Good morning, everyone. Thank you very much for joining us. I know it's a busy day for healthcare investors and med tech analysts, but I appreciate you taking the time to be with us. I'm Mark Wilterding, Head of Investor Relations and FP&A here at Edwards Lifesciences, and we've got a really exciting event planned for you today. We've got some presentations from all of our group leaders. We've got a panel where you'll hear from a physician and a clinician as well. And we've got a number of highlights across our product portfolio that we'll share with you. So for those of you who are in the room, you'll see a card in front of you. You can scan that and get access to the slides, as well as for those of you who are online, they are available on our website at ir.edwards.com.
Please take a minute to familiarize yourself with the important slide behind me. During today's event, we will be making forward-looking statements, and it is possible that actual results will differ from our expectations. For more information, please refer to our Investor Day presentation and our latest SEC filings. We'll also discuss our non-GAAP financial measures regarding our performance. Our SEC filings, along with our reconciliation of any non-GAAP financial measures utilized to the most comparable GAAP measures, are available also on our website at ir.edwards.com. So with that, thank you once again for your interest in Edwards. Really appreciate you all being here, and we hope that you enjoyed today's event. With that, I'm pleased to introduce our CEO, Bernard Zovighian.
Thank you, Mark. Good morning, everyone. Thanks for joining us. We appreciate and we value the interest you have in Edwards. I'm super excited about sharing our vision for next year, 2025, but also about the long term. Let me start by saying how proud I am of leading this amazing company. You know as well, we have a very unique innovation strategy, and it is around three key elements. We are focusing on very large and complex unmet patient needs. We like to go first. We like to bring breakthrough innovations in order to create and basically define new therapeutic categories. So when I mean category, I mean category like TAVR, category like tricuspid replacement. And this puts us in a very strong position to deliver sustainable long-term growth.
Now, what I want to talk about first is the opportunity we have in front of us, and it is quite an opportunity. So we have made many, many strategic decisions over the years. It started with our long-term commitment to innovation, the funding of TMTT more than seven, eight years ago, the sale of critical care this year, together with the four acquisitions we did in 2024. So all of that expanded our reach, and we are now reaching a broad base of patients between aortic, mitral, tricuspid, aortic, and structural heart failure. Each one of these is large and growing with millions of patients. In addition to being large, it is very tough on the patients. They are facing a very high mortality and a terrible quality of life. It is also tough on the healthcare system, a significant burden and cost.
We believe that the company Edwards is uniquely positioned to lead for many reasons. We bring breakthrough technologies, and we have these very unique and large and the most comprehensive portfolio of technologies. How do we do that? Our deep expertise and commitment based on 65 years of surgical category leadership, 20 years of TAVR category leadership, and us being the pioneer in tricuspid replacement. Now, one of the main benefits when Edwards lead, it is to the patient. They suddenly have access to a range of lifesaving therapies that we didn't have before. Let me tell you a little bit about the company we are today, a very special company. I like to start with our culture: 16,000 employees completely dedicated to the patients. We have a global reach. We are present across more than 100 countries. We have a very strong supply chain, very resilient.
Even during the tougher time, I'm sure every one of us remembers COVID. We didn't have any disruption when many, many companies had supply chain disruptions. We have had consistent, strong financial performance over the last 24 years, and together, the 16,000 employees, we care about elevating the standard of care for patients. Innovation is in our DNA, and we do it in a very unique manner. First, we have a long-term commitment, so we start with large unmet patient needs. We bring a concept, then another concept. It is a very iterative process, and then when we are ready, we launch Gen One. But after Gen One, we continue to innovate, and it is again an iterative process for lifetime management, so think about it. Today, with the SAPIEN platform, Ultra RESILIA is Gen Five, so this is very complex, and it requires commitment, expertise, and investment.
Two, we are not afraid to take risks, be agile. And very often, multi-shots on goal is required. And this is why we have a strong pipeline, diverse pipeline, and healthy R&D investment. Three, we lead with science, high-quality science. We have more than 10,000 patents, more than 1,000 publications, 10 FDA-approved studies published in the New England Journal of Medicine. FDA-approved study means what? Means that this is the highest level of scientific rigor. Not all studies are the same. Four, we have a very deep stakeholder relationship: providers, payers, policymakers, regulators, physicians, to make sure that we bring this lifesaving solution to patients. And all of that together enables us to be the pioneer, the leader we are today, where 95% of our technologies are category-leading. What I like to do now is look back at 2024.
