. We can talk about WATCHMAN, Cameron Health, RHYTHMIA, Bard, two recent single-shot technologies.
These are all aimed at surrounding the EP with highly innovative solutions from Boston Scientific. We believe that both takes 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 Guidant has had a rich history, and this is really kudos to Ken, of driving really market-leading, market-creating clinical science. Whether you look at what we've done with the S-ICD, the multiple studies we've run, we're up to two randomized studies completed, two 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&D or we invest in a startup, we complement that with phenomenal clinical science. 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, then we'll switch to EP. Ken?
Okay. Thanks a lot, Joe. Again, I'm going to begin to walk you through the differentiated portfolio and pipeline within our core CRM first. 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. I'll say a little bit more about HeartLogic 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 greater cardiac 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. Actually, my dad just got one of our devices a week ago. I can now go online and see that his battery status is normal, see when his next scheduled clinic transmission is, see that his LATITUDE connection is working appropriately. That's available today. You can download it from the App Store on iTunes if you want.
What we intend to do is to fast iterate this and 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. 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 HeartLogic and become much more able, empowered, and invested in their own care. Let me say a few words about the HeartLogic. I think you all know that heart failure today is the single largest DRG, accounting for medical expenditures in Medicare patients in the U.S.
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 independent publications in the literature validating what we've shown in our clinical trials of HeartLogic. Speaking about clinical trials, I can't claim that we're going to get 90% of patients to agree to enroll in our trials. We have finished enrollment in the phase I of MANAGE-HF, which is our trial aimed at actually substantiating the magnitude of the benefit that you see with HeartLogic.
We will begin enrollment next year in the phase II 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 healthcare 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, "How are you implementing HeartLogic?" It was very interesting because our sales force not only calls on EPs, but they also call on the heart failure referring and management physicians. He said, "Well, it's very interesting." He goes, "Your team has done a great job educating the heart failure docs. What I'm getting now are prescriptions. This patient needs a CRT-D. Go ahead and put any device you want. I just need that HeartLogic algorithm and that HeartLogic alert." That kind of shows you the power of the branding of this intuitive, preemptive alert for hospitalization.
Yeah, absolutely. Again, this is something that's unique in the industry. 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 S-ICD now has projected longevity that is roughly equivalent to what competitive transvenous ICDs can offer. We'll be bringing out enhancements to our SMART Pass technology, reduce the risk of inappropriate therapies with the device, enhancements to the S-ICD 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 S-ICD, with more optimal modern implant techniques, we do see a possibility to develop a downsized S-ICD that would be no larger than our competitors' transvenous ICDs are today. 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 leadless pacemaker. We're going to call it EMPOWER.
The thing that is really revolutionary about EMPOWER is that while it can function just like our competitor's leadless 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 S-ICDs and coordinate as a system so that patients with an S-ICD can get brady pacing but can also get anti-tachycardia pacing if they develop that need after their S-ICD implant. We're in discussion with FDA today about our IDE trials and are intending to start our IDE clinical trials in the U.S. 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, Ken mentioned it, when we first purchased Cameron Health, that was in 2012. We obviously had purchased and inherited the first generation. We really kind of moved heaven and earth to get this EMBLEM product sort of designed and out. Our goal back then was let's do that in under three years so that we beat anybody else that could possibly get to the European market. Our goal there was, hey, they might get there by 2015. Back to what Ken said. In terms of a purely subcutaneous that's as minimally invasive as S-ICD, we don't see a single product from a single competitor in development or in clinical studies anywhere. As Ken focused on the first and only for quite a number of years into the future is a really important point.
Let's talk about our ICM. Our ICM brand name is LUX-Dx. If you look at the left side of the slide, we have a extremely competitive implant and set of implant tools. Think of it as a sub 2, 1.3cc device, good longevity, super minimally invasive implant. Put a check mark there. We will offer both through a patient smartphone or through a locked-down smartphone provided by BSC, connectivity to the cloud, and therefore, connectivity to LATITUDE. Most importantly is that we think we've been extremely innovative in how we help clinics and physicians manage data via the LATITUDE Clarity application.
If you go out and you survey 50 or 100 or 1,000 doctors or clinics, their biggest complaint is, "I'm getting a mountain of data off of these devices, and I can't manage it." 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. That will be sort of LUX-Dx gen 1 should launch mid-year HRS timeframe 2020. Importantly, we're not just stopping there. We're going to take this micro-implantable and this cloud-based data management platform, and what we're working on now is to turn that micro-implantable into a chronic monitor of heart failure conditions. Most specifically for the HFpEF, the heart failure patients with preserved ejection fraction.
Think about that. That's a 3 million sort of target addressable market patient population. Think about the ASPs, and you start to get into a multi-billion-dollar opportunity where there is essentially nothing that physicians can do to monitor in an ambulatory fashion what's happening. Is that available today? No. Is it in gen 1? No.
We have done probably more work than you or our competitors know about in terms of taking the parameters that drive HeartLogic and replicating those on this super small micro-implantable. That's LUX-Dx 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 pre-clinical work done, and then to run the clinical trials to prove it. That could open up just an enormous sort of new market. Ken, you want to make a comment on that?
I think this is something that's flown a bit under the radar. I just want to reiterate what Joe said. 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. The mainstay of therapy is water pills, diuretics, but they're very sensitive based on their physiology. There's a huge opportunity to improve the care of these patients if we can get HeartLogic onto the monitor. As Joe said, while we have to do the clinical trial work to prove that we can port 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.
We also get to benefit from 20 years of research, 13 clinical studies that led to the approval of HeartLogic. I think we think we've got a substantial sort of lead on most people in terms of HeartLogic and the ability to sense impending heart failure decompensations. 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. If you look at the EP market on the left hand of this slide, two-thirds of the market is in mid to high teens growth. That is essentially, if you're not colorblind like Mike, the light blue and the gray, that's two-thirds of the market. Was that a HIPAA violation? I'm sorry. Strike that from the webcast. Two-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 probably low single digits. What we disclosed at HRS is that right now we look like the inverse of the market. Two-thirds of our business is in legacy diagnostics, single-tip, non-NAB type of ablation catheters. We've done what I would say, a respectable job of creating a new segment, which is a third of our business today with the RHYTHMIA launch over the past three-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 three years.
By the time we exit 2022, we'll go from two-thirds of our EP business in the low-growth segments to two-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. It's going to be a really fun time. It's driven by the technologies that Ken's going to talk about next. 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. Interestingly, and kudos to our CRM success because that has really funded this investment case. If you think about it, we started our RHYTHMIA launch three years ago. We have been building the commercial infrastructure and the commercial capability to attack the EP, very attractive, very large, very high-growth market.
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. 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. Just a couple of call-outs. That team in three short years, three-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. With that, I'll have Ken lead the discussion on what technologies will drive our expected above-market growth.
Okay, thanks, Joe. 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 LUMIPOINT software module. We sell this as a license.
We've already sold more than 120 licenses, have over 2,000 procedures completed with LUMIPOINT. To give you the quick explanation of what LUMIPOINT is, since 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 on a telecast of an NFL football game. It tells you where the next down marker is.
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 DIRECTSENSE ablation platform. This is our IntellaNav MiFi OI ablation catheter. It is for point RF ablation. This is already approved in Europe, and it is one of the reasons why, in Europe today, we are growing in 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 tissue is being ablated.
Again, as you move to the right on this slide, what's going to be revolutionary will be the introduction of our IntellaNav StablePoint catheter. 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 DIRECTSENSE local impedance, which tells you electrical coupling of tissue. Both mechanical coupling and electrical coupling are what are necessary to actually create a transmural ablation lesion.
Ken, just to add, you don't need to go back, if you look at Europe right now, Europe for several months has had LUMIPOINT, for 18 months has had DIRECTSENSE. Our arrhythmia segment, not the core legacy BSC EP, is growing at multiples of that mapping and navigation segment. That kind of is the prologue to what's going to happen when we get that approved in 2020 in the U.S. That's not a guess. That's based on 18 months now of experience of how physicians react to the arrhythmia software, the catheters, and the actual DIRECTSENSE software and LUMIPOINT. We think we have a really good prediction for what we'll do in other markets as we get just those two of the three critical things across the goal line.
Great. I want to close with our two single-shot technologies. It's like my two daughters. They're both very different. I love them both equally. You all know we acquired a cryoablation platform with the purchase of Cryterion, 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 of time, it's the 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, just to do pulmonary vein isolation for ablation of atrial fibrillation.
When you go to actually freeze the tissue, the balloon expands in size, tends to pop back. You lose the position that you were at, or the physician has to actually push the balloon forward to try to keep it engaged. 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 from physician customers, both in the U.S., Europe, and globally. We are targeting getting CE mark for POLARx in Europe in the fourth quarter of this year, and also intend to start our U.S. IDE trial fourth quarter of this year. Depending on pace of enrollment and the results, anticipate U.S. launch in 2022.
Our other single-shot technology, again, everyone's aware, our acquisition of Apama. This is LUMINIZE. 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. What's really unique and revolutionary here is what you see on the right. My friend Brian Dunkin, as a surgeon, is used to being able to see what he's doing.
We haven't had that opportunity in electrophysiology. This balloon has endoscopic visualization that you see on the right, actually in an ablation, that you can see exactly 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?
I think we're looking at this, it's a little bit behind, just from a design verification development, et cetera. We're expecting both CE mark and U.S. IDE start in the first half of 2020. I love the way that you described that as revolutionary to what people are doing. Thanks, Ken. 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 2/3 legacy, low-growth stuff to 2/3 high-growth, market-leading stuff. 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 in Neuromodulation segment.
With that, why don't we transition to our Neuromodulation and spinal cord stim and DBS business? I'll ask Maulik and Milad to come on up.
