You may submit questions throughout the event by typing in the Submit a Question box on your screen. Questions will be addressed after the formal presentation has ended. Please note this event is being recorded. I would like now to turn the program over to Jon Monson, Senior Vice President of Investor Relations. Please go ahead.
Thank you, Alan, and welcome everyone on the webcast. We have our Cardiology Leadership Team here today, including Joe Fitzgerald, Executive Vice President and Group President of Cardiology; Lance Bates, Senior Vice President and President of ICTx; Dr. Janar Sathananthan, Chief Medical Officer of ICTx; and Dr. Ken Stein, our Chief Medical Officer, who will join for the Q&A. Before we begin, we have a few housekeeping items. The duration of today's call will be approximately one hour. Q&A will follow our presentation, and we'll take questions through the webcast. We'll be making forward-looking statements. So you can see here our typical safe harbor and risk factors apply. You can see here our regulatory disclaimers and our financial disclaimers as well. So at this point, I'll turn the call over to Joe. Joe.
Thanks, Jon. Appreciate it. And thanks, everyone, for joining us. Just an update on our cardiology-served markets. Today, we call this nearly a $40 billion market of things that are happening in the cath lab, growing in our projection at about an 8% CAGR through the end of 2027. What I particularly like about this is if I compare this to maybe five or ten years ago, we have multiple large, fast-growing markets. You can see the growth rates on the bottom. And our dependency on things like DES and defibrillators has obviously been transformed with multiple growth pillars in this market. If you look at our year-to-date growth, U.S. has been growing at 27%, international at 18%. You can see the individual growth rates below and the growth drivers associated with each of those.
One thing in particular I like about our Q3 in cardiology is we saw accelerated growth in both ICTX and in our EP business, and still very solid growth coming from our Watchman franchise as well. So a lot to like about what's happening year-to-date and what we did in Q3 across our cardiology franchises. I'm not going to spend. Lance is going to cover our ICTX stuff on the left of this slide. You've heard most of this on the most recent Q3 earnings call. One new thing that I want to report happened in the EP business this week, yesterday, in fact. So as you know, we got approval for the FARAVIEW mapping software module on Opal earlier in the quarter, and we received the PMA supplemental approval for our FARAWAVE NAV, both mapping and ablation catheter.
And I'm really proud to announce that we went live in multiple accounts mid this week. And glad to report that the benefit, being able to map and ablate, avoid pulling an expensive high-density mapping catheter, and the lesion tagging and the anatomy and the workflow of FARAVIEW was well demonstrated in each of the sites where we went live earlier in the week. So with that, I'll turn it over to Lance Bates, our President of Interventional Cardiology Therapies.
Hi there, everybody. This is Lance Bates, and I will walk us through more details on the markets that we serve. Again, continue to be very compelling, growing around 8% in total through 2027, about $15 billion, and these are the markets and the devices that are the tools for the interventional cardiology community. To give a little more context around drug-eluting therapies, globally, drug-eluting therapies, which includes our drug-eluting stents and our drug-coated balloons, is now growing close to double digits. With drug-eluting stents at now less than 5%, that's less than 5% of our total company sales, which continues to show how we're diversifying our portfolio away from drug-eluting stents. Really excited that our AGENT launch in the U.S. continues to be super successful. We expect to have double digits and actually double our global drug-coated balloon business in 2025 over 2024.
If we move to the next column and talk about Complex PCI, you can see it's a very compelling market over $4 billion. Just as a reminder, the way we characterize Complex PCI, it includes several served markets, which means IVL is in this number, along with guide extensions and crossing wires, etc. We are growing in line with the market despite not having IVL in our portfolio at this time. Overall, Complex PCI is a business that's now larger than our drug-eluting therapies business. I'd also like to really highlight some of the success we're having with our broad calcium portfolio and business, which includes Rotablator and Wolverine. An example of our growth is that in the U.S., we are now growing mid-teens in Q3, and we expect this momentum to continue into 2025.
