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 Mirvus, who is Senior Vice President and President 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 Doctor. Ian Meredith, 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, and then we'll leave 40 minutes for your questions. Just quickly, the usual safe harbor apply, if I can get it to advance there, and then we'll kick it off to Jeff and Cat. Thank you.
Okay. Thanks very much, Susie. It's really a pleasure to be with you. And of course, in 2018, you heard a lot about Boston Scientific and M and A. And so 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. So I think this is a great example of the power of Boston Scientific. And leveraging a great technology from the Interventional Cardiology Division, applying it to a new disease state. And so we're thrilled to be able to bring the FDA has worked very quickly on this, frankly, quicker than we were planning. And so 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 is working 20 fourseven to bring us 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 and then have FDA approval on top of it.
So 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, many months in the making to get prepared for the U. S.
Launch. And so you saw the data, so I don't need to go through this in excruciating detail. But when we designed this trial, we debated many different options. Of course, we could randomize against POBA, randomize against bare metal stents, atherectomy, inclusion. And we settled on a head to head trial, which has never been done before in the peripheral space.
And at the time, our hypothesis was 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. But we thought it's possible we could be superior. So let's pre specify a superiority analysis. And 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.
And on the safety side, we were also very pleased with the results, most notably the clinically driven target lesion revascular rate revascularization rates at half the ZILVER PTX rate. And so not only is this great for patients that they don't have to come back for a reintervention as frequently, Only 1 in 20 patients will come back at a year for a reintervention with Eluvia. So that is a significant improvement for patients but also important from a cost effectiveness standpoint to the health care systems around the world. To avoid the costs associated with the repeat intervention is a really significant value driver to the health care systems around the world. And 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. So we think there is room here to have a very profitable procedure for the hospital. And if a physician chooses to use atherectomy, the reimbursement is even more attractive and will leave again significant amount of room for hospitals to be profitable because we know that that's important in today's health care economy.
And so 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 $1,000,000,000 So 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 single digit, 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. And then, of course, there's DCB where of course, we love DCB because we have one coming. But we think that there's certain patients in lesion subsets where Eluvia could be a better option, especially in patients with calcium, long lesions, calcified lesions, CTOs, etcetera.
And then again, my comments about bare metal stents, like why would someone use polo balloons as a first line therapy? We think that would be an excellent choice for an Eluvia stent. And so 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 ELLUDEA.
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 7.50 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.
So we're very pleased to support a significantly robust clinical program that will help to drive the utilization of Eluvia. And all of that then is sort of just one part of our story. And so 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 impact DCB balloon, whether that be the SOVAL DES for BTK lesions, our venous portfolio and introduction of the VICI stent sometime year, our critical limb ischemia focus and, of course, interventional oncology. So lots more to come. And essentially, all of this is organic growth for the peripheral division.
So with that, let me turn it over to my brother from another mother, Kevin Ballinger.
Thanks, Jeff. And congrats to Jeff and the PI team. What a phenomenal trial. It made for a great TCT between Imperial and COAPT. Mean, it's rare you get 2 kind of practice changing trials on top of each other in 1 Congress.
So really happy. I wish I could take credit. I can't take credit. I told them they'll never work, but I was wrong. So I just want to do a quick flyover of interventional cardiology as well to roll in the Q and A.
And I'll make a few comments on our coronary business, WATCHMAN business and valve business. And that's really how we think about our investments across the spectrum. So on the coronary therapy side, obviously, a large business for us, over $2,000,000,000 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 3 to 6 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, etcetera. So in any given year, we'll be launching multiple products and maintaining our breadth of product line and frankly our clinical relevance. And 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.
So 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. And so if we get that near half of the business growing at those rates upper single digits and then that helps 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. But I think it's a clear headwind forever.
When 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. And so this market kind of is what it is and we're going to continue to innovate. And one example is just last Thursday, we've got a FDA approval for a new product called PROMIS 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 DAP study with Synergy. And so by the end of 2019, we'll have a label. We intend to hope to have a label for 3 month DAP duration in high bleeding risk patients. So all that to say, innovation in drug leading stent is still occurring, a lot of innovation on a complex PCI side.
And importantly, part of our strategy over the long run has been to diversify in the faster growing markets, Obviously, in next year, we believe that our drug related stent revenue mix for interventional cardiology total will be under 40%. And that is a mark we haven't been at since probably the last 15 years since we originally launched TAXIS in the U. S. And so 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.