All right. Thank you, Joe. Good morning, everyone. I'll talk for the Neuromod to start out, Milad will go through our DBS franchise, who's been leading this for a number of years. Overall, as a Neuromod business, this is really an exciting space. 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. As a market, these are large, high-growth markets. At the same time, highly under-penetrated. 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 two, three, four surgeries, then I found out that this alternative exists." Even for the DBS patients, they go through a number of clinical studies, after that, they find out on their own or through another physician, the DBS procedure probably is an ideal procedure for them, as one of the patients Milad will talk about later.
For a pain therapy for us, the focus really is on true category leadership. We focus it on two dimensions. One 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 the longer run. On top of that, providing multiple innovative options so that you are able to personalize the therapy for that patient for that particular time, because 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?" Pain is something that evolves over time. Multiple modalities are very important going forward. On the brain side, simply transforming the therapy. This therapy has been existing for-- DBS has existed for 20-plus years. The innovation that we're bringing, one of the most innovative platform. We're the first to introduce the Cartesia directional system. We introduced that four 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 positive. A lot of good experience and positive outcomes for the patients. It's a very exciting time for us. It's also a platform as we look at in the future, because what this does is our knowledge of building understanding of the neurostimulation. On top of that understanding of the technology is really future unlocking the treatments for the neurological disorders. We have investments in treatment for strokes, 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. These are exciting markets where no other therapy options available, and we look forward to the future.
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. $2.5 billion market. At the same, when we 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, and everyone has been talking about it. We see that continuing. At the same time, we see that there's no fundamental change taking place in the reimbursement. There's no therapy change. When 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.
We see that the new product introductions coming in towards the end of the year with a number of companies coming in. The new product data, clinical data coming out should help to support and bring the momentum back. 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 WaveWriter, superior outcomes, and some of the best outcomes. We continue to see that. We presented some of the data at INS. I'll talk about it a little bit later. At the same time, also the Cartesia system, U.S. launch, the strong international growth.
A few years ago, we started to expand our platform offerings so we could meet some of the needs of the market for internationally, It continues to provide a strong growth going forward. On the pain therapy side, when we look at the break down the market, we're the only player with three therapy options, innovative product options. On the Spinal Cord side, as I mentioned, 7%-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. 2 is indication expansion, assuring that in the longer run, where can you really provide the therapy outcomes. The third is awareness. All those combine as you move up on the pain continuum, you're able to provide much more therapy options.
The key really remains is that you do need to show longevity of the therapy going forward. RF ablation, 10+% 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 million moderate lumbar stenosis patients. This is a fast-growing, innovative, minimal invasive procedure, and really excellent outcomes with five-year clinical data. One of the only one in this space, and we believe that this can provide a really missing link in terms of providing therapy solutions for the pain patients. On top of that, the Neuromodulation, finally having a global franchise, which is introduction of a platform. This expect us to be of a 10+% growth, 1.2 million 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. In terms of the pipeline, when we look at a portfolio of how we see this, in neuropathic pain and SCS, we see this, we expect our combo RCT data coming out, interim analysis data coming out towards the end of the year. A full platform system enhancement tool or WaveWriter platform by before end of this year. A next-generation system in 2021, as well as in the future indication expansion. We're 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 first one or two years, and then you see a number of explants coming out. The longevity of the data really matters, and 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 the infrastructure and the support care necessary.
For the Vertiflex platform, we expect additional clinical investments to drive the clinical outcomes on top of the five-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.
A little bit about Vertiflex. Very excited to talk about it. This is truly a unique platform, and it is 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 as one of the few players in the marketplace and continue to drive future growth. 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 in assuring that we drive long-term success of this therapy, we're very excited about the opportunity.
It is also Medicare reimbursed Category 1 and also expected to reach about $60 million revenue in full year 2019. We expect 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 Neuromodulation portfolio. 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 sub-paresthesia waveform. This is a work that's been going on for us. Almost six years of research went into this. When you look at our real-world data, and this is what was presented, what is interesting is these are patients in five centers, consecutive patients coming in.
There's no cherry-picking, because what's important is you want to be able to provide therapy outcomes for the patient that are every day walking into the clinic, not just in clinical studies. When you look at this 80% responder rate after one year, 102.5 in terms of the pain scale, significant drop. What is most interesting is 23% of the patient was reported pain-free, and 66% are showing minimal pain, one to two.
It's a very strong data set. On top of this, our RCT data will start coming up. We expect similar results, midterm data coming out by end of this year, and the full data set, 140, 150 patients by middle of next year. This should add and substantiate the value of what we see as a WaveWriter, and we continue to see that as a future platform going forward. With that, I'm going to turn it over to Milad Girgis to talk a little bit about DBS. Thanks, Milad.
Thanks, Maulik. Good morning again. It's great to be here with you. My name is Milad Girgis, 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's available in 40-plus countries around the world, and like Maulik said, we're changing the lives of thousands of patients. The other exciting milestone was in the first quarter of this year, we released our Vercise Gevia, our Vercise PC, and our Vercise 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 Maulik said, Parkinson's in the U.S., we estimate there's about 1 million 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 the other 5% are replacements. This market really is severely under-penetrated. 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 through that 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 two goals.
It's to place the lead in the right location, then 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. The wrong stimulation will lead to the wrong side effects. With that, we took on a little different DNA. We came from a neuroprosthetic. We came from a cochlear implant. We used that DNA of a neuroprosthetic to create this technology called Multi-Independent Current Control. Acronym is MICC. Think of it as a dimmer switch for every one of those eight contacts. It's something no one else can do. 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 control study for DBS. We now have two years of data that was released in the second quarter of that study. You can see here on the left-hand side of the screen, for two 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 first-generation system. What's even then more exciting is on the right-hand side is a picture of our STIMVIEW programmer. That's the programmer that's behind our directional capability. We're seeing, again, in studies, in 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.
We're continuing also with a registry that now has over 400 patients across 40 sites and will be looking at over 1,000 patients in 70 worldwide sites to see the real-world long-term capability of what this system can provide.
That's a lot of the engineering and the science. 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. He connected with a patient ambassador of ours, and now in his early 40s, he received a Vercise 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. No.
Okay, good. We're going to shift the stimulation 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 to protect his privacy. Did you notice his voice and how it changed? If you noticed 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. 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. Can we now also help in their quality of life longer term? 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. 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. The theme this morning has been around visualization. In brain modulation, we partnered with Brainlab. What we're doing there is taking a patient-specific MRI, taking that and bringing it to our software. 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's 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. Again, that's the goal. Some of this is available in Europe today, and we'll be further integrating this. Beyond that, in 2021 and 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 Maulik 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, Maulik.
All right. Thanks, Milad. As Milad 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. It's very exciting times. Overall, we see this existing exciting marketplace, under-penetrated, underserved markets.
The key is for us to continue to focus on science-driven approach. Understanding of mechanism 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 on 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 experiences.
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. Overall, leading with technology and the clinical insights that we're learning from both pain as well as on the Brain side, it'll allow us to unlock new treatments going forward in disorders, especially neurological disorders.
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 and visualization. All those will enhance the chance of success for treatments such as Alzheimer's, for treatments such as stroke, as well as indication expansion for pain. 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.
Thank you, Maulik and Milad and Joe and Ken. Now we have about 15 minutes for Q&A, and I promised Rick he'd be first. Rick, 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, I'd be curious to hear you expanding your thoughts on the leadless pacemaker potential. Obviously, your two main competitors have been visible leaders well ahead of you. How do we think about your potential to win in the space longer term? Just curious, does EMBLEM or your S-ICD 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?
I'll try to talk about some of the market dynamics, then I want Ken to weigh in on sort of the clinical side. What we get to watch right now, obviously, one of the competitors stumbled very quickly during their European launch. It's been a little bit of a storied past here driven by that. 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. We get fairly accurate sort of assessments for what kind of penetration. It's in a fairly small market, single-chamber pacemakers are really 15% of the total global pacemaker market. We get really good insight, we see sort of the share uptake 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, that penetration is dramatically lower than what we see, for instance, in Japan and the United States. When you look at the promise of things that are leadless, brady pacing, defibrillation, without putting anything in or on the heart. We're kind of chasing that same vision, although it may not be material in the next few years, we look at it as a space we have to be active in. Honestly, today, if you say, "Hey, let's count everything from leadless pacemakers to leadless S-ICDs that don't touch the heart," we're the clear market leader in that. We're uniquely positioned to sort of innovate in that space. I think Ken hit it really well.
We are the first and only company with a subq ICD. We are going to be the first and only company that has figured out the communication scheme and sort of the collaboration between an S-ICD and a leadless pacemaker. Ken, you want to talk about it from a clinical?
Rick, I'll expand on two points. First, frankly, one of the luxuries in going after the competitors is we've seen what are some of the issues with their systems. 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. The intent is to come out with a delivery system and a retrieval system that is easier to use for implanters 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 is important is when you look at the combined system, the modular CRM system, we're really trying to change the paradigm when we talk about modular approach to therapy.
I mean, today, if you look at the folks who haven't made the switch to S-ICD 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.
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 EMPOWER, physicians can feel confident, start with the S-ICD for that broad swath of primary prevention patients. Then if down the road, they develop a need for pacing, develop a need for anti-tachycardia pacing, they have the option of just getting an EMPOWER device. They stay leadless. You maintain all the advantages.
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 S-ICD.
Okay. Thank you. Just turning to the arrhythmia AFib side of things, sounds like you're very excited about the potential for arrhythmia in the U.S. 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 BSC accounts, that's where your opportunities are. Even more important, do the upcoming catheter launches like DIRECTSENSE and IntellaNav, is this catch you up or put you ahead of others, so we should be a lot more optimistic, or how would you frame how we should feel about the potential for arrhythmia adoption over the next two or three years versus it's been good, but is this the inflection point now? I'm just not sure I'm clear about all that.
Okay, there's a lot packed in there.
I know. Sorry.
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.
