Thank you all for joining us. We appreciate it. We're really happy you're here, and thank you for taking the time to get to know Edwards a little bit more. We've got a great session for you, both, for those of you here in person, as well as those of you joining us online. We're gonna hear from a number of our senior management team. We've got a number of physician cameos. You'll see our latest and greatest products, as well as get updates on our clinical trials and our financial outlook. So with that, let me just flash up a couple of quick slides. I am Mark Wilterding, Head of Investor Relations for Edwards Lifesciences, as you know. The cautionary statement, please take a minute to familiarize yourself with this. Very important.
It's also available on our website, so you can take some time to read through that. We will be referring to non-GAAP financials unless otherwise noted during the course of this presentation. Reconciliations to those non-GAAP financials are available on our website at ir.edwards.com. With that, let me turn it over to our CEO, Bernard Zovighian. Bernard?
Thank you, Mark. Hey, good morning, everyone. You know, thanks for joining, you know, all of you in the room, you know, people on the phone. You know, we truly value your interest in our company. I am super excited to share with you, you know, our vision for next year and our vision, you know, for long term. You have seen the news this morning. We are entering. It is a very exciting day. You know, let me start, you know, there, a very exciting day for Edwards and all of our employees. You know, we are entering a new era of structural heart innovation. So the new era means a number of things. It means a sharpened focus. You know, we will have, you know, more agility.
And you know us as a company, we have been an amazing innovator, and we do believe that with this, you know, sharpened focus, we could even, you know, innovate faster. This new era means also an expanded focus to serve a very large patient population: aortic patient, mitral patients, tricuspid patients, and potentially more. Our foundation as a company remain the same. You know, the company that you know very well. Our credo, this is what guide us. Our special culture, we care and focus on patient, we give back to communities where we live and work. We are good citizen. Sustainability and long-term value to society is important to us, and our unique innovation strategy: to be first, to be the leader, and it is working very well. So think about it. For most medtech companies, bigger and more diversified in so many segments is better.
You know, for us, we go deep in a very large and growing space. A space where no one matches our deep experience, reputation, global leadership, and this is why, you know, I feel like we are uniquely, we are uniquely positioned for sustainable growth. I'm going to talk about, you know, critical care, you know, later. It is also a great news, you know, for critical care. So Katie, you know, will have her presentation, but, you know, for sure, you know, also a great news, you know, for Critical Care, and Katie will become the CEO, you know, at the time of the spin.
So now let's talk about how we will drive this sustainable growth, and we see the four big category of investments: continuing to develop breakthrough innovation, breakthrough technologies, not just, you know, incremental technologies. Developing science and evidence to expand indications. Patient and care activation. Given our great technology, we know it is important. We created this new capability a few years ago, and we are going to accelerate on this one. And exploring new segments in structural heart. I want to start, you know, with the patient. You know, structural heart disease is the leading driver of cardiovascular death. We know in the U.S. alone, 1 cardiovascular patient dies every 33 seconds. Our vision is to transform patient care, where patient are diagnosed earlier, treated in a routine fashion, living longer, and enjoying a better quality of life.
So this new sharpened focus give us this ability to expand opportunities for aortic, mitral, and tricuspid patients. In TAVR, we are a global leader, and we are committed to bring new technologies, expand indication to treat many more patients in needs. In mitral and tricuspid, we are the only company providing a portfolio of differentiated technologies, both repair and replacement, to be able to unlock this very large patient population. Now, within structural, there is also heart failure, and this is not the beginning for us in heart failure. We learned a lot over the last 60 years, treating patients with heart failure due to valvular heart disease. So our vision is to leverage our experience, our leadership to impact patients with valvular and non-valvular heart failure. Altogether, aortic, mitral, tricuspid heart failure, it is a huge opportunity.
In the three big regions, U.S., Europe, and Japan, there are more than 20 million patients in need. So this is why we are so confident in our sustainable growth in the many, many years ahead. If in the past 10 years or so, you know, the TAVR adoption has doubled the treatment rate of AS patients. So we are at the same time, you know, very pleased. We are also, you know, very proud. You know, we had a significant impact on society, if you think about it. However, we know that significant undertreatment remains, and our goal is to improve patient access to care, very similar to cancer screening, you know, for instance. So it is why patient activation is important to our strategy, and we have identified, you know, two patient groups undertreated: in-system and out-of-system.
The in-system patients are the patient diagnosed but not progressing in treatment. This group is more easily reachable with partnership with hospitals, providers, and clinicians. And we learn through several programs that hospital can double the treatment of these patients. So we are scaling many of our program over the next few years. But out-of-system patients now, it's very sad. They are quietly dying, and we are developing additional program to diagnose this patient in an easier and faster fashion to get them into the system. So if you think about it, you know, in-system is more of a near-term opportunity, out-of-system, more of a long-term opportunity. Larry will go way deeper into his presentation. I have talked about the patient, so now let's talk about our special company and our leadership vision. For 60 years, we have been the leading surgical innovator.
60 years ago, we created the first heart valve replacement, and today we are the global leader and still very committed to innovate in surgical technologies. 20 years ago, we had a vision, a crazy vision, to transform AS treatment through TAVR, and today we are the global leader. Our SAPIEN platform is by far the preferred TAVR technology, with more than 1 million patients treated, eight New England Journal of Medicine publication, and we reinforce our TAVR leadership position with new clinical evidence, you know, earlier this year. So we are now focusing on expanding indication and transforming care for the millions more of untreated AS patient. Similarly, six years ago, we had a vision, you know, to help the millions of untreated mitral and tricuspid patients. And today, we are reaching an inflection point with the only portfolio of approved catheter-based mitral and tricuspid technologies.
As discussed already, you know, we see heart failure as a natural progression and a very large opportunity. Yeah, so we plan to apply the same type of vision to expand our reach to treat the millions of heart failure patients. So I will share, you know, more updates, you know, as we PROGRESS on, on this journey. As a recap here, you know, this is who we are as a company. Our strategy is to address large unmet patient needs, create markets, be first, be the leader, and we have a proven track record of success. So I'm very confident, you know, we will continue to expand and grow in surgical TAVR, TMTT, and that heart failure will be an additional large opportunity for us. The result will be a transformation of the experience for patients.
Most of these patients have a high mortality rate, very poor quality of life. They are desperate for solution. And our goal is, with our breakthrough technologies, is to treat them and give them their life back. So now let's talk about our results, you know, this year. We are on track to deliver 2023 sales and EPS in line with our latest guidance, which is, you know, solid financial performance. Beyond the numbers, we achieved important clinical and regulatory milestones, regulatory rapid enrollment of the ALLIANCE for next generation SAPIEN X4, the completion of enrollment of the first-ever transfemoral mitral pivotal with SAPIEN 3, M3, a CE mark for world's first transcatheter tricuspid replacement with EVOQUE, the approval of the APTURE study to evaluate heart failure patients. So as you can see, you know, we are exiting 2023 with a, in a very strong position....
Let's look long term. You know, we see a well-defined path to significantly expand the opportunity through 2028 and way beyond. So all of this, you know, made possible by a few things. One, our new sharpened focus, our commitment to innovation. We invest more than $1 billion in R&D every year. We have 2,000 passionate engineers committed to bring breakthrough technologies, and the use of our very strong balance sheet to fund strategic investments. No one is matching our investment, our commitment, our capabilities, and our leadership. Heart failure is not just an aspiration, we are getting, you know, more and more committed. We have 1 active internal clinical program, APTURE, and multiple external, of which two-three are near term. Now, let's talk about next year, and I am very excited about next year, too.
You are going to hear, you know, from each of the businesses. Let me give you some highlights. A big, big year for TAVR. Expanding SAPIEN 3 Ultra RESILIA globally. Nice progress on the enrollment of the next-gen SAPIEN X4. Learning about patient who can benefit from TAVR through our asymptomatic and moderate trial. Don't you think that's big? In TMTT, we are reaching an inflection point with PASCAL global expansion, launching the first-ever tricuspid replacement valve, EVOQUE, in Europe and in the U.S. And then, you know, the completion of the M3 PIVOTAL, putting us on track to provide the first-ever transfemoral mitral replacement option for patients. In surgical, continuing to bring new technologies, new evidence, and extend our global leadership. In critical care, continuing to innovate, drive adoption of smart recovery technologies.
Financially, we are guiding to 8%-10% sales growth, with EPS growing 9-11. So this next year, we'll have solid financial performance and significant progress to unlock our bright future with new technologies, new indication, and scaling our patient activation programs. Because of all of this, we are confident this will result in faster sales growth of 10%+ and double-digit EPS growth for 2025 and 2026. So I already discussed a lot about, you know, how the strategic spin-off of Critical Care will enable a sharpened focus for Edwards. It also provide an increased focus and flexibility for Critical Care to improve, you know, the quality of care for of millions of patients around the world. We do believe it is the right time. Critical Care today is a very successful business with plenty of opportunity to expand.
It is a large business, you know, nearly $1 billion in revenue, more than 4,000, you know, very talented and passionate employees. So this spin-off is positioning Critical Care to be a, a successful, independent, publicly traded company. So this is all made possible by our 20,000 employee, led by our strong executive team. I have seen, you know, so many leadership team throughout my career, and this is, you know, by far, you know, the best one in med tech because of everyone, very impressive experience, but maybe, you know, even more importantly, you know, how we can collaborate in a very effective manner to execute on our strategy. We have a very highly engaged board of directors. They are deeply committed, involved in key strategic decision of the company. I am so impressed, you know, with our board. They are talented, dedicated, and very engaged.
So this is a look at the agenda for today. You are going to hear, you know, from each of the businesses and then, you know, financial from Scott, but we are going to start with Larry Wood talking about TAVR right after this video. Thank you so much.
Edwards is the company that brought TAVR to the world and allowed us to introduce it to many, many patients. After my TAVR procedure, my shortness of breath was gone, and I just could not wait to get back on the pickleball court. So whatever commercial device I have in my hand, I know that in Irvine, there'll be engineers working on the next two, three, four iterations of the device to make it even better than it currently is. New devices, new iterations, new innovations to help us give patients the best possible outcomes.
Thank you, Bernard, and thank all of you for being here today. I know it's a trip out, and for everybody online, it's always an honor and a privilege to talk about our transcatheter heart valve business. This year was an incredible milestone for us. To treat our millionth patient with our SAPIEN technology is a huge milestone, and it talks a lot about how far we've come. But I'm going to talk a lot today about how far we still have to go... So we see the opportunity, the global opportunity, to exceed $10 billion by 2028. So we continue to believe this is going to be a huge growth platform, and it's going to be driven by many different things. It's going to be driven by expanding indications, but it's also going to be driven by advancing the technology.
We believe our technology is incredibly well-positioned to maximize this opportunity. We talk a lot about patient activation, and sometimes I almost feel we get a little apologetic about it for the lack of progress that we've made because treatment rates remain so low. When you look back in 2010, about 70,000 people in the United States got their aortic valves replaced. If you look today with the advent of TAVR, that's about 160,000 patients in 2022. We have more than doubled the number of patients in the United States in about a decade who get their aortic valve replaced, which is a huge accomplishment. Aortic stenosis is a deadly disease. One in ten patients may die within five weeks of being diagnosed with severe symptomatic aortic stenosis. That is a dismal number. It's worse than almost any cancer.
Yet despite that, treatment rates are about 13 people out of 100, which is still incredibly low, and we need to figure out how to unlock these patients. But as Bernard talked about in his opening, it's patients are in different groups, and we need to understand the different segments if we're going to activate them and accelerate them through the process. So when we talk about the 13 out of 100, this is 13 out of 100 patients who have severe aortic stenosis. Okay? We have tremendous confidence in that, and that's a prevalence number. That's all the people with the disease, and it's backed up by numerous publications. Now, where it starts to get a little bit more nuanced is looking at patients that are in the system.
So when we define in the system, these are patients that have had an echo, and the echo, if you read it properly, and you look at guideline criteria, says these patients have severe aortic stenosis. Okay? But then there's another group of patients that have the disease, but people haven't necessarily ordered an echo yet, or they haven't connected the disease, or maybe their echo's out of date, and they don't have the information in their medical record or the diagnosis yet that they have severe aortic stenosis. Okay? So when we look at the in-system group, and again, these are people with an echo, that if you apply guideline criteria, there's no question they have severe aortic stenosis. Less than 50% of those patients proceed to treatment, and this is backed up by numerous studies.
Probably the most recent and timely one is Sammy Elmariah, who did this for the Mass General system. Now, if this is true at Mass General, you have to project that it has to probably be worse when you go out into community hospitals and other hospital systems. Mass General is one of the top cardiac programs, one of the top systems, one of the most integrated systems in the country, and it sort of probably it ranks up there with about the best that we have to offer, and it's still less than 50%. And that's really perplexing when you think about the sophistication of the system and also the deadliness of the disease. So we've gone a lot deeper on this and tried to really understand and really tease out what some of the challenges are.
When you look at the guidelines, it focuses on three primary criteria for diagnosing aortic stenosis. It looks at diameter. How big does your valve open? This is actually the criteria we used in the clinical trials. We said their effective orifice area has to be less than 1 centimeter squared, and that's what we pivoted off of. But then there's also pressure. As your aortic valve gets narrower, your pressure builds up in your ventricle because it's having a difficult time moving past that narrow area. And so pressure, which we measure by gradient, is another criteria that can determine whether somebody has severe aortic stenosis. And then there's the actual flow, the blood velocity, and that's another criteria that can determine whether a person has aortic stenosis. So when we talk about severe aortic stenosis, it can be any of those criteria.
The guidelines are complicated, and it's difficult for everyone to remember all the complexity, because remember, we're just talking about aortic stenosis, not valve disease broadly. So what people tend to default to is pressure, and they look at gradient greater than 40. So if a patient has a gradient greater than 40 and their heart's performing normally, their ejection fraction, the efficiency of their heart is good, that's just a very classical diagnosis, and those patients tend to move forward. So we look at that group. If your heart's beating normally, you're working with efficiency, but you have a very high gradient, something greater than 40, more than 70% of those patients get referred for therapy. So, you know, 70%, I don't know if that's a number we should be bragging on, but it's, it's not so bad, right?
There's still more work to be done there, but it's probably more than 70%. When you get into patients that have a gradient greater than 40, but maybe their heart isn't as efficient, maybe their ejection fraction's coming down, it gets a little bit more muddied. Doctors start to question, is it their aortic stenosis or is it their ventricle? Is maybe the heart just not working as well, and it's other things? As you get into patients that have gradients between 20 and 40, but maybe their EOA is low or their velocity is high, that often gets missed, and these diagnoses become more complex and require greater knowledge of the guidelines and applying the full guideline.
