Boston Scientific Corporation. (NYSE:BSX) Investor Update at TCT 2019 September 27, 2019 3:00 PM ET
Susie Lisa – VP, IR
Lauren Tengler – Director Investor relations
Jeff Mirviss – Senior Vice President and President of Peripheral Interventions
Kevin Ballinger – Senior Vice President and Global President
Ian Meredith – Executive Vice President and Global Chief Medical Officer
Conference Call Participants
Rick Wise – Steifel
Larry Biegelsen – Walls Fargo
Vijay Kumar – Evercore
Jason Mills – Canaccord Genuity
Hi guys, it’s noon so we’re going to get started. As people are getting settled, thank you very very much for joining us here at the Boston Scientific Transvascular Therapeutics Conference 2019. Really grateful for the opportunity here and my name is Susie Liza, I’m with the investor relations team at Boston Scientific joined by my colleague, Lauren Tengler. We have a great line up of speakers for you today. We’ll try and keep it tight about 15, 20 minutes of prepared remarks. And then we have lots of time for your questions. So let’s move right into. We will be making forward-looking statements today, and the usual regulatory disclaimers apart.
As well as from financial disclaimers we encourage you to seek our latest 10-K and 10-Q filings with the SEC for a full discussion of risk factors. And with that, I’m very happy to turn it over to Jeff Mirviss, our Senior Vice President and President of Peripheral Interventions. Thanks Jeff.
Super. Thank you, Susie. Hello everybody. Just a quick reminder relative to the peripheral space, I touched on this in June at Investor Day, but you know we’re very comfortable with this mid-single digit growing market. A lot of patients still have low awareness and under penetration in these disease states, so we see really good market fundamentals and we’re happy about that. And about half of our TAM is in the arterial segment where we’ve been really focused on drug eluding and PAD products and now we’re moving more focused into the CLI space.
And then the other half of the TAM is sort of broken up roughly 50:50 between Venus and Interventional Oncology. And prior to the BTG Acquisition, we were very focused on the deep venous system with the things like AngioJet and stents and balloons. And I will focus a lot more of broadly in Venous with both superficial as well as pulmonary embolism. And on the oncology side we sort of had a very focused point of view on liver cancer and our sort of opening the aperture of the camera if you will on other cancers in kidney and other other places.
So you know we like the market. We like the fundamentals and we see a really a lot of opportunities to innovate and grow in the future. And that’s obviously aided in large part by our organic portfolio, but also with the BTG acquisition. So we see a lot of complementary aspects of the portfolio on the oncology and venous side, where we can bring together our delivery tools and our capabilities in that area with their cancer treatment and our vast commercial footprint on the venous side.
And this acquisition lets us move faster into some of these higher growth adjacencies that I just touched on. Some of the key highlights being Superficial Venous insufficiency with Varithena and pulmonary embolism, and obviously treating cancer. And you’re aware that the BTG business is largely U.S. based. And so, one of our top priorities right now is focusing on the geographic expansion opportunities. And so the team is working very hard on figuring out which products, in which geographies, and in what sequence, do we bring the BTG portfolio. And we’re very excited about being able to treat more patients and bring these technologies to more patients in more countries around the world.
And then finally, we see a lot of Boston Scientific capabilities to be more efficient with the BTG business, both on the revenue side that I just touched on, but also on the cost side. And so the team has been hard at work, it’s only been less than two months. But the team’s been hard at work figuring out exactly how we can accelerate our way to get these efficiencies in place, and we are very comfortable with our commitment that we made out of 175 million in synergies by year three, and as soon as we get more sort of data on that, we’ll give you an update as soon as possible.
So we’re feeling quite good about where we’re at right now with the BTG aspect of the PI business. And of course, the other thing that’s taken up a lot of time is Paclitaxel. There’s been some updates here at this TCT meeting. You know the FDA is very interested in additional studies and of course additional randomized studies. And the good news is, we have one of the biggest trials, that’s underway right now, that’s going to help elucidate this issue more going forward. And that’s the Eminent Trial, which will be done enrolling at the end of this year beginning of next year. That’s a European trial with Eluvia 750 patients randomized to all FDA approved bare metal stents. So I think that’s going to be an important dataset for the future that will help figure out what’s going on with this signal and help in terms of the resolution there.
I’d also say that physicians are having really good conversations with patients, better conversations with patients about the importance of medical therapy, you know exercise their comorbidities, as well as what we’ve seen in the signal. So I think that’s helping the market sort of returned back to some improvement, and we see many hospitals now putting Paclitaxel back on the shelf, making it more available for their physicians to treat patients.
And then of course, there was more data here at this TCT meeting. It seems like every time this — these same trials get reviewed and more patients come into the analysis, their signal goes down. I think it started at something like a 93% signal it’s down to something in the 20s, so I think we’ll see that continue as more patients come back in those trials, and then of course new trials, new registries, new randomized trials, new analysis from Medicare I think will help really resolve what’s causing this signal.
And we think through all of that, BSC is well positioned, you know first, because we have a highly differentiated portfolio, and second, because we’re the only company that’s investing in comparative data and it’s the type of contemporary evidence that physicians want to see to help inform the decisions that they make for treating their patients.