There are thousands more of labs that we can target. 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 IntellaNav MiFi OI catheter, which is our latest, combined with DIRECTSENSE software, what that has done in the European market. That continues to accelerate and build momentum. I'm not going to get into specific numbers, but think about Europe with current generation RHYTHMIA HDx, our latest catheter, not our final catheter, but our latest catheter and our latest software growing at multiples of the market growth rate. Again, we're still very early in that launch.
I won't get into how penetrated we are, but even with partial penetration, even into our user base, we're growing at multiples of the market. Now, we still have the issue in every market. Our old legacy stuff is not really growing. We're still fighting that headwind. 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 IntellaNav MiFi OI and DIRECTSENSE. Ken, you want to add anything to that?
I think the only thing I'd add is, this is a tough market because the competitors aren't standing still either, and we know that. That's why the long-range strategy isn't to focus on just one segment of what it takes to win an ablation, but it's to provide the complete toolbox. Single shot with cryo, single shot with an RF balloon, advanced mapping navigation with RHYTHMIA, advanced tip technology on point RF catheters with DIRECTSENSE, and then with StablePoint. I think, ultimately, it takes having that complete portfolio to win.
Jayson?
Jayson Bedford, Raymond James. Just to follow up on Rick's question, EP growth, low teens market, your goal is to grow faster than that. What's the timeline on that? Is that 2020? Is it 2021?
It is dependent on when we deliver those technologies. Go back to my Europe statement. Two-thirds of what you saw, let's split this from a single-shot statement to what's happening in that advanced mapping and navigation category. With only two-thirds of what we think are the major sort of accelerators, we're growing at multiples of the EU market. We think that will accelerate when we bring the last barstool leg, which is StablePoint force sensing catheter. If you look at force sensing alone, force sensing catheters make up almost $1 billion of the $5 billion market. We don't have a product in that category. Two-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 third leg of that stool comes in 2020, opens up another sort of billion-dollar global opportunity as we launch a force sensing catheter that's specifically designed to leverage everything we do with RHYTHMIA and the RHYTHMIA software.
Okay. Maybe for Maulik 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? You've mentioned awareness is needed, or 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, healthcare policy, anything like that. They also believe strongly in SCS being one of the best alternatives for pain treatment. We see that with the new introduction of new platforms coming out towards the end of the year, some of the clinical data coming out, we see the momentum starting to pick up after that.
Just raising awareness?
Sorry. Patient awareness?
I think that's just given. 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 60,000 to 70,000 patients getting treated. Number of patients coming into the pool every year, 1 million back surgeries, 30% failure rate, you expect about 300,000 patients coming in every year. On top of that, additional neuropathic, additional pain patients coming in. You're combining that, and you're looking at about 0.5 million patients, new patients coming in on top of the pool that is there. I think that as we go forward, the longevity of the data will support an interest from the patients. There's no decline in terms of the patient referral coming into the pain physicians.
It's a matter of time till you see that momentum pick up.
Okay. We're running a little bit behind, I think we're going to cut there. Happy to take additional questions for these guys at our wrap-up session. We'll ask that we take just a 10-minute break, and we'll start promptly at 10:30. Thank you.
All right.
[Break]
Ladies and gentlemen, please take your seats. Our program is about to resume.
Thank you very much everyone for your flexibility in that quick break. Recognize there's still a queue for some of the facilities. 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 Interventions. Super exciting time for this business. With that, I'm happy to turn it over to Jeffrey Mirviss, our Senior Vice President for peripheral, as well as Catherine Jennings, our VP for marketing and new business development. Jeffrey and Cat?
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. We wanted to get your blood moving, get you going here.
If you do, we have a great portfolio to help you out. We're going to be talking about that in our presentation here about, our category leadership strategy on venous. Overall, I'd say peripheral has been a really strong growth sector. We see many new catalysts for growth as we look at the future. We believe that BSC is extremely well-positioned to continue the above-market growth that we've been enjoying here for the past couple of years. Over the next 25 minutes or so, Cat and I will cover the following key points in this presentation.
This is sort of our high-level summary for you. First and foremost, we serve very large and under-penetrated disease states, and we see that there are many unmet clinical needs that we can help patients with. As the global population ages, patients are entering the period of life where these peripheral diseases are becoming more prevalent. Probably most importantly, these large and under-penetrated 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-effective, minimally invasive solutions. Second, we see that BSC has a 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. 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. 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'll help us drive above-market growth. What you'll see in this presentation is how we plan to expand into new spaces where we can leverage our Boston Scientific capabilities.
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 BTG products. There's a significant number of countries where we have yet to reach our full potential as a peripheral business. Looking at the market, we see the total addressable market in peripheral at over $6 billion last year. We estimate the market will continue to grow around mid-single digits in the next three to five years. This growth is well-balanced across our three franchises, which is arterial, venous, and interventional oncology, as well as from a geographic perspective. In particular, we see really good, strong growth coming from the Asia Pacific region as we look forward over the next several years.
Last year, BSC PI organically grew 9% to reach $1.2 billion in global revenue, which was accretive both to the market as well as to the BSC enterprise average. 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. This slide highlights the significant amount of unmet clinical needs across the three franchises we're focused on. In arterial, we have a category-leading position in PAD, where there's over 200 million patients around the world who suffer from the disease, and less than 1% receive an intervention. We have expanded our investments to patients with critical limb ischemia, which is the most severe form of PAD.
Nearly a quarter million of these patients receive an amputation each year in the U.S. and Western Europe alone. 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. 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. On the venous side, we see this market approaching $2 billion in 5 years as it continues to grow in the high single-digit range. 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.
We'll also be uniquely positioned in the DVT space as the only company with a full portfolio of products. We're investing in new clinical trials to ensure that our innovations are supported by the most contemporary clinical evidence. 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. It's a pretty large and difficult market for patients. We believe that a minimally invasive approach to treatment can not only help patients, it can be more cost-effective to the healthcare system. There's lots of data that supports that earlier diagnosis and treatment can significantly reduce these high mortality rates. In terms of interventional oncology, this market is also growing high single digits, where nearly 1 million patients every year are diagnosed with liver cancer.
While technology has improved dramatically in liver cancer, survival rates continue to be very poor, with the second lowest overall cancer survival rate at 5 years. 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. 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. 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. 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 BSC PI, 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. We've experienced above-market growth over the last several years.
On the other hand, BTG has a differentiated portfolio that's focused on higher growth adjacencies that I mentioned on the previous slide. They've consistently grown double digits, and their innovations are a perfect complement to our current portfolio. Upon close, BTG will provide BSC Peripheral an entry into a greater than $1 billion of new adjacent markets. We're stronger together, and we'll accomplish more as one team than either company would have accomplished on their own.
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 very good capabilities at integrating companies. We see this as right in our execution sweet spot. The combined BSC and BTG teams have been hard at work over the last several months, planning for integration and getting prepared to begin execution upon close. We feel like we're ready, and we're ready to go. We're reiterating our expectations that this acquisition will have a really strong ROIC, approaching double digits at year five. 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 AngioJet, VICI stent, and EKOS. In interventional oncology, think about TheraSphere Y-90, the Galil cryoablation, and of course, our leading delivery and embolization portfolio. A portfolio combined of premier leading brands in the market.
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. There's so much on this slide that I could talk about, but let me just cover two innovations from BTG that we believe will provide a differentiated option for our customers and their patients. The first one in the middle on the bottom is this Sentry vena cava filter that's used to prevent life-threatening pulmonary embolism. It's 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. The Sentry filter is the world's first bioconvertible 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. This Sentry filter was designed to solve this problem and has demonstrated excellent safety and efficacy with two-year data that was reported at VIVA last fall. The Sentry filter expands our total addressable market by roughly a quarter billion dollars and will be an opportunity for us as a combined BTG and BSC team now to change the current paradigm of retrievable filters. The other innovation I'd like to touch on is the TheraSphere Y-90 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. We view the TheraSphere product as a platform technology that can be leveraged into other radiation-sensitive tumors.
TheraSphere works by delivering a high dose of radiation right directly into the tumor. 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. TheraSphere offers a single treatment, and it's convenient and cost-effective for patients that have liver cancer. It also has some advantages over the other Y-90 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 Y-90 option, which is a meaningful difference. TheraSphere will be supported by new clinical evidence, which we anticipate will read out over the next 12 months or so.
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. 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. Each TheraSphere case utilizes a number of delivery tools, such as a catheter or a guidewire, which previously wasn't part of the BTG portfolio. 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.
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, Jeffrey. It's a real pleasure to be here with you. My name is Cat 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 a report of increased mortality with paclitaxel devices.
Boston Scientific has over 20 years of experience working with paclitaxel eluted 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 TAXUS can be leveraged when looking at safety data for Eluvia. TAXUS data in almost 2,800 patients randomized versus bare metal stents showed no difference in mortality at five years.
This data set has three times the number of patients that were included in the Katsanos, FDA, and VIVA meta-analysis. These randomized trials were designed to be pooled. The stent design has been used in over 6 million 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 a drug-eluting stent is unique, safe, and effective. Our unique polymer-based design allows for two key attributes. One is the lowest paclitaxel dose of any product on the market, in some cases, up to 20 times lower than DCBs, and two, the lowest particulate burden compared to other paclitaxel devices.
We have seen no safety signal with Eluvia. Eluvia was not a part of any of the meta-analysis showing a safety signal, either performed by Dr. Katsanos, the FDA, or the VIVA group. We have five-year data on almost 2,800 patients with TAXUS stent, which has the identical design principles with no safety signal.
We also presented brand-new two-year data on Eluvia at the panel, including a statistically significant reduction in reinterventions at two years versus our control arm, Zilver 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 seven patients to avoid a revascularization at two years versus the PTA control arm in the FDA meta-analysis, really demonstrating the unique benefits of this differentiated technology. I wanted to share some of our perspectives from the panel.