If we move over to PCIG, which also includes physiology, it includes capital equipment for IVUS and our s5s for IVUS, we continue to outpace the market in terms of growth. And I'd really like to focus here on our IVUS s5 market share, which is now over 50% as we continue to launch our latest AVVIGO+ platform globally. So we're really enjoying the success there with our physician partners. And if we move over into the TAVR space, you can see it continues to be a very compelling market, high single-digit growth. And what I'd like to do is highlight our ACURATE performance in EMEA, where we continue to have growth approaching the 20% range, and we've now crossed the $200 million mark in revenue in EMEA with our ACURATE platform.
We've also recently launched our ACURATE Prime platform, and we continue to see strong momentum in the last few weeks that we've had at launch with its clinical performance, such as the ease of use for commissural alignment, coronary access, both of which are critical for lifetime management of the patient, and as we wrap up this slide, I'd call your attention to the bottom of the slide where we've called out before our investments in the mechanical circulatory support space, and that diversification in this high-growth market is compelling for us, and that we're excited to announce that we completed our EFS for the Vitalist system, and we continue to invest that we will be in this space and hopefully start our IDE in the U.S. by the end of 2025.
If we go to the next slide, I'll do a bit more highlights and details on the success of integrating the portfolio and the pull-through power of our portfolio with AVVIGO+ and our AGENT DCB. If you look at the left, this highlights the fact that we continue to add to the compelling amount of data supporting the clinical viability of using IVUS in your procedures. We're now launched in 45 countries, and the good news as well is that we have a Class 1A indication for IVUS imaging in ESC guidelines, which is the highest level of guideline recommendation that's achievable, and we continue to see the adoption of AVVIGO+, which is the next-gen above our AVVIGO-based platform, and AVVIGO+ has advanced features such as automatic lesion assessment and things that make real-time measurements possible in the cath lab and is built upon AI.
We have a tremendous AI platform capability in AVVIGO+ that we are continuing to invest in, and what you can see is the physicians see that benefit because when we have AVVIGO+, they actually are using our imaging at a factor of 2X in more procedures compared to the base AVVIGO+ platform. In the center portion of the slide, I just want to continue to reiterate our philosophy in terms of our clinical treatment pathways. That is, you need to see what you're treating. That helps you determine what you use to prepare or to make that vessel ready for the treatment, whether that treatment is a drug-eluting stent, it could be a drug-coated balloon, or in some cases, leave the vessel alone. We have a super compelling success rate to where IVUS is now being used in 96% of our AGENT cases.
This is really, really important because we want to make sure physicians see the vessel appropriately to make sure that they are choosing the right therapy for that particular pathology. That's great to see that physicians are using it 96% of the time. Another key factor, and this is getting to the pull-through power of the portfolio with our calcium portfolio, is that a device was used to prep the vessel, meaning using some sort of calcium prep like Rotablator or Wolverine, in 100% of all Agent cases. Agent is being used in combination with our calcium treatment and our IVUS portfolio. If you look to the right, this is just a little bit of what we're looking to continue to invest in our leadership position, is potentially having additional clinical trials to focus on potential growth through indication and matrix expansion.
Some of those areas could be long and diffuse lesions, small vessel disease, bifurcations. We potentially could look at the ACS patient, basically looking for the clinical opportunities that could have benefit versus just putting in a drug-eluting stent as the first-line therapy. We're also excited to announce that our AGENT IDE for the 40-millimeter long lesion has started, and we are underway with the first patients having been enrolled, so very excited about the full portfolio, and with that, I'd like to turn it over to Janar Sathananthan.
Thank you, Lance, so I'm going to take you through the ACURATE IDE trial. This was a trial that, to remind the group, was presented today as a late-breaking clinical trial at TCT 2024 by Professor Michael Reardon from Houston Methodist.
In terms of its study design, this was a large prospective randomized control trial, 1,600 patients that were randomized to two groups, one group being the test valve with ACURATE neo2 and the mixed control group representing two commercial valves in the United States with the Evolut and Sapien platform in a two-thirds, one-third ratio. Composite endpoint was an endpoint of all-cause mortality, stroke or rehospitalization at one year, which is the primary endpoint, and this planned follow-up out to 10 years. I'll reinforce that this is the largest head-to-head TAVR trial that has been done and an important data set. The trial had some complexity related to it as that it's one of the largest TAVR trials done in a head-to-head fashion with an all-risk patient population and was also impacted at time points by the COVID pandemic.