The other question that happens, though, is people say, "Well, hey, maybe not all of these segments benefit from having their valve replaced, and that's why they don't get referred." Doctors are smart people. Maybe they just don't refer people because they don't believe they would benefit. Well, this is where Sammy Elmariah went really deep, and he looked at all the different segments. If you have normal heart function and a high gradient, you absolutely benefit from having your valve replaced. But the group that doctors sometimes question, they say, "You have a lower ejection fraction, but you have a high gradient. Maybe there's other things going on," that is the group that benefits more than any other group from having an intervention. And this isn't something that, that creates mortality late in the game, at a year or two years. This is something that happens almost immediately.
You can see that mortality curve. These are the patients that don't wait well, but need an intervention, and only about 50% of these people move forward to therapy. This is a group that deserves more focus... Now, when you get into the more complicated diagnosis of lower pressure gradients and other criteria, if they have poor heart function, clearly they benefit from an intervention. If they have low pressure with normal heart function, they also benefit from an intervention. It doesn't matter which group you fall in for severe aortic stenosis, you benefit from having the intervention, but the diagnosis just gets more complicated. As we start thinking about how we address these different segments, for patients with a more classical diagnosis, with normal heart function, with a high pressure gradient, we believe we can do a lot of this with education.
We have many different work streams on this. We do television, we do digital, we do pretty much every digital platform that's available. We can target these to caregivers, we can target these to the patients themselves, we can target these to caregivers, we can target it to referrers. And we have different education work streams for each one of those segments. And we've actually got pretty good about targeting physicians based on their referral history. Some people don't refer any aortic stenosis patients who need more basic education. Other people refer, but maybe they only refer to surgery, and so maybe they're not up to speed with the latest in TAVR developments or the indications that are approved. So we're much more sophisticated with our digital platform about how we target the different communities.
But for patients with a less classical diagnosis, where it requires a little bit more complexity, it's a little bit silly when you think about it, that we require physicians to almost memorize all these guidelines to get an echo report, either a paper one or electronically, with all this data and all this information on it, and apply something from memory in terms of all of the guideline criteria. That's probably an unrealistic ask from the clinical community, but there are several work streams where we can improve this for the clinicians by applying AI and teasing all of those things out of the medical record.
There are some physicians that have started running pilots on this, where a system goes in and it looks at the record, and it looks for all those guideline criteria, and it just actually creates a prompt, where when it goes back to the referring physician, they can simply click a button and say, "This patient looks like they have severe aortic stenosis. Would you like them referred to a heart team?" And when we see people implementing that, we see a dramatic change in the number of patients that flow through for evaluation from a heart team, and the overwhelming majority of those patients are available to get therapy. Now, it's not always going to be TAVR in every case.
Sometimes it'll be surgical, sometimes it will be other criteria, but the important thing is that they get the right intervention from them, and there's absolutely things we can do with technology to ease the burden on the physician community to make sure their patients get treated properly, and this can streamline the workflow for patients. Now, beyond that, there's this whole issue of symptoms, because even if you have severe disease, you're supposed to also have symptoms per the guidelines, and that just adds another layer of judgment and another layer of complexity to the system. This is an area where we feel evidence is going to be the critical criteria. We have our EARLY TAVR trial, and this is a trial that we designed where we randomized patients who have severe aortic stenosis without symptoms to therapy or to watchful waiting.
And this is the first time that we've used protocolized stress test to determine whether a patient is truly asymptomatic. Now, this trial, we've been working on it a long time, and you sort of start to feel like, are we ever going to get to the finish line on this trial? But we've actually not only enrolled it, but we complete the follow-up early next year, and this data we expect to be presented at TCT. And this is going to answer a number of questions that right now no one can answer. First of all, what percentage of patients are truly asymptomatic when subjected to a stress test? The data on that is very poor, and this is going to definitively answer that question.
It's also going to answer the question about if somebody has the severe disease, but they haven't been referred and they don't have symptoms, and how fast do they progress to having symptoms? And the third question it will answer is, during that waiting time, do bad things happen? Do complications happen? Do they do damage to their heart? And we'll be able to definitively answer those questions from a very high-quality randomized trial. But if this trial is successful, the data is compelling, and we can take the symptoms out of the question, we can take that judgment out of the question, and then using AI to refer patients will radically streamline how patients move through the system. So the combination of evidence and using AI can really work hand in hand in terms of streamlining this referral process for patients.
The other thing that we have is we're working very closely with trying to create more urgency around this diagnosis. We show you those curves, and we show how fast the mortality creeps in for patients who don't get referred for therapy and how much better they do if, when they get definitive care. But it takes, on average, about 180 days for a patient from referral to actually getting their, their TAVR valve. And that's simply too long when we look at a disease that's this deadly. The sad part about this is this is not a metric that commonly gets measured within hospitals. So when you ask hospitals what your referral time is and how does this work, most people say, "Oh, we do it within a couple of weeks.
Certainly, we do everybody within 90 days." Well, in running this pilot with the AHA, we actually took, I think it was 11 premier centers in the country, and we had them go back and look at their own data, and very few patients actually moved through in this 90-day criteria. So the goal is to create a quality metric that hospitals would be measured at, based on moving patients through the system from diagnosis to referral within 90 days. The first benefit that we would get from that is just people tracking their own data, because if people think they're doing a good job when they're really not, that's the first problem that we have to solve.
The second thing, though, is if it's a quality metric, and we've seen this work in things like door-to-balloon and other areas, where once there's a quality metric and people are paying attention to it, then they actually start making changes to the system to improve that. But this will also stop people from needlessly dying, but it will accelerate the referral process, which we think is super important. So when we talk about the in-system patients, which again, as Bernard said, is more of a near-term opportunity for us because these patients have the disease, they're in the system, we have a number of different work streams, from education to working on quality metrics, to AI, to the evidence generation that we're working on.
So a lot of different work streams that we think we can accelerate this, and we're very pleased with the progress that we're making. When you get to out-of-system, it's a little bit more complicated just because you don't have people that necessarily have the disease, and right now, we don't have an echo standard in this country. Unlike colonoscopy or breast cancer screening, there's no age that's automatic to go get a screening echo. We don't think that makes a lot of sense, especially when you consider how non-invasive and relatively inexpensive an echo is. So one of the things we're working on is creating that guideline criteria through evidence generation about what's the sweet spot for age that a patient should have a diagnostic echo. But even beyond that, there's a large number of companies that are working on alternatives to echo for identifying aortic stenosis.
Things like smart stethoscopes, and there's a lot of people that are working on EKGs. My good friend, Gabe Ziman, is working on, can ClearSight identify aortic stenosis? And we're partnered with a number of institutions. The great thing about that is it's just not an Edwards activity. There's a number of companies are working on it for their own reasons and their own motivations to make this happen. And once these start to come to fruition, once EKG can work, once other technologies can work on this, we can accelerate these patients out of the system to in the system. And if we've done a good job of fixing the in-system part of it, then as we get into the midterm and the later term, these out-of-system patients will start feeding our growth. With all of that that I've talked about, that is just severe aortic stenosis.
That's all we've covered so far. We have a number of work streams and other things to work on it, but the next thing is moderate aortic stenosis. We have our PROGRESS trial. I will tell you, when we modeled this trial, we modeled the enrollment rates a little bit off of our learnings from EARLY TAVR, and we created enrollment criteria, and we thought how long it would take us to enroll that trial, and we were really surprised. We exceeded our enrollment expectations significantly. We expect to complete enrollment of that trial very early next year, and that's about two years ahead of what our expectations are. I think it speaks to a couple of things. I think, one, it speaks to the clinician interest in really understanding, is watchful waiting till people get severe the right strategy for treating aortic stenosis patients?
This is a high-quality randomized trial with a two-year endpoint, but if you look at the opportunity, for every patient with severe disease, there's two patients with moderate disease. So when we think longer term and we think opportunities and indication expansion, this is a huge part of our long-term strategy to continue to add to the scientific base that can continue to expand indications, but most importantly, improve the care of patients with aortic stenosis. This concept of watchful waiting and thinking that we're not doing damage to a person's heart during this period of time doesn't make a lot of sense, and frankly, a lot of that is a holdover from the old surgical paradigm. When surgery was your only option, this goes all the way back to the Braunwald curve in the 1960s.
If surgery was your only option, and surgery was very risky, it made sense to wait as long as you could. But now we have a procedure that 99% of our patients in our low-risk trial were alive and well at a year. Does it really make sense to wait and do damage to the heart or risk complications when we have a therapy that's so elegant? And honestly, we don't think it does. We believe our technology is best positioned to serve the patients, and the way that we think about it is, lifetime management, but we break apart the components. Life. Life starts with the index procedure. It's doing a great procedure, getting that patient out of the hospital in a day, getting them home to the home they came from, with minimal to zero complications. Time. Do we give them a durable valve?
Do we give them a valve that's going to last? And then the third thing is, everyone, if they live long enough, will outlive their bioprosthetic valve. If they live that long, what can we do? And that's about management. And so to talk a little bit more about our five-year data and how we think about the time element, we have a quick video from Martin Leon.
First, we had to prove that in low-risk, younger patients, we could achieve equivalent or superior clinical outcomes to surgery, and we were able to do that four years ago when we presented the one-year endpoints for PARTNER 3. But the reality is, everybody has been waiting for this presentation. five-year follow-up findings from this study reaffirm the clinical and echocardiographic benefits of SAPIEN 3 TAVR as a meaningful alternative to surgical therapy for low-risk, severe symptomatic AS patients. We didn't know that we could achieve the same clinical outcomes out to five years with a transcatheter alternative. Now we do. TAVR wins coming out of TCT 2023. Now what we'll be able to say is that even in younger patients in their seventies, that there's no difference at five years.
These data and more are published today in the New England Journal of Medicine. This is the eighth New England Jour nal of Medicine manuscript from the series of PARTNER trials. It should give our patients, our referring doctors, our proceduralists, a sense of confidence that, you know, this is a starting point for where we can go in the future.
So we're obviously very proud of our five-year data, and I think we're even more proud that it's our eighth New England Journal of Medicine publication, which is pretty much unprecedented for one technology class to be able to drive that in about a decade's time. So I talked about life, that index procedure. From our PARTNER 3 trial, 99% of our patients were alive and well in a year, a remarkable achievement. You think about time. In our PARTNER 3 trial at five years, ninety-five, 90% of the patients were alive, and that's a remarkable achievement for patients that were 73 years old with severe heart disease at the time of the trial.
Management, being able to do that valve-in-valve procedure, and this is the only platform with a valve-in-valve option. So to talk about lifetime management and what it means in the clinical community, we have a short video from Curtis Stinis.
Lifetime management means to me, putting in a valve that is going to last as long as possible and get the best possible initial results. That means no leakage, tissue that's going to last as long as it can for that patient, and a valve that also gives us options to treat the patient again in the future successfully without any difficulties. Younger patients ultimately will outlive their first valve and require a second valve. So we want a valve that's is going to be compatible and make it easier for us to do a valve-in-valve procedure. And I think also it allows us to access their coronaries and to do a standard angiographic procedure on them, if necessary, in the interim, without difficulty. The SAPIEN 3 Ultra RESILIA valve really, to me, represents the pinnacle of a TAVR valve at this point.
It has all the features that are very important for lifetime management. We've got a better sealing skirt to avoid paravalvular leak. We just don't see paravalvular leaks anymore with this technology. We've got Resilia tissue that's going to last as long as possible and try to avoid calcification and deterioration. We've got a frame that's low enough height that it's easy to access coronaries and is also suitable for valve-in-valve in the future. And so I think that this is a representation of Edwards' commitment to this space, and I know that their engineers are going to continue to iterate on this technology. I'm very excited for future developments and where this is going to take the space, and I'm very hopeful that this is going to provide a lot of benefit to our future patients with this disease.
So as excited as we are about our five-year data from PARTNER 3, something to remember is that valve is two generations ago. That was our SAPIEN 3 valve. We moved on to SAPIEN 3 Ultra, which we knew had benefits for paravalvular leak, and now we've moved on to our SAPIEN 3 with Ultra RESILIA. So we continue to advance this therapy in ways that we think are very meaningful for patients. We see the adoption accelerating. It's now the majority of our procedures in the United States. In Japan, it's more than 95% of our procedures, and we're now expecting approval early in 2024 so that we can bring this technology to Europe. Beyond SAPIEN 3 Ultra RESILIA, we have our X4 platform. We continue to advance that in the clinical trial. We're actively enrolling. We're very pleased with how that's going.
We think that this brings meaningful advances for patients and for clinicians, and so we're excited about that program. And so when you look at everything all together, and we look at short term, midterm, and long term, as it relates to patient activation, again, we're focused on those in-system patients now, but over time, we will increasingly move forward in bringing the out-of-system patients into the system. When we look at indication expansion, pretty near term now, we're, next year, we're going to see the early TAVR data, and we believe if that trial provides a compelling data set, that that can be a, a real streamlining of the system and can accelerate patient activation.
Just slightly longer, you know, only a couple of years after that, we should be looking forward to the PROGRESS trial completing its follow-up and seeing that data set, which we're very excited about, which again, if that's successful, becomes another long-term driver for us. And then technology. We continue to expand. We're just still in the launch process for S3 UR. We expect the approval early next year. We have SAPIEN four, or excuse me, SAPIEN X4, but then we also have future technology beyond that. So we're very excited about that. So when you look at our outlook, we're now projecting our growth rate to be between 8% and 10% on a constant currency basis.
You know, when we think about headwinds, you know, there's just the overall healthcare spending, and, you know, there are some competitive product launches which we've modeled into our guidance. But we also see the healthcare system continuing to improve with staffing and creating a little bit more redundancy in the system. And then there's also the technology and the new evidence that we have over the time, and we think our fundamentals remain incredibly strong. So with that, I would like to invite my good friend, Daveen Chopra, up to talk about our Transcatheter Mitral and Tricuspid Therapies. Thank you.
When you're not getting enough oxygenated blood, you don't realize what is going on. I mean, I couldn't do many things. I was tired, and I was sort of listless. Millions of patients suffer from mitral and tricuspid regurgitation in the United States. For many of these patients, there aren't any therapies available. It's a true unmet need to continue to find transcatheter therapies for these patients. While we are addressing a lot of patients' needs using the edge-to-edge repair technology, the fact that we have already tested and performed these clinical trials using transcatheter mitral and tricuspid valve replacement devices gives me tremendous hope that we'll be able to treat a large number of patients using less invasive techniques. I was extremely lucky to be able to receive the device. It's made such a difference in my life, and it's going to affect a lot of other people.
Like the patient, Steve, in the previous video, millions of patients are suffering from mitral and tricuspid regurgitation. These are patients that are not living the life they want to lead. For these patients, surgical and medical treatment options for them are just suboptimal. For many of these patients, they can't do things that just make their life what they want it to be. They can't often walk up the stairs, play with their grandkids, take care of themselves. And we believe that Edwards' transcatheter repair and replacement technologies together can help really transform patient care for many, many of these patients.