First, 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 reduce revascularizations 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. 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. We just started our unrestricted launch with full supply in Japan. We continue to be optimistic about China approval in 2020, and 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. 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 IN.PACT balloon, will be available in Q1 of 2022. That's 414 patients randomized across those two products. 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 Jeffrey 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 have seen with Eluvia. SAVAL received FDA breakthrough designation, the first in the peripheral branch, and our trial is over one-third enrolled. Once approved, we believe SAVAL could become a frontline therapy for the millions of patients that suffer from critical limb ischemia. To summarize, we are currently modeling a drug-eluting market that is $700 million 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 am going to now switch to our venous franchise. As Jeffrey mentioned, venous disease is a large underserved market, and we are 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 ultra-high-pressure balloon in development, representing a billion-dollar market by 2022. Importantly, we will 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 obstructions.
Through the BTG acquisition, we will double that addressable market by entering into pulmonary embolism and venous insufficiency. The EKOS 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. Jeffrey touched on Sentry and the opportunity to reenter the vena cava filter market. The last product from BTG that I would like to touch on in venous is Varithena. Varithena is a strong competitor in the fast-growing, non-thermal, non-tumescent segment of the over $400 million superficial venous insufficiency market, commonly known as varicose veins, where it competes with Medtronic's VenaSeal. We continue to hear physicians share their positive experience with the product, and with strong reimbursement in place in the U.S., 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. Similarly to our strategy in venous, we continue to place small bets in interventional approaches to treat hard to treat cancers like RenovoRx for pancreatic cancer. As Jeffrey outlined, BTG's TheraSphere and cryoablation product lines build on our category leadership strategy. They are viewed as highly differentiated and enjoy market share leading positions in their respective categories. TheraSphere 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, and are designed to provide a better chill zone. There are two TheraSphere trials, as Jeffrey 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 billion 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 guidewires, as well as a best-in-class therapeutic offering with TheraSphere beads and cryoablation. Next, please. These platform technologies, as we learn more about BTG'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 million patients annually. Tumors that have historically responded well to radiation therapy and where we can get a catheter are potential targets for TheraSphere, 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 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. 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, 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, where we have consistently delivered double-digit growth. Using our regulatory capabilities in places like China and 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, they also represent some of the largest opportunities for BTG products. Half of the world's primary liver cancer patients are in China represents a great opportunity to bring these new technologies to help treat these patients in a less burdensome way. Last but not least, Japan represents the second-largest market for drug-eluting technology, where we continue to see fantastic excitement around Eluvia and our entire drug-eluting pipeline. To summarize, we operate in large, under-penetrated disease states where our highly differentiated product positions us 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, Shawn, and Ian up on stage.
Good morning. Hi, Mike. This is the last leg in our triathlon of businesses. Hopefully, it feels like an Olympic distance triathlon and not a test of survival Ironman. 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. 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. We built a large, profitable coronary therapies business that's very stable and is 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. 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 that are changing the foundation of how we deliver care to cardiac patients. 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. Last year, our interventional cardiology division delivered $2.6 billion 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'll grow around 6% annually over the next few years, led by double-digit growth in structural heart. 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 billion segment.
It serves as our foundation, and we expect the combined structural heart market will reach a similar $8 billion size over the next few years, enabling BSC in our space to compete in a $16 billion global market. 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. 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. In the recent launches of LOTUS Edge as well as SENTINELS have gained good early momentum, and our ACURATE system continues to be the fastest-growing valve in Europe.
Also with the success of WATCHMAN, our LAAC business continues to grow impressively, and we expect to be the only player in the U.S. market for the next 18-24 months. Over the past several years, we've focused our R&D investment portfolio on growth and diversification. 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. Complex PCI has taken a much more prominent role in our coronary portfolio.
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 three fronts. First, protecting our position in stents. Second, extending our leadership in complex PCI. Third, disrupting the fast-growing structural heart market. 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 PCIG or imaging, is a substantial $8 billion segment that encompasses over 5 million PCI procedures on a global basis annually.
For over two decades, Boston Scientific has focused on building an 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. In 2019, we expect that more than 50% 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.
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'll 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. In any given year, what you should expect from our coronary team is to bring between five and 10 new products to physicians around the globe. Our leadership in this space in coronary is a result of intense focus on diversification, even within this segment. We talk a lot about diversification of the overall interventional cardiology business.
Even within coronary, we've got over 20 distinct product families. We're uniquely positioned to look at the full PCI procedure, and we've been developing and investing in a full portfolio of devices that treat the most complex and challenging cases. In the past, many of these cases had to go to surgery. Through innovation, through physician training, through improved workflow, we're now able to help physicians treat the most complex cases with less invasive procedures.
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 billion this year and be larger than our stent business. Our team in coronary has the broadest portfolio of any player in the market, and we continue to invest in meaningful technology to extend 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 working on ways to simplify that procedure further with an electric version of Rota. 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 IVUS tools. High-value, complex PCI tools create a unique portfolio advantage for us. We're also continuing to iterate our flagship SYNERGY product line, which includes expanding the size matrix, creating a dedicated large vessel stent, and developing a new extra deliverable catheter.
Additionally, we ran a large clinical study, EVOLVE Short DAPT, to assess the shortened DAPT duration in high bleeding risk patients. We believe the mechanism of SYNERGY with its unique early healing benefits is particularly well-suited for this patient population. We anticipate the results of that study will be presented later this year. Through meaningful innovation, through consistent execution, we expect to maintain our position in stents and extend our leadership in complex PCI. That will enable in the coming years for us to maintain growth at or above the levels of the overall coronary market. I'd like to turn to what I believe is one of the most innovative and fastest-growing areas in med tech, our WATCHMAN LAAC franchise.
Approximately 33 million people around the globe suffer from AFib. 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. This quote from Marjorie, who's 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. Two 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. 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. We also reestablished our market leadership position in Europe earlier this year and anticipate expanding our position with WATCHMAN FLX in Europe, which received CE mark in Q1.
In China, the adoption of LAAC with WATCHMAN 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 two years, and 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. Together, these opportunities give us confidence in continued strong performance from this franchise.
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. Beginning in 2017, we piloted a patient awareness campaign in select markets to learn how to identify and engage with these patients.
Using highly targeted digital approach overlaid with selective cable TV buys, we connected the right patient population and drove implant growth. 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. Results from those pilot markets gave us confidence to expand the campaign nationally.
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. 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 a patient's engaged, their journey's not over. 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 and engineering investments in product innovation to build on that leadership in outcomes, workflow, and ease of use. I honestly couldn't be more excited about our next-generation WATCHMAN device called FLX.
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. It's my pleasure to talk about the WATCHMAN FLX device. You've seen on the previous slides the WATCHMAN original device was a parachute-shaped device, so it was open-ended. You can see here very clearly, WATCHMAN FLX is enclosed. It's rhomboid in 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. The benefit of this device, the WATCHMAN FLX, is that it will be able to treat more anatomies, more different shaped anatomies, and therefore reach more patients. The way the device has been designed allows much more control during delivery. In fact, actually, you can lead with the device, the head of the sheath. That's very important.
The left atrial appendage is a very thin-walled structure, being able to lead with the device and land it 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 an atraumatic fashion. Of course, because it's more conformable and it seals better, and because the screwing section of the valve has actually been flattened off, we believe there's optimal healing capabilities here and less likelihood of having a leak. Thus far, we have substantial data already. Patients in the PINNACLE FLX U.S. IDE trial, record recruitment speed. We're now in follow-up phase for that.
Because of the European rollout, we have more than 1,000 patients who've had experience with WATCHMAN FLX so far, and the physician feedback from that experience, both in the PINNACLE FLX trial and the European rollout, has been very good. To attest to that, we have a video here from some leading physicians who can speak to some of these features and that validate some of these design features that I've spoken to.
The first time I encountered the FLX device, I had two reactions. One, when I looked at the device and I saw that it folds back on itself, just based on that, you know that it's going to be a very atraumatic close. Less chance of having complications as you maneuver in the left atrium. The second response after I did the procedure was just the feeling that that was a very simple procedure. I think the device is very easy. The ease of use of this device is going to be probably a standard that all other devices we do are going to try to measure up.
The three words I would use to describe FLX would be atraumatic, controlled, and precision. The most important thing for me is the atraumatic nature of deployment for the FLX.
The WATCHMAN FLX has really changed my perception because people have always said the lobe and disc causes better sealage. Once you use a WATCHMAN FLX with its 18 struts, it conforms so well with the orifice and the left atrial appendage, it seals it almost perfectly.
The criteria for FLX 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 biggest advantage I find with WATCHMAN FLX, especially for new users, is that you can completely recapture the device and use it again. I think WATCHMAN FLX is going to be a game changer. It's going to improve the safety of the procedure. It's going to improve the effectiveness. It is so easy to use. It is recapturable. It's soft and it's safe. Most importantly, sealing of the appendage orifice is so complete that I really don't think we need another device.
Very powerful validation. I think the words you've heard there, atraumatic. You heard ease of use. You heard simplicity. You heard good sealing and game changer. We're very excited about this technology, and we do believe that this will actually suffice for the vast majority of patients who need left atrial appendage closure. It's not just simply a question of the technology. You have to expand the evidence base as well. We believe there is an enormous opportunity to grow robust evidence to broaden the patient population that we can treat. 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. Now, of course, we're conducting the ASAP II trial in truly contraindicated patients.
Moving forward, there is a real opportunity to expand this to lower and moderate bleeding risk patients. Of course, our first foray here is with the OPTION trial. 1,600 patients, 130 sites. Patients who have undergone pulmonary vein isolation for the treatment of atrial fibrillation are being randomized one to one, 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. We're incredibly excited about this option. I'll hand back to Kevin. Thank you.