There were also, as a result of that, issues with enrollment pace, with a four-year enrollment period and an average of approximately three months between cases at an individual site. There were issues with supply constraints and also low operator experience with approximately three-quarters of implants implanting less than five ACURATE neo2 valves. And of course, we're all well aware of the staffing and case support concerns during the pandemic. On the left-hand side of the screen is the primary endpoint, which was a Bayesian endpoint. You can see here that we had a non-inferiority median difference of 6.63 with a non-inferiority margin of 8%, where our alpha bound exceeds the pre-specified non-inferiority margin. So non-inferiority of the ACURATE neo2 platform versus control, but the primary endpoint was not met in this study.
On the right-hand side, you can see what was performed in a post-hoc analysis, which was a careful assessment of all the cases that were implanted with ACURATE. As part of this work, there was clearly some inconsistencies that were identified with regards to procedural steps, specifically pre- and post-dilatation, which were discordant from commercial practice that we see in other markets where the valve is commercial. As a result, there was an impact on valve expansion, which you can see on the images on the right-hand side. Through this post-hoc work, a very easy binary way was assessed to identify severe valve under-expansion, which is the image on the right, and that was seen in approximately 20% of cases, with the other 80% of cases having adequate expansion.
When specifically looking at that breakdown in this curve between ACURATE neo2 valves that were expanded versus those that were underexpanded relative to control, the outcomes with ACURATE neo2 valves that were expanded were better. Specifically on this next curve, I'll spend a little bit more time in detail on this because if you look at the hard endpoints of death and stroke, when you look at the breakdown of these two groups, and I'll focus on the left-hand side, you can see that purple represents ACURATE neo2 valves that were underexpanded, and the rates of events are much higher relative to ACURATE neo2 valves that are expanded relative to the control, where the rates are numerically the same or very similar, 3.7 versus 3.6.
Similarly, that trend is also seen with relation to stroke, where ACURATE neo2 valves that are expanded have a very similar rate to control at 3.5% and 3.4% in comparison to the purple curve, where you can see events of stroke are much higher when the valve is underexpanded. This is some work that has been done by our engineering team, which looks at mechanisms for this. I'll remind the cohort that when we looked at clinically relevant valve thrombosis, this was actually significantly less with the ACURATE platform versus control. However, when we looked at the impact of potential underexpansion, if I focus your attention to the images on the top, you can see that this is a valve that is expanded well. It has what looks to be a nice Mercedes-Benz sign, and the leaflets coapt and open in a very symmetrical way.
The image on the top right shows you what the flow looks like, which is a very laminar and column-like flow of blood. In comparison to the bottom image, you can see that that Mercedes-Benz sign no longer exists. This results in impaired movement of that leaflet, and similarly, on the bottom right-hand corner, you can see that the red symbolizes very turbulent flow, and so this may lead from certainly our understanding on the bench to mechanisms that may explain some of the events and why having an expanded valve is better, clearly demonstrated by the data. As Lance mentioned, we're encouraged by our ACURATE Prime platform that has launched recently in the last few weeks. I remind the group that this also has incorporation of an additional size, which increases the potential eligible patient population to approximately an additional 20% for the available valve matrix.
It also has some enhancements to the frame, which increases the radial force by about 20%, and the delivery system has been further enhanced to optimize ease of use. And here you can see Professor De Backer with one of his successful test cases in Copenhagen in Europe. There were also some other important relevant data that was presented at TCT across our entire franchise. On the left-hand side, we also did have another late-breaking clinical trial looking at our Sentinel device. This was a post-hoc analysis from the protective TAVR study, specifically looking at the U.S. cohort, which represented approximately two-thirds of the overall protective TAVR study cohort. And it demonstrated in this post-hoc analysis that there was a lower rate of overall stroke at 72 hours and also a significantly lower rate of disabling stroke at 72 hours in the U.S. cohort.
Also, patients also had a much lower likelihood of needing additional services and were able to return home more likely, which is, of course, an important consideration for patients. No major safety endpoints were identified. With regards to our AGENT drug-coated balloon, which we are in the midst of, of course, launching and continuing to expand across the United States, this is an important first-to-market drug-coated balloon. We have continued to also look at three subgroups from the AGENT IDE trial, which looks at three different focuses, particularly two patient groups, which are, of course, important for physicians, which is minorities versus white patients, males versus females, and also vessel characteristics between small and large vessels. In all three of those, we see consistent benefits of AGENT drug-coated balloon across those three groups.
