All right, great. Thank you very much, everyone, and good morning. We're very pleased to have all of you here for an investor update for Boston Scientific from the 2018 Transcatheter Cardiovascular Therapeutics scientific meeting. With me this morning, I have Jeff Mirviss, who's Senior Vice President and President of Peripheral Interventions. He also is joined by his colleague, Kat Jennings, who's the Vice President of Marketing for Peripheral. We also have Kevin Ballinger, Executive Vice President and President of Interventional Cardiology, and Dr. Ian Meredith, our Executive Vice President and Global Chief Medical Officer. We probably have about 15, 20 minutes of slides from all the data presentations and product updates, then we'll leave 40 minutes for your questions. Just quickly, the usual safe harbor apply. If I can get it to advance there. We'll kick it off to Jeff and Kat. Thank you.
Okay. Thanks very much, Susie. It's really a pleasure to be with you. Of course, in 2018, you heard a lot about Boston Scientific and M&A. This morning, I'm thrilled to be able to talk about a homegrown innovation in the Eluvia drug-eluting stent. We have many examples at Boston Scientific in our pipeline, that's to come over the next several years of organic growth. I think this is a great example of the power of Boston Scientific in leveraging a great technology from the Interventional Cardiology division, applying it to a new disease state. We're thrilled to be able to bring sustained release to the SFA and deliver superior results. Of course, you saw the press release this morning, the FDA has worked very quickly on this, frankly, quicker than we were planning.
We're working as fast and furiously as possible to bring Eluvia DES to the U.S., which we plan to launch next month. The manufacturing team's working 24/7 to bring us the product. We were just chatting earlier about the rare trifecta to be able to bring a concurrent presentation at an international congress, both here in San Diego at TCT, as well as in Lisbon, in the largest interventional radiology congress in Europe. That was kind of fun to see both happen essentially at the same time, followed by the online publication in "The Lancet." We're very humbled and thrilled that "The Lancet" chose to publish the data, then have FDA approval on top of it. That was very exciting. We will be training our sales reps, kind of our capstone training in the next few days.
We started in January, so this has been many months in the making to get prepared for the U.S. launch. You saw the data, so I don't need to go through this in excruciating detail. When we designed this trial, we debated many different options. Of course, we could randomize against POBA, randomize against bare metal stents, atherectomy inclusion. We settled on a head-to-head trial, which has never been done before in the peripheral space. At the time, our hypothesis was that Eluvia would be non-inferior, and we thought if we could get maybe 3%, 4%, 5% delta, that would be enough to prove that this therapy could take some significant share. We thought, it's possible we could be superior, so let's pre-specify a superiority analysis.
I'm sure glad we did that, because we were able to show a 9% delta in primary patency, which is obviously statistically significant and I think will be an important driver of utilization. On the safety side, we were also very pleased with the results. Most notably, the clinically driven target lesion revascularization rates at half the Zilver PTX rate. Not only is this great for patients that they don't have to come back for a reintervention as frequently, only one in 20 patients will come back at a year for a reintervention with Eluvia. That is a significant improvement for patients, but also important from a cost effectiveness standpoint to the healthcare systems around the world. To avoid the costs associated with a repeat intervention is a really significant value driver to the healthcare systems around the world.
When you look at it from a hospital perspective, what does this mean from a profitability point of view for administrators in the hospital? You can see that the reimbursement today in the U.S. for drug-eluting stents is $10,500 compared to a DCB, which is less than half of that amount. We think there is room here to have a very profitable procedure for the hospital. If a physician chooses to use atherectomy, the reimbursement is even more attractive and will leave, again, a significant amount of room for hospitals to be profitable because we know that that's important in today's healthcare economy. How do we look at the market? We look at the market as an SFA opportunity. We don't think of this as just a drug-eluting stent opportunity. We think that the addressable market is roughly $1 billion.
Why do we think that? Well, first of all, we think we can take share in the DES segment with superior efficacy. We question what is the role of a bare metal stent as a default therapy any longer, and why would bare metal SFA stents not go the way of bare metal coronary stents? With low single-digit TLRs, we think that the role of a bare metal stent as a first-line therapy should really be reconsidered towards Eluvia. Of course, there's DCB, where, of course, we love DCB because we have one coming, but we think that there's certain patients and lesion subsets where Eluvia could be a better option, especially in patients with calcium, long lesions, calcified lesions, CTOs, et cetera. Again, my comments about bare metal stents, like why would someone use plain old balloon angioplasty as a first-line therapy?
We think that would be an excellent choice for an Eluvia stent. All of that is underpinned by what I would submit is one of the most robust clinical programs in the industry. We'll have over 2,000 patients studied in trials. You're aware of the 3-year published results of the MAJESTIC trial with Eluvia. You saw the IMPERIAL results today. We'll have more data at VIVA and other congresses over the next year-plus. We are doing a trial in Europe of 750 patients with Eluvia randomized against all bare metal stents that are approved by the FDA, with health economic endpoints as a primary endpoint. So this will be an important data set to prove in randomized data the health economic advantages of the Eluvia stent. We'll have a real-world registry, and then there is a trial that's looking at DCB against Eluvia and bare metal stents.
