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Investor Update

Nov 5, 2019

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Boston Scientific Investor Update at VIVA 2019 conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Instructions will be given at that time. If you should require assistance during the call, you may press star then zero, and an operator will assist you offline. Also, as a reminder, today's teleconference is being recorded. At this time, we'll turn the call over to your host, VP of Investor Relations, Ms. Susan Lisa. Please go ahead.

Susan Lisa
VP of Investor Relations, Boston Scientific

Thank you, Tony, and thanks to everyone for joining us for a VIVA update from our Peripheral Interventions team. Good morning to those of you in Vegas, and good afternoon elsewhere here on the East Coast. We'll jump right in. I would first like to introduce our lineup, including Jeff Mirviss, whom you all know well, our Senior Vice President and President of our Peripheral Interventions business. He's joined by Catherine Jennings, our VP of Marketing and Business Development. We have a new member of the team. I'm very pleased to introduce Dr. Michael Jaff, who is the incoming Vice President of Clinical Affairs, Innovation, and Technology for our Peripheral Interventions team. Finally, our Global Chief Medical Officer, Dr. Ian Meredith, is joining us on the line as well for your questions.

As usual, the typical safe harbor protections apply. We will be making forward-looking statements on the call. With that brief introduction, I'll hand it off to Jeff. Thanks, Jeff.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

Great. Thanks, Suzy. Hello, everyone, from sunny Las Vegas. It's great to have some time with you to talk about what's going on in Peripheral Interventions, both generally, but also some new data that we just reported here at VIVA this morning. I thought I'd start on the first slide with just a little bit of a reminder about peripheral and how we see the market and our portfolio. I think, first and foremost, I'd just like to stress the point that in peripheral, we are serving pretty large and under-penetrated disease states, and we see a ton of room to innovate and an opportunity to help patients. There's a lot of unmet clinical and patient needs. As a result of that, we view the market as fundamentally sound and good fundamentals in terms of growth for the future.

Second, you know that our strategy is category leadership, and it's strengthened by the BTG acquisition. We're really focused. We're focused on PAD, venous disease, and interventional oncology. The category leadership strategy is really driving our investments in portfolio and clinical data. Nothing is more visible than today from those investments, which is the new data and new opportunities we have with DCB and the RANGER data that Michael will talk about in a little bit, and then the durable results for the Eluvia drug-eluting stent. We see lots of opportunities to continue to grow and bring really differentiated technologies in both of those products for the future. We see opportunities also outside the U.S. I've talked about, in the past, just BTG and the opportunity for us to bring those products to more international markets around the world.

We have plans both for the short term, medium term, and longer term to extend the portfolio from BTG outside the U.S. Of course, our own portfolio, that's always been a part of our plan and helping us with our growth right now in some of the key geographies like China and the emerging markets. On the next slide, just gives you a sense of how we see the market breaking down and then a reminder on our portfolio. What's really going to help us next year with the RANGER launch in the U.S. is being able to come to our customers on the PAD side, which we see as roughly half of our total addressable market in peripheral with both products.

Regardless of whether the physician wants to use a scaffold with drug or a drug-coated balloon, we're the only company that will be able to serve our customers in that way and provide them whatever they feel is best for their patients. Of course, have the comparative evidence with both of those products, with the IMPERIAL trial and then the COMPARE trial that will be coming out in January. Of course, everything else that supports those two flagship products, like atherectomy and balloons and bare-metal stents and the whole portfolio. We sort of cut and paste that across venous and interventional oncology. Now with BTG, we are a scaled player in both of those portfolios with venous and interventional oncology.

We're taking our position that we have in arterial and really doing the same thing in these two other higher growing markets with venous and IO. We have a good portfolio coming for venous and in the IO space. We're excited about not only the current products that are on this page, but the new product launches that we have in 2020 and beyond that will support both of these franchises. Having the commercial team now that's focused and having a scaled portfolio like we have across each of these three franchises, I think bodes well for the opportunities for us for future growth. Finally on this next slide, before I turn it over to Dr. Jaff to touch on the clinical data.