It is my second year as CEO, and boy, it has been a busy year. We achieved a lot. I'm super proud of the team. Two things, though, let me start over. It didn't go the way we wanted. Obviously, the TAVR growth was below expectation, and the performance of the stock was disappointing. But I am pleased about so many things, so for instance, we are on track to deliver on our original total company sales growth guidance of 8%-10% that we gave you in December 2023. And different mix, and this is only possible because we have today two growth drivers in the company: TAVR and TMTT. This would not have been possible a year ago, two years ago, three years ago. And for instance, also the strategic sale of critical care.
In addition to the sale of critical care, about 5,000 employees left Edwards to go to BD. We right-sized the company. We also continue to be a heavy investor in structural heart disease: $1 billion internally, $1.6 billion externally, and our return on our R&D investment is above average, above 20%. Also, very exciting about our category-leading technology, ultra-resilient EVOQUE, that we are launching in the last few months. Finally, at TCT this year, two practice-changing publications: TRISCEND II and EARLY TAVR, so in summary for 2024, we are exiting the year in a very strong position in my mind. We have now three growth drivers: TAVR, mitral, and tricuspid, and two significant emerging opportunities. One of the reasons we are so excited about our future is the fact that now we have diversified sources of growth.
Surgical, our $1 billion historical leading business is positioned to grow in a consistent fashion. TAVR was a growth driver, is a growth driver, will remain a growth driver. Very excited about mitral and tricuspid, which are becoming more of a source of growth for the company. A new emerging opportunity with structural heart failure and AR, with a lot of potential here. In addition, you know as well also, we have been significant investors internally and externally in the past. We will continue to do so. But when we are going to do so, there are a few things that matter. The first one is the strategic fit, structural heart disease. The second one is about long-term value creation. Now, each business has meaningful, significant catalysts. So for instance, TAVR, the foundation of TAVR is what? A leading technology, a leading platform.
But now, with this practice-changing trial result, EARLY TAVR, which will impact 2025 and 2026. And with the expected success of PROGRESS, this could impact 2027 and 2028. So in TAVR, when people ask me, "Is it a mature business?" I say, "Absolutely not." We have many years of growth ahead of us. In TMTT, we are the only company with a portfolio: PASCAL, EVOQUE, and the launch of SAPIEN M3 this year and next year in Europe, and the year after in the US. So here, what you can expect is multi-years of growth from TMTT. Surgical will continue to extend its leadership globally. And structural heart failure and AR, these two business groups have a potential to transform care for many patients in need. So let's go into 2025.
In my mind, 2025 will be a year of strong financial performance, led by this diversified source of growth in TAVR, mitral, and tricuspid. We expect the total company to grow between 8% and 10%. We maintain the TAVR guidance growth between 5% and 7%. We are assuming early TAVR approval in mid-2025. TMTT will continue. We expect to continue with rapid expansion to grow again to 50%-60% sales growth in the next year. So TMTT is starting to be now a big business for us. $500 million plus next year, that's a big business. So clearly here, you see the impact of our strategy. We're moving critical care sales with structural heart businesses with higher growth potential and better strategic fit. EPS $2.40-$2.50, which is a strong base for double-digit earnings growth in 2026 and beyond.
So summary for 2025: set to be a strong year, the first year as a solely focused structural heart company, but also setting the stage for sustainable, long-term, profitable growth. Let's now look at beyond 2025, and we have a number of additional catalysts to accelerate growth for Edwards. Let me give you an example about just a few things that will happen in 2026. It will be the first full year of the early TAVR contribution, after having had an indication approval, potentially some guideline changes that Larry is going to talk about. Also, the PROGRESS readout in 2026 at TCT. For TMTT, the U.S. launch of SAPIEN M3, the continuation of PASCAL and EVOQUE adoption, the acceleration of Cordella for implantable heart failure management. So as a result of all of this for 2026 and beyond, this is the kind of sales growth guidance that we can expect.