Eluvia is continuing to open up new accounts in the U.S. I think we’ve opened up more than 75 new accounts since the panel meeting. So we’re seeing some nice progress there. And you know the topic of Eluvia not being in the meta analysis has been a nice talking point for physicians as they consent their patients. And then we have Ranger, which we believe is around the corner next year.
And so Ranger will be the only drug coated balloon that will have comparative evidence you’ll see that that link, in January of 2019 or 2020 that’s a 414-patient trial head-to-head against Medtronic. And then you’ll see our pivotal trial results at Viva which is the Ranger Drug Coated Balloon randomized against [Indiscernible]. So two really robust data sets in the next few months. And then of course, we will have long term data coming more with Ranger.
We already have three year data now. So essentially, what the FDA asked for which is longer term data. We’ll have that, and ensuring that the device is no less safe than what’s on the market, we’ll have comparative evidence. So we feel good about Ranger in 2020.
And then, we have seen a pickup in the SAVAL enrollment since the panel meeting. So we are comfortable with our projection that you’ll see SAVAL released in the 2022 timeframe. So we’re feeling pretty good about where things are at in the drug leading space. Obviously we’d like to see it accelerate more, but I think the guidance we gave earlier in the year still holds and we’re seeing positive signs and we’ll keep you posted as we get more data.
So with that, let me turn it to Kevin for an icy update. Thanks very much.
All right, thanks Mur. Good afternoon, everyone. So thanks for coming, and spending some time with us today. I’m just going give a little bit of quick context of kind of the latest updates for intervention cardiology, and then we’ll Ian will make a couple of comments on the clinical side and we’ll get into Q&A.
So a slide that I showed at Investor Day, just to reiterate, kind of what our strategy has really been for several years. So we put a lot of effort into reviewing our portfolio and really driving into higher growth markets and we’ve really reshaped our portfolio, so I’m very proud of the internal team, but our commitment has never been stronger to category leadership in Stents and coronary of our foundational business and Complex PCI and also in the structural heart. So, you see some of the numbers here, so just a few points of observation.
So in 2019 as I mentioned in Investor Day, our non-DES Coronary business will be bigger than our DES business. So this diversification strategy and growth we’re seeing in Complex PCI is certainly healthy and paying off from a coronary perspective.
Structural Heart this year will represent over 25% of our revenue. So we’re getting scale, we’ve got scale, and we’re getting scale every single day. So we’re excited about the — our entries into the TAVR field to complement our WATCHMAN procedures. This number is 26% is a number that corresponds to our revenue guidance for structural heart of 700 to 725. We feel committed to that. I feel strongly that that, that’ll be achieved and we’re holding firm to that.
So good underlying growth markets, overall intervention cardiology broadly, $13 billion market growing at 6% annually and that’s primarily driven by structural heart, but also a kind of underlying coronary therapies market that is flattish to maybe a slight single digit growth.
On the Coronary therapy side, our commitment and our strategy has always been to in any given calendar year to launch five to 10 new products or indications, and so we’re maintaining that that philosophy this year, and just a couple of examples right now. So our complex PCI business has been growing really nicely. In fact for the last many quarters, we’ve been growing at double digit rates, in complex PCI, and we see that has the capability of staying at a high single digit kind of top line grower, and it’s driven by product innovation and ROTA is a good example that.
So ROTA chose our commitment to the calcium space, some numbers from this year through the first half growth, we’ve grown ROTA over 20% globally this year, and we’ve also introduced a new product ROTAPRO which really expands upon the ease of use, and you can see some of the numbers there. We’ve launched about 650 accounts globally with ROTAPRO but just in the U.S. alone, we’ve seen over 40% growth in our ROTA business this year. And so I think, the ease of use improvements have been appreciated.
On the Stent side, we’re happy to announce this past week that we got CE approval for our MEGATRON SYNERGY, MEGATRON Stent. So a purpose built Proximal Stent, a stronger Stent. I think this type of innovation is going to be what matters in the Stent side. We’ll have a 48 millimeter Stent launching in the U.S. next year later next year as well. So we anticipate from an FDA approval perspective, that should come sometime in the first half of 2020, and indication expansion is certainly something that’s very important as well.
So Alqahtani [ph] just presented yesterday the first prospective global randomized trial in the U.S. of not randomized trial – I’m sorry the first prospective trial with the high bleeding risk patients. We’re very pleased with those results and we look forward to Synergy being the first product in the U.S. with the indication for high bleeding risk.
On the WATCHMAN side, very excited to announce we’ve passed the 100,000 patient threshold since the original launch. So that’s a key milestone that the team is very proud of. With that, we’ve got reimbursement that’s been a good story over the last few years, really since 2015, when we’ve launched. We expect in fact next week the next reimbursement increased to go into effect, so that’s good for profitability of U.S. sites. WATCHMAN FLX in Europe, we finished our limited market evaluation and we’re really pleased with that. So we’re now in September moved in to full launch mode and the performance been exceptional.
Japan is going to be another critical market for us in WATCHMAN, 1.8 million patients, lot of concern about bleeding on OACs. And so, I think it could be one of the more important individual countries for WATCHMAN overtime. So, the launch is under way. It started in September. So we’re maybe four weeks in it launch right now and so far so good.