Turning your attention to the right-hand side of the slide with regards to our Watchman FLX Pro device, this, the HEAL-LAA clinical study, was also presented, which was a post-market study. Important to stress that this study met its six-month primary safety endpoint for all-cause mortality, stroke, systemic embolism, and major bleeding, and what is encouraging is also that it met its 45-day primary efficacy endpoint with zero cases of leak observed, and we remain reassured by the sealing ability of Watchman FLX Pro, so in summary, that summarizes the ACURATE IDE data, but also some of the other key data that was presented at TCT 2024.
Excellent. Well, thanks, everyone. And we will move now to Q&A for the next 40 minutes or so. And Alan, can you reiterate the instructions on how to submit a question?
Certainly. We will now begin the question-and-answer session. As a reminder, you may submit questions through the webcast by typing in the Submit a Question box on your screen. This time, we will pause momentarily to assemble our roster.
All right. Well, great, everyone. We've got questions coming in, so I will read them out top to bottom, and the team can answer them here. So first one here from Robbie Marcus has two from me. Do you expect these results to negatively impact sales in Europe? And actually, we've got a few of these questions that have come in. And so why don't we hit that one first, and then we'll answer each other.
Hi. Thanks, John. I'd say at this point, we're still very pleased with the results of Prime and the ACURATE platform overall, and as many of you know, we've got a lot more experience in Europe, and that's why we've been enjoying a 20% growth rate. Physicians there have had almost a decade of experience with the platform, and what I would say is that we're going to continue to monitor this closely and stay involved, make sure that the physicians in Europe have the learnings that we shared at TCT, and continue to support the platform and continue to monitor the situation.
Great. Thanks. And then kind of part two here from Robbie from J.P. Morgan. Why didn't physicians have better training and oversight in the trial under-inflating the valve? It's normally something that we don't see in trials. Dr. Sathananthan.
Yeah. So thank you, Robbie, for the question. I'll just clarify that under-inflating the valve refers to a balloon expandable valve and filling volume specific to the ACURATE platform. What was observed was a difference with regards to the sizing of a pre-dilatation balloon, which is a preparatory step required before ACURATE is implanted. I touched on some of the factors related to that, which I'll remind the group that this study started enrolling in 2019, and the peak of the COVID pandemic occurred soon after. So as a result, as we're all well aware, this prevented ability for outside groups or physician support to be presented in cases, and there were also significant supply chain issues with regards to available equipment that may have impacted the results.
All right. Thank you. Next question comes from Travis Steed at Bank of America. Actually, Travis had a similar question on the European business. I think I'll skip over that. And so then second question from Travis. When will we be able to see Prime data in the trial? Is it likely to have the same limitation as neo2?
As part of the ACURATE IDE study, we did have a nested registry looking at PRIME-XL, which is the next-generation system, as you saw on the slide. There will be data presented at London Valves with the first report of the ACURATE PRIME system.
All right. And our next question comes from Vijay Kumar with Evercore ISI. And several questions on the regulatory path from here. So when do you expect to file with the FDA? Do you anticipate the FDA calling for an adcom? Dr. Reardon felt strongly about the FDA looking at the totality of the data. Could the FDA ask for a small follow-up study? So maybe may I ask Dr. Sathananthan some of your thoughts on the FDA path and Vijay's question?
Yeah. Well, thanks for the question. We remain in active discussions with the FDA at this time with regards to our regulatory pathway forward.
I think as well with the questions on panel and what kind of trial that panel is hard to predict for any sort of original PMA submission, so it's hard to answer that, and the exact question on is there additional data needed and what is that type of data, how large, what type of follow-up, we just were still in active discussion, so need to take those further before we can really get granular on that.
Got it. Thanks, Joe. And similar questions from Matt O'Brien, Piper Sandler. Just reading through your questions here, similar on the FDA pathway. Maybe Lance or Joe, a question here. How much would you be saving if you decide against investing in a domestic TAVR program? So maybe just a question about the TAVR program in the U.S. Is it still compelling?