As we look at the market first for transcatheter tricuspid repair and replacement, we see that tricuspid care is now at the start of a revolution, where previously, many years ago, tricuspid was the forgotten valve, where people didn't really give it a lot of notice, didn't really treat it. But now, today, we're starting to see more and more contemporary data, where not only patients, referring physicians, and heart teams are starting to realize that treating the tricuspid valve actually can have a great benefit for patients. As we move forward to 2024, we see that we're gonna have both repair and replacement, contemporary transcatheter technology available in both the U.S. and Europe. Very exciting, and then to grow in many markets afterward. And we also see that into the future, past 2024, that we'll continue to have new innovations.
We'll continue to have changes to all of our products. We'll continue to have new evidence that will grow this therapy of transcatheter tricuspid care for the many patients, so that in the future, starting with the first technology, we'll continue to expand to more and more patient groups with both repair and replacement technology. But what about the mitral patients? So if you look at the mitral market today, mitral repair, transcatheter edge-to-edge repair, TEER technology, continues to grow. We see that there have been more recently large contemporary data sets that are showing that TEER is a great solution for many, many patients. As a result, we're continuing to see increased disease awareness, increased disease diagnosis, and referral to heart teams for treatment.
As we move forward in 2024, we'll continue to see our TEER technology grow not only in the US and Europe, its first markets, but we'll see it grow globally, with new centers around the world continue to open and use this technology, and more centers having patients flow through their, through them as we have increased disease awareness, diagnosis, and treatment. But as you move into 2025, we see that there, there's an inflection point where replacement, mitral replacement, transcatheter, transfemoral replacement, will come to the market and treat a whole new group of patients. While TEER is a fantastic technology, there are still many patients for which transcatheter technology does not make sense for anatomical and other reasons, other reasons.
So we believe that replacement will add a whole new group of patients and extend transcatheter treatment to a group of mitral patients who are looking for solutions. We believe that our portfolio strategy of both technologies is really gonna help drive this future market opportunity in the TMTT space. With us, it's our portfolio strategy, our three-pronged strategy, that we think is really gonna help the market grow. Our strategy to success starts with innovation. For ourselves, as I've talked about, we believe we need both technologies, repair and replacement, for both the mitral and tricuspid valve, to really treat the maximum number of patients. Secondarily, after you have a great technology, you've got to have lots of evidence. This not only includes the pivotal studies you see on the slide, many of them randomized, but also includes first-in-human studies, other single-arm studies, large post-market studies.
It's a variety of data that is going to continue to grow the marketplace for these technologies. Finally, it takes real-world outcomes. It takes amazing data in the day-to-day as patients get treated. This is actually the collaboration of the Edwards high-touch model, where we work very closely with the physician on each and every patient, not only in the pre-case planning, but being in the room for the procedure to help make sure we get maximum outcomes and post-procedure. We think it's those great real-world outcomes are really gonna help drive this marketplace into the future. As I mentioned, it's gonna take both repair and replacement technology, so let's first dive a little bit into repair technology.
We believe that the PASCAL repair system is a differentiated technology, and we are continuing to build a huge database, a huge data set of different clinical evidence to help show this. Most notably, as we've talked about before, we have three very large pivotal studies around the PASCAL system for three different kinds of therapies. The first one is the CLASP IID study for degenerative mitral regurgitation. This is a study that helped drive U.S. approval that we presented one-year follow-up at TCT just a couple of months ago. And this showed amazing clinical results and safety, efficacy, and durability of the PASCAL system with one-year follow-up. We also are currently enrolling the randomized CLASP IIF. That's a trial that we continue to enroll for functional mitral regurgitation. We also have the CLASP II TR study.
That's a randomized study of PASCAL versus optimal medical treatment in patients, and we believe that this study will finish enrollment in 2024. So this is the OMT versus PASCAL tricuspid study. And so we're very excited to finish enrollment by the end of 2024 with this study. Beyond pre-market studies, we also have a variety of post-market studies that continue to show great real-world outcomes for PASCAL. Most notably among them, we have two large European studies, the MiCLASP study and the TriCLASP study, for both degenerative functional and tricuspid patients between the two studies. And we actually had readouts of these studies at the London Valves meeting just before Thanksgiving, where we had a large number of patients with one-year follow-up showing great results in all three different kinds of etiologies.
Together today, the PASCAL program, clinical evidence program, is now already well over 2,000 patients who are already under trials and in follow-up, and we're still enrolling more patients. Beyond just great clinical evidence, you also have to have fantastic innovation. For our innovation, it means we've got to keep innovating. With PASCAL only out for now barely fiv years, we've already had four different iterations where we've brought out not only a new, more efficient implant, we brought out new delivery systems that are more precise to really get great outcomes. We brought different procedural innovations to streamline cases, and we're working on many more future products, where we continue to innovate to ensure that TEER products will not only be easier to use, but have better clinical outcomes.
Outside innovation, we see that PASCAL Precision is really going to continue to grow globally in 2024. We see that we started originally in Europe, and in Europe, we launched almost five years ago, where we continue to actually still open up new sites and new centers throughout Europe. We're actually going to just launch in France, where we are in the process of finally gaining reimbursement and expect to start cases in France, Europe's second-largest tier market, in just the coming weeks. Additionally, we've only launched in the U.S. a year ago, and in the U.S., we continue to train new centers. We continue to expand usage of PASCAL. We continue to hire new reps, new field clinical specialists in the field, and continue to grow the market in the U.S.
In Japan, we've actually received both approval for PASCAL and just recently, reimbursement, and expect to actually start first cases, initiating our launch in the next two weeks or so. Very close to entering the Japanese market for commercial cases, which is very exciting. Now moving from the repair side, let's move to the replacement part of our portfolio. The replacement part of the portfolio starts with EVOQUE. EVOQUE, we believe that Edwards is going to pioneer transcatheter tricuspid valve replacement with EVOQUE. This is an amazing, exciting technology. This is a technology where we believe that it's applicable to a large number of tricuspid patients through multiple valve sizes, all going through a sub-30 French delivery system. Through our clinical program to date, we've treated almost 1,000 patients, and we've learned from these 1,000 patients that we're confident.
We're confident in this device and how it can help patients. We've also learned that it is a very predictable, repeatable procedure, where physicians can consistently treat a patient in about an hour. So it's fantastic for throughput, where people can really get the predictability, where they know what happens in each case. And we've also now started to present some of the data to support this. Some of those 1,000 patients obviously come from clinical trials. We're continuing to present more and more data. Most recently, at TCT this fall, we presented the first 150 patients from our TRISCEND II randomized study of EVOQUE versus medical therapy. And in this study, which it has already enrolled its full 400 patients, the first 150 patients had excellent outcomes, where patients met their safety endpoint. They also had obliteration of TR.
94% of patients had mild or less TR in this study. Fantastic results. We had huge quality-of-life improvements, 22 points. These are kind of hard to get with numbers like KCCQ. What does that mean? You know, five is small, 10 is moderate, but this is 22. This is the same levels as the original TAVR trials. This is the same level of PARTNER in terms of improvement in quality of life for patients. Most recently, even at London Valves, again, a couple of weeks ago, we actually started to present some two-year data from our TRISCEND I study. This is the first study we did with the EVOQUE study. Now, out to two-year follow-up in 90 patients, a single-arm study, where again, out to two years, we continue to see durable, great results in both TR reduction as well as quality-of-life improvement.
It's hard to always fully understand quality-of-life improvement and what this means. Let's hear from one of our EVOQUE patients, Mary, about what quality of life meant for her.
She was not able to walk. Her lips would turn blue just in casual conversation. I was breathing, but barely. The symptoms were preventing me from living life. Patients with tricuspid regurgitation have substantial symptoms and other limitations. A lot of them have substantial shortness of breath, fatigue, they have swelling. TRISCEND II was a groundbreaking study. What we saw in this trial is we were able to eliminate the leak in the vast majority of patients. This is what leads to functional improvements.
Quality of life was part of the primary endpoint of the TRISCEND II trial because it matters. It matters a lot to these patients. In the patients treated with the EVOQUE valve, there was a substantial improvement in their quality of life as measured by the KCCQ, which was apparent right out of the bat. They're able to enjoy their activities, they're able to spend time with their families, and do the things that they care about. When I got home, the switch flipped, and it was amazing. Her quality of life is a complete 180 from where it used to be. The bottom line right now is we need therapies for-
... severe TR in these desperate patients that don't have options. Trials like TRISCEND II and devices like EVOQUE are therapies that are gonna help people not only live longer, but just as importantly, have improved quality of life.
It matters for patients. It really does. So we are so excited that EVOQUE, as we recently announced, got CE mark and is now in its initial commercial launch in Europe, where we are starting to roll it out to our initial centers and treating patients. Also, more excitedly, we are excited to bring this technology to the U.S. in mid-2024, where we've had a great collaborative back and forth with the FDA around this technology. Beyond U.S. and Europe approval, we see that in the fall of 2024, we'll present the full cohort of data, the one-year follow-up on the 400 patients with its primary endpoint at TCT. Additionally, we have been working on a larger valve size, a 56 mm valve size, that would add a significant number of patients to the treatable pool, and we expect to bring this technology out in 2025.
So a lot of work happening there. And we've also learned from those first 1,000 patients that we've already treated with EVOQUE, that we can continue to make iterations and changes, and we are already working on our next generations technologies to make this product even more adaptable, more applicable to more patients. So we're excited to continue to work on that. Moving from tricuspid replacement to mitral replacement, SAPIEN M3 is really gonna extend care for a whole new group of mitral patients. This is an exciting product that is on track to be the first transfemoral, transseptal, sub-30 French product to come to the market. Very exciting. And the amazing thing about this technology is that it's built off SAPIEN 3, an amazing platform of TAVR, that's already been treated in over 6,000 patients, generally in previous surgical repairs or replacements, over 6,000 patients.
And then this product, on its own, has already been treated in over 500 patients. Not quite the one million number yet, but we're getting there on our way, and it's very exciting. And what we love is that this product can really treat a whole group of patients that are commercially unsuitable for other technologies today. And the key data set that's gonna help bring us to commercial approval is our ENCIRCLE trial, and I think as we previously mentioned, we finished the pivotal cohort enrollment of 300 patients. And with that data set, and you kind of work forward, we expect to bring this to European approval by the end of 2025, and soon after, to the US. So an amazing technology that's gonna help more patients.
So kind of in summary, we really believe that Edwards now, as Bernard said earlier, we're at an inflection point of TMTT. We're at the point now where repair and replacement is coming to the marketplace for both the mitral and tricuspid patient. On the tricuspid side, we really believe that PASCAL and Tricuspid, as well as EVOQUE together, are gonna drive Edwards' leadership forward. On the mitral side, we'll continue to see that PASCAL for mitral will continue to accelerate, will continue to gain above-market growth, while SAPIEN M3, with this launch in 2025, will really help us establish leadership in that new space. So if you think about the waves of technologies, right now, PASCAL is really gonna help us continue growth right now in the repair space.
Then, in 2024, we bring EVOQUE, which we're gonna launch and gain adoption for in both the US and Europe, with this amazing transcatheter tricuspid technology. By the end of 2025, SAPIEN M3 now adds in the mitral replacement option to add more patients to the pool. So with all this, if you look at kind of how we look at 2024, we believe that we'll have a range of between $280 million and $320 million of revenue in 2024, with headwinds of overall healthcare spending pressure, as kind of Larry mentioned, that's, that's in the marketplace today. And we're bringing out a new therapy with EVOQUE. We're training people a first time, so that always takes time, and we've got to work through that. But there are a lot of good tailwind opportunities, right?
The contemporary mitral data is showing that TEER today is an amazing opportunity that's continuing to grow. And we see that as we start getting more tricuspid real-world outcomes, we'll see probably more referrals coming that'll help be potentially a tailwind for us. But overall, if you look at where we are in this inflection point, we see that there are millions of patients out there with a mitral and tricuspid disease. They're looking for better options, as the current ones are suboptimal. And we believe that by having both repair and replacement, we can treat a maximum number of patients for both mitral and tricuspid disease and really transform their care. So with that, I'd like to introduce a good buddy of mine, Wayne Markowitz, the General Manager of our surgical business, a business that's very near and dear to my heart.
2023 has been an exciting year for Surgical. Double-digit growth and well outpacing the global market. Our premium and differentiated RESILIA portfolio, combined and backed by our clinical evidence, has been leading the charge for these gains. Looking forward, we're confident that we will continue to deliver above-market growth with our innovation strategy. We expect the global market to exceed $2 billion by 2028, and combined with our robust portfolio in development, we will continue to bring life-saving therapy to patients who are in need and untreated today. Now, for 2023, there were three critical factors that were fueling our growth. First, it was RESILIA aortic adoption with INSPIRIS and KONECT. Physicians are now recognizing the value RESILIA tissue technology can offer to their patients. Next, it was MITRIS sales acceleration, doubling the revenue year-over-year.
And third, the revenue we're generating in the emerging markets is growing at a clip three times that of the developed markets. Now, these three factors, combined with the Edwards TAVR patient activation initiatives, are identifying and bringing new patients into the system to receive treatment. Now, a decade ago, we were confident in saying surgery would continue to be compelling and prominent, and if you look at today, our prediction has come true. Over the last decade, we've seen the market evolve, and significant opportunities now exist for patients who are best treated surgically. This is becoming evident to us in three key areas. First, we're seeing a shift in the mean age of the average SAVR patient, a shift from 71 years old to 66 years old. While we're seeing some older populations of patients shifting to TAVR, we're also seeing younger patients now receiving SAVR.
Next, we're seeing an increase in the complexity of the SAVR procedures, with more pronounced growth in the concomitant and non-severe symptomatic AS etiologies, procedures where patients can be best treated surgically. In fact, today, over 80% of the SAVR procedures are in areas untreated by TAVR, and nearly 2/3 of the market is now comprised of concomitant SAVR as well as mixed disease and AR. Moving forward, we expect to see continued growth in these non-TAVR patient segments. Third, tissue valves continue to be the dominant therapy in the developed world. Within the U.S., tissue valve procedures have increased 30% in the 50- to 65-year-old patient segment, where U.S. guidelines allow a choice between tissue and mechanical valves. Interestingly, even in the less than 50-year-old segment, where guidelines would suggest a mechanical valve, we're seeing a 50/50 split between tissue and mechanical.
This demonstrates that both physicians and patients are seeking optimal lifetime management with future valve and valve options. With our RESILIA portfolio, we are pioneering new standards of care for patients today and into the future. Starting with aortic, we have INSPIRIS. It's our flagship product. It features a RESILIA tissue technology for enhanced durability, and it's the leading SAVR valve globally. It's the only valve in the world with VFit that enables future valve-in-valve expandability for patients' lifetime management. KONECT, it's an optimal solution for complex Bentall procedures. It's the only ready-to-implant tissue valve conduit available. Moving on to MITRIS and our mitral products. MITRIS brings all of the great benefits of RESILIA tissue technology, its differentiated features for greater ease of use, like foldable stent posts and a low profile.