TAVR accelerating from 5 to 7 to mid- to high single-digit growth. TMTT continuing to have an increased contribution to Edwards' growth year over year, targeting $2 billion by 2030. Surgical maintaining a healthy mid-single-digit growth, and structural heart failure and TAVR AR increasing contribution to Edwards' growth. So in summary for 2026 and beyond, it will be super exciting for the company. We believe we are targeting 10% average annual total company growth. We feel it is achievable, realistic. But like in the past, though, I'm sure we will experience some variability year over year based on timing of catalysts. So for example, timing of NCD, timing of approval, timing of study readouts. But in addition to this acceleration on the top line, double-digit EPS growth, so showing a meaningful and nice leverage. So in closing, we are confident in our strategy.
Structural heart is a large and growing space with millions of patients in need. We are uniquely positioned to bring a portfolio of lifesaving solutions to physicians and their patients. 2025 will be a strong year with three growth drivers: TAVR, mitral, and tricuspid. 2026 and beyond, even more exciting with the addition of two emerging opportunities. All of that positioning us for long-term, sustainable, and profitable growth and shareholder value creation. So let's talk about now today's conference, starting with the leadership team of our team. I'm very proud of our executive team. They are very experienced, deep expertise. We welcome a few new leaders, as you can see on the slide. And all together, we know the company well. We are fully aligned on the strategy. What truly differentiates us is how well we work as a team.
Today, you are going to hear from some of them, including our newest member, Diane Gomez-Thinnes, who is leading our newly implantable heart failure management business. She's a tenured executive with digital experience, which will be important for these new business groups. What we prepared for you is a very exciting agenda. The business leaders will go deeper into the many opportunities we have in 2025 and beyond. You are also going to hear important clinical perspectives from Dr. Mike Mack that everybody knows and Carrie Reddick, so now let me introduce you to the next presentation. As we enter 2025, solely focusing on structural heart disease, we think it is important to provide a perspective on the burden of structural heart disease, and I have asked Todd Brinton to provide that perspective. He has a very unique background.
He's an interventional cardiologist, an innovator, an engineer, and the chief scientific officer of the company. With that, Todd, please welcome to the stage.
All right. Thank you very much, Bernard. All right. Good morning. It's a pleasure to be with all of you. Now, Bernard just described the significance of structural heart disease and Edwards' plan to respond to that challenge. I'd like to take a few minutes to offer you a perspective on how I approach the enormity of structural heart disease as a clinician, as a scientist, as an engineer. I want you to think about it as these are the needs out there of which we're targeting at Edwards Lifesciences. Now, I've come to know that the burden of structural heart disease is quite significant. Keep in mind that the increasing population age drives the incidence of structural heart disease.
Over time, as structural heart disease goes untreated, patients enter an aggressive downward spiral, which can be seen demonstrated on this slide. As the chronic nature of the disease persists, it leads to rapid deterioration in the quality of life as well as additional damage to their heart. As the quality of life continues to decrease, structural heart disease is accompanied by hospitalization. In fact, structural heart disease is the number one cause of hospitalization in the middle-aged population, which drives an immense burden and, in fact, the number one cost to the healthcare system. Now, structural heart disease is comprised of valvular heart disease. I'm sure most of you know that. We can think about that as it's separated into two groups. We'll start with one.
The first is valvular stiffening, such as aortic stenosis, which is caused by calcification of the leaflets, reduction in valve mobility, and reduction in the affected orifice area. The other is thought of as enlargement of the valve annulus, such as in functional mitral regurgitation. This is the result of enlargement of the left ventricle, which pulls the valve annulus apart. Now, what you may not think about, what isn't obvious, is structural heart disease is also comprised of non-valvular disease. Non-valvular structural heart disease can be categorized in the same category: stiffening and enlargement. When the ventricle stiffens, like in heart failure with preserved ejection fraction, we see impaired relaxation and filling. When the ventricle enlarges, like in heart failure with reduced ejection fraction, we see impaired pumping. Now, both of these structural abnormalities are ultimately the result of coronary disease, hypertension, diabetes, obesity, or a combination.