We're very pleased to support a significantly robust clinical program that will help to drive the utilization of Eluvia. All of that then is sort of just one part of our story. I can't wait to talk to you more about our other products in the future, whether that be Ranger and our head-to-head trial against the Medtronic IN.PACT DCB balloon, whether that be the Saval DES for BTK lesions, our venous portfolio, and the introduction of the VICI stent sometime next year, our critical limb ischemia focus, and of course, interventional oncology. Lots more to come, and essentially all of this is organic growth for the peripheral division. With that, let me turn it over to my brother from another mother, Kevin Ballinger.
All right. Thanks, Jeff. Congrats to Jeff and the PI team. What a phenomenal trial. It made for a great TCT between IMPERIAL and COAPT. It's rare you get two kind of practice-changing trials on top of each other in one congress. Really happy. I wish I could take credit. I can't take any credit. I told him it'll never work. I was wrong. I just want to do a quick flyover of interventional cardiology as well to roll into Q&A, and I'll make a few comments on our coronary business, WATCHMAN business, and valve business. That's really how we think about our investments across the spectrum. On the coronary therapy side, obviously a large business for us, over a $2 billion business. Similar to the last slide that Jeff showed, deep category leadership is our objective. That's our strategy.
That's been the playbook we've been running. What does that mean? In any given year, we'll launch anywhere from three to six products within coronary therapies, and we need to keep a very fresh pipeline, and this year is no different. We've got multiple new product launches between Wolverine, ROTAPRO, et cetera. In any given year, we'll be launching multiple products and maintaining our breadth of product line and frankly, our clinical relevance. I think that's something that's really differentiated us on the coronary therapy side over the past years. Complex PCI has been a nice story for us, that's been consistently upper single-digit grower, and occasionally touching on low single digits. If you combine complex PCI with our PCI guidance business, which is our imaging and FFR business, that's approaching the size of our drug-eluting stent business.
If we get that near half of the business growing at those rates, upper single digits, and then that helps kind of offset some of the headwinds in the drug-eluting stent side, where the market isn't necessarily growing. We've certainly performed in past years well above market, I think it's a clear headwind for everyone. It's a competitive market. It's a market that, like I said, is flattish. We do still think there's room for innovation. I don't think there's substantial share changes, big share shifts on the horizon over the coming years. This market kind of is what it is, and we're going to continue to innovate. One example is just last Thursday, we got a FDA approval for a new product called Promus ELITE, and that is a durable polymer stent that vastly improves the deliverability, the track, the pushability.
We also completed enrollment earlier this year on our short DAPT study with SYNERGY. By the end of 2019, we hope to have a label for three-month DAPT duration in high bleeding risk patients. All that to say, innovation in drug-eluting stent is still occurring. A lot of innovation on the complex PCI side. Importantly, part of our strategy over the long run has been to diversify in the faster-growing markets, obviously. Next year, we believe that our drug-eluting stent revenue mix for interventional cardiology total will be under 40%. That is a mark we haven't been at since probably the last 15 years, since we originally launched TAXUS in the U.S. That is a strategy that we're pushing towards by growing other businesses around drug-eluting stents.
WATCHMAN has been a great story for us, as you guys know and follow closely. We're over 60,000 patients since the beginning of WATCHMAN. Very pleased with the utilization, the awareness, the adoption. The reorder rates have been very strong. We have done a lot of direct-to-consumer, direct-to-patient marketing. You're aware we've done television ads in certain markets. We did four markets last year. We're expanding now and just recently expanded to eight new markets. That's working in terms of awareness of qualified leads, indicated patients. These are motivated patients. We do surveys, in fact, in these markets, last year's markets, and what we see is patients that have been more exposed in these markets to WATCHMAN are six times more likely to talk to their general cardiologist about the therapy.
The general cardiologist, when we survey in those markets versus the base markets, are three times more likely to bring WATCHMAN up in initial conversations with patients, meaning it's top-of-mind therapy. Been pleased with the reimbursement trends for WATCHMAN, too. Next week, on October 1st, another reimbursement increase. Last year, it was increased, and this year again an increase. That increase is 9% on average to the most commonly used DRG, which is DRG 274, in effect next week. The economics, I think, are strong for providers as well. Very good execution on clinical milestones. WATCHMAN FLX, which is our next-generation WATCHMAN, enrolling in PINNACLE FLX. That's a 400-patient study, and we are well ahead of schedule on that trial, actually, and the feedback has been exceptional, and we expect to finish enrollment in the month of October on that study.
That's a bit accelerated from our base plan. Very pleased with that. We'll also look to expand indications and study WATCHMAN in different patient populations. One example of that, next year we'll start a trial called OPTION, and that's WATCHMAN versus NOAC in post-ablation patients. Post AFib ablation patients will be studying WATCHMAN therapy randomized versus patients that continue on NOACs. International expansion, a big theme for us as well. WATCHMAN, as you know, has been fairly U.S.-dominated since the U.S. launch. I think two markets that we're really excited about are China and Japan. China, just the sheer numbers, there's five million strokes a year in China. That compares to one million in the U.S., and the growth we've seen thus far has been very strong.
Japan, we think, has a great chance to become the second-largest revenue country for WATCHMAN, given some of the concerns of bleeding in Japan and the well-established kind of network that Japan has. In terms of timing on Japan, we expect reimbursement in Japan to occur in the first half of next year, the approval to occur in the first half and reimbursement about 6 months later, so that the second half of next year, we'll be launching into that important market. Coming off PCR London Valves, a very exciting conference for us a couple of weeks ago. A lot of momentum with the ACURATE program. We've said before, fastest-growing valve in Europe. Obviously, that was from a fairly small base previously.