We're seizing opportunities that we've identified in specific geographies, opportunities for conversion, conversion from mechanical and porcine valves to bovine ones. With the European approval, we now have Mitris commercially available in greater than 50 countries. Recently, we achieved a significant milestone with our Resilia portfolio, exceeding 250,000 patients that have now benefited from our Resilia innovations. Now, as Mitris continues to expand its global footprint, we're excited about the impact it will have for surgeons and patients. Let me share a story about Gary, one of our Mitris patients.
Last year, I had an infection in my toe. One day, the infection escalated, it seemed like, so we knew right away that we needed to call 911. ... The infection had already seeded his mitral valve and had caused 11 small strokes. There was no way of saving this valve. It needed to be replaced. For Gary, I had chosen a bovine valve from Edwards Lifesciences. The MITRIS valve with RESILIA tissue has been designed with newer anti-calcification treatments that will potentially allow the valve to last longer.
The operation went great, and we were able to achieve the operation in a minimally invasive fashion. Dad has made tremendous strides from where he was, and we love it. We love that we've got our dad back. I would like to personally thank the employees with Edwards. I feel myself getting stronger every day, and I'm grateful for the opportunity to spend many more years with my wife, my kids, and my grandkids. Thank you!
It's so inspiring to see Gary back to the activities and the life that he enjoys after getting his MITRIS valve. So in addition to our innovative portfolio, we are committed to generating clinical data to support the RESILIA value proposition for patients, with COMMENCE aortic seven-year and COMMENCE mitral five-year results being published earlier this year. In addition, we have MOMENTUS, featuring our MITRIS valve. It's the largest MVR study to date, and it's currently enrolling. We're not done, though. We're continuing to invest in meaningful clinical evidence, 28 post-market studies ongoing, with over 13,000 patients. We're thrilled about the seven-year outcomes of the COMMENCE aortic trial. It's presented at AATS and published in JTCVS. It showed 99.3% freedom from SVD at seven years. This is fantastic, truly amazing, and it's outperforming previous generations of surgical tissue valves. At Surgical, our future is extremely bright.
We have substantial growth opportunities where we can help patients receive the therapies they need, and in both developed and emerging markets, there is more progress we can make to bring these therapies to patients. Our RESILIA portfolio, it's best in class, and we're so proud of that. We're pioneering new standards of care across the globe, and we remain committed to innovation, building our robust pipeline and backing it up with meaningful clinical evidence. Now, as we look into 2024, while every business has its headwinds, let's turn our attention to our tailwinds. Global RESILIA aortic adoption... Did we lose it? All right. Global RESILIA aortic adoption and MITRIS penetration will lead our way to above-market growth in 2024.
Overall, we set sales guidance to $1.0 billion-$1.1 billion, and we're very optimistic and confident for the coming year and what we can do to further expand our impact to patients. Thank you for your time, and with that, I would like to introduce Katie Szyman, our CVP of Critical Care.
Good morning, everyone. It was so great to get a chance to hang out with many of you last night at the tech showcase and get a chance to see all of you today. So let me start by sharing why I'm so excited and why the entire Critical Care leadership team is excited. We're honored, and we're really grateful for the opportunity to spin out Critical Care into our own independently traded public company. Why are we excited? We're excited because the spinoff is gonna give us an opportunity to actually impact the care and improve care for millions more patients. We're going to be able to increase the speed of innovation, and we're going to be able to expand into new areas, and that's actually going to help us to increase our long-term growth potential.
Every year, I share with you our core strategies for growth of technology, evidence, and innovation. This year, I'm gonna go a little bit deeper. I'll give you an update on that, but I wanna share with you more about smart recovery and a new concept, which is called smart expansion. Because everything we do in Critical Care is focused on getting patients home to their families faster. I'm also gonna get to share with you a little video with the story of Cynthia and her daughter, Hannah, and her high-risk obstetric birth situation, where we were able to monitor and improve her care. I often get asked: What is smart recovery? No one understands what it is, so let me explain it for you.
So smart recovery is taking smart monitoring technology, combining it with faster recovery for patients, and that's what we call smart recovery. We are the leader in the OR and the ICU environments, and there's approximately 20 million patients that can benefit from our technologies. Smart expansion is a new concept for us this year, where we're taking continuous non-invasive blood pressure monitoring and we're looking at the highest clinical need in the lower acuity patient areas and saying, "We can actually expand in a smart way by taking our core technologies into these new areas." We see great opportunities in all the patients that have moved to outpatient surgery situations since COVID. We see great opportunities in pediatrics and obstetrics. We estimate there's approximately 30 million patients that could benefit from our continuous non-invasive blood pressure technologies in these areas.
So if you're gonna pay attention to any slide today, you wanna pay attention to this one. This very quickly summarizes our entire business, and basically, you see that we are 80% a disposables business and 20% capital, so easy to understand. In the disposable side, we have our classic monitoring technology, which is about 50% of our revenue and has 14 million patients per year. Then we have our 30% of our revenue coming from our smart monitoring disposables, and that impacts about two million patients per year. So if you wanna understand what is smart recovery, it's basically trying to improve the quality of care for millions of patients. The two million patients that get smart monitoring today should actually be the 14 million that currently get classic monitoring.
If you think about what's our market potential, it's really to shift all of the patients over to smart monitoring technologies. We're doing that by adding advanced algorithms and adding continuous, less invasive, predictive, and prescriptive technologies to the smart side. What does that mean from a business perspective? If you take a step back, you say, on the disposable side, today, classic monitoring is about 50% of our revenues. About five-six years ago, when I presented to you, I told you that it was about 60% of our revenues at that time. So we've been very successful in moving this shift, and we see that continuing, and then we have the solid foundation of our classic monitoring technologies that we believe will never go away. Very strong, gold standard. Everybody uses them and recognizes our brand in that area.
So now I'll give you the update on adoption and clinical evidence. We have over 75 studies that show the importance of smart recovery. Why is that important? If you go in for a high-risk surgical procedure, you have about a 25% chance that you're going to have some kind of complication to your surgery. And if you use smart monitoring technologies, we can actually reduce your complication risk, reduce morbidity, and actually reduce the length of stay, which makes hospitals more efficient by up to one-two days. On the kind of predictive analytics or artificial intelligence side, a few years ago, we launched Hypotension Prediction Index, or HPI for short.
With hypotension prediction, we were the first company to get FDA approval for an AI algorithm, and we predict up to 15 minutes in advance when a patient is going to have a dangerously low blood pressure event. So your mean arterial pressure is basically the average of your systolic and diastolic blood pressure levels. So if you have a mean arterial pressure that goes below 65 for more than 10 minutes, it's been associated with very negative clinical outcomes. And so when we show here that if you use our predictive algorithms, we can actually reduce that from 28 minutes on average to 12 minutes, and we have recent data coming out that says they can get it all the way down to zero minutes using our predictive technologies in Europe.
It's great to hear all of this from me, but let's hear it from one of our top physicians, Dr. Maxime Cannesson.
So I do believe that smart monitoring, which is the combination of classical monitoring paired together with artificial intelligence solution and clinical decision support system, is actually going to completely transform the field of monitoring. For the first time, these monitors are going to forecast the future and predict the evolution of a patient during surgery or in the critical care setting, which is going to help clinician being more proactive and intervene before a bad outcome even happens. These monitors are going to provide recommendations to physician. These recommendations are going to help decrease the variability of care. They are going to help clinician make the right decision. They are going to help personalize the care, and eventually, they are going to help improve patient outcome.
Finally, I think it's going to completely transform the field of monitoring because it's going to make the life of physicians, nurses easier, and this is going to help them focus on what matters for their patient care, and it's going to also improve the way we deliver care and improve patient outcome.
So Dr. Cannesson is one of our trusted partners who's actually worked with us to develop some of our smart algorithm technologies. In fact, this year, we're actually launching an artificial intelligence algorithm called our Assisted Fluid Management. That actually is a closed-loop, semi-closed loop algorithm that makes recommendations to physicians about the amount of fluid that they should be giving to their patients, and it does those calculations for them, and it's been shown that the, the computer, if you will, or our algorithm, is able to do it more accurately than physicians have always done it, the way they do it today, which is in their heads. So now I'm gonna switch and start talking about capital and also our smart expansion strategies.
So in capital, we actually launched the HemoSphere in 2018, and I'm proud to say that this year we're gonna be launching the seventh generation of our platform. So if you do the math, that was six years ago, and we're on the seventh generation of software, so we kinda think we're, you know, innovating a little bit faster than Apple, but we don't like to brag. But anyway, we are now about 50% into the conversion cycle. So at the end of 2023, we'll be just over 50% of that conversion cycle, and by the end of 2028, we should be fully through that conversion cycle of our existing installed base. So what does that mean for us?
Well, it means that we've got to start focusing on ways to expand the installed base, first of all, and then second, we've got to come out with the next-gen platform. And I'm happy to say that our next-gen platform is under development. It's got amazing, cool technology on it, and it will be launching full launch in 2025, and we're gonna be doing some pilot launches with the technology here this year. It has some cool things like voice, gesture, things that you would expect by taking tech into med tech. So we're very excited about sharing more about that with you next year. So what is smart expansion, and why are we excited about going into some of these lower acuity or lower-risk patient environments?
So this past year, we kind of took a, took a step back and said, "If you actually go in for a surgery." So a couple of years ago, I actually had shoulder surgery, and during the approximate two hours that I would have been under anesthesia, the current standard of care is that every five minutes, they're required to blow up an arm cuff on me as a patient, and then they record that every five minutes, and then that goes into the electronic medical record. That's how it works today. There's a couple of problems with that. First of all, arm cuffs, oftentimes, especially in low blood pressure, below 65, are often less than 50% accurate. Not 15% accurate, 50% accurate.
So they're inaccurate, and then the second thing is, during that intermittent period between the five minutes, something can be happening to the patient, and there's no visibility to that. So we are both continuous and more accurate, and so we are going to be launching what's called the Vital Wave Finger Cuff, which is taking a lot of our complex algorithms, simplifying it, only displaying blood pressure, and launching that on a new platform. And the new platform is called HemoSphere Vita. So that is smart expansion with HemoSphere Vita, and it's saying that with the Vital Wave Finger Cuff on a monitor that is just focused on blood pressure and cerebral oximetry, non-invasive technologies, we're going to be launching into the new markets. And we have a great quote here from a good friend of ours, Dr.
Thomas Fogarty, who, back in 2003, said that one of the things that he was sad about in all the innovations that he's done in his life, was that he was never able to solve this continuous non-invasive blood pressure solution. And we have it, and we are going to be launching it this next year. So I wanna show you a really great patient story, where you're actually gonna hear about how this happens.
I found out I was pregnant with our first daughter a little over seven years ago. I had to go in for an emergency C-section. During the delivery, she started convulsing. I thought I was gonna die. We always knew we wanted to have another baby. It took us six years to say: "Let's try again. On the day of her C-section, Cynthia looked so nervous. The anesthesiologist told me that because of ClearSight, Cynthia's procedure went more smoothly than they would have expected. It helped her actually titrate her vasopressors and prevent Cynthia from vomiting during her procedure. It was just such a different experience this time. Today, Hannah is seven months old. She's just constantly trying to keep up with her big sister. They just love each other so much.
I love the baby stories. So now I'll kind of transition and explain how that translates to our market. So today, we estimate our market to be about $1.2 billion of the hemodynamic monitoring segment, and as the global market leader, it's really on us to drive growth in the market. So we estimate that with the smart recovery strategy, we would see the market go to $1.8 billion by the year 2028, and that's above the market growth rates that you see in your kind of standard patient monitoring segments. Then with these additional new patient segments, we don't have estimates. We just know there's lots of patients out there, that we have the technology solution, and we're gonna start to pilot into those markets this next year.
In conclusion, as we look at 2024, we anticipate, again, that above-market growth rate of mid-single digits. We also are excited because we think that we have momentum in smart recovery and smart expansion, and the headwinds that we faced have started to calm down a little bit in patient monitoring, where you see hospital budget constraints and supply chain risks that have kind of plagued the industry since COVID. We see that calming down quite a bit. In summary, let me end where I began, which is that we are thrilled about this opportunity, and the entire Edwards Critical Care leadership team is excited and thrilled about the opportunity to stand up our own company and spin out, or we think of it as a graduation, into our own independent company. We believe that we have the leadership team.
We have 4,000 employees dedicated to our critical care patients and clinicians. We have the size. We have the scale. We're focused on our patients and our clinicians and our space, and we are ready, and we promise you, the best is yet to come. Thank you so much, and you now have a 15-minute break. Thanks, everybody.
Ladies and gentlemen, the meeting will resume in approximately two minutes. If you can make your way back in the auditorium. Thank you very much. Okay, let's get restarted again, everyone. Please take your seats, and we'll keep the program going. That'll be helpful. Thank you.
... All right, welcome back, welcome back from the break. Thank you. You've had a chance to see this morning why we are so enthusiastic and passionate about the opportunities that lie ahead for Edwards. For those of you who got to attend the product showcase yesterday afternoon, you saw that this isn't just enthusiasm shared by the presenters today. It's nearly 20,000 employees across the world at Edwards who have a mission to try to increase the impact that this amazing company can have on the way patients get treated. Now I'm gonna talk a little bit about how that translates into value for shareholders as well.
So, our goal is to generate 10% or more sustainable organic sales growth on average over time, and at the same time, generating healthy earnings margins and deploying the cash flow that results from that in high-returning investments, internally and externally, and I'll talk more about that in a couple of minutes. We always hold ourselves accountable for what we plan to do, and I'll tell you now what we said last year about 2023, which was to expect sales growth of 9%-12%, gross profit margins of 76%-78%, and EPS of $2.45-$2.60. Now, during the year, last year, and, or during the year of 2023, we increased our sales guidance to 10%-13%, and we're on track to achieve that sales guidance.
Quarter to date, things are turning out to be about as we had guided at our October third quarter earnings call, and so we expect to be in the range of 10%-13%. For TAVR, specifically quarter to date, we're in line with our guidance expectations, which would put us for the full year at the low end of 10%-13% full year growth. For gross profit margin, still in the same range. Earnings per share, we increased our guidance during the year to $2.50-$2.60, and we now expect the same thing that we guided to in October, which is $2.47-$2.53 in earnings per share for the full year 2023.
So turning to future financial goals, you saw in our press release this morning that our sales guidance for next year is 8%-10% for the company and for TAVR, operating margins of 29%-30%, and earnings per share of $2.70-$2.80. Over time, our aspiration and our goal is to generate more than 10% sales growth on the top line, excluding critical care, and the separation of critical care from Edwards will result in some top-line and operating margin accretion. Earnings per share, we're expecting double-digit growth. In fact, in 2024, the 9%-11% is a little bit understated because of the impact that foreign exchange has on our earnings.