But we're talking about the impact on the structure. So, in fact, one structural defect can lead to another. Whether it's non-valvular defect leading to a valvular defect or vice versa, the abnormalities of structural heart disease can be interlinked. In fact, they can be paired. So, as structural heart disease progresses, patients develop heart failure. In fact, heart failure is the common pathway for untreated structural heart disease. However, patients and care providers experience heart failure very, very differently. Let's talk first about the patient. Patients experience clinical symptoms of the disease. What does that look like? Looks like shortness of breath, fatigue, swelling of the lower extremities, or even the abdomen.
Whereas physicians actually experience the signs, and they think of the signs of structural heart disease through their physical exam, such as a murmur on auscultation, blood tests, biomarkers that might be positive for impact on the heart, or potentially defects of the heart valves or the chambers on imaging, such as an echocardiogram and CT. But, in fact, guidelines globally have reached a consensus. The two most prominent heart failure guideline committees from the American Heart Association and the European Society of Cardiology committees clearly define heart failure as a complex clinical syndrome with symptoms and signs that both result from structural or functional impairment of the ventricle filling or ejection of blood. So, as a result, structural heart disease in its entirety is the most common cause of heart failure globally. That's the connection.
To illustrate the impact and potential for multiple abnormalities with structural heart disease, I want to introduce you to two patients. The first is Paul. All right. Paul is a 72-year-old male who has a long-standing history of hypertension. Besides taking his hypertension medication, his cholesterol medication, he's been doing great, except for nagging knee problems, which have progressed into severe debilitating knee pain. He's been quite limited because of his knees and has been unable to participate in regular activities. Paul has been evaluated by an orthopedic surgeon and has been offered knee replacement surgery. But as a result of his risk factors and his advanced age, he must be evaluated by a cardiologist because of the risk of anesthesia for his knee surgery. As part of that evaluation, and this is very common, the cardiologist orders an echocardiogram, and the results were very surprising.
Despite the fact that he has no heart disease symptoms, Paul has a stiffened aortic valve with an effective orifice area of less than 1 centimeter and a gradient across the valve of greater than 40 millimeters of mercury, consistent with severe aortic stenosis. What does that mean? It means he needs to have his valve treated before he can actually have the surgery for his knees. A very common presentation for patients. Now, let's talk about Sally. Sally is a 65-year-old woman who until recently has been taking care of her daughter's 5-year-old grandson. She has a long-standing history of hypertension and ischemic heart disease. But Sally has noticed that no matter how she does, she cannot seem to keep up with enough energy to watch her grandson and recently noticed new swelling in her lower extremities.
As a result of her progressive symptoms, she's been admitted to the hospital. Upon admission to the hospital, an echocardiogram again was performed to demonstrate an enlarged left ventricle, elevated left atrial pressure, and a reduced ejection fraction, which is typical of heart failure with reduced ejection fraction, something we see every day in the hospital. But Sally actually has a pair of structural abnormalities. Just like up to 60% of patients with enlarged left ventricles, the mitral annulus is enlarged, which is evident by an EROA of 0.35 square centimeters and results in grade 4 mitral regurgitation. Sally has a diagnosis of multiple structural abnormalities, which require treatment. Both require treatment, demonstrating that patients can present with two abnormalities at the same time. Now, what physicians need to help these patients is a partnership to help address the complexity of structural heart disease.
Whether a patient presents with a singular abnormality such as aortic stenosis, mitral regurgitation, tricuspid disease, pulmonic aortic regurgitation, or a complex combination of those abnormalities, or, in fact, a clear structural heart failure problem with congestion that needs to be managed, our partners need best-in-class therapies. They also need procedural training to optimize the outcomes because this involves a procedure and the ability to appropriately identify patients with the disease. And ultimately, they need world-class, actionable evidence that they can care for their patients for their lifetime, the strategy of how to take care of their patients. Not only do physicians need to be enabled with world-class evidence and treat these patients, but these patients need to be met where they are. They all present differently in their disease progression. This is because, as demonstrated earlier by this curve, structural heart disease is a chronic progressive disease.