And in the OPTION trial, 1600 patient trial looking — its the first trial looking at kind of contemporary OACs versus WATCHMAN and this is in a post-ablation of population. But I’m proud of this trial. The commitment to a clinical science is strong. And finally on Structural Heart before I — valves that is before turning over to Ian for few comments. A lot of good momentum here obviously, so those maybe saw the cases more in from Columbia on LOTUS, really great example I think of the typical types of cases we’re seen and the results frankly. So, we’re positive. We’re encouraged on LOTUS, the early stages of the launch is now going very, very well.
We’re on track to open 150 accounts in the first year, and that’s the first year from FDA approval which was April. So by Q2-sh next year, just to give you a sense of the pace of our plans to launch we’ll plan to be in 150 or more accounts. We’re launching it in a very thoughtful measured way. Pacemaker rates, I’m sure that will come up in the Q&A. We do think we’ve got competitive pacemaker rates. We can say more about that. But I think what we’ve seen so far is only given us more confidence that this will be a competitive product relative to pacemaker rate.
And one of things we certainly need to do and we realize that is, is to have a smaller Sheath offering, some expandable Sheath. And we are now in a limited market evaluation for our 15 French iSLEEVE expandable Sheath. Previous to that, we’re using the larger Sheath and that certainly has been something that has held back some usage, but we’re now in an LME for the 15 French and expect to four commercial and 15 French in the fourth quarter likely in mid-November timeframe.
SENTINEL; a lot of really good momentum as well, we’re in over 400 accounts. We think we’ve — its use right now in 15% of all TAVR procedures in the U.S. In the U.S. we’re in about 250-ish account, so the 400 numbers globally. So that’s going to continue to rise. It gives us some really unique opportunities and rounds in our portfolio in a very clinically relevant way. We were happy to announce this week a randomized trial. We’ll say more about that I’m sure in the Q&A, but we plan to do a randomized trial on SENTINEL in 2020 and that’ll be a hard stroke end point. Ian can say more about that, but we’re doing that because we got more and more confidence that this SENTINEL results I think we’re more confident than we’ve ever been about what we’re seen in the fact that putting a randomized trial data out there could be really powerful driver for those that are still are nonbelievers.
And on ACURATE neo2, so we’ve started the U.S. enrolment that trial is underway. And recall neo2 has the anti-PVL skirt to prevent or at least diminish PVL. U.S. trials enrolling, the customer feedback has been very good. We anticipate the U.S. approval as I said, Investor Day being in the 2021 timeframe, our CE approval for neo2 in the 20, mid 2020 timeframe. As Ian comes up now he can make — give some perspective on the clinical trials that have been presented, SCOPE I obviously was just presented this morning that was with the neo1 version and I think that the neo2 will certainly improved some of the PVL performance that was seen in that trial. So, Ian, I’ll ask you to make a few overarching comments on some of the trial activity at TCT and then we can move into Q&A.
Thanks very much Kevin. So, well, I think most of you are aware of the trials that we presented or been involved in here at this meeting. I think if I could make a couple of very brief comments. Firstly that on page three, we presented the three-year data with this randomized trial. I would say that their results look very consistent and well sustained after three years. They strike difference of almost double, half the strike rate is still there and PVL benefits are still there. As a consequence of that, we also had an economic study showing that the costs associated with LOTUS were significantly less when you take into account, even though there was a higher pacemaker rate, there was a significant less need for a second intervention, because you didn’t put a valve as frequently with LOTUS AS you did with CoreValve, and of course there was low PVL, so fewer are re-hospitalizations for heart failure.
So, great durable results in REPRISE III and the economic analysis shows that it’s a net win of 12 months to use a LOTUS valve. I think — I’ll just briefly touch on EVOLVE Short DAPT, you heard Kevin mentioned that; critical studies, single arm study against an objective performance criteria, not a randomized trial, but we showed that in patients at high bleeding risk three months of dual antiplatelet therapy was great outcome. You saw, there was no difference in mortality at the 15-month endpoint. And there was certainly no difference in MI. We met the expected objective performance criteria for stent thrombosis.
Now paradoxically there was slightly higher bleeding in the short capped arm versus the historical control. That doesn’t make sense. If you’re on no anti-coagulation or no antiplatelet agent, it’s unlikely that you’re going to have a higher bleeding rate than a person who is on long term dual antiplatelet or anticoagulant therapy. So, the difference there is probably ascertainment of low acuity bleeding between the subjective and indeed the — well I use this microphone because it’s pretty irritating isn’t it? And indeed the study arm — perhaps the one [Audio Gap] search was a randomized trial with a complex compound multifaceted safety and efficacy composite end point at 30 days. And you saw the number of variables went into that. We missed that primary non-inferiority endpoint. So we were not non-inferior and that not non-inferior was driven by an increased rate of paravalvular leak in consequences and indeed acute kidney injury and the latter is really a consequence of the former.
So I think for those of you who were there for the discussion after that I think it was very balanced and reasonable endpoints out that S3 is a mature third-generation technology. ACURATE neo is a second generation device in evolution and of course the device we have starting in the U.S. is the ACURATE noe2 with the extended skirt. And we already know from the CE Mark trial that was conducted with the ACURATE neo2 that the rate of paravalvular leak core-lab adjudicated moderate PVL is about 3%. So that is just one study of course in a multitude of studies that are ongoing. We have the U.S. IDA which is a randomized trial head to head against either S3 or CoreValve, Evolut PRO and R, that’s currently under on the way. And of course there’s the SCOPE II trial which is also randomized against Evolut R and PRO in Europe. And that’s also in the context of many other studies that are going on in Europe and studies that have previously been undertaken that are propensity matched analyses.