We view this portfolio as a highly differentiated opportunity to deliver meaningful innovations to our customers. To not only have the type of products that they look for from a clinical perspective, but from an acute handling and deliverability perspective with both Eluvia and RANGER. Eventually [SEVAL]. Low dose, which I think is an important message for us to continue to stress. The comparative evidence, which our customers are telling us these are the type of data that will help them make more evidence-based decisions. It's exactly the type of trial data that we'll look to build on in years to come with the longer-term results in both Eluvia and RANGER, and then ultimately [SEVAL].

We still maintain our position that we're on track for a 2020 RANGER launch in the United States, and things are going well with the clinical trial enrollment that I mentioned at TCT with [SEVAL]. As of now, we still believe this is a 2020 launch. A really nice cadence of new launches on the drug-eluting side, which is an important part of our growth down the road. With that, let me turn it over to Dr. Jaff to share a little bit more color on the data that we just recently announced.

Michael Jaff
VP of Clinical Affairs, Innovation, and Technology, Boston Scientific

Thank you, Jeff, and hello, everyone. Some of you I've met over my career. For others, I look forward to meeting you. It's been quite a morning for Boston Scientific around the field of peripheral artery disease and drug-eluting technologies. If we can go to the next slide, talking about the RANGER II SFA trial. This is an important data release for the field because of the fact that this is a highly deliverable 0.18 Sterling balloon. It's designed specifically to increase efficacy with minimized downstream particulates. The goal here is with a lower drug dose, get efficient drug transfer in the same scheme. The trial, as you know, was a randomized trial of the RANGER DCB versus uncoated PTA in the superficial femoral artery in a 3-to-1 fashion as a single-blind study. The total cohort, 376 patients. 278 received the active RANGER DCB, 98 uncoated PTA.

These patients will be followed through five years. There was a PK substudy to look at the pharmacokinetics of paclitaxel on the RANGER balloon in 12 patients. Patients included were the classic Rutherford 2 and 3, those were claudicants, and those in Rutherford 4 with ischemic rest pain. Patients were eligible if they had high-grade stenosis in the femoropopliteal arteries with lesion lengths up to 18 centimeters in length. Total occlusions would be included with a total lesion length of 100 millimeters, 10 centimeters or less. Again, the treatment was randomized to RANGER DCB or an uncoated PTA balloon. If we go right to the key result on the next slide. This is a 12-month interim data that was pre-specified in the study trial design, looking at primary efficacy.

This is a 12-month Kaplan-Meier curve showing you that the primary patency of the RANGER DCB was 89.2%, with the PTA uncoated balloon, 72.9%. This reached high statistical significance. Important to this is to note that binary primary patency was 82% with the RANGER balloon, 68.8% with the uncoated balloon. That was a P value that was statistically significant. This definitely demonstrates that the trial met its primary efficacy endpoint and superior primary patency. Comparing the RANGER patency results at 12 months to the other drug-coated balloons on the market, this is among the highest primary patency rate of any of the competitors. If we go to the next slide, obviously, we're all interested in safety and very pleased to show that first of all, there was absolutely no difference in mortality at 12 months in these interim results between the RANGER and PTA cohorts.

Of great importance, not only to the physicians demonstrating the efficacy of the device, but also the patients, is the dramatic reduction, a two-thirds relative risk reduction in clinically driven target lesion revascularization rates, a 6% TLR rate with the RANGER device versus a nearly 18% TLR rate with the uncoated PTA. That demonstrates a great benefit because even with a lower dose, this demonstrates a very low TLR rate, which is exactly what patients want to avoid having to come back and have a subsequent procedure. The major adverse event rate was also strikingly impressive with a 93.5% freedom from major adverse event rate with the RANGER DCB versus 82.1% with the uncoated PTA. That was also statistically significant. A highly effective device in a randomized trial with tremendous safety results.

The next slide just gives one glance at the 12 patients who were included in the RANGER pharmacokinetic substudy. Out of the 12 patients studied, when blood levels of paclitaxel were assessed at one hour, 11 of the 12 had no measurable levels of paclitaxel in their bloodstream. Obviously, the protocol mandated multiple lab assays over the course of this to truly demonstrate the PK curves. That included seven days and 30 days after the last RANGER DCB treatment and removal of the balloon. All these 12 patients obviously received the active device with paclitaxel, and the average number of drug-coated balloons used per patient was 1.75 on average for the group. Demonstrating that in the vast majority of these patients, there was no detectable paclitaxel in the bloodstream.