For instance, we'll go back to our examples. Patients like Paul may present with no apparent symptoms but with significant structural abnormalities. Paul was lucky enough to be caught for his disease during surgical consult and ultimately received treatment prior to his knee surgery. Patients like Sally were not as fortunate. She has progressed further along in the disease with multiple significant symptoms and multiple structural heart abnormalities requiring hospitalizations, in fact, likely multiple hospitalizations. The earlier we intervene with the right solution, the better the opportunity to shift the trajectory of the disease, leading patients to a new outlook on their life expectancy, decreasing their hospitalizations, and giving a better quality of life that matters most to them and their families.
Today, you'll see how Edwards is developing breakthrough technologies and generating world-class evidence to meet patients where they are in their disease progression and to support physicians in treating structural heart disease. We'd like to start with TAVR, and Larry Wood will come up after this video. Thank you very, very much.
In the EARLY TAVR trial, the primary endpoint of death, stroke, and unplanned cardiovascular hospitalization was 61.2% in the surveillance and 35.1% in the EARLY TAVR group. The findings of EARLY TAVR really shattered 60 years of knowledge that we had on the disease. The watchful waiting era is over. We are now in an era where if you have severe aortic stenosis on your ultrasound, you deserve assessment and treatment.
I'd been seeing the cardiologist for a number of years, and my echocardiograms had gotten progressively worse, but I wasn't showing any symptoms.
If that echo is showing possibly severe AS, refer them. Don't sit on it. Refer them to the heart team.
I wanted to maintain the health that I had. Waiting has its own risks. If you have the opportunity to have TAVR, do it as quickly as you can because you can use your health to stay healthy.
Edwards is clearly the leader as they're the most innovative of the companies involved in this space. I think the Resilia tissue increases the durability of the valve. That really does offer an important opportunity for lifetime management of the patient.
Edwards Lifesciences has realized, perhaps sooner than most, that partnering on the care pathways is as important as the technology. Right now, in 2024, I think we are about to enter a whole new paradigm.
Welcome. It's always an honor and a privilege to be here and provide an update on our transcatheter heart valve business. I think the TAVR journey has been an amazing one, and I think it continues to be, and I think our future looks amazingly bright. I think it's driven by a number of different factors. First, we have just our base opportunity. This whole opportunity for the last 17 years has really been driven by the severe symptomatic aortic stenosis space. We've expanded indications. We've expanded risk levels for patients. But that base opportunity remains hugely undertreated. And we know that there's opportunities we have with improving diagnosis and treatment that we can continue to address more of these severe symptomatic patients. But now, for the first time in about five or six years, we have additional growth opportunities and catalysts.
Early TAVR, we just saw that data at TCT, and I'll talk more about that and why I believe it's so significant. But then in just a couple of years, we're going to have the readout from the PROGRESS trial. And that has the potential to open the door to moderate patients assuming the trial is successful. We also have very differentiated technology, and we maintain our leadership from the technology perspective. And then there's an exciting new category, which is aortic regurgitation. Now, it's no secret that last year we saw TAVR growth slow. And I want to talk just briefly about some of the things that have been driving that. One of the things that's been driving the growth of TAVR has been our ability to add centers and to add capacity to the system. And every time we add centers, it just creates more capacity.
The National Coverage Determination, though, has limitations on that, and we've sort of hit the peak of that, which is about 850 centers. But we've seen TAVR continue to grow, even though we haven't been able to grow the centers. But the other thing that's happened is we've had an amazing introduction of new technologies that are all coming into the same heart team and the same structural heart space. Things like mitral procedures and tricuspid procedures and the growth that we see there and even things like left atrial appendage occlusion. All of those things are coming into the same heart team, and those put pressure on capacity. We've seen this sort of thing before.
When we've had new indications come up for TAVR and we see a flood of new patients, it strains the workflow for these centers as they try to figure out how to deal with these things. But hospitals always have figured out how to add capacity and how to be able to treat their patients. And we'll have a couple of clinicians here who are going to shed some light on that and provide some of their own insights. So this journey has really been driven by primarily two things. One, the evolution of the technology. From our original SAPIEN platform to our SAPIEN 3 Ultra RESILIA, every time that we've advanced the technology, it's opened up the opportunity to treat more and more patients because we have better technology that provides better data and more confidence. The other thing, though, has just been about the evidence that we've created.