So our earnings would be in the mid-teens were it not for FX headwinds that flow from sales through the P&L, part of which is relating to our hedge program, which I'll talk about in a minute. So our financial objectives really fall into three categories. The first one is, addressing, in terms of sales growth, addressing large and growing patient populations, and our sales growth is fueled by investments that we make in research and development. We also do acquisitions, but the real, the real engine behind our sales growth is in R&D programs that we invest in over long periods of time. The reason Edwards has been performing well now is because of investments that we made over the last 5 and 10 years, and the investments we're making now are gonna benefit our top-line growth rate in the years ahead.
In terms of sales by product group, you heard Larry talk about 8%-10% growth expectation for TAVR, driven by the continued launch of SAPIEN 3 Ultra RESILIA around the world, and increased focus, activation initiatives for patients. You heard Daveen talk about $280 million-$320 million of sales in TMTT, driven by the introduction of EVOQUE in Europe and the continuing expansion of our PASCAL platform, in Europe and in the US and beyond. Surgical structural heart, Wayne talked about what's going on with this amazing business that just continues to grow and distinguish itself, based partly on this RESILIA tissue platform, that's really changed the way surgical patients are getting treated.
Finally, Katie talked about advancing the next generation of predictive sensor technology in connection with driving our smart recovery platform. The second pillar of our value creation strategy is around profitability, and profitability, of course, starts with gross margin. Our gross margins are relatively high and reflect the value that our therapies provide to health systems, to patients, and to payers. In addition, we are really focused on trying to drive value through our global supply chain. At Edwards Lifesciences, we've got investments in five different structural heart plants today, in Europe and in the Americas and in Asia, and we drive that production volume through those different supply chains.
Together with our partners, our suppliers, end up in a very favorable position in terms of cost and redundancy and resiliency of our supply chain. In terms of research and development, we continue to stay focused in research and development, and we couple our internal investment initiatives with other, acquisitions in, in the areas of intellectual property, which I'll talk about in just a minute. Finally, in terms of spending, this is an important focus of ours. We invest heavily in research and development, and at the same time, we try to be very efficient in the way that we're achieving scale advantages from running this global company, especially in areas like, general management support and administrative overhead, that we are driving to support the company's growth.
In terms of earnings per share, our guidance for this year, as I mentioned, is $2.47-$2.53. That reflects FX headwinds of $0.19-$0.21, and so FX has hit us pretty hard in 2023. We expect it to be less of a factor in 2024, and to end up hitting us by about $0.08 at the midpoint of the range, against the $0.24-$0.30 of improvement from operations and earnings per share. Overall, it's gonna be a pretty healthy year for earnings growth for Edwards, and we're pleased with the setup going into 2024. Critical care will be a part of Edwards for all of 2024, and the results will be reported the way we always do.
There are not gonna be any separation activities that happen until the event of the actual separation, which is planned for year-end, or more specifically, the beginning of 2025. We do expect that we're gonna incur special charges associated with separation and typical and 100% tax-free spinoffs. We'll be reporting those during the course of the year as carve-outs to our adjusted earnings per share, and we'll talk more about what those look like as we get into the period of time when we are preparing to file our Form 10 with SEC, which is expected to be around mid-year in 2024.
It's too early to provide any estimates of the one-time expenses that we're expecting to incur to stand up the business, but expect it'll be typical types of things that are connected with spinoffs like this. So the third pillar of our financial value creation strategy is robust cash flow and smart deployment of capital. So we expect another good year of cash flow in 2024. We are today, in 2023, aiming for nearly $1 billion in cash flow. Remember, there was a tax law change that started last year that ended up spreading out the benefit of tax deductions that we get from our research and development investments. And as a result, our free cash flow declined a little bit from 2022.
This is the same issue that other public companies have, have been managing. But in 2024, we're expecting $1.1 billion-$1.4 billion in free cash flow, which is greater than 70% yield versus net income for 2024. We're also expecting shares outstanding, again, to be 600-610 million in 2024. So share purchase continues to be an important focus of capital allocation for Edwards Lifesciences. We think there's real value in buying back stock. This year, we're expecting 600-610 million shares outstanding, and you saw in our press release this morning that we just received authorization for another $1 billion of share buyback. That's par for the course.
Normal practice for us is when we reach below a level of the prior authorization, then we seek new authorization, and it was time, and so we just reloaded, and we're-- You should expect that we're gonna continue to be an active buyer of the stock opportunistically over time when, when opportunities present themselves. We're also committed to buying back stock to soak up dilution from employee shares and incentive option programs. So in terms of CapEx, most of our CapEx goes into manufacturing, resiliency programs, and research capacity, so think laboratory space, like what you've seen walking around campus here, yesterday and today. This year, CapEx, we're expecting to be over $300 million, which is somewhat consistent, a little bit elevated compared to 2023 and 2022. So portfolio management.
We've been and will continue to be active strategic investors in external growth opportunities. Our focus is on early-stage companies that can complement our internal programs, but really focused on structural heart. We have options to purchase several companies, as Bernard mentioned, and we'll determine whether to exercise those options based on established performance milestones that we entered into when we originally negotiated these transactions. We're also committed to portfolio management, and Edwards has a history of exiting product lines that are not aligned with our strategy or have a profitability profile or a growth profile that no longer fits. So for your reference, here's a summary of all the guidance statements you saw in our press release this morning and that are in your books, for those of you in the room.
I won't go through all the numbers, but this is just a collection of the key guidance metrics. Longer term, in summary, we expect that 10%+ top-line growth is achievable as our technologies and our indications for structural heart innovations benefit even more patients in the years ahead. There are no structural constraints on expanding our operating profit. So a lot of times we'll get a question, "Geez, what are the opportunities? What are you doing to expand profit margins?" We've got, we've got lots of leverage to be able to do that, but we're also very deliberate about choosing when we're going to extract more margin benefit versus invest in our top priority, which is generating long-term, sustainable, organic growth.
There are—if there are no new changes to tax laws, we're expecting that there's gonna be some upward pressure on tax rates. We're seeing it with the Pillar Two, the OECD Pillar Two changes, and that's impacting our tax rate. So the next year, we're expecting 14%-17% tax rate, and there's upward pressure on that beyond 2025 and 2026 without any additional tax law changes. Overall, we feel really, we feel really good about how the company's positioned competitively, how the company's positioned in terms of innovations behind our product portfolio, and how we're positioned just having our employees lined up with the mission and the patient populations that we're trying to serve. And ultimately, we have a lot of confidence that's going to result in very attractive shareholder returns over the long term.
So with that, Bernard, over to you to close, and then we're going to take a quick break and set up for Q&A and give us a couple of minutes. Go ahead, Bernard.
Thank you, Scott.
Yeah.
So as you have, I don't see my slides. So as you have seen, you know, this morning, we are very confident. We are entering this new era of structural heart innovations with this, you know, sharpened focus, which is going to give us, you know, more agility and allowing us even, you know, a faster pace of innovation. Expanded opportunity, you heard a lot, you know, from the GM. You know, we believe that we are well-positioned to serve a very large and growing patient population. We are the only company, global company, solely focused on structural heart disease, uniquely positioned, don't you think, to deliver sustainable growth and extend our leadership? We have been the pioneer in structural heart disease, you know, for more than 60 years, and in our mind, it is just, you know, the beginning.
This, you know, future direction will enable us to expand opportunity, extend leadership in surgical, TAVR, and TMTT, where we have plenty of opportunities. In addition, we will use our expertise, reputation, and leadership to progress in heart failure. So let me summarize our bright future. 2024 will be an exciting year, building momentum with key milestones and strong financial performance, 8%-10% top-line growth, 9%-11% EPS growth. In 2025, 2026, we are well-positioned to deliver even faster growth, you know, 10%+, driven by new indication, asymptomatic TAVR, new technologies, EVOQUE, M3, and the impact of a patient activation program that Larry talked about, to be able to serve, you know, the many more patients that TAVR can do. Long term, we will expand opportunities and continue our healthy momentum.
At the end of the day, it is all it is about, don't you think? You know, we are proud to, we are proud to have helped millions of patients who are now enjoying life, and there are millions more to be treated. Let me leave you with this: Edwards is best positioned to transform patient care for those with structural heart disease in the most impactful way. So with that, we will take a very short break, and we are going to be back for Q&A. Thank you.
... All right, everybody, we've come to Q&A. We've got about an hour allotted for this session, so we'll go until about 11:30 our time. To try to get as many questions as possible, please limit them to one and one follow-up. I'll call on you. Please identify yourself and hit the red button in front of you to access the microphone. It'll make it a lot easier to hear. So with that, I'll kick it off. Maybe first question from Robbie Marcus.
Great, thanks. Robbie Marcus, JP Morgan. Appreciate you hosting this today. Maybe we could start with the long-term guidance, the 2025, 2026, 10%+ for TAVR and the overall company. You're going to 8%-10% this year. You have some new indications and products coming, but it's still an acceleration versus 2024. So maybe just walk through the thought process behind it and why that's a good starting point that you hope to exceed over time.
Yeah, no, sure. You know, thank you, Robbie. You know, good question, you know, for sure. So let me start with, you know, how do I feel about, you know, 2024? You know, solid, you know, fundamentals. I'm sure we are going to talk more about it and, you know, eight-10. Now, if you think about, you summarize, you know, what we discussed with you this morning. What we are, you know, coming is more patient activation, you know, the SAPIEN Ultra RESILIA, you know, being, you know, by far, you know, the preferred, you know, platform, which is, you know, we are going to have an expansion, you know, globally, you know, in 2024.
Then we are going to enter into 2024 with asymptomatic for TAVR, and this one has the potential, you know, to be a big, you know, a new indication, you know, for us and for TAVR. Now, you know, a technology like EVOQUE, think about EVOQUE, you know, like TAVR. You know, it is not, you know, the day you launch that you see, you know, all of the benefits, correct? You know, we are going to see a gradual benefit of EVOQUE in the next, you know, five years, maybe more. We will have, you know, to build, you know, the market, train the physicians, build, you know, the referring network. So every year, we are going to see a healthy benefit from EVOQUE.
So altogether, and then in 2025, late 2025, you have M3, where we are going to do the same. So we have plenty, if you think about, of fundamental are strong and great catalyst, asymptomatic, EVOQUE, M3. So this is what give us, you know, confidence that next year is going to be great, the years after, even better, even faster. Want to add anything?
Yeah, I'll just add to that. The separation of critical care is an automatic mathematical 50-100 basis point benefit to top-line growth. So you already—the bridge from 8%-10% in 2024 to the goal of 10%+ beyond that, if that's the consideration, there's a pretty straightforward bridge to get you there. In addition to all the fundamentals that Bernard mentioned around new indication expansions, new technologies coming online, and new geographies that we're serving, that are really going to grow top-line.
Yeah.
Just on the indications, I think, you know, next year we don't expect asymptomatic to contribute because if it's presented TCT, it's very, very late in the year. But one of the things I think gets underappreciated when we get a new indication is we not only get the benefit of the new indication, but we tend to get some pull-through from the previous indication. So, for example, you know, when we only had a high-risk approval, high risk was still a debate, but once we got intermediate risk approval, it sort of ended all the discussion on high risk, and all those patients started to flow through.
And so when we get things like asymptomatic and longer term, when we get things like progress, we think it's not only going to be those new opportunities, but we think it accelerates even the existing opportunity, and that's why I think we feel really good about the longer term after 2024.
Maybe a quick follow-up. As we think about the 10%+ TAVR growth during the 2025, 2026, how do we think about the building blocks to that? There's US versus faster OUS growth. You have some new competitors coming into the market. You have some new products launching with price and mix. How should we think about the building blocks that, you know, equal up to that 10%+? Thanks.
Want to take it, Larry?
Sure. Well, we modeled all that in. You know, we have places like the U.S., which we talked a lot about the penetration rates in the U.S., and we think there's big opportunities there. But Japan is even much less penetrated, so we think there's a lot of opportunity in Japan for us to continue to do more. You know, there's a lot of competition, pretty much all the competitors exist in Europe, so we're familiar with all the competitors and the strengths and weaknesses of their platforms. You know, we remain really convinced with a tremendous amount of conviction around our platform and its ability to compete.
I walked through a lot of the outcomes that we really drive, but as we move to younger and younger patients and even less symptomatic patients, it's not about just that index procedure anymore. It's about what happens when those patients outlive their valves, and we think our platform just gives us a huge strategic advantage for being able to maximize that over the long term, and that's why we feel really good about the present and the future for us.
Joanne?
Good morning or afternoon at this stage. Can we spend some time on the critical care spin-out? Up until now, it's been critical to Edwards. Why now? What makes this the right thing? And I get the idea of, you know, it increases the remaining company's revenue, operating margins, and stuff like that, but is there a way to start getting us to think about how much? Why and what is critical care going to look like when it's standing on its own?
So maybe, you know, let me start, and maybe Scott and Katie, you can add, you know, a few things. You know, first is, you know, critical care became a large, successful business, have reached, you know, scale, and size, you know, to, to be, you know, independent and be very successful as an independent company. So that's the first, you know, things. The second one is, if you look at our, you know, structural heart disease, you know, businesses, TAVR, TMTT, and surgical and critical care, you know, you know, we, the technologies, the innovation process, the regulatory process, you know, the business model are very different.
So for a leadership team, you know, like ourself, you know, this will give us, you know, a sharpened focus on structural heart disease, and there are so many opportunity in front of us with TAVR, TMTT, and surgical, and maybe more. So we will have, you know, this expanded opportunity. So this is, you know, the strategic, you know, thinking behind it. You know, Scott, you want to add anything?
I know everyone's eager to understand what the margin profile looks like for critical care on a standalone basis and Edwards post-spin-off, and we'll be able to provide that, but not now. So what we can say is, and I think everyone knows, critical care gross margins and operating margins are lower than Edwards consolidated. And so just mathematically, the remaining Edwards should go up, and critical care will present a different, a lower margin profile than it looks like inside of Edwards. But we're not going to quantify any of that right now. It is very early stages of getting this structured and announced and getting a project team kicked off.
Our plan is that over the next six months, we'll do a lot of work around the numbers and putting together pro formas and then ultimately culminating in a submission of a Form 10 with SEC midyear next year. And that's a point at which we'll be able to give you a lot more detail about what this looks like.
Katie, do you want to add any things about, you know, the kind of opportunity that you see ahead of you, you know, after you become independent?
Yeah. So it's a little bit like what we talked about before, but, I mean, if you talk about, like, why now? As we've looked at the patient populations, I mean, critical care originally was like cardiac surgery, OR, and intensive care unit patients. Now, we're really broad OR and intensive care for all types of patients, and then we're looking to go even beyond that. So the patient groups are kind of diverging more and more. The pathways to innovation, whether it's 510(k)s that we live in, the 510(k) land, versus implantable devices that take a lot longer. So we just kind of continue to see this divergence in the focus of both two great market leaders. So, as we look to the future for critical care, there's a lot of things happening in monitoring.
There's remote monitoring, there's artificial intelligence, there's the idea that all patients should be monitored while they're in the hospital. So as we want to pursue those types of opportunities, we're going to be able to, I think, get access in different ways to those types of expansion opportunities, and that's what we're excited about.