Moving on to the next late-breaking trial that was presented this morning at VIVA is a follow-up two-year result of the IMPERIAL study. Obviously, you know that the IMPERIAL study was a landmark study that was a head-to-head trial of the Eluvia paclitaxel-coated device versus the Zilver PTX device as the only other available paclitaxel-coated stent for peripheral use. Obviously, the Eluvia device utilizes a polymer that enables controlled drug release. It offers the lowest drug dose density among all drug-eluting technologies. Remember, it was last year at TCT that we presented the 12-month results of the IMPERIAL study, a randomized study of Eluvia versus Zilver PTX in a 2-to-1 single-blind non-inferiority study. The trial was designed to show non-inferiority of Eluvia versus Zilver PTX. You'll remember there were 465 people in the cohort. 309 received Eluvia, 156 received Zilver PTX.

This was an international study involving 65 centers. A very similar inclusion criterion to what you saw from the RANGER study. The only difference I would make here is that the total lesion lengths range from 30 to 140 millimeters with standard vessel diameters. If you go to the next slide, this is the first time you'll see 24-month results from primary patency based on Kaplan-Meier estimates. You'll remember that the trial was designed to be non-inferior, and despite that, at 12 months, it showed superiority in patency of Eluvia versus Zilver PTX. You'll notice at 24 months, there's continued durable separation of the curves, although statistical significance was not met at 24 months. Again, important to remember, this was a non-inferiority trial, and this is a lower dose agent. In addition, the clinical outcome improvement rates remained quite robust.

84.4% for Eluvia, 78.2% for Zilver PTX, showing that these patients actually garnered durable clinical benefits, which is clearly the reason why we do these procedures in the first place. Going on to the next slide, looking at 24-month safety results. Looking at purely safety results here, the statistically significant reduction in CD-TLR at 24 months remained quite impressive. 12.7% TLR rates with Eluvia, 20.1% with Zilver PTX, and this TLR reduction rate was statistically significant at two years. Looking at major adverse events, almost 86% of Eluvia patients were free from major adverse events versus 79.9% of the Zilver PTX patients. Important to note that there was no difference in all-cause mortality between the Eluvia group and the Zilver PTX group, 7.1% at 24 months versus 8.3% at 24 months for Zilver PTX. All in all, excellent safety profile.

A statistically significant durable 24-month reduction in clinically driven target lesion revascularization rates. Really great results. As I look at the next slide, summarizing the data that the field has seen today and you're discussing with us today. The RANGER II DCB SFA trial at 12 months demonstrates really great safety and efficacy of this platform with an excellent deliverable balloon, a low-dose drug that was efficient and good at lowering particulates. We clearly look forward, as Jeff mentioned, to the commercialization of this in 2020. Then very rewarding to see the 24-month results of IMPERIAL with durable two-year efficacy of this technology, controlled release, lower drug dose among all drug-eluting technologies, statistically low clinically driven target lesion revascularization rates. With that, I'll pause, Jeff, and hand it back to you.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

Great. Thanks, Michael. I think we're going to open it up for questions. As a reminder, we have Catherine Jennings here and Ian Meredith on the phone as well. Happy to answer any questions that you may have.

Operator

Thank you very much. Ladies and gentlemen, if you wish to ask a question, please press 1 then 0 on your telephone keypad. You may withdraw your question at any time by repeating the 1 0 command. If you're using a speakerphone, please pick up the handset before pressing the numbers. Again, for your questions, you may press 1 followed by 0 at this time, and please allow just a few moments as questions are queuing up. We'll take our first question from Robbie Marcus with J.P. Morgan. Please go ahead.

Robbie Marcus
Analyst, J.P. Morgan

Oh, great. Congrats on the nice data. Was hoping you could give us what you think the pathway is forward for RANGER, given the issues we've seen in the drug-coated balloon market. Should we expect a longer processing timeline for this? Just your latest thoughts on the pathway to the market here.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

Thanks for the question, Robbie. I think the short answer is we don't know precisely. We are working very closely with FDA. The PMA is moving forward. I wish I could narrow down 2020 a little bit more closely, but at this time we're going to keep it just general in 2020. I do believe we will get approval. We have everything that was discussed at the FDA panel back in June, laying out what they wanted to see or what the panel recommended to FDA that they wanted to see to approve a new device, which is that the product is at least as safe as what's on the market. Our investment in the COMPARE trial, which has two-year follow-up in the first 150 patients and we'll have the 12-month follow-up in January, will, I believe, satisfy that requirement.