Great. Thank you, Ian. 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. The other key piece of our structural heart business that's a key component, obviously, centers around our valve portfolio. With the recent commercial launch of LOTUS Edge, this is a very busy and very exciting time for us in this space. To tell you more about this business, I'd like to turn it over to Shawn McCarthy, who's our general manager for structural heart valves.
Thanks, Kevin. Good morning. Structural heart valves continues to be one of the largest and fastest-growing segments in medical device. 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. 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. For sure, TAVR continues to grow. 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. In essence, we have called what we're expecting to be a $9 billion market by 2024.
The vast majority, roughly $6 billion of that, in the TAVR landscape, and close to $3 billion of that in mitral therapies, again, primarily in the repair segment. 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. In terms of the landscape that we see and being able to disrupt the established players, we're well-positioned.
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? To cut to the chase, one of them. One of these devices was the SAFARI wire. In a reasonably short period of time, we have established a portfolio that's incredibly impressive to our physicians, most importantly, and the patients that they serve.
How is it that we drive innovation? It's all about the patient. If we think about in the TAVR landscape, by example, what matters most to them in terms of the best outcomes? Limiting mortality, driving the greatest benefits. It happens when we reduce paravalvular leakage, when we prevent stroke, when we improve pressure gradients and lower pacemaker rates, and then, of course, we lower vascular complications.
The beauty is our portfolio uniquely addresses all of those things. When you think about LOTUS Edge, it's designed to offer the best-in-class PVL. 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, first and only to that market so far. ACURATE's designed to give us those optimal low gradients and also lowest pacemaker rates, as well as iSLEEVE, which is our expandable sheath 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. This 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 and disrupting the landscape. 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 sides 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 an intra-annular and supra-annular valve. Why is that important? You can think about the early cases that have already been done with intra-annular 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 intra-annular, and then you follow up with supra-annular. The ability for a single company to provide all of those options to physicians, we believe, is incredibly powerful. 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. If we think about the bicuspid valve arena, one obviously we're studying right now with LOTUS Edge, we see that about 15%-20% of all TAVR procedures worldwide are bicuspid valves, and about half of the cases in China, 50% of TAVR procedures.
That's an important market, as well as heavily calcified native valves. Both of those segments important. Those heavily calcified native valves, also about 15%-20% of the market. You put those pieces together, and those are really well-suited for the design intents that we laid out with LOTUS Edge. Let's also think about more tortuous anatomies, small annulus. We think about horizontal aortas.
These are also challenges, 15%-20% of the market there, wonderfully suited for the ACURATE 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. 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 PVL outcomes, to nail your delivery exactly where you want it, never have a malposition, having superior stroke rates as seen in our study in REPRISE III, and also competitive pacemaker rates. As you know, we're commercializing both in Europe and the U.S. as we speak. Our launch plans are controlled and measured.
They're basically focused, certainly early on the REPRISE III centers or centers that have had experience with us. 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.
Of course, we'll 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. Our focus will be to launch in roughly 150 accounts within the first 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 TVT conference in Chicago just a couple of weeks ago. 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. "Nothing else feels like LOTUS Edge." Those are impressive comments.
At TVT, 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. 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. Maybe, Ian, a couple thoughts on Lotus Edge?
Yeah. Thanks, Shawn. On Monday, I was assisted in two cases in California, two incredibly difficult cases. The first patient had severe annular calcification and sub-annular calcification, which is always the risk of annular rupture when you do balloon dilatation or a balloon expandable stent. Person also had critical coronary artery disease. They were worried about paravalvular leak from the severe annular calcification.
We deployed an appropriately sized Lotus valve in under 10 minutes. We did that with no paravalvular leak, no pacemaker, no other complications. Most importantly, we were able to reposition the valve once just to obliterate the paravalvular leak. That was all done without either pre or post-balloon dilatation. The second patient was a 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 paravalvular leak, no pacemaker, no complications. Case done.
Tremendous. Thank you, Ian. 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. Exciting to say that we continue to drive our pathway to broadening out our indications. 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. Behind the scenes, never anything other than a relentless effort to drive innovation forward. 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 intra-annular valve thrombosis. It also generates the optimal radial force inside of the LVOT, which will also help us to further drive down rates of pacemaker. Our initial focus will be to bring the LOTUS Mantra 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 timed 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, then in 2021 for the remaining sizes, plus the motorized electronic delivery system. Excitingly, ACURATE neo is a self-expanding super annular valve that remains the fastest growing valve in Europe as it's become widely appreciated for its ease of use. It allows physicians in a top-down deployment to provide outstanding clinical results. We saw those earlier in our SAVI-TF 1,000 patient registry, which was the basis for our European approval.
In that dataset, ACURATE neo was shown to have a 98.7% procedural success rate, a low single-digit moderate and mild PVL rate. It had a single-digit pacemaker rate. It had a six and a half minute average device usage time. It had zero coronary obstructions. 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.
We've recently received approval also in France, one of the largest markets in Europe. Not only approval, but reimbursement, and 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. 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. You'll recall the SCOPE 1 and SCOPE 2 studies, randomized trials, and roughly 1,500 patients. We'll combine those European data with the U.S. 500 patients, who will serve as the basis of our PMA submission and FDA approval. With LOTUS, we continue to invest in ACURATE futures as well. Never anything other than a relentless pursuit of meaningful innovation here. Next generation would be the neo2 valve. neo2 basically carries all the great attributes of the original neo, but it has an extended, elongated external skirt, which continues to drive down the rates of PVL while maintaining these great pacemaker rates. We expect that to reduce leakage by an additional 50%. It's a tremendous move in that neo2 valve.
ACURATE NEO Prime has enhanced radial strength throughout all sizes and expands also to include an extra small and an extra large size range. ACURATE Prime will be the first valve in this product family to be launched in the U.S. Of course, next-gen ACURATE. Don't stop there. The next-gen is a lower profile valve to support improved delivery accuracy and a smaller vessel size indication, and also reduce PVL even further. We have a bit of a revolutionary sealing 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. We expect the ACURATE IDE enroll the U.S. randomized trial enrollment to conclude early next year. Okay.
The basis of that would be a U.S. approval estimated in 2021, followed by approvals in Japan and China in 2022. 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 PVL rates. One of the items brought up there also was their stroke rate. 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 embolic protection on their family member or their friends, every hand gets raised. 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 in roughly 65% of their procedures. That ends up being about a 15% of TAVR penetration. 15% 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.
This 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 the accounts, and yet we're having all that growth in front of us. Importantly, CMS has also come back and proposed that the NTAP, the new technology add-on payment that was put in place specifically for SENTINEL. It's only one of nine 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. We also see the benefits of providing direct-to-patient 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. 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, Shawn. As with any medical device that is used in the treatment of a significant condition, there are three Ps that matter. The patient, the prosthesis, and the procedure. 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. This is where the SENTINEL device plays in. From the very outset of TAVI, we knew that there were three powerful predictors of mortality, vascular complications, paravalvular leak, and stroke. Stroke is perhaps the worst of these. It is dehumanizing. It is debilitating. People never recover fully from a stroke. You live with the consequences there forever. It's true to say that the rate of stroke is underestimated. I think we all know that.
More importantly, who is going to have a stroke during a procedure is entirely unpredictable. Data that have been established thus far hasn't shown any relationship to physician volume or center volume, nor to any specific TAVR device. If you look at the totality of the large trials, 15-plus trials of 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 patient before and after by a neurologist with MRI imaging shows that the rates can be as high as 9%. There's a cost to this.
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%-4% absolute reduction in the risk of periprocedural stroke at 72 hours. The number needed to treat is around 25 in order to prevent a major event. We also know that there's about a 60%-80% relative risk reduction from the number of large registries in the rate of stroke in the first 72 hours. This is supported by a 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. All of this actually points to an important role for protected TAVR by supporting the patient 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 mitral program. 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. Functional mitral regurgitation is a critical element of age-related heart failure. As we speak, there are more than 53 million people on the planet with severe functional mitral regurgitation. 53 million.
By 2030, that number will be in excess of 84 million people. If you take the entire population of 2030, that's nearly 380 million people with mild, moderate, or severe functional mitral regurgitation. As you all know, functional mitral regurgitation, the leaflets are actually normal. It's just the annulus that's being pulled apart. 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. As Shawn 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.
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. It all begins with treating the most common cause of functional mitral regurgitation, annular dilatation. As any surgeon would know, it's about the annuloplasty, to get the leaflets to coapt. 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. When a surgeon does a mitral valve repair, they do that with the heart cardiopleged, with the circulation through an extracorporeal system. The heart isn't beating, it isn't pumping.
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 annuloplasty in a beating heart, and you can actually see the integrity of the coaptation 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. 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.
This is a surgical view looking down on the mitral annulus from the left atrium, from above. The device steers very much like a MitraClip. You land the device on the annulus, and you anchor it. We've got over the anchoring issues because we've got an integrated intracardiac ultrasound that allows you to see the tissue integrity circumferentially around the annulus as you're screwing it in. Because now you can avoid hitting the circumflex or the coronary sinus. Once you've anchored it's a case of just manipulating these sliders to cinch the annulus in to the desired level to get the coaptation. If that's adequate, you simply uncouple the device and remove the delivery catheter. If it's not, you don't uncouple it, you simply take it out.
This really is a foundational tool for mitral valve repair in the largest valve market there is, that's mitral, that's nearly 300 million people by 2030. Very exciting time.
Perfect. Thank you. To put a specific date to it, as some of you may have seen at the bottom of the chart, we do expect to be with Millipede in an early feasibility study next year. Progressing this category forward to drive a continued waves on a beach growth strategy for the structural heart valves business, both aortic and mitral at Boston Scientific. I would just maybe end this segment with who better to bring structural heart and cardiovascular innovation to life than a company with this 40-year history? 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.
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. 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.
We're going to continue to invest in our sales force. The interventional cardiology group has a lot of responsibility to support these sites. 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 with the highest level of customer service that they've grown to expect from Boston Scientific. Kevin?