I think those that were at PCR London Valves will see and would appreciate that ACURATE really is a mainstream valve in Europe. It's really talked about in that category with the biggest competitors and really gotten a lot of momentum since we closed that deal last May. 40% growth. If we include the Symetis revenue pre-acquisition in the first half of last year, we're looking at greater than 40% growth year-over-year in more than 130 new accounts since launch. Obviously, we've scaled up the operations capacity substantially, near tripled it. I think one of the key stats is that in the accounts that were launched with the ACURATE, we've averaged around 20% market share. There's some accounts, obviously, where that's the preferred valve. It's an 80% or 90% valve. Some are less than that.
I think that shows that where we launch and focus, we can get penetration. We're pleased with that a year into the integration of Symetis. Importantly, bringing this valve to the U.S. market is a key strategy for us. We intend to file the IDE for ACURATE in the fourth quarter, and that's likely to happen, frankly, within the next 30 days or so from now. We'll be off and running on that. It's a high and intermediate risk trial combined into one. It's 500 patients, and it's randomized to any commercially approved valve. We can talk more about that, but we're excited to bring that technology, and U.S. physicians are excited to be exposed to that technology here in the not-too-distant future. ACURATE neo2, the next generation of ACURATE.
We expect the CE mark and launch to occur in the first half of 2019. That is a push from what we had communicated previously, which our previous expectation was by year-end. The data was presented at PCR London Valves. I think the data was excellent, and we can talk more about the data. The slight push really has nothing to do with the data or anything operationally. It's just getting alignment with the notified bodies on the number of patients they want to see out through one-year follow-up as opposed to six-month follow-up. We're not real concerned about that. ACURATE current version's doing great, and we're on a track to get that approval in the first half of 2019 in Europe. Lotus. A lot of positive news finally. Yes, the rollercoaster called Lotus. We're on the upswing again with Lotus.
We filed the FDA final module, the technical module that we've all talked a lot about, on August 15th. That is in, it's filed. The FDA is reviewing that module. The previous two modules were reviewed and effectively closed previously. That's the third and final module. As part of that, we had mentioned at the last investor meeting that there's this REPRISE III nested registry that's going to be enrolled in parallel with the FDA review process, and this is a 50-patient confirmatory registry that is looking at kind of confirming the acute performance of the Lotus Edge system. This is Lotus Edge. That trial is going well. It is underway, and that is a trial we expect to have fully enrolled during the month of October. A lot happening in the month of October in the TAVR space.
Later in the quarter, again, likely in the first half of fourth quarter as opposed to the second half of fourth quarter, we also intend to file the REPRISE IV intermediate risk trial with Lotus Edge, and that's an 810-patient, single-arm study for intermediate-risk patients versus some type of objective performance goal. Single-arm study, and that'll also include a bicuspid sub-study in that patient population. All of that to say, kind of confirming the timelines we talked about at the last meeting, which is expectations for Lotus Edge is an EU launch in the first quarter of 2019 and a U.S. launch sometime in the mid 2019 timeframe. We'll be purposeful about how we launch this and make sure that we're launching in a way that drives stickiness and penetration, and we go the right pace for this launch.
Really excited to participate in this very important market in the U.S. with TAVR. Finally, just the last slide, just showing the strategy that we deployed in coronary therapies previously is really what we're trying to do on the structural heart side, and that's really being relevant, clinically relevant with a broad array of products. Obviously having two valves that are very different but very complementary is an important part of that strategy. Also key clinically relevant accessory technologies, adjunctive technologies. I think Sentinel being one of those key technologies. The Sentinel cerebral protection device, you all know the NTAP was approved. That's up to $1,400. That goes into effect on October 1st, which I think is next Monday. We're excited about that. The clinical belief and clinical evidence, I would say, is growing. I think there's a Sentinel symposium at 11:30 today.
If you look across the kind of array of trials that have been done, even since the original approval study, these are trials from at prestigious sites from Rotterdam to Cedars-Sinai to Cleveland Clinic to Ulm, Germany. They all basically say the same thing. They all point in the same direction, which is about a 3% absolute risk reduction in absolute stroke, which we think is around 4% for TAVR and not super dependent on which device you're using, and a 60%-80% relative risk reduction. Talking to physicians, I feel like the clinical evidence is really starting to take shape. I think physicians get that. The economic side is obviously going to be improved with the NTAP, and our belief is protected TAVR over time will become the standard of care. We're excited about that acquisition.
We've got other adjunctive technologies like SAFARI, the market-leading guidewire, VISUAL ICE, and then Millipede, finally. Millipede, we were very pleased to see the COAPT results. Congratulations to the trial investigators and to Abbott, the sponsor. I think it was a very important trial for mitral and mitral repair, in particular for secondary MR. I think Millipede, the path forward really, I think, is a lot more clear in terms of potential trial designs and patient populations, et cetera. We're really pleased with that given the play we've got in the mitral repair side. The deal, Mike had mentioned previously, we had talked about the deal would likely trigger sometime before the end of 2019. I think Mike talked recently about likely in Q4 of 2018, and that really is our expectation, that it'll be somewhere around year-end.
It may trigger by the end of the year and close early into next year. But sometime in the early part of 2019, we think we'll close that deal and formally own that asset. They're making extremely great clinical and technical progress on the acute performance side in the continuing FIM work that they're doing. Really, really excited about Millipede as a hallmark to our structural heart portfolio. With that, let me turn it over to Susie for one last slide.