Not only is it sort of the benefit of delivering to the market the second head-to-head trial in the peripheral field, but it also sort of fortuitously is what's needed to get the product approved. I think that's a really important sort of milestone for the Ranger program. All of the other data that we will submit to FDA, most importantly, the longer-term data. We will have long-term follow-up, three-year follow-up from the Ranger One trial, which was 100-patient randomized trial against POBA, as well as much long-term data as we can get from this Ranger 2 SFA trial because many of the patients have two-year and beyond follow-up, and we will submit all of that data as it comes in to FDA. I believe we're in good shape.

I believe we have what the FDA is looking for, but really, since this is somewhat new, this is the first PMA that will be approved post the paclitaxel panel. I think it's just unclear exactly what the timing will be. We are confident we will get there.

Robbie Marcus
Analyst, J.P. Morgan

Got it. RANGER will be fourth market in the U.S. for drug-coated balloons balanced against clearly the best peripheral business at Boston Scientific. Maybe you could just spend a minute on your go-to-market strategy here and how you'll drive adoption given some entrenched competitors. Thanks.

Catherine Jennings
VP of Marketing and Business Development, Boston Scientific

For us, as we think about Ranger, it's got a couple of really key differentiators. First, it's the only 018 platform that we'll be launching in the United States that has this low drug dose that also has comparative effectiveness data at the time of launch. If you think about us launching into a market that is looking for ever more deliverable products, Ranger really delivers on this particular aspect, as well as having demonstrated efficacy similar to the IN.PACT balloon while having half the drug dose on the balloon itself. I think as physicians are thinking about how do I get the easiest-to-use product? How do I ensure that I'm delivering the right amount of drug to the vessel itself?

This is really a product that physicians are going to want to use.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

I would just add to that all along we knew we would be fourth to market. One of the value propositions that we can bring to the table for our customers is the fact that we're the only company that has both a contemporary drug-coated balloon and drug-eluting stent. It's the combination that we believe will afford our customers an advantage in working with one company with great data. I think it affords us the opportunity to have some creative solutions for our customers and ultimately recommend what's best for the patient. We're the only company that is in a position to be able to do that. I think that does set us apart.

Robbie Marcus
Analyst, J.P. Morgan

Great. Thanks a lot.

Operator

Thank you. Once again, if there's questions, you may queue up by pressing one followed by zero. Again, one, zero for any questions. We'll take the next question in queue from Larry Biegelsen with Wells Fargo. Please go ahead.

Larry Biegelsen
Analyst, Wells Fargo

Hey, guys. Thanks for taking the question. Jeff, a couple questions on the PE market, if that's okay. First, Jeff, how many device-based procedures are done in the U.S. each year, and what's the growth outlook for procedures? I have one follow-up on EKOS.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

You want to handle that, Kat?

Catherine Jennings
VP of Marketing and Business Development, Boston Scientific

Sure, no problem. A couple of comments. It is a little bit difficult to accurately describe how many interventional procedures are done simply because there are a lot of different products that physicians use in this particular segment. What I would maybe point you to is that we've seen a tremendous amount of growth in this market. However, the market itself continues to be tremendously under-penetrated. Just a quick stat for you. There are 100,000 patients that die every year in the U.S. because of PEs. That was a stat that was recently discussed at the PERT meeting.

As you think about our opportunity here to continue to further penetrate this market through some of our market development activities, driving therapy awareness with physicians, and being able then to take this to more global markets, we believe that this is a market that has a lot of continued room for growth, recognizing that there are more competitors that are going to be entering this market over time.

Larry Biegelsen
Analyst, Wells Fargo

That's helpful. Kat, do you see this as a double-digit growth market from a procedure standpoint? Just second, on EKOS, what are your expectations for that product going forward from a growth standpoint, given that there is more competition, as you mentioned? Thank you for taking the questions.

Catherine Jennings
VP of Marketing and Business Development, Boston Scientific

Sure. I'd say that we continue to expect double-digit growth in the PE market. I don't believe that we are breaking out EKOS revenue separately at this time.

Larry Biegelsen
Analyst, Wells Fargo

Thank you.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

Larry.