Great. Thank you. Thanks, Shawn and Ian. Just one last slide here, kind of a teaser slide as we move to Q&A. 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. 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. These include areas such as tricuspid valve repair, an entire suite of interventional heart failure tools in the important area of circulatory support. We at BSC have got several investments, many venture investments, as well as, in some cases, internal programs aimed at these significant markets. We look forward to highlighting those more in detail at future events as those opportunities mature.
With that, I'll hand it back to Susie for Q&A.
Great. Now I'd like to have Cat and Jeffrey join us again. Questions for our cardiovascular team. Go to Larry here in the front. Thanks, Nancy.
Thank you. Larry Biegelsen, Wells Fargo. One for Jeffrey, one for Ian. Jeffrey, the $700 million 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 million or so. What gives you the confidence that we can get to that $700 million based on the panel last week? Ian, this first head-to-head study comparing WATCHMAN to novel anticoagulants, PRAGUE-17, at late breaker at ESC, is that an opportunity or a threat for WATCHMAN? How should we think about that? Thank you.
Coming out of the panel, our view is that the dialogue at the conclusion of the panel was very constructive. Just yesterday, the FDA posted answers to the 12 questions. 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. 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 two.
If that's the case, our view is that the market begins to recover here in the back half of this year and grows heading into 2020. Could be double-digit growth to get to this roughly $700 million in the next 3 to 4 years. We're modeling this somewhat off of the coronary DES, because this is what we experienced over a decade ago, is it takes a little while for the market to sort of digest it and then move on. We believe that we have a differentiated position with Eluvia. 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. On top of that, we'll have Ranger coming next year.
We think that the market will begin to recover sort of beginning next year, we'll have a decent shot at having a good chunk of that market growth.
Ian, then Mike.
Thanks, Larry. The short answer to that is we don't see it as a threat. We see it as a potential opportunity. It's 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. I think it'll provide us insight. There are methodological differences with the PRAGUE-17 trial. We see it as an opportunity, not a threat.
Matt? Bar mic, please.
Hi, Matt Miksic from Credit Suisse. Thank you. 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 the elements of change between your $6.5 billion 2021 estimate and your $8 billion 2022 estimate. What are the components of that? I have one follow-up.
I can take that. Thanks, Matt. I don't know how much they've changed necessarily, but I think it's important to just ground on the build up to that market. If we say structural heart now, we're growing in 2022 to about an $8 billion market. That's the timeframe we were talking about the LAAC market, roughly approaching $1 billion, plus or minus. You've got mitral that in that time is probably a billion and a half on its way to $3 billion by 2024. That puts TAVR being the balance at five and a half-ish or upper fives by that time period. 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. On the rollout, Lotus and 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 and a half, how many U.S. centers do you think you'll have running clinical studies for TAVR? Various trials for various devices.
I'll let Shawn expand. I would just say in general, a lot of these bigger studies are 40-plus centers. When we run intermediate risk trials, when we run an ACURATE IDE, you might be talking about 40 to 60 centers. I think that if we've got multiple trials going on the same time around the same patient population, we tend to not want to overlap centers, having them enroll and compete with themselves for patients with their own devices. If we've got unique clinical trials, you might get upwards of 70-ish centers going at any one time if there's overlap. We've got a lot of trial activity planned, obviously, in both products over the coming years. I don't know if you want to expand any more.
Maybe just to add that of the 40 to 50 that are in each of those studies, as mentioned previously, we expect from a U.S. Lotus launch to be in roughly at about 150 accounts in the first 12 months. The balance obviously being outside of those 50.
Thanks so much.
Go to Matt Taylor there. Matt, who's to your right there, white shirt and beard. Thanks.
Thanks, Susie. Matt Taylor from UBS. I wanted to ask a follow-up question on the 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? 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? Could you comment on your own mix? How much Ranger versus Eluvia do you see kind of growing in your forecast?
Yeah. I think there is a perception amongst physicians and healthcare systems around the medical-legal issue. 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. We estimate up to 40% of hospitals don't even have paclitaxel devices on their shelf, so the use is zero. If the FDA makes a statement similar to the first letter, then they reintroduce products back on their shelf, that will provide a meaningful growth catalyst for the market. 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. The FDA is very interested in the outcome from that trial. I think Eluvia is well-positioned. We obviously believe in the benefits of Eluvia, we think kind of on balance 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. 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.
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 have 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?
Yeah. Thanks, Mike. Good question. Shawn, you can expand if you'd like, because you're in the field every single day. I would say in Europe specifically, and it's a little different situation, obviously, than in the U.S., our European team has enjoyed a great product like ACURATE for the last couple of years.
They've got momentum with ACURATE. 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, in that built sense. I would say the predominance of the mix in Europe going forward, for a while, will be on ACURATE. 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.
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 Shawn represented nicely intra-annular, supra-annular. 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. 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 think this next six months of the back half of the year is going to be pretty informative to us as well in terms of the adoption. 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. 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. 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.
Thank you.
I probably said an impossible thing.
Anything to add, Shawn? We'll go in the middle here, please, to Danielle.
Hi. Good morning. Danielle Antalffy with SVB Leerink. One question for you, Jeffrey, and one for you, Kevin, on the follow-up on the panel from last week. Just curious how you're thinking about how FDA will approach new product approval. 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?
Yeah. I'll give you two data points that give us confidence. I think the first was the discussion at the panel about future products and future clinical trial endpoints. They reaffirmed that a 12-month endpoint was appropriate and following the patients out to a full five years, which is what we were already doing with Ranger. Second, we have continued to file modules with the FDA and enroll patients in our trials. None of that has changed. Everything is going according to how it would normally go if the panel wasn't taking place. Both of those things give us confidence that things will move forward.
Okay. Helpful. As it relates to Lotus, 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 rates?
Sure. Great. I'm going to kick that to Shawn, get him back in the Q&A game here.
For sure, 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. 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. 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, REPRISE IV for the intermediate risk study, as well as the nested registry, which was part of our FDA submission, are capturing data points. What we'd like to do and we expect to do is probably see something later this year. 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. 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.
Thanks, Shawn. 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 have had a great runway. How do you think about that? Then I'll quickly ask my second one. Can you discuss the Millipede clinical trial design that you expect to start in 2020? We're hearing more and more about sort of angioplasty 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. Our preference would be competition doesn't enter the market for LAAC, but that's probably wishful thinking. I think the short answer to this is we launched first in the U.S. in 2015, and the U.S. market for LAAC is the predominant market right now, and over time, international markets will come more on board. 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 FLX is one of these products as well. I grew up in engineering, so I've got a lot of experience in product development, and I would say over that time period, every once in a while, a product comes along that potentially will way exceed your expectations.
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. I think WATCHMAN FLX is going to put further distance between us and competition, along with just a very rich set of clinical data. Those coming behind us need to kind of establish that same level of clinical comfort. There's a whole ecosystem beyond product and clinical, in terms of how we're engaging with the centers and making workflow more simple and things like that I think are all very helpful. Our goal is just to act like a market leader and continue to try to stay three steps ahead. Competition's inevitable. We understand that, but we feel pretty good about our standing.
I could deal with the second two-part question. I'll deal with the second part of your second question and then the first part. The second part was the combination of annuloplasty and mitral clipping. There's a long history outside the U.S. of doing that sort of procedure with direct and indirect annuloplasty devices to bring the leaflets to closer to coaptation so that you could actually clip. 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 clipping. Of course, clipping actually inhibits your ability to do other things later on in disease progression, such as mitral valve replacement or chordal repair. Yes, you can do those procedures. Yes, they will happen.
The ideal would be to have the best possible annuloplasty first, 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 clinical trials, I'm more in the process of developing a strategy for an early feasibility study in the U.S., 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.
To add on real briefly, I think the COAPT trial was obviously great for patients and for the field. That opens up some degrees of freedom, potentially. We're not that far along with FDA discussions. It opens up some degrees of freedom to have reasonableness in trial designs in terms of whether it's non-inferiority trials, device versus device. More work to do there. 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 TCT, 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 hospitalizations. For the 40 years prior to that, it was merely speculation. We have to pay credit where credit's due. 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. Jeffrey, Cat, Kevin, Shawn, and Ian, thank you very much. Our final two speakers are Spotlight on Emerging Markets. We'll wrap up with Dan on a financial outlook. 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 to be here. I think it's a very exciting time to be part of the Boston Scientific emerging market story. It's actually also good to see a couple familiar faces from the investor event 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 billion in revenue.
Countries like China, Russia, Brazil, continue to execute on its local strategy. We anticipate that growth trajectory will continue about 15% over the next few years. A long runway remains for our business to improve patient outcomes in those regions. 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 Interventions, and complex PCI. Many of our products have been able to enable developing markets to transition more towards minimally invasive technique, which ultimately we believe improve the quality of care as well as lower the overall cost of care.
That's why you see us leading in those regions because of the significant investment in physician education. 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&D presence, and manufacturing. We now have R&D presence in China, in India, and we have manufacturing facility in Malaysia, as mentioned earlier.
Let me switch gear and dive deeper on China. China medtech market remains to be one of the most attractive and high-growth market globally. Boston Scientific China today facing a total addressable market of $3.5 billion, growing at a 15% CAGR, and we're expected to reach about $5 billion market size by 2022. The growth is highly supported by strong fundamentals, aging demographics, unmet patient needs. We talk about AFib, there's about 10 million patients, AFib patients in China. 4.5 million patients are heart failure. PCI procedure volume will exceed the case volume in U.S. for the first time in 2019. There's a tremendous opportunity in those underserved markets in lower tier cities and lower tier hospitals. There was this 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. The cost impact on our China financial so far has been very manageable and limited. There are growing concerns over other aspects in terms of market access and hospital listings. So far, we haven't really seen any major large-scale retaliatory treatment. We're all looking forward to the G20 meeting between the two 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. China tender system has been extraordinarily convoluted, very complex.