You look at all of the randomized trials, starting with PARTNER 1 and going all the way through PARTNER 3 for low-risk patients, and there is more data that exists on transcatheter heart valves and specifically our SAPIEN valve than any heart valve in the history of cardiovascular medicine. And this evidence has been a huge driver for us. In terms of how our technology performs, honestly, it doesn't matter which data set you look at. Any independent country registry that you look at, our platform always shows incredibly well. And that's been one of the things that's driven our leadership. Even in the most recent randomized trial, FDA randomized trial, you can see how our SAPIEN platform compares to two contemporary platforms, and it compares incredibly favorably. And this is a trial that Edwards had no stake in and had nothing to do with.
So it's independent as it relates to us. And it shows the high quality of our platform. We still have the only platform that's been able to deliver on what we call lifetime management. It all starts with life. 99% of our patients in the PARTNER 3 trial were alive and well at a year. And those were patients that had an average age of 73 at the time of their procedure. That's an amazing accomplishment in that population. 90% of those patients were alive at five years. That's the highest survival at five years that's been reported in a major trial. And the other thing that we have is we have the TAVR and ViV option. So for patients, and as we treat younger patients, this is going to become a bigger reality. They're going to outlive their valve.
And when they outlive their valve, what is their option then? And if they get a SAPIEN 3, they have the opportunity to get another TAVR option and avoid cardiac surgery a second time. And we're the only platform that's treated a million patients. So the data and evidence provide so much confidence for clinicians and patients with our platform. But we never stop. We have our SAPIEN 3 Ultra RESILIA platform now. This is the leading valve in the U.S. It's the leading valve in Japan. And just earlier this year, we started the launch in Europe, and we continue to make great progress there. So we're excited about this platform, and I think people see the real value of this innovation with both a resilient tissue that's backed by all of our surgical valve experience.
And also, we've added the ultra cuff to the 29-millimeter valve, which are significant advancements for the platform. Beyond this, we have our SAPIEN X4 platform. We've been studying this in the Alliance trial. That trial is now fully enrolled. So it has a one-year endpoint, and in a year, we'll be able to take a look at that data, and we'll be able to see how this platform compares to our market-leading platform and see where its place is. And beyond that, we have future platforms. We have ideas, and we still believe that there's meaningful innovation even beyond our X4 platform to improve not only the patient experience but also the clinician experience and advance this therapy. So early TAVR. One of the things that I think it's easy to lose sight of is what we've accomplished to date with the Partner series of trials.
The PARTNER trials was all about whether it's better to do surgery or whether it's better to do TAVR in a particular patient population. We started with high risk and how does surgery compare to TAVR, intermediate risk, how do they compare, and low risk, how do they compare. But the disease we were treating was exactly the same: severe symptomatic aortic stenosis. The EARLY TAVR trial was our first attempt to say, "Is this the right way we should be treating the disease? Should we be waiting for symptoms?" The people have the severe disease. Does it really make sense to have people sit with a severe disease waiting for symptoms to occur? And we just presented that data at TCT, and it was published in the New England Journal of Medicine. And it's a trial that we're incredibly proud of because it really is a landmark trial.
But I want to walk through some of the key learnings from this trial that I think maybe some people have overlooked or some people have missed. The first thing is we screened almost 1,600 patients for this trial. And these patients were over 90% of the patients were subjected to a protocolized stress test so that we really tried to screen out any patient that had the possibility of symptoms. And one of the things we found is 20% of patients, when subjected to real screening, actually do have symptoms. That means one in five patients that's sitting right now who says they're asymptomatic actually are symptomatic, which is a class one indication for treatment. So we excluded all of those patients from the trial, and we also excluded patients that had anatomical issues that made them unsuitable for TAVR.
What we were left with was about 900 patients. Those 900 patients were randomized one-to-one to getting a SAPIEN 3 or getting clinical surveillance. Now, this patient population is a lot different than the patient population we typically treat. The first thing is, as I pointed out, over 90% of patients had a stress test, so we know that they truly are asymptomatic. But their KCCQ score was almost 93. Now, the KCCQ score is a scoring system from 0 to 100, and 100 means you feel perfect. That's the highest score that a person can feel about how you're feeling, what your quality of life is. These patients were 93. That meant they felt fantastic. They felt great.