Yeah. I think it's definitely a compelling market demand, as we showed on one of the slides I presented. It's also, frankly, at the stakes that you have to be a complete structural heart player. And I think we've disclosed before that we've done investments in tricuspid and mitral and electrosurgery-type devices. TAVR is a critical component. So we view ourselves that ultimately we want to be a full portfolio player in structural heart to serve the interventional cardiologist. Just as we have on the coronary side of the business, we are committed to the interventional cardiology space, and we are continuing to invest in the full structural heart portfolio broadly.
I think it's a similar question that we faced with NEP for years, right? We literally executed about a 20-year strategy, multiple acquisitions, a lot of wins, some losses, to be a meaningful player in what today is probably greater than a $9 billion market. Did it go as fast as I wanted? No. Was it as easy as I would have wanted? No. But we've talked about this, and you saw it on my first slide. We want to be the preeminent cardiology company. The FHV space is $6.7 billion growing high single digits, so don't be surprised if we're really resilient, even as we hit some adverse times like the outcome of this study. But as I had mentioned before, right, we have some questions to answer regarding pathway to the U.S., and we're active with FDA in getting those pathways identified.
Great. Thank you. All right. Next question from Danielle Antalffy with UBS. For the ACURATE IDE, how much of the valve under-expansion might be addressed by the larger valve size Prime? And so did not having that in the trial impact the outcome?
Yeah. Thank you for the question. I guess I'll just clarify firstly that what we have launched in Europe is PRIME across all the sizes, and so one thing that may potentially impact expansion is that the PRIME design does have an increased radial force strength of approximately 20%, and so we will continue to understand the impact of that moving forward. In terms of mitigation, we feel strongly, as was iterated in the presentation in the late-breaking trial, that this can be corrected with procedural factors, and specifically the performance of adequate predilatation with an appropriate size balloon and also post-dilatation will be able to address the majority of this under-expansion if and when it occurs.
Janar, can you also highlight, because I think it was important at our symposium, the normal things that we look at, PVL, EOA? Can you just go through sort of beyond that, what this alignment has done for our understanding for the ACURATE platform?
Yeah. I think it's a good question, Joe. So I think as part of our deep dive, there was a theme that emerged that we're seeing more and more of these conversations about under-expansion in the entire TAVR space. This was a similar journey that happened in the stent era, where post-dilation and optimization with imaging also came about in the stent era. Some of the discussion that we've seen and the deep dive, and certainly related to the TAVR space, is that typically the two reasons that we think about ballooning a valve is to address paravalvular leak or elevated gradients. And what we saw in the ACURATE IDE trial was actually the gradients were actually better for ACURATE than balloon-expandable valves. And also leak was not a concern.
This is a sign that, instead, we've updated all of our training, that identifying and correcting for expansion is also going to be a key part, and I think an important point for the entire TAVR space.
All right. Thank you. And next question, another question here from Vijay from Evercore ISI. I'll do my best for this one. I'll definitely turn on you, Gerald. So how can we explain why a normal echo finding at 30 days would under-expand at one year? Is this a sign of valve design, for example, not strong radial force? And then do you want me to read the second part or hit that one first?
Yeah. I can start with that. So the use of an echo at follow-up times after TAVR, which are typically the next day afterwards or 30 days as it was done in this trial and also after one year, is purely to look predominantly at leak and gradients. Echo is a poor imaging modality to look at expansion. What we have found from our learnings from this trial is that we have identified a very simple fluoroscopic method to identify under-expansion factors that can be seen at the time of the procedure and also optimize with ballooning. And so I think that's the key message from the IVE findings.
Got it, and part two?
Mm-hmm.
If we do use post-dilatation, how do we know how much pressure one should be using? Is there a risk of higher pacemaker rates if you expand too much?
Yeah. So I would say that the key piece is the size of the balloon that is used. In our recommendation, certainly for commercial use, since the valve has been on the market for over 10 years commercially in Europe, the pre-dilatation balloon size is one millimeter below the perimeter-derived diameter. That was not followed in approximately 80% of the cases in the ACURATE IDE trial. Similarly, with post-dilatation, you would use up to a similar size balloon for post-dilatation or relative to the annulus. We have seen that in Europe, and there's lots of data that shows consistently single-digit pacemaker rates with the ACURATE platform in all U.S. data.