Great. Thanks, Kevin. The focus on this meeting today obviously is our clinical and product updates. We thought it might be helpful to tie back the comments that Mike made at his September 13th investor conference, talking about our outlook for faster operational revenue growth in 2019 and 2020. Previously, we've called for 6%-9% operational revenue growth, now calling for 7%-10% growth in both 2019 and 2020. Really a combination of improvement in the core, as you can see, great acceleration in both Kevin and Jeff's businesses here, but also based on the 8 deals that we've done year to date and the Millipede investment, see strong uptake from those deals as well as they begin to contribute really in layers over the years in 2019, 2020, 2021 and beyond. We'll get more specific on what the split is between organic and inorganic.
There is acceleration in both the organic revenue growth outlook in 2019, 2020 as well as the deal contribution. We also said on September 13th, that given the multitude of long-term growth drivers that we're developing, both internally as well as the recent M&A, we feel a more appropriate pace for margin improvement is now 50-100 basis points per year, versus we had previously said in 2019, 2020, we were shooting for something 100+. Still, I think top tier operational revenue growth 7%-10%, top tier organic. We'll get more specific as 2019 and 2020 get closer and we close all the deals. 50-100 basis points operating margin and still a target for double-digit adjusted EPS growth as always. With that, love to take your questions and if we could start with one in peripheral. David, you want to go ahead?
Mic's coming.
David Lewis, Morgan Stanley.
Go ahead. Keep going. We'll repeat it.
I'm fine if you are, Susie. Okay. David Lewis, Morgan Stanley. Jeff, just start with you, obviously, Susie's making me ask about peripheral. Look, you said $150 million DS opportunity in a couple of years, but the facts are there's this billion-dollar opportunity in POBA, BMS, and DCB. There was a drug-eluting stent on the market for years, and you didn't see this sort of billion-dollar market inflection. Why are you so confident that that billion dollars is now on the table and it wasn't on the table the last 5-7 years? Obviously, the data is better, but it's more than just the data.
Yeah.
Why is the inflection happen now?
Right. I'll stand up so I can see you. Thank you for starting with a peripheral question. I think for a couple of reasons. I do think the data does change things. Peripheral has not seen comparative effectiveness research. What I've heard at this congress and from text messages and emails from physicians, just got one here just 20 minutes ago, is it changes everything. It really, for the first time, we can now understand how things compare one thing against another, not to mention the excellent clinical results. The second is, I think the acute handling of the Eluvia stent is a nice improvement over the Cook Zilver PTX stent. The Cook stent was a stent that wasn't designed specifically for the peripheral vascular use.
It was leveraged from a different indication, whereas the Eluvia and the bare metal Innova platform was purpose-built for the SFA environment, it's quick, easy to deploy, the acute handling is excellent. I think that is a big difference. I also think drug technologies is now viewed as the standard of care. I think when you have a technology that's quick, easy to use, that has excellent data, I think it will have a lot more momentum than where Cook was in 2012 with okay data and a device that might not have been as quick and easy to use.
Just a quick follow-up. Thank you. A quick follow-up for just Kevin. If you think about now that we have Lotus and ACURATE on the market for next year, I think Ian has talked a lot about how each valve is going to be a better position for a specific patient cohort. You talk to interventionalists ex-U.S., and there is a platform-driven approach to some of these valves, so they want to standardize around one system. Can you just talk more about the ex-U.S. commercialization now that you're going to have two valves? Is it going to vary by region? Are you going to price these valves at parity? What do you think the commercial message is going to be to broader countries and accounts?
Yeah. Thanks, David. Good question. The question really is around outside the U.S. positioning. Some countries are easier. Japan, for instance, Lotus will be on a quicker track, and then similar to the U.S., ACURATE will launch 18 months or so later. That will be a little bit easier, and we will deal with that as it comes. Europe in 2019, ACURATE is doing very well. I would say for Europe, you have got some really passionate Lotus users that were previously very passionate that are really anxious to try it again. We have got some markets like France where Lotus will be the first entry into that important market too. That is a large market that we are not in TAVR right now. It will be a heavy focus in France. Beyond that, I think it is going to be a rifle approach in terms of where we take Lotus.
I think in terms of pricing, obviously, I think people are aware the margins on ACURATE are better right now. If you look at country mix, until we get scale and volume on Lotus, ACURATE COGS are going to be better. I think in terms of country mix, you can look at countries that support relatively high prices for TAVR and then some countries that are substantially lower, and there is wide variation in Europe. I think we are not going to be in a big hurry in some of those lower ASP countries to run out with Lotus. We will if there is passion around the technology in a given account, if there is a BSC relationship that drives a lot of incremental value by bringing Lotus to that account it will be part of the strategy.
I would say in general, I think the European relaunch of Lotus is going to be a kind of precision strike versus a wide launch. We will focus heavily on France, the U.S., and then specific accounts within Europe out of the gate. We will see how things play out over time then.
Rick Wise, Stifel. I will start with a peripheral one too, Jeff. Just out of curiosity, you called out the death knell of POBA and other peripheral technologies. I am curious to know what you think the implications of Eluvia are for atherectomy in general and for your business specifically, and then I will follow up with a question for Kevin.