Operator

Thank you. Once again, for questions, you may queue up by pressing one followed by zero. Next in queue is Jason Mills with Canaccord Genuity. Please go ahead.

Jason Mills
Analyst, Canaccord Genuity

Hey, Jeff. Thanks for taking the question. I have one question for either you or Dr. Jaffe, and then one for Kat perhaps on the peripheral thrombectomy side. The first question is just how these data from both RANGER and Eluvia, how it contributes to the body of evidence and the argument, I suppose, that was made at TCT and even before that at CRT throughout the years, since the meta-analysis data came out and disrupted this market. How do these data contribute to the argument in favor of drug-eluting technologies, and the debate that will continue to rage on? I think at TCT, Renu Virmani and others were fairly vocal and somewhat unbiased opinions, as they seem to be, especially Renu's, about perhaps an overshoot in a reduction in use in drug-eluting technologies.

Since then, our checks would suggest that we're seeing a bit of an improving market for drug-eluting technologies, and I'm just curious if you could confirm that, and also what you think these data will do in support of perhaps additional use of drug-eluting technologies going forward.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

Thanks for the question. I'll make a few comments and then ask Michael to weigh in with his opinion as well. I can confirm that the market is beginning to recover. I think it's been a slow movement in a positive direction. I think post-panel, as I mentioned at the TCT analyst call, I was a bit more bullish based on the 24-hour summary, and then when the third letter came out from FDA, I think it was sort of walked back from the 24-hour summary. I think that's helped. There still are a lot of institutions where we're putting Eluvia, for example, on the shelf for the first time. We're opening up new accounts on a regular basis. We do see a beginning of more of utilization in the accounts where we're at, and so it's going in the right direction.

I don't think it's a big catalyst where it's all of a sudden going to get back to where it was or all of a sudden flip overnight. It's heading in the right direction, and I think where these data help is one of the questions we had over the past year is, well, what happens when the drug stops releasing? Because as you know, the sustained release on Eluvia is for roughly a year. The answer to that question is, what you get is when the drug stops releasing, is you get statistically significant reduction in TLR, which is what the patient cares the most about. I think when a physician is trying to understand the risk-benefit trade-off, now they know at least at two years, and then we'll have three, four, and five years with Eluvia.

They know that the clinical efficacy results are durable and that there's no difference in terms of safety between these two devices. I think that builds a lot of confidence for physicians who are going to choose a drug-eluting stent. Michael, any comments from your perspective?

Michael Jaff
VP of Clinical Affairs, Innovation, and Technology, Boston Scientific

Thanks, Jeff. I'd just say a couple of things in addition. At TCT, I ran a panel and asked the members of the panel, about six or seven, given that the FDA letter talks about use of these devices for patients at high risk for restenosis, what percentage of their practice, or the patients they see, would meet that definition of high risk for restenosis? The answer was anywhere between 90% and 100%. I think the days of seeing chip shot, mid SFA, two-centimeter long lesions is rapidly disappearing, and the patients that we're seeing who were included in these studies and more represent those patients in which durability is key. A reduction in TLR rates is the name of the game, and the fact that this data shows that we now have 24 months durability really helps. That's number 1.

Number two, I guess I'd agree with all of you. I find all of this of statistical interest but clinical irrelevance. The data is what the data is. I do think that the market will rebound. I'm skeptical to believe that it will come back to how it was, let's say, when we announced IMPERIAL at TCT in 2018.

Jason Mills
Analyst, Canaccord Genuity

Thank you. That's unbelievable color. Kat, if I could ask you a question following up on the peripheral thrombectomy discussion. Could you talk about the market in total, not just PE, but also addressable disease states outside of PE, and where Boston Scientific is, and frankly, where the market is with respect to addressing clot, where it is in the lung, where it is in the leg, even where it is in the heart to some extent, and the extent to which it's penetrated or not penetrated now with mechanical thrombectomy. The second part of that question is, what do you believe is the most important inflection point? Is it technology? Is it data? Is it a combination of both? I guess the third part, because I'm great at asking multi-part questions that people forget is, do you see competitors yet?

Is the market so under-penetrated it's land grab, and it's plenty of room, land out there to grab for the primary competitors that we all know about? Thank you.