There's tendering at the hospital level, at the provincial level, at the central government level. There's a lot 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 pharma side. We know China has also been having a very complex market access system. To get product registered in China has been very tough and challenging, and certainly local competition has escalated to a different level. Lot of local players, we see them starting to reach scale because of the international expansion.
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. 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 MedSurg. 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 onto DES.
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 four pillars, portfolio strength, innovative channel expansion, local partnership, and talent development. Specific to portfolio strength, a prime example for us is our WATCHMAN business. We're very fortunate to be the first-in-market in China. Our WATCHMAN got NMPA approval way ahead of the U.S. approval. To promote the therapy awareness, the China team actually orchestrated the world's first 72-hour live case broadcast, which covered about 19 centers across the U.S., Germany, and China, with total case volume of 79. At any time during that 72 hours, a physician could log onto the stream and view live cases. As Kevin mentioned earlier, we've completed about 8,000 WATCHMAN cases in China already.
Despite the tough local competition, we remain to be the market leader in that space. We know how important it is to train physicians 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, one in Beijing, one in Shanghai, couple co-founded with large hospitals, and we're about to open another one in Chengdu, sometime this fall. 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. Over the years, Boston Scientific China has built a very strong IT infrastructure and some innovative programs to allow us to activate, segment, train, and empower our leaders, 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 consistent with Chinese government's goal to shift more healthcare resources to improve the patient access in those lower tiers. 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're actually a very active participant in the healthcare ecosystem. Last year, we launched a T3 engine, which is an innovation accelerator/incubator 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 four of a partnership deal with a top-tier cardiologist-led group to accelerate and support more local research and product development. We're going to continue to do more of those partnerships, with various stakeholders in the ecosystems and to expand our presence in China. A few last comments, 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 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. 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 strong 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, June. 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, I changed to horse racing, I guess, from the triathlon analogy, but last section, finance, then we'll get to Q&A.
Hopefully, over the last five 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 three years and beyond from our perspective. We're showing you through 2022 today, but we run the company for the next five to 10 years. You have that relative to our revenue outlook. My job over the next 15 minutes is to give you that same level of confidence in our financials. 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 two years ago and compare it to what we actually did. We showed this slide in June of 2017 at our Investor Day for what we said for 2017 and 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 two-year timeframe. Importantly, years five and six on a journey of six straight years of double-digit adjusted earnings per share growth. Really, almost one of the most important things, adjusted free cash flow, we added almost $450 million, $448 million of adjusted free cash flow in two years.
As I look at our report card, and we'll show you this again in two 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 two years. Going forward, this is a nice look of what we have for the last three years and the three years going forward with this year kind of in the middle. First 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%-8%. Operational revenue, 110 basis points, so 8.1%-9.1%. Adjusted operating margin, 50 to 100 basis points on top of last year's 25 and a half, so 26%-26 and a half%.
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. It's nice to see for us. Adjusted EPS growth 10%-13%. That does include the $0.07 one-time tax benefit that we had last year, in that 10%-13%. If that were to happen, that would be year seven in a row of double-digit adjusted earnings per share growth for the company and a target of adjusted free cash flow of $2.2 billion. You put that all together as a composite for the last three years, and you take the midpoint of guidance for 2019, say, how'd the company do the last three years? Organic revenue, 7, operational, 8. Operating margin, we added 125 basis points over those three years.
The FX impact was clearly a headwind, 2019 neutral, but 2017 and 2018, a clear headwind, so a net headwind over that period. Adjusted EPS growth of 11% and free cash flow growth of 13%. Very proud and very solid performance of 2017-2019. Mike touched a little bit on these goals here for 2020-2022 and what we think we can do. It would largely be an acceleration from what we've done the last three years. That's our goal. 2020-2022, next three years, 6%-9% CAGR in organic revenue, midpoint 7.5. That would be acceleration of what we did the last three years. Adjusted operating margin, 50 to 100 basis points improvement annually in each of those years. Some years may be closer to 50, some years may be closer to 100. 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 five to six years. 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. 2020 would be our eighth year, 2021 would be our ninth year, and 2022 would be our 10th year in a row if we're able to achieve these goals that we've established. Free cash flow growth of 10% in line with the rest of that. As we look at 2017-2019, 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. 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&A, R&D. Gross margin.
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 2012. Team's done an awesome job of really driving improvements in gross margin. I'd 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%-10% of standard cost out.
Optimize the plant network. That's pretty simple, make sure you're making the right products in the right plants. Improve the portfolio mix. Sounds simple, Dan. It's been a big part of our recent success and something we're keenly focused on continuing going forward. Then the playbook approach for integration with our acquisitions. As you know, a lot of acquisition integration's 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. 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 would look to continue that. Gross margin should contribute on our journey over the next three years. SG&A. We've publicly 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.
Two, it's 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. 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 can 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. When we acquire new technologies, the vast majority of those go right into the existing sales bags.
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. 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.
Finance is really leading the way in Boston Scientific with RPA, particularly in the area of tax. Think of tax return preparation. Yes, tax return preparation. We've been able to eliminate thousands, literally thousands 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 the G&A of the company to better leverage against the sales growth that we have. RPA is something that we're really looking to broaden throughout the entire G&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 on the capacity curve and the maturity curve to do more.
In the back office centers of excellence, I give credit to our India team. They've done a wonderful job of really doing this, 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. It's a model that they've perfected, and we're looking to share that across the company. 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.
As we go through the next three years and our next stop on the journey here in our investor day in a couple of years, you should see SG&A lower on that path to 33.5% by 2021. R&D is really about efficiencies. It's not about reducing the amount of R&D we're doing. We actually think if we do the efficiencies right, we can actually do more R&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'll 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&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. 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. What Dr. 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. That all adds up to this slide here, operating margin. If you look back to 2015, 22.3. Again, proud that in 2018 we were 25.5, so we had added 320 basis points. That's good performance.
If you look at 2019, 2020, 2021, adding 50 to 100 basis points per year during that time frame. 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, I think it's often overlooked. People tend to focus on the P&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, working capital management is a big piece of that as well.
If you look here, we've converted over 100% of our adjusted net income over the last five years to adjusted free cash flow. We plan to continue that trend. 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've 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 kink that curve and have less inventory relative to our sales growth.
That's something that I would say we have not done yet, and that's a big piece of the chapter over the next three to five 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 four years, 2015 to 2018, two-thirds of our cash went to satisfy existing and contingent liabilities. One would argue, very non-strategic uses of the cash. 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 and 2020. That's exciting.
95% of the cash in 2019 and 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&A, those types of activities. This would also include the $1 billion of debt pay down we have associated with the BTG acquisition. That's a strategic use, obviously, to bring now BTG into the fold. 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.
For us, below the line is our interest expense, the equity method dilution from our VC portfolio, and the cost of executing our FX hedging program. This year, recall that guidance is $325 million to $350 million. That includes the make-whole call that we had on the bonds that we issued in February. As I look forward and think of the next three years, I think 325 is probably a good proxy for that number as we go forward. That obviously excludes any BTG-related interest. We talk about that once the deal is closed. I think if you use 325 for below the line going forward, I think that's a reasonable estimate. M&A. The traditional M&A is at the top of this slide and our venture capital portfolio at the bottom.
The M&A is actually shown, it's not just a scatter plot, it's actually shown relative to when the meaningful revenue contribution should hit from each of those deals, right? 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. 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, that we'll do over time that will show up on this slide. Really exciting for us to be able to look at what we have from a traditional M&A perspective. 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. Doesn't mean we're going to buy any of them, doesn't mean we're going to buy all of them, but when you get to the table, having been with a company for five years, maybe you had a board observer seat, maybe you had some other type of strategic rights, you're just in an advantaged position when you get there. We've seen it. We've acquired five of them. Mike mentioned earlier we acquired four in 2018, and we acquired Millipede in the beginning of 2019.
We've acquired five of these companies over the last 18 months, which has been a nice fuel and a pool for our M&A activity. I will close. These are really the three 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 on the P&L for a reason.
You need durable revenue growth. We've shown that over the past six years, but certainly for the last three years, 7% organic, 8% operational CAGR for 2017-2019, again, at the midpoint of our goal for 2020-2022, that would be acceleration versus that. Second 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 a hallmark of the company. We've done this extremely well as a global team over the last six or seven years. We don't plan on stopping now. 320 basis points since 2015, and a goal to put 50 to 100 more on each year over the next three years.
With that long-term opportunity to get to 30% plus. 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. 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.
Great.
With that, I'll turn it back to Susie.
Thank you, Dan. I'd 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 a final round of Q&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 O'Sullivan gets a special shout-out for the slides. Lauren Tengler, Matt Cruz, and Robin Foreman. Also, huge thanks to logistics to Joanne E. Flaminio and to our partners in accounting, legal, and corp comm. 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 three 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 the potential for accelerating growth. I guess I'm curious how to reconcile those two things. Also, the follow-up to that is you're not giving us anything for BTG yet. How should we think about the trajectory over the next three years as that folds in as well?
Thanks, Raj. A couple of things on there. One is, I laid out in the very beginning, we like to actually hit our commitments and deliver on, hopefully exceed them like we've done the last few investor days, and we plan that trend to continue. If you look at that 6%-9%, even at that 6%-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. 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. If you look at the volume of activity we have and 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%-9%, you're at the high end of the peer group, our goal, as I laid out in the very beginning, is to accelerate our growth over the next three years versus the past three years. At the midpoint, 7.5%, we've got many growth drivers that could improve that, our goal would be two years from now to report out that we've delivered accelerated growth rate over the past three years.
It's helpful. Then maybe just to end, one question on the tax rate over the next three years as well, how does that play into the double-digit earnings growth you've outlined?
I would see the tax rate being somewhat similar to where it is this year. This year it's 11% before stock comp. It's 10% after. I think a range of 11%-12% over the next three years is a very reasonable pre-stock comp. 11%-12% versus the 11% this year is a good range.