Got it. All right. Next question from Larry Biegelsen at Wells Fargo. And Joe, you touched on this earlier, but maybe ask this again from Larry. How committed are you to neo2? Would you do another randomized clinical trial if FDA asks for one?
I'd say, Larry, just to clarify, neo2, we've now transitioned to PRIME. PRIME is the next-generation platform that is being launched commercially in Europe that, as we mentioned earlier, has got some excellent clinical benefits compared to neo2 as well. I would say we are committed to the platform, and we are going to continue to work with the FDA on what's the most efficient, prudent path forward with ACURATE Prime in the U.S. and in other markets around the world.
All right. Thanks, Lance. And I've got an IVUS question here from Patrick Wood at Morgan Stanley. Do you have any plans to move into AI interpretation of CT scans to measure plaque as a longer-term alternative or to complement the IVUS?
Yeah. And I think maybe part of the question also relates to the high use of IVUS in relation to AGENT use. I would say, Patrick, we have been very encouraged by the high utility of imaging to plan procedures with the commercial launch of AGENT in ISR that has been encouraged in guidelines and, of course, reflects our strategy and teachings around prep-treat in the coronary space. We've also seen that imaging has impacted valve preparation as well, and we've seen increased use of Wolverine for lesion preparation in our commercial cases. We're also fairly committed to IVUS as a platform, and part of the emphasis for AVVIGO+ is the incorporation of AI to make it easier for physicians to interpret with the aid of technology, and we plan future software updates to that end in subsequent iterations of the system.
Great. All right. Next question, an embolic protection Sentinel question here from Joanne Wuensch at Citi. Does the new embolic protection data on Sentinel change your view on utilization?
Yeah. I think it's important also just to be cautious that this was a sub-study and a post-hoc analysis of an overall negative study. I do believe, though, that it is valuable to continue to understand the utility of this technology, and physicians are clearly looking for areas where the technology would be beneficial. So I think it highlights more the need for further evidence in this space.
All right. Back to ACURATE. This is from Mike Polark with Wolfe. Why was the post-hoc analysis only done on approximately 700 of the 1,500 total patients? Were there imaging on the patients?
Yeah. So firstly, I'll reiterate this was an RCT, so one-to-one randomization. So there's 750 ACURATE cases. We interpreted all the available images, and so there were approximately 47 cases that did not have an image that could be interpreted for expansion.
I think it's fair to say, Judar, we looked at all of the ACURATE cases to explain the data that we were surprised by, right? And so we looked at half of the patients in the trial, which were the test. We didn't go back and look at the control.
No. That's true.
All right. Thank you. Our next question is from Matt Miksic with Barclays. Do you expect PRIME to be part of the path forward for potential FDA approval? Would that require a registry or something more?
I'd say PRIME is the platform for TAVR globally, and we are still in communication and conversations with the FDA to determine what that path forward is. We just don't know right now.
Yep. And next question, kind of similar vein, Jason Bedford, Raymond James, maybe other regions. Does this data impact ACURATE Prime approval in other regions, for example, Japan? Maybe path in Japan.
Potentially. Again, it's the same situation we're dealing with. We're collaborating with the FDA first, and we will simultaneously start communicating with the Japanese regulatory authorities as well.
Fair to say that the ACURATE IDE was our clinical trial set for both Japan, China, and other markets like the U.S., where we're not approved. So we're going to have to, like Lance said, we're going to have to have similar conversations with each of those regulatory authorities.
Great. Thank you. Okay. Another one from Larry Biegelsen at Wells Fargo. Ken, this may be for you. It's on the Inari Peerless data. We'd just love your view on the Inari Peerless data and what impact you expect relative to EKOS.
Yeah. Yeah. Sure, Larry. I think, first off, right, it's just good to see more data come out on interventional therapies for the management of pulmonary embolism. They're still way underutilized. I think the really important clinical question is just how do interventional therapies like EKOS compare to standard of care, which is anticoagulation alone? I think as you look at the comparison to EKOS, right, realize this is a very complicated composite endpoint using a win ratio. And when you look at the really important objective measures like mortality, intracranial hemorrhage, and bleeding outside of the brain, right, there were really no differences in between the arms that were studied. And I think, again, recognizing that being observed in an ICU as an endpoint is guaranteeing a certain result since that's standard of care when you are getting catheter-directed thrombolysis.