I think what will happen, what I hope happens, because there's been a paucity of data, is that we can develop an algorithm for the treatment of SFA disease. It's very heterogeneous today. I think there is a role for atherectomy in certain patients, DCB, Eluvia, as well as POBA and bare metal stents. I think with data like this and data to come that's more robust, I believe we can figure out what that algorithm is and hopefully change guidelines. Of course, we're the only company that has it all, that is our sustainable competitive advantage. Whatever the physician sees in the lab, we have the tool in the toolbox to support their needs. Whatever they think is best that's evidence-based, we can support that.
We don't have to go in, try and convince them that just because we have a hammer that they should use it. I think it's a nice evolution for peripheral, that's where peripheral needs to go.
Got you. Kevin, just to follow up again on Lotus. You covered your thoughts about Europe. I've been struck over the last three days how many times just sort of randomly, doctors are saying, actually from the data, very positive things about Lotus. "Well, geez, I think Lotus would be great here." Just curious how you're thinking about how you'd have us reflect, okay, all these years later, is Lotus the niche? You described ACURATE as a mainstream product. Is that the way you want us to sort of start thinking and that's the way you're going to be messaging as ACURATE gets closer? Lotus is a niche, ACURATE your valve family. Thank you.
Thanks, Rick. I'm going to, in a minute, ask Ian to comment on why is Lotus relevant for the global TAVR market. I absolutely don't want to communicate that we expect Lotus to be niched. I think the sentiment in Europe's different than the U.S. Europe was on the market, off the market a couple of times, right? There's a little more history there. The U.S. market, really, other than the clinical trials, have not gotten exposed to TAVR. I'm glad to hear physicians are excited. They're certainly excited when they talk to me, so it's great that they're excited when they're talking to independent folks as well. It brings something new to the table. Our sales force is certainly excited. REPRISE III, talk about showing superiority on certain important endpoints.
That trial was a trial that I think was very important and maybe get a little bit lost in our operational stumbles after that. We don't see Lotus being a niche at all. Even in the U.S. market, when we bring ACURATE to the U.S. market, we don't plan to really kind of drive customers to one valve or the others in these markets like the U.S., where eventually there'll be both. We'll see how things play out. Physicians might have preferences for self-expanding valves, superannular valves versus annular valves, controlled expansion. Some will appreciate the full recapturability more than others. The lack of PVL, the predictability. We'll see how it plays out. What I really want to communicate is the market.
Big markets like the United States are certainly large enough to let this play out and ensure that physicians really make the choice, and that we've got a pipeline behind it. Definitely don't want to communicate that it's a niche. I'm communicating more that in Europe, ACURATE's got more traction. We can focus a little harder initially this year on Lotus in the U.S. and the markets like France, et cetera. I said I'd give Ian a chance. I'll give him the next question after.
Vijay Kumar from Evercore ISI. Then I'll start one on the peripheral side. The comment that you made, you could see the bare metal drug-eluting conversion similar to what happened in the coronary space. That's a strong statement, right? Should we be thinking about the next two to three years, this market completely converting into DES? Or do you need to see longer term data, right? Because again, peripheral, I think 12 to 24 months, you do see some deterioration in performance. Can you just give us some thoughts on how you see the pacing?
Yeah. Then I can ask Ian or Kat to chime in. I think good things take time, and I don't think the market will flip from bare metal to Eluvia overnight. I think the clinical program that we laid out will be an important kind of driver of that, but I would suspect it would take a matter of years. I don't know if you
No, I think I'd make the comment, and I think this relates to the comment that Jeff made earlier, that we don't want to underestimate the power of evidence. As Jeff nicely pointed out, the field of peripheral intervention is replete with anecdote, small biased series, case reports, and what have you. This is the first large global randomized head-to-head independently adjudicated trial, and Jeff and his team are to be truly congratulated for changing the standard of how we review evidence in the peripheral space. I think that point will not be lost and is not lost on physicians here. Now, to the point of atherosclerosis, you said before, it is, after all, a systemic disease. It just has slightly more burden of calcium in the periphery. We know the atherobiology.
We know that there's a proliferative response and an injury response to anything you do in a vessel. We know that there's a need for a scaffolding effect. We know that that scaffolding effect is associated with some proliferative response. A drug-based therapy is going to be a benefit. I would say exactly as Jeff said, we will slowly, consistently build an evidence portfolio to say where drug-eluting stents might be superior to balloon-only or drug-coated balloon technology, where you'd need atherectomy as an adjunct to that technology. I suspect we're seeing the very first sign of the way coronary therapy is developed in terms of a logical scientific approach to where to prioritize therapies. That's why I would say this is a historic meeting for 2 reasons, COAPT, of course, that the Eluvia, it's not lost on everybody here the importance of that trial.
I do think that progressively, that you will see more drug-eluting therapies because it makes sense to prevent the injury and proliferative response. You only need to treat 10 people to actually prevent revascularization compared to treating with a Zilver. That basically tells you drug's good, but actually controlled delivery of drug to affect the atherobiology over time makes sense.
That's helpful. Maybe one on Lotus. Some comments on share gains in Europe. I'm just curious, when you think about the U.S. market, this is a portfolio approach. Right now, you have a very unique product in WATCHMAN. You're the monopolist. You do have now SENTINEL, and you have Lotus, right? How should we be thinking about share gains in the U.S.? Is this 20% similar to Europe? Should it be higher because now you have a portfolio?