So 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 4 markets last year.
We're expanding now and just recently expanded to 8 new markets. That's working in terms of awareness of qualified leads, indicated patients. These are motivated patients. So 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 6 times more likely to talk to their general cardiologists about the therapy. And the general cardiologists when we survey in those markets versus kind of the base markets are 3 times more likely to bring WATCHMAN up in initial conversations with patients.
I mean it's top of mind therapy. Been pleased with the reimbursement trends for WATCHMAN 2. So next week on October 1st another reimbursement increase. So last year it was increased and this year again an increase and that increase is 9% to the most commonly 9% on average to the most commonly used DRG, which is 2.70 4 in effect next week. So the economics I think are strong for providers as well.
Very good execution on clinical milestones. So 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. So that's a bit accelerated from our base plan, very pleased with that.
We'll also look to expand indication in studies indications and study WATCHMAN in different patient populations. So one example of that next year we'll start a trial called Option And that's WATCHMAN versus NOAC in post ablation patients. So post afib ablation patients will be studying WATCHMAN therapy randomized versus patients that continue on NOAC. 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 2 markets that we're really excited about are China Japan.
So China, just the sheer numbers, there's 5,000,000 strokes a year in China that compares to 1,000,000 in the U. S. And the growth we've seen thus far has been very strong. In Japan, we think has a great chance to become the 2nd largest country, 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 in Japan, we expect reimbursement in Japan to occur in the first half of next year and we're on track then for I'm sorry, the approval to occur in the first half and reimbursement about 6 months later.
So that second half of next year we'll be launching into that important market. On the valve side, coming off London Valve is a very exciting conference for us a couple of weeks ago. So a lot of momentum with the ACURATE program. So we've said before fastest growing valve in Europe. But obviously, that was from a fairly small base previously.
But I think those that were at London Valves would see and would appreciate that Accurit 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. So 40% growth, if we include the Sometis revenue pre acquisition in the first half of last year, we're looking at 40% 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. And 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.
So there are some accounts obviously where that's it's the preferred valve, it's an 80% or 90% valve, some are less than that. But I think that shows that where we launch and focus we can get penetration. So we're pleased with that a year into the integration of Simetis. Importantly, bringing this valve to the U. S.
Market is a key strategy for us. So we intend to file the IDE for ACURATE in the Q4 and that's likely to happen frankly within the next 30 days or so from now. So we'll be off and running on that. It's a high and intermediate risk trial combined into 1. It's 500 patients and it's randomized to any commercially approved valves.
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. And then ACURATE neo2, so the next generation of ACURATE, we expect the CE Mark and launch to occur in the first half of twenty nineteen.
That is a push from what we had communicated previously, which our previous expectation was kind of by year end. The data was presented at 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 1 year follow-up as opposed to 6 month follow-up.
So we're not real concerned about that accurate. Current version is doing great, and we're on a track to get that approval in the first half of twenty nineteen in Europe. In LOTUS, so a lot of positive news finally. Yes, so the roller coaster called LOTUS. So we're on the upswing again with LOTUS.
So we filed the FDA final module, the technical module that we've all talked a lot about on August 15. So that is in. It's filed. The FDA is reviewing that module. The previous two modules were reviewed and effectively closed previously.
So that's the 3rd and final module. As part of that, we had mentioned at the last investor meeting that there's this REPRISE 3 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. So this was 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. So a lot happening in the month of October in the TAVR space. Later in the quarter, and 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 8 10 patient single arm study for intermediate risk patients versus some type of objective performance goal.
So single arm study and that will also include a bicuspid substudy in that patient population. So 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 Q1 of 2019 and a U. S. Launch sometime in the mid-twenty 19 timeframe. And 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.
But really excited to participate in this very important market in the U. S. With TAVR. And 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. And obviously having 2 valves that are very different but very complementary is an important part of that strategy, but also key clinically relevant accessory technologies, adjunctive technologies.
I think SENTINOL being one of those key technologies. So the SENTINEL Cerebral Protection Device, you all know the NTAP was approved. That's up to $1400 that goes into effect on October 1, which I think is next Monday. So we're excited about that. The clinical belief in clinical evidence, I would say, is growing.