So the only other thing that I’d like to draw your attention is the WATCHMAN FLX early clinical experience, we’ve seen excellent data thus far from the firm, from this suggesting that it’s going to do very well in clinical hands. Very high rates of procedural success, great rates of C Link and extremely low rates of complications, so all good news on that front.
So, perhaps we could open it up for questions.
A – Susie Lisa
Thank you. So please get the microphone. So we’ll start with Rick, we’ll go down that row and then down the row here, please. So, Rick thanks.
Hi, Rick Wise, Steifel. A couple of questions just to start, maybe just start in an odd spot with SENTINEL. I think [Indiscernible] as long as you’re talking about in. Talk about some of the early experience some doctors are talking about time to lucidity dramatically better with SENTINEL, some of the anecdotal feedback there?
Okay. So if I can deal with the first question first, and we are confident, because if you look at the totality of evidence, Rick, from registries are the single side registries or pulled registries, we’re seeing that the 72-hour stroke rate is reduced by anywhere between 60% and 80% plus the evidence that we saw from a post hoc analysis from the original SENTINEL trial. And there’s other datasets emerging. But again single registries, all point in that same direction. So the trial that we’ve designed is a properly powered, hard endpoint, real stroke 72-hour study for two and a half thousand patients randomized to SENTINEL supported or protected TAVR versus no protection of TAVR.
And we believe, we’ll hit this endpoint and you need only look at the SCOPE trial that you just heard, which is contemporary practice in Europe that just finished. And you saw the S3 had a 3% stroke rate, ACURATE had a 2% stroke rate. Now, going back to what you said before about the low risk side, you remember that the S3 low risk study Partner 3 excluded by cuspid valves, excluded heavily calcified low risk valves. So in the real world where you don’t exclude patients and you take the universal set of low risk patients as opposed to a selected subset within that universal set, you will see a constellation of risk. And so, we’re pretty confident that the stroke rate is going to be around 4%.
The other thing is we have a neurological assessment. Now when you have a trained neurological professional see the patient beforehand and then after their event, the ascertainment of stroke is much more thorough and accurate. So an estimate of 4% we’re aiming for a 50% reduction in that event rate. So we think all of the evidence points to that. But at some point we need that powerful scientific evidence if we’re going to change practice, get it in the guidelines to be a standard of care. You have to have it. We believe we will get it with this trial. What was the other question?
Well, I’ll leave that for second and turn to the SCOPE trial. Obviously as Dr. Ian eloquently said that, not typical for a first-generation device we saw. Not thrilling results. Help us put in perspective, I mean, should we be disappointed and concerned that this is some kind of terminal psychological blow for ACURATE or no — help us find a more balanced thought process? Thank you.
I’m going to take a break, Dave, can you ask Kevin a question and then we’ll come to Ian, is that okay? Okay, David.
So, I think I’m right actually. Is this working?
Just give us a second. Go, ahead David.
Kevin, could you repeat the question.
Yes. The question essentially was in the interim time period where we have neo1, not neo2, which is essential for the European, our European. And you know I’d say in general Dave my view on that. It certainly it’s a headwind, but I would say, I don’t view it as a enormous headwind. And the reason is we’ve got 20,000 patients in Europe that have been implanted with ACURATE neo. There is a really rich experience set. The physicians that use neo really have their own large rich patient sets and they know the performance of that device. Generally where neo, ACURATE neo is used, it’s one of the primary valves. So we have neo in many of their patients.
And I just think that overarching point of 20,000 patients worth of individualized experience is going to win the day. Now clearly we’d like to have neo2 sooner, but and we’re doing everything we can to attempt to accelerate that. But I think it’ll be okay over the next several months just based on individual physician experience.
Maybe you can still grow ACURATE claims during this period or could do rest growth to flat?
Well, I think ACURATE it’s been growing very strongly, 30%, 40% on many quarters. So I think it’ll — it’s got the potential to flatten out a bit, but I do think there’s still opportunities for growth there, especially if you look at the holistic Boston Scientific type portfolio with SENTINEL. Now, we’ve got healthy production levels of SENTINAL so we can be more aggressive in terms of commercial bundles in Europe and you get through the summer months in Europe, and you can really start to work more deals. So I think with LOTUS in Europe, I think that also can help through ACURATE in the portfolio you can work hand in hand. So, potential for a little bit of momentum growth blunt in compared to what we’ve experienced for this interim period. But I think the net-net of it will still all kind of balance out based on other geographies and price set.
Rick, maybe, can you finish up on SENTINEL. Could you repeat the question?
Not – this is I think the reality is that PBL will be addressed by placebo and a larger size will actually aid in the future as well [Indiscernible] will be able to best see the complications. And almost all of the kidney injury that you saw here was related to managing maybe [Indiscernible]. So I think that once you address the PBL that this issue will be significantly reduced. And just to your point, I – a very important point is that we are reviewing day sales that people are going to present at [Indiscernible] and you can say this results that will deeper than what we’ve seen in historical funds. So I think that considerable falling loyalty to the accurate [Indiscernible] doing high volumes and getting good results. I don’t if that will really change that practice.