In terms of their cardiovascular function, their left ventricular ejection fraction, which is the measure of how healthy their heart is and how well it is pumping, was 67%. The normal range is 50%-70%. These people felt perfect, and their hearts were pumping incredibly well. If you'll remember, we actually designed this trial with a two-year endpoint because we said if you take people that feel this well, that hearts are working this well, if there's ever a group of patients that's going to be able to go for a long period of time without developing symptoms and delaying their care, it would be this population of patients. We needed to make sure there was enough time in the trial that we could see how these people would perform over time. As it turned out, it didn't take very much time.
We saw an immediate separation of the curves, and the curve separation was dramatic, and we achieved the primary endpoint very easily statistically. Now, all-cause mortality, there wasn't much of a difference there, and I'll speak more to that in a minute of why we believe that's the case, but you look at stroke, and there was actually a numerical benefit to early treatment over surveillance, and I would say this is a big surprise. Most of the time when you run a trial, and you're running a trial, and you're comparing an intervention to watchful waiting, the interventional arm always pays an immediate penalty because they have a procedure which carries all the procedural risks of having some sort of complication of having the device, some sort of complication such as stroke or death or a vascular complication that could lead to a hospitalization or recurrent event.
So you always have to have that initial risk of having the intervention where surveillance is perceived to not have any risk, but then what you hope over time is that the intervention improves the patient's outcomes and those curves eventually cross. What we saw in this trial was there was absolutely no mortality penalty, and there was no stroke penalty for early intervention. And we saw a massive improvement in unplanned cardiovascular hospitalizations. Now, a lot of people have, not a lot of people, a few people have challenged that and said, "Okay, so what?" So people progressed. They developed symptoms, and then they got treated. What's the big deal? Well, here's the big deal. If you look at this chart, and I think this is probably the most important learning that we had from the trial.
You take a look at this, and the yellow part of the curve is people going from NYHA 1 to NYHA class 2, people developing a little bit of fatigue, a little bit of shortness of breath, what most people consider to be the classic progression of aortic stenosis. They went from not having symptoms to having symptoms, and then they were referred for an intervention. That's not what happened with the red group. The red group are people, and remember how healthy these people were when they started, and look how fast this happens, that went from NYHA class 1 to NYHA class 3 or 4. They had episodes of syncope. They developed arrhythmias. They developed atrial fibrillation, and they were hospitalized as a result of something that was serious, and anybody who thinks that's a benign event just isn't looking at this from a human perspective.
And I will challenge anybody in the room. Imagine if you get a call in the middle of the night from a sibling, and they say, "Mom woke up in the middle of the night, and she couldn't breathe, and we don't know why, and we just took her to the emergency room, and they're evaluating her." If anyone thinks that's a benign event, then I don't know. I don't know what to tell you. I probably don't want you in my family. So these things are critically important. The other thing is people point to the lack of a mortality advantage, but there's an important consideration here. And it deals with the way the trial was designed. Every patient had to be randomizable to TAVR, which means every patient who was asymptomatic sat with the heart team and understood what all of their options are.
They knew that they were a TAVR candidate because they had a CT, and they were pre-screened. So they knew they were anatomically suitable, and they'd already agreed that they would have a TAVR if they were randomized to the TAVR arm, which means any of these patients, once they presented with symptoms, could immediately move to therapy. They could immediately move to treatment. And the average time was 32 days. In the real world, a patient would not have had any of that upfront screening, and when they presented with symptoms, that would have started their journey, which on average, right now in the United States, takes about 160 days.
If this would have been a real-world experience and you could have designed that, and these patients would have sat for 160 days instead of 32, I think you very well could have seen a mortality advantage, and you can surely assume that more bad things would have been happening to those patients while they were waiting. So how does this matter? What's the big takeaway from this? Well, you have to look at this from the patient pathway. Right now, a patient has a visit with the GC. They maybe hear a murmur. The patient's having some concern, some symptom perhaps, and they get an echo, and they're diagnosed with severe AS. Then they're returned to their general cardiologist, and the general cardiologist recognizes the symptoms. They recognize the echo, and then they refer the patient to the heart team. And again, that takes about 160 days.