I think there's a SENTINEL Symposium at 11:30 today. But 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% to 80% relative risk reduction. So talking to physician, 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. So we're excited about that acquisition. We've got other adjunctive technologies like Safari, the market leading Guidewire, iSleeve and then Millipede finally.
And Millipede, we were very pleased to see the COAP results. Congratulations to the trial investigators into 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, etcetera. So 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 previously talked about the deal will likely it's going to trigger sometime before the end of 'nineteen. And Mike talked recently about likely in Q4 of 'eighteen. And that really is our expectation that it will be somewhere around year end. So it may trigger by the end of the year and close early into next year. But sometime in the early part of 2018, 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. So really, really excited about Millipede as a hallmark to our structural heart portfolio. So with that, let me turn it over to Susie for one last slide.
Great. Thanks, Kevin. So focus on this meeting today obviously is our clinical and product update. So we thought might be helpful to dive back to comments that Mike made at the September 13 Investor Conference, talking about our outlook for faster operational revenue growth in 2019 2020. Previously, we've called for 6% to 9% operational revenue growth, now calling for 7% to 10% growth in both 2019 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 8 in 2019, 2020, 2021 and beyond. We'll get more specific on what the split is between organic and inorganic, but there is acceleration in both the organic revenue growth outlook in 'nineteen, 'twenty as well as the deal contribution. We also said on September 13 that given the multitude of long term growth drivers that we're developing both internally as well as the recent M and A. We feel a more appropriate pace for margin improvement is now 50 to 100 basis points per year versus we had previously said in 2019 2020 we were shooting for something plus. So still I think top tier operational revenue growth 7% to 10%, top tier organic we'll get more specific at 2019 2020 get closer and we close all the deals 50 to 100 basis points operating margin and still a target for double digit adjusted EPS growth as always.
So with that, love to take your questions. And if we could start with 1 in peripheral. David, 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 is making me ask about peripheral.
But the but look, you said $150,000,000 DS opportunity in a couple of years. But the facts are this is $1,000,000,000 opportunity in POBA, BMS and DCB. There was a drug related stent on the market for years and you didn't see this sort of $1,000,000,000 market inflection. Why are you so confident that, that $1,000,000,000 is now on the table and it wasn't on the table over the last 5 to 7 years? Obviously, the data is better, but it's more than just the data.
Why is the inflection happened now?
Right. So I'll stand up so I can see you. So thank you for starting with the peripheral question. So I think for a couple of reasons. I do think the data does change things.
Peripheral has not seen comparative effectiveness research. And so what I've heard at this Congress and from text messages and e mails 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 Cooke Silver PTX stent. Cooke 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 Inova platform was purpose built for the SFA environment. And so it's quick, easy to deploy. The acute handling is excellent. I think that is a big difference. And I also think, drug technologies is now viewed as the standard of care.
And so 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.
Quick follow-up for just Kevin. If we 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 better positioned for a specific patient cohort. But you talked to INRVENTIALIS ex U. S. And there is a platform driven approach to some of these valves that they want to standardize around your one system.
Can you just talk more about the ex U. S. Commercialization now that you're going to have 2 valves? Is it going to vary by region? Are you going to price these valves at parity?
And what do you think the commercial message is going to be to broader countries and accounts?
Yes. Thanks, Dave. Good question. So the question really is around outside the U. S.
Positioning. So we go some countries are easier. So Japan, for instance, LOTUS would be on a quicker track. And then similar to the U. S, ACUR to launch 18 months or so later.
So that will be a little bit easier, and we'll deal with that as it comes. So Europe in 2019, ACURT is doing very well. So I would say for Europe, you've got some really passionate Lotus users that were previously very passionate that are really anxious to try it again. We've got some markets like France where LOTUS will be the 1st entry into that important market too. That's a large market that we're not in TAVR right now.
So it will be a heavy focus in France. Beyond that, I think it's going to be kind of a rifle approach in terms of where we take LOTUS. I think in terms of pricing, obviously, I think people are aware of the margins on ACURATE are better right now. So if we get into you look at country mix, until we get scale and volume on LOTUS, the accurate COGS are going to be better. And so 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's wide variation in Europe. And so I think we're not going to be in a big hurry in some of those lower ASP countries to run out with LOTUS. But we will. If there's passion around the technology in a given account, if there's a BSE relationship that drives a account, it will be part of the strategy. But I wouldn't I would say in general, I think the European relaunch of LOTUS is going to be kind of precision strike versus a wide launch.