Catherine Jennings
VP of Marketing and Business Development, Boston Scientific

Sure. I appreciate the question. First, I'd say, with regards to the total addressable market. The current belief is that there's 10 million cases annually globally of venous thromboembolism around the world, and with 1 million of those in the U.S. alone. I think when you think about the broader, under-penetrated market that we're talking about here, there's tremendous continued opportunity. I think when you think about inflection points, which was your second question, one of the things that I think is incredibly important in this space is continuing to deliver the clinical evidence that will help support interventions, appropriate interventions in this patient population.

For example, we at Boston Scientific are investing in a clinical trial called C-TRACT that is meant to help produce more of that evidence around the value of using thrombectomy in DVT patients, in particular, hoping to further clarify some of the data that we saw from the ATTRACT trial a few years back. I think those type of data points are going to continue to hopefully drive this market forward as we provide more and more clinical evidence that intervening in these patients leads to better outcomes. I think with regards to your third question around competitors, I think that there are different needs in this market that some of these different devices can address. Whether you're looking to be able to deliver a short, lytic-based therapy that has been proven to be safe, like with EKOS.

Whether you're looking to mechanically remove the clot for a DVT like you do with AngioJet. Whether you're looking to prevent PEs in patients that have a high risk for a PE with a vena cava filter like our new Sentry device. I think all of these instances require different types of tools, and so I do think that there's room for many of these competitors to really coexist in this market and address different needs.

Jason Mills
Analyst, Canaccord Genuity

Thank you, guys.

Operator

Thank you. Once again for questions, you may queue up by pressing one followed by zero at this time. Again, for additional questions, you may press one followed by zero.

Susan Lisa
VP of Investor Relations, Boston Scientific

Jeff or Kat, this is Suzy. I wonder if you could just expand a little bit on the vena cava filter opportunity, that's the Sentry product, and I think one that perhaps people aren't as familiar with. If you could just talk about that market or the advantage of the Sentry a bit would be helpful. Thank you.

Catherine Jennings
VP of Marketing and Business Development, Boston Scientific

Sure, Suzy. The vena cava filter market, as many folks know, is a $200 million-plus market globally. One of the things that physicians have really struggled with in this market has been retrieving these filters for a number of reasons. One is that sometimes patients aren't very compliant with their follow-up. Second is that sometimes these filters can become very challenging to retrieve if they tilt or have other complications. What we have acquired as part of the BTG acquisition is the Sentry filter, which is the world's first bioconvertible filter. What makes this filter unique is that it doesn't require retrieval but converts into an open stent effectively in patients, therefore reducing the need for a repeat intervention in patients where you're trying to address a potential acute risk of pulmonary embolism within a 60-day period.

As we've talked to physicians about this product, we've been able to really get some interest and excitement from the physician community about something that's very novel in a space where there hasn't been a lot of innovation over the past few years. I think that that's a space that is really ripe for some growth and some new technologies.

Jason Mills
Analyst, Canaccord Genuity

Yeah, Michael. I was just going to say, Michael, I know that you were an author on a paper looking at the health economic burden of retrievable filters. I wonder if you have any comments from that perspective as well as just the number of filters that are supposed to get removed but actually end up staying in patients either permanently or much longer than anticipated.

Michael Jaff
VP of Clinical Affairs, Innovation, and Technology, Boston Scientific

Sure, Jeff. This has been an area I've spent a lot of time in my life on. The practical aspect of this is that it used to be when all you had was a permanent indwelling filter, the procedure was owned by the doctor who did it. Once it was in, there was nothing you could do. That was the end of that. Now the supposition is that the vast majority of patients who get a filter placed ought to have it retrieved. In order to do that, it requires a whole process of flow that doesn't classically exist. The proceduralist, once done, has to communicate with the primary care doctor or whoever the captain of the ship is to make sure that that's tracked and retrieved.

That's an added burden that most primary care docs have not had to do in their careers. Even when I was at Mass General, we built a computerized system that forced reminders to the interventionists that, "Hey, that filter needs to be retrieved, and if not, you need to come up with a reason why not." There's a lot of work that has to go into this. Obviously the total medical expense burden that this places is not inconsequential, because the cost is significantly greater when you put the filter in and then have to retrieve it. From a health economic standpoint, it becomes challenging as well. Great. Thank you.