Just maybe other one Kevin, for you on LOTUS one of things we’re hearing this conference is enthusiasm over ICD expansion, backlogs are moving low risk is having some impact on the market. We actually heard other interventional Cardiology companies like [Indiscernible 30:27] suggest that their business is being impacted by to get mindshare with interventions right now because of the low risk inflection. So got me thinking by your launch of LOTUS in the U.S. as you think about the progression of the launch relative to plan has this distraction over low risk inflection kind of altered your view about how that launch is going and just more broadly how is that launch going kind of relative to plan? And when should we consider this being a full commercial versus moderately commercial launch? Thank you.
Yes. So I think really I wouldn’t call — I would say September this past month and we’re now almost in October, was really the — what I would call the full launch mode in terms of opening the number of accounts we plan to on a go forward basis per month. So we’re kind of at that clip now fully ramped through LME and launching the rest of the multiple next months will look like September in terms of account openings. I’d say there’s been very little a distraction by this low risk expansion. And I think you get wildly different views of what that all means.
But I think the one thing about LOTUS and I’ve talked a lot about this before is even for the staunchest CoreValve or sapient users for the most part we hear them say, LOTUS has a role after using it. Then they say that even more strongly after using it LOTUS has a place. Now, what does that mean in terms of share? Well it varies by account. So some users we’re already seeing will adopt this as a mainline therapy, front line workhorse product. Others are kind of dipping their toe in the water around more complex cases. So it’s an interesting dynamic and all my years in this space, you typically would go in launch a product and typically would be first used in you know relatively simple patients and you would work your way up from there. And it’s flipped on its head with LOTUS that in many situations it’s used in the absolute toughest of the tough cases where they literally reserved that patient like this we need a LOTUS here.
And so and it might be their first experience. And I guess the good news is what sets us to build that, I think pretty frequently where account starts. What they might have a perception that it’s a device they use times and it’s not a complicated device and it actually it’s a stress out of the procedure. Final point I would make is there is, expansion of additional accounts, just s trying to get to your question directly, the potential under capacity in the system from the expansion that might be needed over time. There are a lot of accounts and this isn’t our first, our frontline strategy, but there are a lot of systems or accounts that want to open new TAVR shops that are certainly talking to us about can LOTUS be one of the initial entries into this new TAVR shop.
Now, that is not our strategy. They might occasionally be that. But I think you saw Dr. Isaacs quote, I think you know his belief is that for operators that have less experience LOTUS would be an excellent valve of choice because there’s no point of no return.
So I’d leave it at that, but you know momentum is good. It’s on pace with our expectation, the performance — given the twists and turns we had to get in this point, I would say for me personally it’s in terms of just the valve performance itself. It’s probably even exceeded my expectations and I had very high expectations coming in terms of clinical performance. In today’s case the Columbia was an exceptional example of that where you’ve got leading physicians like that really thrilled over a result in that type of complicated patient.
Thanks Kevin, Larry.
Thanks. Larry Biegelsen from Walls Fargo. Jeff, I’ll give you a chance to do some talking. Couple questions on PI. First, for BTG, the Y90 trials, the two big ones; Epic and stop HEC, what’s the status? And maybe you can help us put those into perspective how important are those for that interventional oncology business, number one? And second, on paclitaxel, it does feel like we’ve hit the bottom. At least that’s my sense from talking to doctors here. And we should maybe gradually improve a little bit coming out. Would you agree and how do you feel about the $700 million number that you’ve talked about in June? Thanks.
Thanks Larry. On the BTG Y90 trials, so we’re learning a lot more about them. I would say they’ll probably be a little bit later than what’s published right now on clinicaltrials.gov. So the trials need to just read out for all the patients. So I would expect them probably sometime later in 2020 or first half of 2021. That’s as of right now our best estimate. And what we’ve modeled in our model is sort of no change in the market for Y90, so not a big catalyst one way or the other. So I think it’s modeled conservatively and we’d like that business and it’s a differentiated product and so we think that with the geographic expansion as well there’s lots of opportunities there for Y90.
Then on Paclitaxel, I would agree with your comment that it does feel like we’ve turned the corner. Things do appear to be improving. I mentioned the number of new account openings does appear that physicians have resumed using some paclitaxel especially the ones that haven’t used it because it wasn’t available to them. I think the patient conversations are dramatically improved and so FDA’s guidance from our perspective is being executed in the marketplace by physicians. You’ve seen the labeling, will all the companies will go ahead and update the labeling and we see that as just another data point.
And then I think as more data comes forward then it will elucidate exactly what is causing the signal. I think that’s the big question. I don’t think anyone saying that there isn’t a signal anymore, it’s more like you know what is the cost? A lot of doctors feel it, it’s not paclitaxel. So we’ll just have to see as more data comes. And we, again, we think we’re well positioned in that regard. And my comments at Investor Day were optimistic based on the 24-hour summary. And I think you all picked up on that. And I think the official statement from the FDA was different than the 24-hour summary. And it was more in line with our original guidance which is why we make the comment that we’re comfortable with the original guidance that we made earlier this year. Hopefully that clarifies.
Would you want to add anything.