So we'll focus heavily on France, the U. S. And then specific accounts within Europe out of the gate. And we'll see how things play out over time then.
Rick Wise, Stifel. I'll start with a peripheral one too, Jeff. Just out of curiosity, you called out the death knell of POBA and other peripheral technologies. I'm curious to know what you think the implications of the OER for atherectomy in general and for your business specifically. And then I'll follow-up with a question for Kevin.
So 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. And it's very heterogeneous today. And so I think there is a role for atherectomy in certain DCB, Eluvia as well as, POBA and bare metal stents. And so 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. And of course, we're the only company that has it all.
And so that is our sustainable competitive advantage. Whatever the physician sees in the lab, we have the tool in the toolbox to support their needs. And whatever they think is best that's evidence based, we can support that. We don't have to go in and try and convince them that just because we have a hammer that they should use it. And I think that's it's a nice evolution for peripheral, and that's where peripheral needs to go.
Gotcha. And Kevin, just to follow-up again on LOTUS, you covered your thoughts about Europe. I've been struck over the last 3 days how many times to sort of randomly doctors are saying actually from the day us very positive things about most of all, I think Lotus would be great here. And just curious how you're thinking about how you'd have us reflect, okay, all these years later, is LOTUS the niche and 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 Accurate gets closer, LOTUS as a niche, Accurate your valve family?
Thank you.
Thanks, Rick. So 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 niche. I think the sentiment in Europe is different than the U. S.
So Europe is on the market, off the market a couple of times, right? So there's a little more history there. The U. S. Market really other than the clinical trials have not gotten exposed to TAVR.
So 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 3, I mean, 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. So we don't see LOTUS being a niche at all. Even in the U. S.
Market when we bring Acura to the U. S. Market, we're not going to we don't plan to really kind of drive customers to one valve or the others in these markets where they're 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. So, we'll see how it plays out. I think the market 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.
So, definitely don't want to communicate that it's a niche. I just I'm communicating more that in Europe Accurate's got more traction. And so we can focus a little harder initially this year on LOTUS in the U. S. And then markets like France, etcetera.
So I thought I'd give Ian a chance. I'll give him the next question after.
Avicore, Hi, Sai. Maybe I'll start one on the peripheral side. The comment that you made, you could see the parameter drug loading conversion similar to what happened in the coronary space. That's a strong statement, right? So should we be thinking about the next 2 to 3 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. So can you just give us some thoughts on how you see the pacing?
Yes. And then I can ask Ian or Cat to chime in. I think good things take time, and I don't think the market will flip from bare metal to Eluvia overnight. And I think the clinical program that we laid out, it 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'd
No, I think I can make the comment and I think it relates to the comment that Jeff made earlier that we don't want to underestimate the power of evidence. And as Jeff nicely pointed out, the field of peripheral intervention is replete with anecdote, small biased series case reports and what have you. And this is the 1st 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. And I think that point will not be lost and is not lost on physicians here. Now to the point of atherosclerosis, you said before, there are many it is after all a systemic disease.
It just have some slightly more burden of calcium in the periphery. We know the astrobiology. 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.
So a drug based therapy is going to be a benefit. So I would say that exactly as Jeff said, we will slowly consistently build an evidence portfolio to say where drug eluting stents might be superior to a buoyant only or drug coated buoyant technology, where you'd need atherectomy as an adjunct to that technology. But I suspect we're seeing the very first sign of the way coronary therapies developed in terms of a logical scientific approach to where to prioritize therapies. And that's why I would say this is a historic meeting for 2 reasons, co opted of course, but the ILUVIRA is not lost on everybody here the importance of that trial. And I do think that progressively that you will see more drug polluting 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 the ZILVA. So that basically tells you drug is good, but actually controlled delivery of drug to affect the athero biology over time makes sense.
And then maybe one on LOTUS, some comments on share gains in Europe. I'm just curious, right, when you think about the U. S. Market, this is a portfolio approach right now. You have a very unique product in WATCHMAN, right, 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, right? Is this 20% similar to Europe? Should it be higher because now you have a portfolio?
For LOTUS in the U. S? Yes, thanks. I mean, honestly, I think the way I'd like you to think about 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 kind of 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. So I'll say all that.