Chris?
Thanks. Chris Pasquale, Nephron. Devin, I had a couple questions for you on the transcatheter mitral and tricuspid businesses. So one, just a clarification on M3. You talked about CE mark in 2025, and CIRCLE is, my understanding, basically a US pivotal trial. So why the lack of a definition around a US approval timing for that?
So thanks for the question, Chris. It's just more of a logic that we know that it's going to follow the CE mark just based on the timelines we think for submissions and how long everything is in the FDA process. We assume things like advisory panels and that kind of process. So from our timelines, we think it's just going to be a little bit after. It wasn't meant to purposely vague or anything like that, but we think it's more 2026, so we just got to the guidelines through the end of 2025.
Got you. Okay. And then a lot of focus on the replacement technologies today, which are very exciting. Curious just to get an update on the status of the US TAVR market as it stands right now. It's been slower over the last couple of years, and I think we would've expected, in particular, functional. You know, hear some mixed feedback in terms of the different outcomes in the trials there, COAPT very positive, MITRA FR not. Just latest thoughts there and why CLASP 2F is taking quite a while to finish.
Yeah, sure. So, if I look at overall the TEER market, if we look at mitral TEER in the US, that's obviously just one segment in the broader TMTT market. So I'll dive into that, which is the only one in the US today, but obviously, tricuspid is going to be, we think, revolutionary, and mitral replacement will also be an amazing part of the overall TMTT market. But deep diving into mitral TEER, we definitely saw that during COVID, those couple years of COVID, we saw a definite slowdown quite a bit, even more so probably than aortic stenosis, where to a greater extent.
And then, as we've gotten out of COVID and we've kind of seen staffing get back to not perfect, but more normal levels, we've seen that the market, we believe, has gone back to kind of that double-digit growth, and it's, it's a healthy market where, and now with the most recent new data sets, when you start having more data and more competitors and more innovation, you get more referring physicians, more patient knowledge, more heart teams involved, and you start seeing better flow of the patients. So we've kind of seen, I think, today, that there's very healthy double-digit growth kind of growing in the mitral TEER market in the U.S. If you look at etiology of,
You talked about 2F for a second, about that. That's obviously our indications right now are for degenerative MR, and that's where we see our growth coming from. When you have an existing indication already for functional, as we saw with the COAPT study, it took a long time to enroll that study. And with 2F, where we're also talking about patients that have to go through, you know, pretty strong GDMT, we're seeing that it is a little bit slower to enroll than we like. I wish it was definitely enrolling faster, but we do see enrollment continuing to move along. But we think that we continue to see very strong functional data coming out of studies like our MYCLASS study that we just presented in Europe. We had an amazing functional arm.
I feel confident that PASCAL, for functional patients, is doing fantastic, and we've got great 1-year clinical data to help support that. Hopefully, that helps, answer your question.
... Yeah, thanks, Chris. Danielle?
Thanks so much for taking the question. Danielle Antalffy from UBS. If I could, just a question on the, the split and how to think about capital. So Scott, you did spend time on this, the capital deployment side of things, but just trying to think about, you know, this will make Edwards more focused, more nimble. You could deploy capital in a different way. You mentioned the interest in interventional heart failure and expanding into that. We didn't get into that a ton today, so just curious about what you could say on where Edwards' focus could move to over the next few years once the spin is complete.
Maybe I can start, you know, and then you can-
Sure
... you know, continue here. You know, Scott, you know, so the capital deployment, you know, for us, will be focusing first on, you know, TAVR opportunity, TMTT opportunity, and surgical opportunity. This will remain the priority of the company. Now, we see heart failure as a natural progression. We have some options. You know, I told you, you know, two-three in the near term, so we will make some decision, you know, in the near term for sure. And we are going to look at, you know, in a very opportunistic manner, if there is any opportunity within structural, you know, for us. But, you know, Scott, anything to add?
Our overall capital allocation priorities have not changed at all. So number one priority is always to invest in the business, invest in our physical infrastructure required to keep production capacity up with demand, to make sure that we're funding internal programs, and as Bernard just described, the external investments that we make as well, and then finally, buying back stock. As I mentioned before, we always want to, at a minimum, cover the dilution from option exercises, but as well work the overall net share count down over time. You know, it wasn't long ago when we had 700 million shares outstanding on a split-adjusted basis. Now we're down closer to 600 million shares outstanding, and so that will be an important part of our capital return strategy as well.
Rick?
Rick Wise, Stifel. A question, Larry, for you. I was really intrigued, it's hard not to be these days, about your comments on AI and the AI algorithm potentially accelerating, or more accurately, nudging patients along. I was hoping you'd just expand on what are the initiatives that you're implementing? Where are you with that? And, you know, I'd like to ask, is it gonna help next quarter? But, you know, when does it seriously start kicking in and helping?
Yeah, well, we're running a number of pilots with a number of different institutions, and there's some people that are working on their own, but we're trying to pilot with them and really focus on the undertreatment. I think one of the things that's been a big learning for us is, you know, we've done, there's been so much research to come out, whether it's Sammy Elmariah paper, whether it's University of Michigan or other places, that Trying to think of the recent paper that came out from AHA, that really focused on this massive undertreatment of aortic stenosis. But for whatever reason, many hospital systems, they think that's everybody else, and they think in their system, they do a really good job.
It's become increasingly important to us that for some of the large hospital groups, we're gonna have to show them their own data. So what we're really focused on is running pilots where they're gonna get to see their own data, and they're gonna get to see what it really looks like. But with electronic medical records and with more automation in the echo side, there is ability to put overlays where we can go in and extract the data out of the echo and apply the guideline criteria to it and pick up all those things that are being missed today. And we have a number of those pilots that are running. We do believe it is scalable.
It does take time, it does take effort, it does take energy, but we're from the pilots that we've done, I can tell you we are more convinced than ever. There is zero doubt in our mind that the patients are there. And the incredible work that's been done identifying the in-system patients and where they're falling through and where they're happening, that is definitive. And so for people who think, "Hey, the reason it's slowed down is just because you're so deeply penetrated, it doesn't matter anymore," I just don't even remotely believe that that's true. And, and again, that's still just the in-system part, and the out-of-system part's probably even slightly larger.
So the opportunity here is still really, really big for us, but it's gonna take more of a ground game than just putting out 10 publications that all say the same thing and have everybody say, "Oh, okay, we need to get serious about this." But this is where the work on creating a quality metric, creating an echo standard, creating all these things, they all really work in unison along with the evidence creation we do with asymptomatic and then, you know, later on, progress. So it's all those things. I've been doing this for a really long time, as you guys all know, but I look at what's ahead of me for the next seven years, and the opportunities almost seem bigger than what they were when we started because our knowledge is so much deeper.
That's not to say it's simple, but it's all there in front of us.
Gotcha. And if I could follow up with Katie. Katie, just thinking about the spinoff, you know, it's been. I'm sure having critical care as part of Edwards is, has been, is wonderful, but what are you going to be able to do as a separate entity that you weren't able to do here? Scott kept you on a tight leash, I understand, but... Sorry, Scott.
Does not have to work with us, Fox.
Well, I didn't want to say that.
Yeah.
But does this accelerate? Are you able to sharpen your focus on smart technology and maybe what's next? Could you just expand on that? Thank you.
Yeah, so thank you. We talked a little bit earlier on the smart expansion. We could go in so many directions. And so for us, it's really focusing on what are gonna be the opportunities that are going to, you know, build momentum for us in the short term that we can build onto, right? And so, one of the things I was just gonna add to what Larry was saying on the algorithm side, so we've done a study with the Cleveland Clinic and shown that we can actually detect severe aortic stenosis with the ClearSight finger cuff. So we may go into the detection and screening business as part of that. We've already submitted the algorithm to the FDA. We're in the review process with them.
Trying to figure out what's the best form factor of ClearSight to do those types of screening assessments and screening tools.
... We're really excited about that as an opportunity. So we, for us, it's really about having the freedom to kinda go after some areas, and if we need extra capital to do that, to be able to raise some of the capital, too. The opportunities, in a sense, are really endless. We just have to focus, right? Thanks. Thanks for the question.
Larry.
Thanks. Larry Biegelsen, Wells Fargo. Hopefully, you can hear me okay. Larry, I wanted to focus on asymptomatic a little bit. So, what do you need to show in EARLY TAVR to drive adoption? The primary endpoint, death, stroke, hospitalization. Can you frame the opportunity for us? Earlier slides I've looked at have shown asymptomatic to be basically the same size as symptomatic, so doubling your market opportunity. And how much could this accelerate TAVR? It's very different, like, than low risk, where a lot of it was cannibalization of a surgical heart valve, so $5,000-$30,000. This is really just expanding procedures. Thanks.
Yeah, no, I think, I think you're right. I think it is expansive. And there's... You know, I talked about just all the different layers to doing diagnosis for severe aortic stenosis, but then you add this whole other layer on top of it, which is this judgment. And I think that judgment is one of the things that really impacts that group of patients that has maybe a depressed heart function but severe AS, because this judgment starts to come into play of, well, is it their AS, or is it their heart function, or is it this other sort of thing? And are their symptoms attributable to their AS or not? And I think there's just a lot of mental gymnastics that go into that, where people are applying judgment or waiting for symptoms to worsen.
If you look at this, again, the Sammy Elmariah paper, there was a significant group of patients that doctors were saying they were waiting for symptoms to worsen, but there's no criteria for symptoms have to be severe. It's just any symptoms really are supposed to be criteria. So it's just gonna remove that judgment out, and, you know, I like to think of it as it's gonna go from Olympic figure skating to track and field. And what we really wanna do is be able to say, "Look, if you meet these criteria by your echo, and we have a way to extract that data, you should immediately move to a heart team for evaluation with no intermediate layer, with no judgment, with no other things being applied to it." And I think it's that streamlining of the workflow that EARLYTAVR has a massive ability to predict.
The other thing we're gonna get from EARLYTAVR, though, and I mentioned it before, is just all the learning. What percentage of patients truly are symptomatic, asymptomatic, and how fast do they progress to symptoms, and what happens to them during that progression time? And, and I think it's just gonna be just a war chest of data that, that is gonna inform how we attack that opportunity.
Well, just one follow-up. I mean, the pushback is that asymptomatic patients don't wanna get a procedure. How do you address that? And it's just pull forward, but patients who otherwise would get a procedure.
Well, my best counter to that is we have moderate patients who aren't even on guideline, and we enrolled that trial faster than we ever would've expected. So the physicians were able to convince patients with moderate disease that they needed to go get a therapy earlier than what even the guidelines recommend. So I think it's all about the discussion we have with patients. If we can prove to them that waiting is not benign. I mean, there's a lot of patients with coronary disease that have absolutely no symptoms, none, but the doctor tells them, "You have a ticking time bomb, and if you leave this alone, you can have a heart attack, and you can die." And we don't treat aortic stenosis with that same energy, and I think if patients are told waiting is dangerous, they will move forward.
If they're told waiting has no penalty, then they'll wait. Nobody wants to have a procedure before they need it.
Right. Thank you.
Josh.
Thanks, Mark. Josh Jennings from TD Cowen. Just a follow-up on Larry's question for Larry. Just on the EARLYTAVR submission, I know the data will be presented at TCT, but just thinking about investors' focus on the potential for TAVR to reaccelerate in 2025, could this submission occur well in advance of TCT and potentially approval in the early days of 2025? And then the follow-up there is also, does your team expect to have exclusivity in that indication, with no other TAVR players having data in the asymptomatic indication? And then lastly, SAPIEN 3 Ultra RESILIA, that's—I don't believe that valve was included in the EARLYTAVR trial, so can SAPIEN 3 Ultra RESILIA have that label expansion into asymptomatic as well? Sorry for the multi-parter there, but thank you.
That's the most amazing one-part question I've ever heard. So the expectation is that we would not get an approval next year for EARLYTAVR. We expect the data to come out at TCT, and we wouldn't expect to get the approval next year, so we think the benefit's largely gonna happen in 2025, again, assuming the data is compelling.
I will say, you know, this data set, it's, it's because of COVID and because of the other things, there's a lot of re-adjudication of events and bringing the patients back, and we really need to do a high-quality job of all the monitoring and all the other things, and that's why we're you know, we're planning to present it at TCT so that we have the appropriate amount of time to really make sure the data's all been completely reviewed and adjudicated and all those things are done. But it's also TCT is the biggest stage, you know, frankly. So we think that that's, that's an opportunity. The exclusivity of the indication is, is a fascinating one. On one hand, I wanna say, like: "Hey, look, I did all the work. I did all the effort.
I deserve exclusivity." But if we're also talking about changing guidelines, and really changing the course of medicine, you sort of almost have to say: "Hey, look, it's really a class effect." And the idea that, you know, if a patient came in and they were anatomically unfavorable for TAVR, then we're gonna say, "Wayne, you guys gotta wait until they have symptoms, but they can go forward with TAVR." I just don't know there's a good logic stream to that. I think it's the disease that's deadly, and I think whether we treat it with a transcatheter valve or whether we treat it with a surgical valve, I think what we're really focused on is treating earlier and more appropriately. So from that standpoint, I really believe that this is more about changing the guidelines than it is about anything else. And...
I'm focused on how we treat patients better, and ultimately, I think that's the best thing. And I think trying to go for an exclusive indication would be trying to turn this into a share play in terms instead of a helping patients play. And for me, it's all about how do we treat this disease better and more effectively? And if it grows the market broadly, you know, given our position, we'll disproportionately benefit, and that's what I think I care about the most. So I think, you know, that answers your second question, which I think it would cover our entire platform of products.
Matt?
Hi, Matt Miksic from Barclays. I have one question, one follow-up, if I could. So the first, on the way you've talked—you're talking about in-system and out-of-system patients now, and we've kind of been talking about those challenges for the last two or three years, and wondering what you're assuming for those strategies and contribute, you know, contributing to 2024 growth, if anything. And then also, in particular, kind of zooming in on the sort of underserved communities of that bigger market, maybe 30% of the population or something. Are those strategies gonna work there, or are there other things you're having to do there to make that?
Yeah, it's a great question. So for the in-system patients, I think what we're learning is. I think for a long time, our strategy, again, was sort of, I call it the air war, where we put enough data out in the world, and people just accept it and start reacting to it. I think one of our key learnings is that it hasn't. People just don't believe other people's data the way that they probably honestly should. And so now we've really switched that more to much more of a ground game, where we're working with individual systems and individual hospitals to run these programs and overlay the AI angle. And again, it takes time to scale, but our early pilots are super encouraging that, and that's why I can say definitively, I know the patients are there.