Susan Lisa
VP of Investor Relations, Boston Scientific

Any other questions, Tony?

Operator

No additional questions, but as a quick reminder, you may press one followed by zero to place yourselves in queue.

Susan Lisa
VP of Investor Relations, Boston Scientific

I have one more. Maybe Kat, if you could just round out the rest of the venous portfolio from BTG and highlight the Varithena system on the superficial venous side of things, and then maybe just any color commentary on VICI, our venous stent, if that's a highlight at VIVA or any color to mention there. Thanks.

Catherine Jennings
VP of Marketing and Business Development, Boston Scientific

Sure. I'm happy to, Suzy. Thanks. Maybe I'll start with VICI, and then I'll talk a bit about Varithena. With VICI, we continue to see really terrific physician feedback on the product. We continue to open new accounts, and we're extremely excited about this technology. We had a standing room only symposium here at VIVA, talking about our interventional treatments in the venous space, and a lot of discussion about VICI and the really great results physicians are having with that venous stent. We're continuing to be very excited about that product. With regards to Varithena, the largest AVLS congress is going on at the end of this week, AVLS, and we'll be traveling there to talk with physicians about Varithena. This is a product that has really enjoyed tremendous growth over the last few years, really driven by two factors.

One is phenomenal physician experience with the product. I can't tell you the number of physicians who come up to me unaided and tell me what wonderful patient results they're seeing with Varithena in really challenging patient populations. That's incredibly rewarding. As many of you know, they received a reimbursement code and are enjoying really good coverage in this space. They have really demonstrated some very nice growth over the last few years, and this is an area that we continue to be very excited about with regards to being able to treat now not only deep venous disease, but also superficial venous disease.

Susan Lisa
VP of Investor Relations, Boston Scientific

Great. I think that there are no additional questions in the queue. We very much appreciate all your time. Jeff, I think while we have it, maybe just a quick highlights of the Interventional Oncology franchise while we have everyone's ears. If you want to talk about potentially 2020 catalyst or the outlook there, we'll close the call, if that's okay.

Jeff Mirviss
SVP and President, Peripheral Interventions, Boston Scientific

Yeah. Thank you. I always say that we should probably start with interventional oncology on some of these calls because we sort of talk about our franchises and our sort of strategies in terms of arterial, venous, and IO. IO is really going to be a strong growth driver for us. It has been in the past when we were sort of the delivery system company, and now it will be in the future now that we're becoming the scaled player across the therapies as well as the delivery tools. Obviously Y90, the TheraSphere product, is the flagship product. This is enjoying strong growth. We look forward to the clinical data when it comes out, whenever that is, in the next, say, year or so.

I think what's new for us and what will be a nice catalyst going forward is just the fact that we're so scaled relative to the competition, and we're really the only company that can sort of cover the vast procedural approaches that IRs are doing to treat cancer. We will also have sort of the broad footprint. One of the nice elements of the BTG acquisition is when the coming together of our sales force is we're sort of doubling the feet on the street. I think that will give us more focus in IO and more coverage across the U.S. and geographies outside the U.S., and give us the opportunity to get pull through and bring along both sides of the business from legacy BTG and BSC. We have a terrific lineup of new launches coming over the next year or so.

Probably the highlight is a new ablation modality, and our ablation business from BTG is growing strong double digits. I think we have some differentiation there with the cryo device. We'll be launching a microwave ablation sometime mid-next year. Kind of back to being the scaled player, all of a sudden we'll have some scale in the ablation side of the business to go along with our strong beads portfolio, whether it's drug-eluting beads, bland beads, or radiation beads. Of course, pulling through all the other devices that were legacy Boston Scientific. We have other sort of portfolio additions that will be coming in terms of new catheters and new coils. I'm very pleased with just the lineup of new innovations that will be coming to serve the IR.

I'm excited about just broadly the portfolio across all three franchises. I think IO in particular is a bright spot for Boston Scientific PI.

Susan Lisa
VP of Investor Relations, Boston Scientific

Great. Thank you, Jeff. Thank you, Kat. Thank you, Michael. Thank you, Ian. We appreciate all of you dialing in. Tony, if you could close us out.

Operator

Thank you very much. Ladies and gentlemen, that does conclude your conference call for today. We do thank you for your participation and for using AT&T's teleconference services. You may now disconnect.