What I don't want to do, I need to I'd like to be humble up here about share gains. We have to go prove it. So 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. We, 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. But in terms of the amount of time it takes 2019 versus 2020 kind of I don't really want to put a precise share number on other than to say we're in it for the long haul. And in this market, it's important enough for us to have kind of a 5, 10, 20 year view on this market.
So I'll leave it at that. Thanks.
Chris Pasquale, Guggenheim. Doctor. Meredith, a couple of questions for you. First, I agree with you on SENTINEL. It appears as though the conversation around IMbock 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. And not only single center data now, but you actually saw Julius Seager's data here, which is actually a patient level pooling of the SENTINEL CLARATE trial with the OMB 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. But 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. And if you look at the national U.
S. Data for readmit 30 day readmissions after TAVR. And so data set of 2000 in 2017, about 30,000 patients and 2.8% readmission rate. And that's an underestimation because some people are still in hospital with their stroke from their first event. So we believe that stroke is incredibly important in TAVR and it's a disabling and dehumanizing condition.
We need to develop evidence that continue to develop evidence that puts beyond doubt, the value of this technology.
Thanks. And then just curious your thoughts on how COAP 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, it's now going to be unethical to randomize patients to medical management, but this was a highly selective population. Mitral patients come in lots of flavors and not every edge to edge patient may be a good candidate for annuloplasty and vice versa. So as you think about advancing an annular modification technology, how do you think about what that clinical program looks like?
It's a beautiful question, very well thought out. I know exactly where you're going. So, at first, we have to acknowledge that, well, and I sat with my team yesterday, I've been coming to this meeting since 1991 and in the interventional practice for 30 years. The debate has 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. So you can say you were there the day that at least some evidence has been established in a well conducted unbiased clinical trial.
Yes, you're right. They threaded the eye of the needle to with in terms of the management of all of the variables that could affect the patient's outcome, but Abbott are absolutely to be congratulated for this. 2nd 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 a replacement because you're much better off actually doing something with your own native valve than you are with a prosthesis. And I'll draw you to one statistic.
96.6 percent of the patients were free of a major adverse event at 12 months. So the safety event rate was 3.4%. You can't do that with a transapical valve. You can't even do that on the 1st day of a transapical valve, let alone at 12 months. So they've set a very high bar.
Now to the other and 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, but you saw the MATRA FRR data and there are other trials that come in the future. We have to take those in totality.
We heard the arguments as to whether this is level 1 evidence or 2A. It's 2A 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, but it's all going to be about the patients. Now 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 noted 100 of these cases because that's all you had. So the all you had option because you wouldn't desire to clip the leaflets worked beautifully.
But we want we're aiming to do an optimized physiological surgical predicate in terms of the marginal angioplasty to bring the native leaflets together without actually clipping them together. Now can we add to that? That's what we have to test out. But I think it's a great day for mitral regurgitation, functional mitral regurgitation and it's a great day for the idea of appropriately done repair strategy. So to me, I'm very buoyed by this and I think it's we can say it's like the 1st day of TAVR.
You can say I was here when they actually showed this. I mean, this is an argument that's gone on for 30 years more. And that so you saw everybody would just broke into spontaneous clapping. How many times have you seen that in the late breaking trial at TCT because it's fine tingling to see that. Not one of you really thought that there was going to be a mortality advantage and I emphatically said that there wouldn't be because I've looked after patients like this, my entire career.
So it just goes to show well conducted trial, appropriately selected patients, well monitored, the therapy works. So mitral regurgitation gets just
the iris update that we have from Doctor. Rogers yesterday?
Yes. Now the iris FFR trial? Yes. Yes. Okay.
Very important study because the IRIS FFR study
No. Militheed IRIS.
Our trial? Yes. Sorry, there is an IRS FFR trial. Yes,
the update from Doctor. Rogers
that is transseptal, transvenous transseptal with a mitral clip 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 focus on the ability to get the device there. So we have integrated intra cardiac 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.
So the procedures that we're currently doing to optimize the delivery and deployment are going extremely well.
Thanks. Robbie Marcus, JPMorgan. I want to circle back to something I saw on the slide, dollars 150,000,000 Peripheral DES global market in 2020. By my math, the market is $120,000,000 today, plus or minus. So how should we interpret that data point on the slide?
Sure. So as you can imagine, battling is going through things like that 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 twenty nineteen in Japan. And we believe that that will be another accelerator for this movement.