Larry, you were present yesterday at the FDA [Indiscernible] and see that there’s an understanding that there is this [Indiscernible] here, but considerable data [Indiscernible] just a byproduct of the quality of trials that really…
Thanks. Chris Pasquale, Guggenheim. Ian, I’m curious on SENTINEL, the [Indiscernible] obviously an important step for that product. Any plans to iterate the design of the device itself. Do you guys not feel like covering the entire arch is worth it for the added complexity? And are there any plans to look at that product in other procedure categories?
So, good question. So first of all there are plans to iterate the device. But at that point those devices [Indiscernible] trial of the stents. Single device will be used in the project TAVR trial. The question of whether you deflector on the arch and therefore if you would see with part where device is crossing the arch or whether you actually are in the great vessels or near to the origin of the great the arch in the great vessels, that’s the important question. So the future devices we have [Indiscernible] vessels, but those trials for that in true time and that becomes a reality. Now as to other sizes we are exploring those options at the moment. Clearly [Indiscernible] valve from high risk — isolation indeed other complex base sided procedures could all benefit from this asymptomatic [Indiscernible] very common even after closure. So there are a number of options than even in surgery as well. So we’re exploring that with a few small — path forward, but clearly that’s fine where we are.
Thanks. And then one for, Kevin. I’m curious how you translate the Synergy results or the Evolve results into actual share gains on the stent side. Is it really just a matter of going to physicians and saying hey this should be now your preferred option in high risk patients or patients where you have compliance concerns or can you actually make an argument to payers perhaps there’s a cost saving advantage or anything along those lines?
Yes. It’s probably more of the former and we’ve certainly tried the latter and believe in the latter. But I think you know the benefit of a label is real, you know it may not be the extent — the extent in terms of a driver as a brand new product launch anymore. But it is meaningful. I mean it’s meaningful to some sites more than others, but I think the appreciation for the fact that Synergy was designed to do, the Synergy was designed for the drug in the polymer to go away over the first few months and to get back to a very safe healing, fast healing product and even a lot of the other bioabsorbable, abluminal bioabsorbable polymer stents that still take 12 to 24 months to degrade.
And so I think you know I think it’s just another positive factor for synergy, synergies already the market leading stent in the U.S. and I think this just builds on that being first with the label, being the first with a U.S. trial many will try to talk about it as a class effect over time. Others will need to do their U.S. studies to get that label. I think generally people believe all stents are safe, so I’m not — I don’t want to overemphasize that it’s in a completely different category on healing alone. But I will say that the deliverability of synergy is still exceptional still best in class in my mind and then adding products to the synergy family like the 48 millimeter like the MEGATRON dedicated large vessel stent. And then also later next year Synergy XD, which is a version of synergy that’s really designed for radial procedures. I think it all goes hand in hand and along with our Promus ELITE platforms allows us to segment the market well and compete in a very broad way. And I think it sets ourselves — it sets us up for a continuation of a market leading drug-eluting stent portfolio.
Thanks. Vijay Kumar from Evercore. Kevin, back to SCOPE I, you mentioned ACURATE possibly flattening rate, but then when I tied it in with your comments on LOTUS, the pace of account opening in the U.S. that’s ramped up. What caused that space to change? Is this based on feedback you’re getting from the marker or just maybe your commercial footprint build out training et cetera that’s you know and maybe that’s improved. And I’m just wondering if that U.S. ramp, is that enough to offset the slight flattening ACURATE in Europe?
Yes. I’m not making any predictive statements right now on an ACURATE European numbers specifically, but in the context of a business that’s 2.8 plus billion dollars I think things will be okay. In terms of the puts and takes of the very diversified portfolio especially with the neo2 on the way and especially with frankly the ACURATE experience that the strong ACURATE users already have and the belief in the product that they have. Just on that on the U.S. LOTUS launch, so what I would say is the ramp has now accelerated into the mode that we predicted in terms of the – so opening the number of accounts per month that we predicted at full launch. And so we purposely over the course of this summer we’re more in a self constrained limited market evaluation mode. And we started loosening that obviously in July and August timeframe with a stronger ramp and now September we’ve launched about the number of accounts that we think is appropriate to ensure that we do exceptional proctoring and training and giving the product the best chance as possible to stick and get the attention that we need.
So, we don’t want to treat this like a drug-eluting stent launch where it’s a big bang launch. We want to think about it more like the way we rolled out WATCHMAN and launch it at a pace that’s appropriate for you know gives us the best chance for the physicians to really appreciate the product performance. So we’re in that mode now. September was the first month. We’ll do it again in October and November and multiple months from there. So I think when I view our TAVR business with SENTINEL with two valves, its dual valve strategy I think is really going to be important for us.
I think this is one that it’s a growth orientation that can continue for many quarters in years. So it’s — I look at it as really a long term growth profile as opposed to one big bang incremental step up. I think it’s something that we can keep expanding on for many quarters into the future assuming the performance continues to be what we think and with the strength of our team. So that’s exciting to have what could be a real long term growth driver, just like WATCHMAN since 2015 has been a — it just keeps giving. I mean we’re investing in it to keep giving but it’s nice to have those types of things in the portfolio and I think we can do the same TAVR and SENTINEL. So that’s exciting.