I don't. It's not an area of question anymore for us, and so it's just a matter of putting those systems in place. But then the next part about it is when they turn these prompts on, and we've seen this happen already, they turn the prop on, and it almost overwhelms the system. So now they have to, you know, do we need more valve clinic coordinators? Do we need more schedulers? Do we need more of these things? But it's sort of like a chicken and the egg thing with capacity. Do you wait until there's a need to build your capacity, or you just build capacity in advance of the need? And most hospitals, frankly, wait until, you know, they're pushed into adding capacity. And I think that's a little bit what's gonna play out, which is why it's gonna take time.
But, you know, if you look at our history, we've been adding more and more patients every year, and as our base gets bigger, we have to add more and more patients every year, and we're still confident that we're gonna see an acceleration and get back to double-digit growth over the long term, and it's a lot of these programs. In terms of underserved communities, it is something that feeds our growth, but it's something more that I just find to be completely just socially unacceptable in this country, that after 11 years of TAVR, only 4% of the TVT Registry is representative of Blacks. And it just speaks to a lot of things around reimbursement, around policy, but even how patients move through.
I think the more judgment there is, and not having TAVR programs that service these things, we have to build a network of hospitals that can address these communities and make sure that they get the care they need. You know, we ran a large study in former NFL players because we knew we would disproportionately pick up people of color to add to the natural history data that doesn't really exist because people of color aren't getting the product commercially. They're certainly not getting it in a clinical investigational setting. So we have to add to that knowledge base for a couple of reasons. But we have other active programs now where we're doing partnerships that get us out in the community, and what we can bring is our expertise on screening patients and evaluating them.
What we look for in partners is that they can bring their credibility in the community so that we can draw those patients in and demystify that. And that it's a marginal contributor to our growth, but it's just more like, we can do better than this. And I think part of our responsibility as running a successful company is we have to be givers to communities we live and work, and this is just an unacceptable situation that's gone on for far too long. And so it's just... I think it's an area of passion for all of us on the leadership team, that we just make this better.
Okay. Then one to follow up, if I could, just on, kind of like that, that capacity versus, some of the, the bullets that you've mentioned across a bunch of your markets have been headwinds and healthcare spending in 2024. I'm just wondering if that's, you know, concerns about coverage or if that's actual something to do with reimbursement. And we think of, we think of surgical and TAVR as kind of moving in lockstep. Are they still moving in lockstep, or is there some change in trajectory in terms of reimbursement for TAVR and SAVR?
You know, I think we've seen the system largely recover from COVID, but I will say we don't have the redundancies in the system we had pre-COVID. We still get more disrupted by vacations or, or those things than what we did previously. And as Daveen's new technologies come out and all of these things happen, I don't feel like TAVR competes as much with surgical resources. I feel like they're, they're pretty dedicated within the hospital systems for the most part. But I think, you know, as these new technologies come forward, one of the things Daveen and I partner on really closely is trying to work with hospitals to understand what the, what the capacity needs are, if they want to be leaders in these new therapies and the things that they're gonna have to do.
You know, if the leader of the TAVR program right now wants to be a leader in TAVR, he's gonna have to get a second team, you know, up to speed on TAVR. Most big hospitals, they have second teams and third teams, but they're gonna just have to be more efficient about how they triage patients through if they want to be leaders in these emerging new therapies.
But we feel like, you know, we are exiting the year and entering next year with a, with a very stable environment. You know, from a hospital's, you know, staffing standpoint, yes, we are leaner than what we were in a pre-COVID, but it is, you know, stable, so we feel it is a positive, you know, for us.
Yeah. We all wish there was more redundancy built into the system, I think, especially as they're building up more, but so when things, something, some kind of small shock happens, it'll affect things a little bit, but overall, to Bernard's point, we're definitely in a much more stable situation, which is nice to see.
... I'm sorry, but what then, what is the spending headwind, the healthcare spending headwind that you, you cited a few times throughout the presentation? All right.
I think it's just general pressure on reimbursement.
Okay.
We see that in different markets. But, you know, at the same time, you know, that I think that's a little bit more of a European thing probably, is where we probably see the most pressure on that, where people are most price sensitive. In the U.S., you know, we obviously went for a price increase for S3UR, and, you know, Wayne's whole strategy is premium products that come with our premium as well. And, you know, last time I checked, Abbott stuff's not that inexpensive. So, you know, I mean, we still believe the system will pay for quality if the evidence backs it, and that's why we spend so much time and energy generating the high-quality evidence that make people feel they're getting great value for their investment.
It's also a great cost-
Go ahead.
I was gonna say, like, to the point of hospitals running a little bit leaner, so they're always putting more pressure on right now, and especially as we bring new technologies, everyone sees the value, but they've created, you know, a system to try to bring it in-house. You go through the VAC committee, you go through the system because they're all running leaner, regardless of the therapy space. So it's just a consistent kind of headwind that we're working through, that's been around, and we work through, and Surgical's working through. Every business works through it. That's a part of it.
As an innovator, you know, we bring, you know, breakthrough technologies, premium technologies, you know, with a premium price that are bringing, you know, value to the entire healthcare system. Nevertheless, when you come with a premium price, you know, you get some, you know, you get some... You know, you need to do some explaining to the hospital system-
Sure
... you know, why your technology is having a higher price. We explain that we have, you know, we bring in a higher value to the patients and to the healthcare systems.
Rich.
Hi. Hi, Rich Newitter, Truist Securities. Thanks for taking the question and hosting the day. So maybe just to start, maybe for Scott, the guidance that you provided, anything that you'd call out between kind of first half 2024, second half 2024? You got a lot of considerations that I'm thinking about, just comps are kind of a little, you know, probably a little tougher in the first half. And then you mentioned that your guidance considered or contemplated competition, so I'd love to hear how and where, and then I have a follow-up.
Sure. Why don't I start on the overall company, and then on competition, it's probably related to TAVR, so I'll let Larry comment about what's going on there. The first half of 2024 will have very different comps, harder comps, higher comps than the second half of 2024. So recall in 2023, we had greater than 12% sales growth for Edwards in both Q1 and Q2, so higher, higher bar to clear, and as a result, probably expect an increasing year-over-year growth rate by quarter during 2024, or at least second half higher than first half. In terms of TAVR, Larry, do you wanna talk about competitive landscape?
Sure, yeah. Well, I mean, competition is certainly, you know, it's factored into our guidance, it's factored into our model. We do expect to see some impact from competitors launching new products. We have a new competitor coming, we anticipate in the U.S., you know, sort of late next year. So there's some impact of that, and, you know, we have deep respect for our competitors and for the work that they're doing in this space. At the same time, we, you know, we get benefit of a full year of pricing of S3UR, and, you know, so that's a little bit of an upside for us. But at the end of the day, it's all about market growth.
It's all about getting these patients off sideline and driving up the market, and that is the biggest thing that drives our guidance.
Got it. And if I could just ask one more. The comment that you made about critical care being 50-100 basis points accretive to your top-line growth, with respect to 2025 and 2026, you know, the 10%+ commentary on the top line, is that- are we to think that you can get to 10%, you know, without the spin, and that that's 50-100 basis points on top of that 10% floor? Or the 10%+ contemplates the benefit that you would get from the removal of the spin?
Let me start, let me start. We see the multiple catalysts. You know, critical care is one, but the biggest one are, again, you know, asymptomatic, EVOQUE, M3, you know, big technology, new technology, new indications, you know, coming for TAVR and TMTT. So it is, you know, all together where we are, you know, feel confident about, you know, the 10+, 2025 and 2026.
Yeah. But on pro forma for the separation, TAVR is 35% of the company. So, TAVR has to be growing, at a healthy levels to get to 10% or above, and we expect it will be. And complement that with everything that's going on with TMTT and the continued strong performance of Surgical, and we've got a lot of confidence about, trying to hit that goal.
David?
Dave, Dave Rescott with Baird. Thanks for taking the questions. Larry, I just wanted to follow up on your comments just on how you're expecting competition to come in, and maybe just attacking more from the pricing angle, how you're expecting in your longer term goals for pricing to be a factor in that. And then I have a follow-up.
Yeah, I think in the U.S., certainly, people have, I think, been pretty respectful of the market and the current pricing. There's certainly people that do some discounting, and they try to sort of lead with price. But I think, you know, we're very fortunate in this country that people still focus on outcomes, and outcomes matter. And I think that, you know, people truly want the best product for their patients, and so I don't think we're as price sensitive in the US as we are in other markets. And it's not to say that price doesn't matter, because it does, but I don't think, you know, a $1,000 discount is gonna move somebody off of a platform that they fundamentally believe is better for their patients.
... And then just to follow up on, from a higher level, I appreciate that you guided or reiterated kind of the $10 billion by 2028 for TAVR. I think at the last analyst day, you called out $5 billion for TMTT. I'm just wondering if, what went into the decision maybe to not include that in this presentation, and whether or not that's a change in the way you think about the market or the way that you help all of us just think about that market. Thank you.
Navin, you want to take it?
Yeah, I'll take that one, definitely. You know, as I mentioned, right, ultimately, right, there are millions of patients suffering from mitral and tricuspid disease. And so we believe over the long term, the opportunity is way beyond $5 billion. But we know, the creation of new therapies, it's never linear. It's always lumpy, it's always changing directions. As I mentioned before, you know, in the couple of years of COVID, we saw that the mitral TEER market, the one existing market, definitely grew at a much slower rate than we'd expected. And also the creation of the rest of the TMTT market, talk about tricuspid, talk about mitral, didn't go as fast as we want to.
But now that we've gotten out, we're seeing both the mitral TEER market continuing to go, and we're also seeing that the tricuspid market's at the start, the revolutionary start of it. Mitral replacement is coming soon after. So we ultimately believe that, yes, we're gonna get to an amazing tricuspid market with both PASCAL and EVOQUE that's gonna be differentiating, create this great market. We definitely believe that mitral TEERs continue to grow very heavily with PASCAL, is gonna continue to accelerate and grow, hopefully above market there. And we see that mitral replacement is gonna come online as well and be another additive thing. When you take all these pieces, yeah, we're not quite sure what the number they all add up to, so we didn't update our 2028 number.
We expect, especially now, hey, we get through a full year of EVOQUE and understanding how the revolution of of tricuspid is gonna take off, that a year from now we'll be able to give you a better number. We just we don't have it now because we think we just see a lot more hazy you know, uncertainty based on how fast each of these markets grow. But we're excited for the opportunity for patients. I know, Scott, looks like you want to say something on that.
I was just nodding in agreement.
Oh, nodding.
Good explanation.
There you go. I like that.
Thank you.
Jason, did you have a question?
Jayson Bedford from Raymond James. I guess maybe for Daveen, can you frame the initial market size for EVOQUE upon approval, and then just the strategy for indication expansion?
Can I frame it? Well, it's an initial market where today there's very few people being treated for tricuspid disease. There's a very small number being done with surgery, whether mostly very few isolated, like they're in the U.S., it's 2,000 isolated patients, right? Very, for tricuspid-
Probably around there.
... and a handful more would think. But those are - that's not really the patient group we're looking at. And there's a handful of off-label patients sometimes being done. That always exists. So it. We know, though, that from our trials, especially TRISCEND 2, we saw really fast enrollment, and we saw really fast enrollment, like PARTNER 1 levels enrollment. So we know the patients are there. So how - the exact number of patients already in the system, hard to get, but we do have this really nice gauge that there is a lot of, there is a lot of interest in technology. I was at, I was at London Valves literally a couple of weeks ago, right? And that's the first time we had EVOQUE there at a, at our booth, right? Public in a booth.
There was, like, a line of physicians to, like, see the new technology. That tells you there's, there's definitely interest. And so for us, obviously, the focus really for the European launch now and the US launch we get there is just, you know, kind of training center at a time, building up, helping centers continue to create or expand their tricuspid referral program. Because if you're in Europe right now, you already have some tricuspid referral program from the recent launches of TEER and Tricuspid, but this is an opportunity to really grow it. In the US, there aren't a lot of strong tricuspid referral centers. There are some that come from people who are in the trial, et cetera, but that's got to be built up as well. So that's kind of how we see the, the expansion of the therapy.
I think you mentioned indication expansion as well for tricuspid. With Europe right now, we have an indication for commercially unsuitable products, so surgery, surgical and TEER and eligible products. We're excited by our one-year dataset, our trial in the U.S., the big randomized patient trial is for severe tricuspid regurgitation. So we think we'll see what that means for a US indication. But in Europe, I think that dataset is really important for us to continue to have a broad indication with EVOQUE because we didn't have that dataset, or the full dataset when we submitted in Europe and got that approval. Does that kind of answer what you're getting at? I know it's kind of a-
Yeah, I was looking for a few numbers, but that's fine.
Suraj.
Suraj Kalia, Oppenheimer. So one question for Larry and a follow-up for Navin. Larry, I just want to piggyback on what the other Larry asked. In your slides, you mentioned compelling data in early TAVR. So in severe symptomatic SSAS, we know the penetration, let's say it's 13%. I know a few years ago, you all had given numbers of 650,000 as the total market. We know the challenges, you know, so on and so forth. In your mind, and also for early TAVR, I don't think so we are gonna get an indication, correct me if I'm wrong, progression to symptomaticity. So what does compelling data mean in your mind for early TAVR, you know, to jumpstart? And I understand the AI part, but specifically in data, what would compelling mean?
Well, I think there are several different options for what could be compelling. If we start stress testing these patients, and it turns out none of them are truly asymptomatic when they're properly stressed, and so few patients get stress tested, then that would sort of say, why are we, why are we going through this whole process? If people crossed over very quickly, if they had a very quick progression time, you know, and right now, the guidelines, they follow these patients annually, then you're basically saying these patients are going to get missed, you know, when they, when they come through. I think the other thing is, you know, do bad things happen to patients while they're waiting? Do they have events? Do they have clinical events? Do things happen to them?
So I think there's many, many different ways the data can be compelling, and we're just going to have to wait to see the data set. But as I talked before, I think the benefits to getting the asymptomatic indication or changing the mindset in terms of when patients could get referred, is also going to have an impact on patients with mild symptoms. I think there's a lot of patients that are sitting there with mild symptoms, and they're just older, and they're slowing down a little, but their doctor doesn't feel they're ready for the intervention yet. I think it'll take those patients off the table.
I think when you think about layering over this AI, it's always going to have a limitation if you're layering over the AI, but there's still somebody has to look at the patient and judge their symptoms in between before they get the referral. If we take symptoms off the table for that and say, "No, symptoms shouldn't play a role in the diagnosis," then you can literally just look at their medical record and say, A plus B equals C, they should get referred, and they should go. And so I think it enables a lot of that activity, and that's why I think the trial is important. But I think there's a number of ways the data can be compelling.
One follow-up for Devine. Devine, EVOQUE mid 2024 launch, which timeline is pulled up. So the data is going to come after you've you guys have started launching. Maybe just walk us in terms of how you think about the imaging component for EVOQUE and also the reimbursement framework as you all start launching in the second half of 2024. Thank you.