So 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, Kath? Yes, absolutely.
And 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 $1,000,000,000 how it goes U. S, Europe and outside Europe?
Thanks. Sure. So as you can imagine, it varies highly country by country. But for example, in Japan, there has already established a separate DES category for drug eluting stents in the periphery in which Koch operates today. So when we launch in Japan, we would be launching into that category versus into the existing bare metal stent category.
And then in Europe, it really varies country by country. And this is where the imminent 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 Biegelsen, Wells Fargo. Let me follow-up on Robbie's question. So Jeff, on Eluvia pricing relative to a DCB parity or not? And then we should think about the 1st year update, Plutonix had impacted about $80,000,000 $90,000,000 1st year in the U. S.
By RMAT. Can you comment on whether you think OLUVIEN should be kind of better or worse or why? And I have one follow-up for Kevin.
Yes. So we typically don't break out product revenue. So 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 $1,200,000,000 Boston Scientific business. And I think this will be a bigger one for us.
And I think just it'll take time to get it into the market and see how it gets adopted. And 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, by our math well, 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% to 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 both go above the corporate average?
I was going to bite and then Susie stared me down. So apparently, I can't comment. But Jeff and I are always in a healthy competition for growth.
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 in a drug release stents and TAVR, right? There's not much else. So with that in mind, in peripheral being an algorithm, mitral seems like it's an algorithm too.
So M and A, one of your comment, Kevin, about M and 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. And 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. And 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 Doctor. Meredith to actually comment on kind of the thoughts on toolkit and what might fit where. So I think we've got a really crown jewel centerpiece.
And then the question is what else do we need to round this out? And we're realistic enough to know that it's not going to be one device kind of takes over the market.
Thanks, Jason. I totally agree. And I think there is a parallel here with vascular disease. There's a role for atherectomy. There's a role for DCB.
There's a role for drug eluting stents. And so in the mitral space, I think why we started with mitral repair with an annuloplasty is we recognize that to do mitral valve disease well, you will need cord repair strategies, you will need mitral valve replacement and there may or may not be a role for leaflet effacement and clipping in that context. So 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 on the that we're delivering as being part of that package. And 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. So 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. And that's a great segue into my follow-up question specific to Eluvia in general peripheral, you mentioned the algorithm, but right now, drug eluting stents in the peripheral leg or in the peripheral is small relative to the overall market. Do you think 2 year data from Eluvia will have an impact, not necessarily on share because it looks like the 1 year data may have an impact on your ability to gain share? I'm wondering if 2 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?
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 Meier's between months 12 and So, I do agree with you. I think that when 2 year data is available, it will only further reinforce the benefits of having a drug eluting scaffolding that helps maintain vessel patency over time.
Thanks, Susie. Just two really quick ones. It's Bob Hawkins from BofA. 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.
Yes. It's really an acute study. So I think we will continue to follow those patients, but I think the interest was really in acute performance during the cases.
Okay. So the FDA is looking for a 30 day data then?
Yes.
They're looking for relatively short follow-up just to confirm device performance.
Okay. And 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. It's already underway.
Okay, okay, sorry. So, okay. So, at least it seems like the potential for an approval in the U. S. Maybe a little sooner than mid year based on that.
Okay. Jeff, one last question for you. I mean, 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? I think the first thing is we weren't planning on getting approval this quickly. So we are behind from an inventory standpoint. So 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 lunches that you'll be referring to where you can just run and gun.
So for us, it's going to be a sort of disciplined, smart, controlled launch to try and penetrate the accounts. And keep in mind, we have 3 specialists in each account. So 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. So 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 'nineteen at a decent run rate.
Okay, thanks. Just as a follow-up to that, it's Kristin here 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?
So 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. But 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. So, I do think that there is maybe an opportunity for us to convert even more new users than we had originally thought.
And then just a follow-up on Millipede. What should we think about going forward in terms of different milestones? Obviously, you're going to acquiring the asset in the Q1, but what about from a clinical milestone perspective? Thanks.
So I'm a little hesitant to say too much. We don't own the company. So they've been doing they've got a great engineering team and leadership team that have been really in control and driving the milestones. But 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 U. S.
EFS study, start thinking about kind of rolling into CE studies in the back half. But I think we'd still 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 then acquire and close that hopefully early in the year. So 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.