That’s helpful. And then maybe one follow-up on EXALT D, new clinical trial has started on clinicaltrials.gov. I’m just curious did the FDA ask you guys to run a new trial. And there was some guidance from the FDA on pre-useful tips. Does that in a FDA his stance? Does that change your view on how adoption should look for this product or one year or two et cetera? Thanks
Yes. So the question is the respect to our industry franchise and our single use to adeno scope EXALT D. We did announced yesterday and the study called [Indiscernible] it’s a 10000 patients study, it solely at our doing in order to arm us with more data from commercialization. And there’s no change to our timelines for a year end 2019 launch for EXALT D. But we can be very excited about the market opportunity and this is solely at our own behest despite market rumors otherwise. So no change to EXALT, it is a thousand patients study to aid in commercialization.
And with respect to a single use stents, I think there was FDA language about three weeks ago, [Indiscernible] a very encouraging sign, recognizing the issues with reusable Duodenoscopes. And I think single use tips as a first step, but there’s no definitive elimination completely of infection unless you have a fully single-use scope and they left the door open for future products, and we’re very excited about that. So..
Thank you. [Indiscernible] so a couple of quick follow ups. Just one on LOTUS, just to continue that line of questions. You talked about sort of hitting a pace in September that you expect to maintain in terms of new accounts, which would suggest that your maybe you can give us a sense of how far are you into your investigational sites in terms of rolling complete availability or is that just sort of you know assumed that they’re going to have that availability. And then I have a couple of follow ups
Yes thanks Brett. So investigational sides, we are specifically talking about Reprise III.
Experience to LOTUS basically, yes.
Yes, so what’s interesting — so it’s a mix? I mean, the honest answer it’s a mix. Some of those sites are commercial accounts now, and some are not because they’re now focused on Reprise IV so the intermediate risk trial. So we’ve got about 40 accounts in — 40 ish— accounts for Reprise IV.
40, 42 out of Re-prise 50.
So it’s — it’s I don’t know the stats that I may have, but I know it’s a mix. There’s some of those that are both commercial and clinical and some that are just deciding to focus for now on clinical enrollment and more open up commercially over time.
Sure. And as you get through bigger through enrollment they’ll join you know maybe whatever sometime next year.
Absolutely. And probably most will join you know even during the enrollment period.
Okay. And then just a follow up on neo, Dr. Meredith, if you talked a little bit about PBL and neo2 obviously addresses part of that. There was a couple of other statistics you know in addition obviously the trial design, of scope if you could talk about what about the trial design, what about if it’s delivery system. We obviously know about this — you know other things it can give you confidence in neo2.
Yes, so the the other endpoint that mattered. I think you saw that was that there was a difference in vascular complications. So being, having the ability to use that 14 franchise sleeve with this will actually reduce vascular complications. The design of the trial I think was reasonable, and the reason it had such a compound complex composite endpoint was that in order to a randomized trial of only 700 patients, they had to have a lot of factors both safety and efficacy, and a device related echo valve function related composites in order to get an event rate of around 22% so that they could have a risk difference of around 7% which gave them a study around 750 patients.
So that’s how it was engineered. But I think, there are a lot of good information in there. If you look at the EOA, the effective office area, you note that they were typical of a super annual valve about 0.3 of a square centimeter larger than you saw with the Sapien three valves when it was aggregated, they had about 1.47 square centimeters. And you also noted that that the gradients associated with those were significantly less. Pacemaker rates were roughly the same in the two arms. So I think the problem there is, there’s so many endpoints that are measured to — and the more questions you actually ask within a given endpoint as this sub question, the more chance you’ll find a chance finding.
But I think the two big things PBL and vascular complications are the things that are going to be addressed and are currently in process. So the U.S. IDE trials ACURATE neo2 and will soon have availability for the 14 franchise fleet which has been used in the study as well.
We’ll go [Indiscernible]
I have 2 quick ones. So first on structural heart guidance, I think I heard you guys reiterate at this meeting for the full year is that correct, despite what we saw today.
700 to 725 million has been our guidance, yes, for the full year.
Yes, we are reiterating.
Okay reiterating despite what we saw. Okay, great. And then Jeff on BTG, just wondering if you could quickly comment on sort of the a little bit of a slowdown in revenues that we saw relative to the original guidance that you guys gave, any more color on what caused that in your confidence you know kind of going forward, in at least high single digit growth.
Yes. So the main cause was just the length of time it took to get to close, which was longer than we anticipated. And you can imagine like open sales territories in the middle of this transition was impossible to fill for BTG.
So we had a higher than expected sort of attrition rate. With some of the U.S. sales reps and then we just had to leave territories open. So that definitely had an impact. That’s probably the biggest, the biggest drivers. And so what we’re working on right now is identifying the key geographies and getting people hired as quickly as possible, and getting the integration of the U.S. sales force done very quickly.
And so, we have a lot of experience integrating companies now. We have sort of built muscle. So we’ve been working very hard to get the U.S. sales force prioritized and done very quickly so that we can then return to growth. And we’re very confident in the high single digits.
Thank you. Jason.