For Lotus in the U.S. Yeah, thanks. Honestly, I think the way I'd like you to think about it is an appreciation for the kind of the track record of our sales organization in interventional cardiology with the same customer base, and an appreciation for the approach we take, which is a highly clinically relevant approach, with products that really matter. Like SENTINEL, I think is going to be. That is a product that is an impactful, important product for the market. I'll say all that. What I don't want to do, I'd like to be humble up here about share gains. We have to go prove it. Every share point we gain, I'll be pleased with. We're going to earn it over time. I don't want to put predictions out other than to also say that, look, we've invested a lot to get to this point.
Buying these adjunctive technologies should signal that we intend to be substantial, serious players in this market. In most markets we play in across Boston Scientific, really strive to be number 1 or number 2. That is our investment strategy around TAVR broadly. In terms of the amount of time it takes, 2019 versus 2020, I don't really want to put a precise share number on other than to say we're in it for the long haul. This market's important enough for us to have a 5, 10, 20-year view on this market. I'll leave it at that. Thanks.
Yeah. Thanks.
Yeah. Thanks. Chris Pasquale at Guggenheim. Dr. Meredith, a couple questions for you. First, I agree with you on SENTINEL. It appears as though the conversation around embolus protection and TAVR is shifting more in favor of broad utilization. We've seen some interesting single-center data sets here. Are you content to let that play out at the center level, or is the company planning to do more to advance the argument clinically?
Thanks, Chris. That's a very important question. Not only single center data now, but you actually saw Julia Seeger's data here, which is actually a patient-level pooling of the SENTINEL Claret Trial with the OMM data and showing exactly the types of outcomes. There's also work to actually take the MISTRAL-C trial in as well at a patient level and do that. The point is, yes, we're not going to rest on the laurels of these registries. We are going to continue to acquire evidence. It's a very strong case. The idea that there isn't stroke related to TAVR is just simply wrong. You only need to look at the STS registry, which has an ascertainment problem anyway, and under-record stroke, that's a 2.8% rate of disabling stroke there.
If you look at the national U.S. data for 30-day readmissions after TAVR, that's a data set in 2017 of over 30,000 patients, there's a 2.2% readmission rate. That's an underestimation because some people are still in hospital with a stroke from their first event. We believe that stroke is incredibly important in TAVR, and it's a disabling and dehumanizing condition. We need to continue to develop evidence that puts beyond doubt the value of this technology.
Thanks. Just curious your thoughts on how COAPT changes the landscape for transcatheter mitral repair, we'll stick with for now, trials going forward. We heard from the podium a few times yesterday that it's now going to be unethical to randomize patients to medical management. This was a highly selected population. Mitral patients come in lots of flavors, and not every edge-to-edge patient may be a good candidate for angioplasty and vice versa. As you think about advancing an annular modification technology, how do you think about what that clinical program looks like?
Okay. Am I still on? Am I still on? Beautiful question. Very well thought out. I know exactly where you're going. At first, we have to acknowledge that I sat with my team yesterday. I've been coming to this meeting since 1991, and I've been in interventional practice for 30 years. The debate's been raging for 30 years as to whether treating functional MR alters the natural history of heart failure can reduce rehospitalization or indeed save lives. You can say you were there the day that at least some evidence has been established in a well-conducted, unbiased clinical trial. Now, yes, you're right. They threaded the eye of the needle in terms of the management of all of the variables that could affect the patient's outcome. Abbott are absolutely to be congratulated for this.
Second point I would say is this really does actually confirm and justify our approach, where everybody else was actually taking transcatheter mitral valves. Everybody said, "Well, why are you doing repair? It's all going to be replacement." You're much better off actually doing something with your own native valve than you are with a prosthesis. I'll draw you to one statistic. 96.6% of the patients were free of a major adverse event at 12 months. The safety event rate was 3.4%. You can't do that with a transapical valve. You can't even do that on the first day of a transapical valve, let alone at 12 months. They've set a very high bar. To the other and a very important question is, how do we view this? Is it unethical to treat patients with medical therapy? No.
This is one trial. This is a beautifully conducted trial of 600 patients. You saw the MITRA-FR data, and there are other trials that come in the future. We have to take those in totality, and we heard the arguments out as to whether this is level I evidence or IIa. It's IIa, and it's great, and it really opens the field for understanding that you can get symptomatic relief, structural changes to the heart, and mortality advantages in correctly selected patients. It's all going to be about the patients. To the technology. MitraClip was never designed as a treatment for functional MR. It's just what the rest of the world did, and indeed, I've loaded hundreds of these cases because that's all you had. The all you had option, because you wouldn't desire to clip the leaflets, worked beautifully.
We're aiming to do an optimized physiological surgical predicate in terms of a mitral angioplasty to bring the native leaflets together without actually clipping them together. Can we add to that? That's what we have to test out. I think it's a great day for mitral regurgitation, functional mitral regurgitation, and it's a great day for the idea of a properly done repair strategy. To me, I'm very buoyed by this, and I think we can say it's like the first day of TAVR. You can say, "I was here when they actually showed this." This is an argument that's gone on for 30 years more. You saw everybody just broke into spontaneous clapping. How many times have you seen that in a late-breaking trial at TCT? It was spine-tingling to see that.
Not one of you really thought that there was going to be a mortality advantage. I emphatically said that there wouldn't be, because I've looked after patients like this my entire career. It just goes to show a well-conducted trial, appropriately selected patients, well monitored, the therapy works. Mitral regurgitation begets mitral regurgitation.