So we're so very confident in the performance of ECOS, and we're forwarding results of our IVUS study.
Excellent. Thanks, Dr. Stein. And next question from Travis Steed, Bank of America. And Joe, maybe if you could take this. Any additional color you could provide on the FARAWAVE launch? Are you seeing in those accounts? Are you seeing any changes in the percentage of cases being mapped? Any impact taking share from other mapping? Changes in penetration of PFA? So maybe a little more color on, I think, FARAWAVE and the Opal launch would be helpful.
Yeah. Thanks, Travis. I think we have said this before, but if you look today globally, this is basically a Europe, select Asia markets, and the United States. One of the things we love about FARAWAVE is it is consistent or can be done in any one of a number of workflows. So if I take Germany as an example, FARAWAVE is largely used in a fluoro-only workflow. If I go to the Czech Republic, it is used in a fluoro aided by ICE visualization. If I go to other markets, like the United States or let's call it Spain, mapping is done in the vast majority of our FARAWAVE cases.
So we're about 36 hours into the FARAWAVE launch, but here's our expectation, is that because of the uniqueness of FARAWAVE NAV on FARAPULSE on Opal, our belief is that our percentage market share of the cases where mapping is used should go up dramatically from where it is today. Why is that? A couple of reasons. Number one, the FARAWAVE catheter now on the FARAPULSE system is both the mapping and ablation catheter. So you avoid the use of a very expensive high-density system, point one. Point two, viewing FARAWAVE on Opal and on FARAPULSE, that is the only platform, our proprietary platform, where you can see dynamic visualization of the actual catheter, no matter what shape: basket, basket, flower, or whatever else we call it. I don't know. Because of the NAV center and because of the integration into our proprietary mapping system.
The third reason it makes us confident that we'll take meaningful share in the mapping market is our proprietary sort of lesion targeting and lesion tracking. So because it's a combined integrated system, you cannot do what we do on other systems where they're kind of using and hodgepodging together an impedance-based workflow. So those three reasons, I think, say that we are very comfortable in saying that we'll take share in the mapped cases of FARAWAVE.
All right. Thanks, Joe. And next question from Travis Steed at Bank of America. You suspended enrollment in the single-arm continued access study but continued to enroll in the extended durability cohorts. Why did the FDA allow you to keep that extended durability cohort enrolled?
Yeah. Thanks for the question. I mean, we've been in collaboration with the FDA, and with regards to the extended durability cohort, there was a desire to complete enrollment of all the randomized controlled cohort patients and also the various sub-studies. One other important point of context for the extended durability is that we were able to bring in optimized training for the back segment of that trial, and we were able to see real differences in operator adherence to the pre-dilatation and also a change in post-dilatation as well with the optimized training.
Okay. Okay. Our next question is from Imron Zafar from Deutsche Bank. And Lance, maybe you can hit this one. Can you give us some more color around your mitral and tricuspid investments? Anything in terms of timing, specific device categories, repair, replace? So maybe a bit of that broader lens on the facts that we have out there.
Sure. We won't disclose specifics at this time other than to say we do have investments and the combination of our VC portfolio, which continues to be really strong, as well as some hybrid structures where we've got collaborations with other entities that we've stood up. And what I would say, if you look at tricuspid, we have both bets in repair and replace. We find that both therapies potentially could be compelling as more and more data comes out, so we want to have broad bets. In mitral, we have a bet that's more on the repair side. We continue to evaluate what would be appropriate bets potentially on the replacement side. And then, as I mentioned earlier, elective surgery is very interesting to us, especially as structural heart becomes more complex in terms of leaflet modification or excisions or LVOT obstruction issues.
Some of the new heart failure drugs are creating opportunities with the HOCM patient. So we see a lot of opportunities there that we've also invested in and plan to leverage some of our own internal capabilities. So we have a very broad view, and as Joe said earlier, this is not something we're investing in for the short term. This is the long-term success of this portfolio and this franchise for the long-term value of the company.
All right. Well, thanks. So we've reached the end of our queue. So with that, I want to thank everyone on the webcast today for your time and your interest. If you have a question that comes up after the call today, please reach out to the IR team. The slides from today will be posted on our investor relations website, and the replay will be available within an hour. Thank you very much.
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