Yeah, I'll. There's several. Yes, the one-year primary data set, the full complete data set we expect in TCT, so we do expect approval before that. So that is true. Yes, right side of the right side of the heart, right? The tricuspid side is different and imaging and a little bit more challenging than the left side of the heart. That's a fact. So I got this question in the last night for the folks. The expertise requires buildup of expertise over time. So when we worked with a lot of centers in the TRISCEND trial or the CLASP II TR side, we're working with them and helping understand how to image the right side of the heart when doing the intervention. So that's a newer skill.
And, our teams with EVOQUE, like when we first started doing this therapy, you know, four or five years ago, we helped create a lot of this stuff. So it's awesome. It's fascinating. So we have a way we know how to do it, we have a way we can help train centers, and we've seen that it can be effective from not only the trial sites in the U.S. through EVOQUE or Class II TR, but from our European, PASCAL experience as well. So that's been cool to go through and see that kind of occur. Switching over to reimbursement, if you think about payment, right? So it is, we've already applied for a new technology add-on payment, so that was, that's public information. You look on the website.
And so, if that were to occur in the, in the right timeline, we expect in-time incremental payment going to a hospital based on all these equations of cost, et cetera, which starts normally October 1st of, of the fiscal year. So that'd be an October 1st kind of start. So that's kind of the payment, but otherwise, luckily, our therapies, as they were in the trial, they're under the existing DRG. So there is a hospital payment. They're not getting something. They're getting the, the existing TAVR kind of payment scheme, so they are getting a, a good chunk of money to help pay for it, and we do have physician coding in place for that as well. So, you know, so we feel pretty good about that, and we're continuing to work at it.
Maybe, you know, small things, you know, to add on the imaging front, you know, the requirement for imaging for EVOQUE and the replacement-
Yeah
... is, you know, way easier-
That's right
than the imaging requirement for a TEER in the tricuspid, you know, position. So we have seen that, you know, in most of the cases with EVOQUE, you know, the, the physicians are able, you know, to, to conduct, you know, the procedure in an hour on average. And again, you know, all of these, you know, cases were, you know, very early, correct? You know, we didn't have any experience. So an hour for something new, a new technology, compared to tricuspid TEER, usually it is taking, you know, longer. So imaging requirement for tricuspid replacement easier than a tricuspid TEER.
I'll even add in the one other point is the variability is less, and that's actually a key point because in tricuspid TEER, right, you can sometimes get these difficult cases where you're trying to grasp the leaflets, and so that adds a lot of time. In the predictability, right, predictability of EVOQUE, where the standard deviation of time, we believe is, from the data we've seen, is much more narrow. It'll allow hospitals and cath labs to be more efficient. So you could, "Hey, I got a couple of TAVRs, and I can do an EVOQUE, too." And you're not like: Oh, I got to block off the whole afternoon in case this case goes long. I don't want to plan that other case. So that's the, the predictability component of that relatively short time is a nice benefit with replacement.
I will say we've really learned that in the TAVR space.
Yeah.
When we first started TAVR, people would only schedule two cases a day. They'd schedule one in the morning and one in the afternoon. And it wasn't because every case took three or four hours, it's because they didn't know whether the case was going to take 45 minutes or whether it was going to take two hours. And if your first case ends up taking three times as long as you thought, it screws up all of the scheduling for the whole rest of the day, and you have patients in the hospitals, and they need to move through in a certain cadence. When we got to...
You know, especially with SAPIEN 3, when we got to an incredibly predictable procedure, we have many, many centers in the country that are stacking five, six, seven cases in a day because they, they know every case is going to be done in 40 minutes to 1 hour, and they can schedule their time very, very reliably. And so that's, I think, one of the real advantages that EVOQUE has, where TEER still has a wider variable amount of time than it takes to do those cases, and, and I think it helps them stack cases.
When we were still in trial, we had a day there was three cases done, you know, in trials. Like, that's awesome. Like, it's predictable.
Shagun?
... Shagun Singh, RBC Capital. Larry, a couple of questions for you. Firstly, just on TAVR, I think you guys specifically alluded to the low end of growth in 2023, 10%-13%, versus prior commentary of 10%-13%. You may have talked about it on the Q3 call, but just any color on Q4, you know, how things are trending. On asymptomatic early TAVR, can you talk about your specific strategy for patient identification? You did allude to it, but I'm just thinking about the ramp, and is this going to be a harder population to tap into versus low risk? And then just the last one on TAVR, with respect to progress, you know, obviously, you've pulled forward the timelines there.
What is now assumed in that $10 billion number, in 2028, for asymptomatic as well as moderate AS?
You guys ask the best questions. But as it relates to guidance and Q4 color, I'm gonna turn to the guy on my left 'cause I'd like to keep my job.
So-
Yeah. So go ahead.
So, I mentioned, we're on track with the expectation that was baked into our guidance for Q4. As a result of that being on track, TAVR specifically will come in for the full year at the low end of 10%-13%. It's consistent with the expectation when we provided guidance for Q4.
So for early TAVR, for the patient identification, you know, we leaned on our clinical trial sites, and, you know, they have patients that get referred to them, and they have an echo. There's a lot of reasons the patients might get referred for an echo, and they identify that they have aortic stenosis, but the patient just doesn't isn't exhibiting symptoms yet. And there's a lot of patients that are being held in the queue, awaiting symptoms. And so that's largely where we drew from, from the early TAVR trial. I think long term, though, that's not the strategy.
I think long term, the strategy is, again, applying this overlay of AI, extracting this data, taking all the judgment out, and then just these patients being able to move directly to a heart team for assessment. And I think taking... You know, every link in the chain is an opportunity for people to fall out and for bad things to happen, and especially when you ask people to apply judgment, especially in an elderly patient that may have other comorbidities. Taking that judgment off the table, we think, just streamlines the entire process, and it takes a big, you know, it patches a big hole in the bucket where I think people where we see a lot of leakage.
In terms of the $10+ billion, you know, we do see progress coming in very late in the strategic plan period, so there's a little bit of that, but it's not. I wouldn't call it the primary driver.
Bill?
Thanks. Bill Plovanic, Canaccord. So, conceptually, I get the in-system strategy that you're putting in place, but I was wondering, executionally, you know, how long does it take you? You've got 850 centers ± in the U.S. You've got to get in there, and you'll get them to agree to look at the data. How long does it take? First, how long does it take to get them to agree to that? Secondly, how long does it take to look at the data? And then third, to implement the AI, you're gonna flow over the top and get through the, you know, all the tech and back-end stuff. You know, is this something that, you know, you think you'll be able to execute within... Is this a, a five-year project? Is this a two-year project?
How should we think about that and the kind of role of that into the numbers? That's it for me. Thanks.
Well, it really is just that easy. It's, I think it depends a lot on the hospital system. I will say we have some hospital systems that they see the data coming out, and when we engage with them, they're asking questions, and they're kinda like, "We're worried maybe we're not doing as good a job as we think. How can we work together, and how can we do that?" And we can get pilots off the ground pretty quickly, and we have some good partners that we've been doing that. I think there's other centers that have their head in the ground. I think there's the issue of once you do turn it on, then they have to really start adding the capacity, and they really have to start adding those things.
I think what we're gonna see is we're gonna see some—like we do with a lot of therapies, we're gonna see some really early adopters that are gonna say: "We're gonna change this. We're gonna get ahead of that quality metric. We want this to be a, you know, a real campaign that we have, that we treat X number of patients under that 90-day window." And then there's gonna be some people that are gonna get straggled along. So I don't think it's gonna be a light switch. I think it's gonna be more like a dimmer switch that we'll continually turn on. But I also think that—you know, we're not gonna see, like, one bolus of it, and then it's over. I think it's gonna be something that's gonna continually defeat our growth over the next several years.
But I'm, I'm very encouraged where the pilots are, and again, I, I don't think you guys have ever heard me be so definitive about, "I know the patients are there." That is a reflection of the pilots that we have run, and in every single place that we've run the pilot, we have not found one single example where they've treated 90% of their patients, and they do it within, within 30 days of diagnosis. We haven't found one single example of that. All of the examples are on the other end of the spectrum, and, and that's why I have conviction that we're on the right path.
I think the biggest learning for us that's different maybe than what we've talked about in the past, is we thought evidence generation and just showing this to the world and the Lindman study and all this other study, that would be enough to make people self-reflective, and it's just not.
Yeah. But you think, though, Larry, you know, we have plenty of learnings. We know what we have to do. Larry, as a team, you know, to execute the plan here, so we feel confident. The patients are there, and we know what to do. This is what is giving us, you know, confidence here.
Rick?
Rick Wise, Stifel. A follow-up question, maybe for Daveen. Daveen, I was lucky enough to spend some time with the M3 team last night, and it seems like... I don't know, I'm not smart enough to know, but the M3 seems more credible now and sort of ready for prime time. I was hoping you'd talk a little bit about how the technology's evolved, where we are now, from that perspective, and maybe your latest thinking about the potential population to be addressed with this version. I appreciate the trial is gonna happen, the data is gonna be good or not. Hopefully, it'll be good, and there'll be an initial indication, but... You know, is replacement back because of M3 now?
Maybe, you know, for the technology side of things, because it was developed, you know, within, you know, the TAVR, you know, business unit, it is best, you know, for Larry to talk about that, then Daveen can talk about the indication.
Okay.
Yeah. Yeah, so, you know, we've learned a tremendous amount. I mean, I think everybody's figured out that mitral replacement's probably been a little bit more challenging than what people thought initially. You know, the thing that was really attractive about M3 for us is there's no mystery of the valve platform. So we've had indication for treating mitral valve-in-valve. We've had indications for treating mitral valve-in-ring, and we also have had clinical trials going on for treating mitral valve-in-MAC. So for patients that are not surgical candidates due to mitral annular calcification. So we know that our valve performs really well in the mitral position, and all of those procedures require transseptal delivery and putting the valve in either the diseased surgical valve or in the ring or in the MAC patient.
So that part of the procedure is all known, and it gets done all over the country, literally every day. What we had to do was we had to figure out how to get the doc there, and how to get the doc there repeatably and reliably. And, you know, a little bit of the learnings are, you know, once TEER got approved, that changed the patient population, the substrate that we were working in, 'cause there was-- became more TEER-ineligible patients than eligible patients. And so I think we've got the doc to a place that it's, it's commercializable. And, and I think it, it's-- You know, we're very pleased with how it's gone.
The fact that we enrolled a 300+ patient trial, in the timeframe that we did it, I think is incredibly encouraging, and I think that speaks to the confidence that clinicians have in the procedure, that it's a good procedure for their patients. You know, obviously, we need to see the results from that trial. But, you know, Daveen can talk about how, you know, we sort of integrate the mitral patient and figure out, you know, what the best therapy is for that patient, and that is gonna define really what the split is between replacement and repair.
Well, I mean, ultimately, right, if you see this trial, it's a single-arm trial done with TEER and surgery in eligible patients, and it enrolled very well. So the reality is, mitral TEER today is a fantastic therapy. It's gotten better and better over a decade as a therapy, and it continues to get refined. But the reality is, even with that, there are still tons of patients who are TEER ineligible, and that's why the initial indication for us is this TEER ineligible indication. We were able to enroll in a single arm, and we're able to hopefully efficiently get it to market and get great results.
Over time, though, we'll see that as mitral replacement, as a therapy continues to evolve, as technologies, M3 is, as Larry said, already a lot of iterations in, and we've still got more iterations we're working on, just like every technology we got. We're always working on new iterations. As it continues to evolve, we'll then see, hey, is this technology right for other types of trials, other types of trials some of our competitors may be doing in the mitral space, or where other patient groups make the most sense? So I'm confident that mitral replacement is gonna add a lot of patients to the pool. Where it then goes, we'll see as we continue to get this in the marketplace, get more usage, and understand what does the technology need to be to continue to expand.
We know it'll expand. We know we'll keep doing iterations. We know we'll keep getting better at the technology. I so hope that kind of helps.
Yeah. Thank you.
Oh, thanks, Rick.
Probably time for one more question. All right, two. Danielle and then Joanne.
Thank you so much. Just a quick question on valve-in-valve, actually, because that's starting to become a topic. I know we don't have a ton of data yet with TAVR and TAVR, but we have a lot in TAVR and in surgical valves. So just curious about what, how you guys are thinking about that through the 2028 timeframe, and how incremental that could be to that $10 billion number.
Oh, it's a great observation, Danielle. We expect valve-in-valve to be an increasing contributor over time, and I think one of the things that we saw in the surgical space is when TAVR got approved and people saw the potential to do TAV and SAV, we saw a shift, even more of a shift from mechanical valves to biologic valves because patients can come back for valve-in-valve, and a lot of those went into much younger patients. And so, that's the whole design proposition for INSPIRIS, is if you're going to do surgery on a patient at a younger age, make sure that they're a good candidate, you know, for lifetime management. I talk about lifetime management in TAVR, but I don't think the equation's really any different in surgery.
You got to put, get a great index procedure, but then how do you, you know, give them a durable outcome, but then how do you manage that patient when they come back? TAV-in-TAV is going to be the next, you know, the next horizon. Now that we have, you know, we've had low-risk approval now for seven years, as those patients live longer and longer and outlive their valves, we think TAV-in-TAV is, is an important part of our future. I, I will say, you know, from an R&D standpoint, as we've evolved over time, you know, our 100% focus back, you know, 15 years ago, was just get the patient through that index procedure, and we were about improving that index procedure. Now, you think about our platform development, it's about how do we have a great platform for the index procedure?
How do we make sure it's a great host valve for that next procedure? And then how do we make sure it's a great guest, you know, for that next procedure that comes along, and maintain all the versatility of our platform, that we can do pulmonic, we can do valve-in-valve, we can do M3, we can do all these things with it. And that versatility of our platform, I think, is one of our real strengths.
Joanne.
Thank you. This may seem a silly question, given how much you have going on in terms of clinical trials. Why is 17%-18% the right percentage of revenue to have? And, is there a moment in time where you say, "Let's lean in and make it higher," or a moment of time where you say, "You know what? We've invested a lot, particularly as our revenue base goes higher?
Yeah, I can. I can start with that. Okay, go.
Thank you.
So, look, our screen is always: What can we do to drive long-term, organic, durable growth? And we build the R&D portfolio around that. Our belief is that over time, we're going to have sufficient capacity to both accommodate additional clinical trial activity for our current valvular structural heart businesses, as well as accommodate investments and trialing in other adjacencies, like the structural heart failure initiatives that we talked about. 17%-18% is current. You know, I can see it trending down from there over time. It's not guidance. It's just an observation that we expect our top line to outgrow our spend over time. Thank you, Scott. So with that, you know, let me close, you know, the meeting. You know, thanks, you know, to all of you who come all the way to California.
I hope you enjoyed last night. I hope you enjoyed, you know, today. I think, you know, it is, I believe, an exciting day, you know, for Edwards and for our employees. You know, we never want to close a meeting, you know, without having a video, a patient video, because it is a great reminder of our work. Thank you so much again, you know, for coming, and we are going to have lunch together.