Can you touch on just the IRIS update that we had from Dr. Rogers yesterday?
Yeah. No, the IRIS FFR trial?
Yeah.
Yeah. Okay. Very important study because the IRIS FFR study.
Sorry. No. The Millipede IRIS.
Oh, our trial?
Yeah.
Oh, sorry. There's an IRIS FFR trial.
Sorry.
Yeah. Okay.
No, the update from Dr. Rogers yesterday.
Okay. As you know, with Millipede, it's a transcatheter mitral repair that is transvenous transseptal with a MitraClip-like movement into the left atrium. The most important thing about mitral repair procedures is that you make the procedure relatively simple so that the deployment of the device doesn't take too long, so that the physician will focus on optimizing the reduction in mitral regurgitation, not focused on the ability to get the device there. We have integrated intracardiac ultrasound into the delivery catheter to enable the physician to adequately deploy and anchor the device quickly. Now, the anchoring of devices that require anchors can often take an hour to an hour and a half within the procedure before you start dealing with the mitral regurgitation. We've been able to take that down to a very short window of time by integrating ICE.
The procedures that we're currently doing to optimize the delivery and deployment are going extremely well.
Robbie. Thank you.
Thanks. Robbie Marcus, J.P. Morgan. I want to circle back to something I saw on the slide, $150 million peripheral DES global market in 2020. By my math, the market is $120 million today, plus or minus. How should we interpret that data point on the slide?
Sure. As you can imagine, as we prepare for launch in Q4 of this year, one of the things that we will be battling is going through things like VAC committees at hospitals. Some of that adoption takes time. In addition to that, we are looking forward to launching Eluvia or gaining approval for Eluvia in the first half of 2019 in Japan. We believe that that will be another accelerator for this movement. In addition to taking share from competitors, the competitive DES, we also believe we're going to grow the DES market.
Okay, because it seems like a very low bar from where you are today.
Can you comment on that, Kat?
Yep, absolutely. We will see how the reimbursement landscape continues to evolve. We will see how adoption plays out in the marketplace. We believe that this product has a very strong place in the treatment of PAD.
All right. Maybe as a follow-up to that, can you help us understand, reimbursement is very favorable in the U.S. for drug-eluting peripheral stents, how it looks outside the U.S.? Should IMPERIAL help grow the market to the same degree outside the U.S. and help us think about the split of the $1 billion, how it goes U.S., Europe, and outside Europe?
Sure. As you can imagine, it varies highly country by country. For example, in Japan, there's already established a separate DES category for drug-eluting stents in the periphery in which Cook operates today. When we launch in Japan, we would be launching into that category versus into the existing bare metal stent category. In Europe, it really varies country by country. This is where the EMINENT trial that we talked about earlier really comes to play. Oftentimes, when we look to separate from bare metal stents and create a new category, it is about the economic advantages that we bring, and that's where things like lower target lesion revascularization play. Those are the types of things that payers really care about in terms of reducing readmissions for patients.
Larry, can you pass it back to Robbie? Thanks.
Thanks. Larry Biegelsen with Wells Fargo. Let me follow up on Robbie's question. Jeff, on Eluvia pricing relative to a DCB parity or not, then we should think about the first-year update. Lutonix had impacted about $80 million, $90 million first year in the U.S., by our math. Can you comment on whether you think Eluvia should be kind of better or worse, or why? I have one follow-up for Kevin.
We typically don't break out product revenue. We're not going to comment on specifics, but I think that Eluvia has the opportunity to be one of the bigger products in our portfolio bag. Peripheral is sort of an amalgamation of a bunch of small things all put together to be a $1.2 billion Boston Scientific business. I think this will be a bigger one for us, I think it'll take time to get it into the market and see how it gets adopted. We want to price it fairly so that hospitals can make a profit, but so that Boston Scientific can also grow and achieve our goals.
Kevin, Jeff has said he thinks peripheral can grow high single digits, maybe low double digits, I think. For you, by our math 2019, 2020, we have you kind of growing actually a little bit above the 7%-10% operational growth. I wonder if you'll bite on that. Is it kind of obvious with all these products you have that you think you can grow above the corporate average?
I was going to bite, and then Susie stared me down, so apparently I can't comment.
All right, thanks.
Jeff and I are always in a healthy competition for growth.
We'll go back from Jason, and then we can go back to Bob and come back to Kristen. I think that'll be it.
Thanks. Jason Mills, Canaccord Genuity. Jeff mentioned earlier the algorithm for peripheral. It seems to me that peripheral is sort of analogous to mitral in that way, whereas TAVR in treating coronary vascular disease is sort of a one-stop shop, drug-eluting stents and TAVR. There's not much else. With that in mind, in peripheral being an algorithm, mitral seems like it's an algorithm too. M&A, wanted your comment, Kevin, about M&A in the mitral space and how much you think Boston Scientific may have to invest over a longer period of time to develop that algorithm in mitral. In light of COAPT, it seems like there's maybe going to be more attention paid by the physician community, therefore maybe more attention paid by Boston Scientific in the intermediate term. Then I have a follow-up for Jeff.
I like the analogy, by the way. I think that is a really nice analogy. I'm going to ask Dr. Meredith to actually comment on kind of the thoughts on toolkit and what might fit where. I think we've got a really crown jewel centerpiece, and then the question is what else do we need to round this out? We're realistic enough to know that it's not going to be a one device kind of takes over the market.