Sorry, let's go to David, then anybody on the phone, if anybody's left? Okay. Sorry, David.
It's David Lewis, Morgan Stanley. Just a couple from me. Dan or Mike, just a structural observation about the guidance this year versus two years ago. You're effectively saying top line is going to grow faster, earnings is going to grow kind of the same, right? Accelerating upper single-digit top line, double-digit earnings growth. How should investors think about that? Is that because that's conservatism as the top line grows faster, or are you finding you have to invest more to sustain these higher levels of growth?
As Dan said, we're showing a three-year picture here. We're not showing a lot of the initiatives we actually have in place for the next three years. When we look at it, we're always making trade-offs. We have actually more good ideas that we could invest in. We want to deliver high end of our peer group on the revenue side and improve operating margins consistently. 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. We think that 50-100 basis points of margin improvement is the proper mix that enables us to provide differentiated top-line growth.
As I said, we're very comfortable with that 6%-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. We're consistently balancing how do we be a top-tier organic revenue growth driver, but also knowing we have room to improve margins.
We're not hastily trying to drive significant operating margin improvement 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 our R&D is in clinical. They take a number of years. We're building out and strengthening our sophisticated commercial teams. We think it's the right mix for BSC and investors to enable top-tier revenue growth.
That 50-100 is more differentiated than most of our peer group as well. We think we're differentiating top line and margin improvement and a consistent tax rate and a free balance sheet. I think all that works. I think the key is we're not playing to 2022. We have many investments in a number of categories that are in play that you didn't hear about that will impact kind of 2023-2025.
Dan, just BTG, in Jeffrey's presentation, he didn't reiterate the low single-digit accretion for 2019. Can you still reiterate the BTG accretion targets for 2019? Those return thresholds that provided the kind of the ROIC at 9%-10%, 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?
I think unfortunately with BTG, we're going to have to wait until we close to update anything there. We're kind of limited with what we can say.
Let's go Vijay, Larry, then Rick. If you just do one question now if you're on your second round, 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 7%-8% organic, you had a number of headwinds, right? TBM got pulled off. The way I look at the 6%-9% outlook, it can't get easier for next year. Revenue should be solidly in the upper half of the 6%-9%. When you look at the product pipeline, it seems to sustain the momentum, right? What would cause you to come in at the bottom half of the range?
We obviously will give guidance for 2020 at the proper time here. We thought that was the right range for a three-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. Based on the strength and the diversification of the company, we're able to offset some of those things and still deliver above-peer growth, and you see all these future platforms that come through. I think it's a responsible guidance to give, first 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'd 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'd 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. That's why we provide that range. 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. You could just go through every piece and say, okay, what's the bad scenario? That's why we have a range. 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 the tender happens? I think you guys sounded pretty excited about BTG opportunity in China. How long is it going to take for you to register those products? Maybe give us a sense of how big BTG could be in China. Thank you.
I'm going to do the easy one first. On the BTG, I think the timeline is quite far out, and probably not going to be the next one to two years. It's probably going to be three 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.
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.
We believe that the government will take a more cautious sort of approach to assess the whole mechanism. The other wrinkle to that is the local players, their profit exposure to the DES market is actually very, very high. If that national tender occurs, it will affect a lot of the profit situation in terms of local med device company. That is a significant part of the implication that the government had to take into account. There are a lot of moving pieces, and like I said, we have very, very strong HIGA team, our tender team, who are working very, very closely with the administrators to figure out the details and specifics. We're going to see how that plays out next year.
Just two other points. One is the SYNERGY stent, which does quite well, is unique with this bioresorbable polymer. We think that provides some unique characteristics in the tender. The other reason why we gave you a transparency to the China number was, five or six years ago, it was drug-eluting stents. I think it should have 17% of that pie of China is DES. Complex coronary is bigger.
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. Much like the rest of the company, it's still balancing these other growth areas. That's the reason we shared it with you, knowing there's some uncertainty in the tender. It's a small piece of our global business and a smaller piece within China.
Thanks.
Good. One question. Larry with Wells Fargo. One question for Mike and perhaps Ian. One thing that was new strategically today is the focus on oncology. Mike-
How about the tax piece with RPA that Dan talked about? That was new.
Mike, can you talk about your vision for oncology? Do you see this as a standalone business with Boston Scientific at some point? One of the slides talked about accelerating acquisitions in this area. What are some of the gaps you have now in your oncology?
We don't see it as a standalone, separate business within Boston. What we have are beautiful platforms that fit businesses that we have now. Jeffrey and Cat did a nice job of talking about BTG with liver cancer and all the rounding of the portfolio, and why we'll be uniquely strong with interventional radiologists in that category. They also spoke about the one slide that Cat showed of the adjacent therapies that are of interest to us. For example, one of those is in lung. Guess what? We've got a great capability in endoscopy with our pulmonary capability. You won't see us create a separate oncology commercial group because they fit ideally within one of our business units. What we'll do is we'll develop capabilities working together. We also have a tech team.
We have a decentralized R&D group, but we have a very efficient tech group that doesn't look at a specific business unit, it looks at therapies. Jeffrey 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 Art's group. Similarly, we have the same thing in urology. Don't expect this whole separate division, but it's more leveraging the R&D capabilities that we have, and we have mechanisms to do that where we don't look at it by you, we look at it by platform. Then we'll leverage our commercial teams when we widen out new indications, leveraging capabilities that we have, and then bringing that to A PAC.
Go ahead, Rick.
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 is relatively unencumbered, to use your favorite phrase, Dan.
I like it.
Maybe, if you reflect on that free cash flow is going to, gosh, approach, exceed $8 billion over the next three years based on your numbers. Clearly, M&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 three years relative to the past? When the balance sheet was encumbered, you had a lot of other challenges. Maybe as part of that, explain to us when you're going to double the industrial relations budget, and thanks for all the excellent work. I think that's how Susie wanted me to say it.
Yeah, I could start.
Great question.
Mike can certainly fill in on the back end in terms of 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. As you look, I won't pick a number, but a lot of billions of cash over the next few years that we can deploy.
We look at the ability to deploy that in smart tuck-in M&A, kind of run the same play we've run, right? That's been successful for us for the last six years. Continue that play going forward, and then fill in on the back of that with returning cash to shareholders over time. It's a great place to be. There's really a tremendous amount of opportunity on the M&A front for us over the next, call it through 2022.
It's an exciting time for us to continue to grow organically, internally, and augment that with some really smart deals from an M&A perspective, continue to invest in the VC portfolio and take those from seed to harvest over time. I'm super excited for the next three years of that journey.
Steve.
Thank you. Steve Lichtman, Oppenheimer. June, you had encouraging comments, I think, that the 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 your 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 are actually imported outside the U.S., so from Europe, Costa Rica. 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 anticipate, I don't want to speculate, we don't anticipate that in our scenario, financial modeling, we don't anticipate that tariffs are going to be lifted anytime soon. We actually did provide some stats about the cost impact on those tariffs. 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. That would help us further mitigate our exposure to increase the tariff for China.
I call the rest of the team is fair game as well.
Sure. Just one big picture question. It's been a great two years for Boston Scientific. It's been a great two 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&P 500. I guess, Mike, I'd love to get your perspective on just how you see the broader operating environment for med tech today versus two years ago during your Analyst Day. If there are any, what are some of the risks that you would point out as we look forward for the next two years? Just want to kind of compare the-
Yeah
operating environment a little bit.
Yes. I'll start because I'm an Irish optimist. I'll start with the positive. It's really amazing, the innovation opportunity. I think you always come to Investor Day to hear about innovation. If I look at the innovation opportunity in medtech, and more importantly to us, the innovation we're embarking on over the next five 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 where we have the 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. Across the board, I think the innovation cycle that we see happening now over the next five years, to me, is uniquely strong versus legacy. I think also specifically with Boston Scientific. You could 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. I think you have a DNA with Boston who can consistently grow their core, but always finds new therapeutic opportunities and growth platforms. You saw it across each business.
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, I think, really a nice wave of new innovation that's coming, and you have a lot of positive there on the growth side. 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 stents and CRM, that's actually a potential positive. You have the China tender risk issue.
We kind of bake in price, we see some of that price actually improving as our profile mix changes. Second thing we always worry about is quality. We invest a lot of money in quality. We have excellent post-market support in our quality capabilities and systems, you just can't afford a major hiccup in quality, or things go awry pretty quickly. I think the other thing that's more difficult now than industry the last two 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 have the right clinical data to support the MDR. 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 bit easier than the smaller companies. I think the regulatory environment's very fluid right now, with a heavier impact in 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 two years ago. I think the pricing environment's always there, our portfolio mix is changing, I think our innovation that BSC specifically is in is uniquely good.
Awesome. I think I'd love to end there. There's time maybe for one or two more. Anybody else? Matt, go ahead.
Hi. Thanks. Matt
Hi.
Mix from Credit Suisse. Just on that outlook and sort of innovation and what is pluses and minuses of growth over the next couple of years. 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 six months in order to sketch out what 2020 will bring.
Yeah. We'll give a lot more details, because I think going forward, I think the area is probably the most questionable is the 25 questions that Jeffrey had on that paclitaxel panel. Lots of questions on that. That one's a bit. Jeffrey gave you our answer, which he thinks is kind of a slowing and then an uptick. Good news, we're seeing good things in Japan. I think that's a question going into 2020 a little bit. We're seeing strong momentum in our structural heart business. Art and the team talked about the EXALT launches, which will be a significant force.
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 adverse circumstances of downside to deliver that 6-9, and we'll give you more guidance as we get closer to 2020.
I think we've exhausted everybody.
All right.
Okay. Thank you very much for your kind and diligent attention. Appreciate the time.
Thank you. Let's give it up for Susie and Lisa here. Thank you very much.