This is Jason Mills, Canaccord Genuity. Kevin, just a quick one for you, and then follow up with you. Wanted to tap back in your stream of consciousness with LOTUS in the United States. You’re bullishness seems palpable and genuine both, and I’m wondering if you could comment on that, as it relates to the advent of low risk data and how that perhaps has created fertile ground for you as more volumes if you’re — if you’re fitting into the 150 centers over the next year as a device that they can use, they have more capacity to use, I guess is one thing. And then also, the case earlier today, shows its proficiency in calcium. If you could talk about sort of the fertile ground that seems to be the case in light of the fact that volumes seem to be increasing.
Yes, I’ll make a couple comments. My stream of — I’m not that conscious after three days at TCT, but I’ll do my best. So look, I’m really optimistic about this market in general, right and the portfolio we’ve put together between accurate LOTUS and clear. I’m also very confident in the commercial team that we have. And the fact that this is the same customer base, really, that we’ve been leaders with for a decade plus on the coronary side, and to some extent on the WATCHMAN side gives me confidence that if we bring the right kind of products that we can be a player in this market.
The other thing that I really like is, it’s a massive market. I mean TAVR in all the years of Medtech you know maybe DES back in the day, but TAVR the TAVR growth has been enormous, and the patient benefit is absolutely enormous. And so coming into a market in the U.S. that’s probably what two plus billion this year just in the U.S. alone, and growing nicely is an enormous opportunity for us with the portfolio we’ve put together.
So then it all comes back down to where do we uniquely fit, and do we have a value that we think bring something to the table. And I think with LOTUS in the early innings, the answer to me is yes. Now we’re clearly limited right now on indication, and we’re clearly limited on you know I would say the size limitation of not having the 29 millimeter is also a limitation, perhaps maybe 20% of the cases not having intermediate risk that’s in process low risk overtime the markets already huge without lower risk.
So we’ve got a lot of ground there to penetrate even without that, and we’ll expand those indications overtime and we’re really committed to doing that as well as expanding the size matrix, so that’s why I think you know the future for multiple years is really bright. That’s why I’m so optimistic because we’ve got a place now for a certain subset and that’s already a large subset. And then we’re going to continue to iterate our portfolio and our clinical science as we as we have, and I think our company has done a nice job at that in other product categories and we certainly are making the investments appropriate to do that.
One super quick one Jason and then we’ll try and get to Kristen and then we’ll be done.
Sure. On the peripheral side, the repudiation [ph] on the podium today by [Indiscernible] was somewhat astounding to me. With respect to that analysis and drug-eluding stent and drug-eluding with paclitaxel. So are we under — the question is, are we underestimating the bounce back perhaps with respect to those technologies if that becomes useless. We use the stream, the stream of consciousness going forward or stream of consciousness, and then really quickly on pulmonary embolism, you mentioned a couple of times, is if Boston Scientific ultimately has the winning strategy in that field – and turn back for PE. Is it manifested in your current technology or have we not seen yet the technologies that will ultimately affect that disease state better?
Yes. So in PE, it’s a small market. And so I think the market will benefit by level of one evidence, which we are looking at, as well as improvement in technology, which we also have in the pipeline. So we do view it as an important space for patients, and to save lives and an important growth driver. And I think you’ll see this market grow as time goes on with evidence and with technology.
On the paclitaxel side, I don’t know. I mean. Obviously post the panel meeting, you know the 24-hour something was you know pretty optimistic I thought. I think the FDA is being very cautious appropriately so. And I think, it’s just going to take time to get the data, to find out what is causing this signal, because what is clear is, it’s unknown that it’s caused by the paclitaxel. And I think, there’s going to be a lot more data, and I would predict that a year from now or two years from now we will have the answer, and I’m optimistic that this market will still be a good market for patients and for growth.
Thanks, Jeff. One, quick, one question.
Kristen Stewart from Barclays. I was wondering if you could just give us your updated thoughts on the Mitral Valve opportunity and where you stand and update on Millipede or just thoughts in general on repair versus replacement and whatnot? Thanks very much.
Thanks Kris. And great question. I’m going to let Ian talk about Millipede specific. I mean, I think the general thought before I let him talk about the device is, you know our teams are working really well and hard, the engineering teams, and iterating the device performance, I think and the goal is to get back into the clinic in 2020, with a U.S. ESF in 2020. We might do some things outside the U.S. before that. But you want to talk big… In 30 seconds, this is going to be a two hour conversation because…
Ageing population, growing burden of heart failure module regurgitation drives that. And so it’s a huge unmet need. Repair will always be the favorite strategy, because the vast majority of module regurgitation, the leaflets are normal to why put a valve in and carry all the inherent risks of a Prosthesis when you if you – all you have to do is bring the leaflets back together again. So the surge what we are adopting the approach to emulate or reproduce the surgical predicate of Annuloplasty. Annuloplasty then leaves the option open for a edge-to-edge leaflet technology, a chordal repair or even a valve at a later stage if you continue to progress.
So the logical physician based approach for patients and what you will want, if you never need a functional mitral regurgitation go repair first, because it leaves you other options should you continue to live beyond 10 years. So Millipede is a transcatheter annuloplasty device that is completely removable if you can’t actually get significant leaflet collection, so it’s transcatheter trend, venous stent device and it actuates so you can customize the annuloplasty to the patient. So we’re just making a few minor tweaks before we get back into the clinic, so that it’s just a lot easier to use.
Terrific. Ian, Kevin everyone thanks very much. And that will ofcourse …