Thanks, Jason. I totally agree, I think there is a parallel here with vascular disease. There's a role for atherectomy, there's a role for DCB, and there's a role for drug-eluting stents. In the mitral space, I think why we started with mitral repair with an annuloplasty is we recognized that to do mitral valve disease well, you will need chord repair strategies. You will need a mitral valve replacement, and there may or may not be a role for leaflet defacement and clipping in that context. We still think that you have to start with a foundational approach, and we see it as our DeWalt toolkit. We want to actually have the look and feel of all our tools, but with the end tool that we're delivering as being part of that package.
If you think there's probably more than 200 ways to do a mitral valve repair by open surgical repair. There's more than 200 different described operations. To think that we could actually solve the complexities and nuances of mitral valve disease with one therapy would be imprudent, and we don't think that way. We just see this as a foundation in the same way that Jeff sees DES as part of a complement of strategies to best treat too complex atheroma in the limbs.
Thanks. That's a great segue into my follow-up question specific to Eluvia and in general, peripheral. You mentioned the algorithm, but right now, drug-eluting stents in the peripheral is small relative to the overall market. Do you think two-year data from Eluvia will have an impact, not necessarily on share, because it looks like the one-year data may have an impact on your ability to gain share? I'm wondering if two-year data will expand the use of drug-eluting stents to those that have somewhat of a deference to using metal in the leg currently, therefore expanding its DES share within the whole pie.
Yeah. I think one of the things that we've certainly heard from physicians as we talk about the Eluvia data is the durability of the data, especially when you look at the Kaplan-Meier curves. When we talk to physicians, with drug-coated balloons, what you oftentimes see is a significant drop-off in the Kaplan-Meiers between months 12 and 13. What you see with Eluvia is a very nice continuation of the primary patency that you don't see with many of the drug-coated balloons. I do agree with you. I think that when two-year data is available, it will only further reinforce the benefits of having a drug-eluting scaffolding that helps maintain vessel patency over time.
Bob.
Thanks, Susie. Just 2 really quick ones. It's Bob Hopkins from Bank of America. First, for Kevin, on Lotus Edge in the U.S., how much follow-up are you going to need for those 50 patients? I'm sorry if I missed that.
Yeah. It's really an acute study. I think we will continue to follow those patients, but I think the interest was really in acute performance during the cases.
Okay. The FDA is looking for a 30-day data then?
Yeah. They're looking for relatively short follow-up just to confirm device performance.
Okay. You said you're starting that in October?
No, I think we expect to complete Remember, that's a 50-patient study, so we expect to complete the recruitment of those patients within the month of October.
Okay.
It's already underway.
Okay. Sorry.
Yeah.
Okay. At least seems like the potential for an approval in the U.S. may be a little sooner than mid-year based on that, but I'll
Don't bet on that either.
Okay. Jeff, one last question for you. Typically, stent launches because of the willingness of the physician base to uptake new technology pretty quickly, stent launches tend to go fast. I'm just curious why Eluvia would be any different.
Yeah. I think the first thing is we weren't planning on getting approval this quickly. We are behind from an inventory standpoint. It's going to take us a while to catch up. We will launch next month, but we will not have the supply that we typically do in some of the stent launches that you'll be referring to where you can just run and gun. For us, it's going to be a sort of disciplined, smart, controlled launch, to try and penetrate the accounts. Keep in mind, we have three specialists in each account. We want to see the surgeon, the cardiologist, and the radiologist, and sort of go deep within an account before we move on to the next one.
Our thought process is we'll take it slow and methodical, and that way, we'll be able to ramp up inventory and then sort of hit 2019 at a decent run rate.
Okay, thanks. Just as a follow-up to that, it's Kristen Stewart from Barclays. I guess, what would you expect to see the penetration rate of drug-eluting stents in your model that's like 150? I saw the market shares, but I'm just curious as how you think about that penetration, and are you basically going to be converting over from existing accounts that you already have some share in, so it's just more of an internal conversion?
Sure. I'll tell you the conversations that we've had here just this weekend. We've obviously had a lot of folks that we currently do good business with come up and show a lot of excitement about the data. I'll tell you, we're making new friends. There are a lot of new faces that are coming by our booth wanting to learn more about Eluvia, maybe folks that haven't used as much Boston Scientific product in the past and maybe have been more loyal to some of the other competitors. I do think that there is maybe an opportunity for us to convert even more new users than we had originally thought.
Just a follow-up on Millipede. What should we think about going forward in terms of different milestones? Obviously, you're going to be acquiring the asset in the first quarter, what about from a clinical milestone perspective? Thanks.
Yeah. I'm a little hesitant to say too much because we don't own the company. They've got a great engineering team and leadership team that have been really in control and driving the milestones. I think this FIM data that they're doing with integrated ICE is really something that as well as that's gone, I think that is a really nice stepping stone to sometime in 2019 expand potentially into a U.S. EFS study, start thinking about kind of rolling into CE studies in the back half. I think we need to take it step by step, and before we get into real detail there, make sure we finish up the current requirement to trigger the option and acquire and close that hopefully early in the year. More to come on that.
Thanks, Kevin. I think it's a good place to end. Thank you very much, everyone. Ian, Kat, Jeff, appreciate it. We've got some time for your follow-on questions if you'd like to stay. Thank you.