But if a patient is deemed asymptomatic, which sometimes it's somebody just saying, "I don't think your symptoms are significant enough," but if they're deemed asymptomatic and very few people get stress tests, then the GC looks at the patient, and they say, "Well, the guidelines say come back in 6 to 12 months and get reviewed." But we know from the data, we know from the chart that 6 to 12 months is completely inadequate because we had 26% of the patients crossing over within 6 months. So that guideline is completely out of touch with the true progression that these patients have. But they can get stuck in this loop, and they can get lost in the system, and some people don't come back for their 6-month visit. They don't come back for their 1-year visit. And most people look at these patients annually, not every 6 months.
This journey that patients go on is very convoluted. The other thing it does is it consumes a lot of resources in the healthcare system. How does EARLY TAVR change that? EARLY TAVR says the ascertainment of symptoms is irrelevant to why these patients should get treated. Having a severe disease is adequate all by itself. This means a patient can go to a general cardiologist. If they have an echocardiogram that has severe AS, they can immediately be referred to the heart team. We can build things into the system where they immediately get referred because they don't need to go back to a general cardiologist to have their symptoms ascertained because that's no longer a relevant part of the equation. This can rapidly shorten the time and streamline the resources needed to treat these patients.
Now, the other big thing here is the AHA has published Target AS, which we talked about for a couple of years, but it's published now that says all of these patients should be treated within 90 days of diagnosis to treatment. The traditional way of running people back to their GC and going through this loop probably will not allow people to be treated within 90 days, and so the only way people are going to be able to meet this new quality metric is by changing the system and changing the way these patients move through. Now we have data that says there's an imperative to move them through quicker, and it's super important that people adopt that. The other thing I will tell you is there's a huge economic incentive to do this. Elective patients are the most cost-effective patients to do.
When you have patients like EARLY TAVR with healthy hearts and they feel well, those are patients that are going to have the most likely to have an uncomplicated procedure and a very short length of stay. As they become urgent, the costs increase significantly. When they become emergent, it's worse, and salvage cases are the most expensive cases. There's no case to be made medically or economically for waiting to treat these patients. Now, so what can we do today? What can we use? How can we use this data today? What can we do now? The thing we can do now, the first thing is one in five patients who's deemed asymptomatic truly is asymptomatic. So you need to subject people to stress tests, or you need to ascertain these symptoms, and anyone with symptoms needs to move immediately for referral and therapy.
The other thing that we can say is if you want to duplicate the results of the surveillance group in EARLY TAVR, when an asymptomatic patient comes in, you should order their CT. You should do their complete workup. You should be ready to go. So when that patient presents and they present unpredictably, they can immediately be referred to the heart team and get therapy. There's a huge educational effort that we have to do. Fortunately, we have a New England Journal of Medicine publication, which gives us an incredible platform to be able to educate people from, and we partner closely with TCTMD. We also work closely with the AHA and working closely with the Heart Valve Laboratory on how do we educate, how do we run programs so that we communicate this message not only to the implanters but to the GCs as well.
Now, we expect by mid-next year in 2025, we expect to get the FDA approval, and that'll really be the impetus for starting guideline changes and doing things like potentially opening up the NCD and being able to update that to be able to ensure that every patient who's asymptomatic is covered in the United States. And then this will be a major, major focus of every single medical meeting that we have from ACC to AHA to EuroPCR, and there's really going to be a global effort here to make sure everyone understands this data. And we also expect more and more centers to be adopting the quality metric of Target AS, which is going to be important as we move forward. And then in 2026, we expect the guidelines to be in place.
We expect the NCD to be updated, and this will be really when the practice of medicine will change. But you have to remember, we're changing 60 years of medical practice. We're changing the fundamental belief of the Braunwald curve that said waiting for symptoms was the key thing. So there's going to be a huge education effort, but it's going to be incredibly meaningful for patients. Why is it so important that we get this done in two years? Here's why. The PROGRESS trial, which is our moderate AS trial, we expect that data to be presented in TCT 2026. For every severe patient, there's two moderate patients. Now, we don't know what this trial is going to say. We don't have any ideas yet, but we've always had a belief, just like we did with symptoms, that waiting didn't make any sense.
I don't think it makes sense for a disease to be severe before you intervene because we believe that damage is being done to the heart over time, and that was the genesis for creating this trial. If this trial is successful, then we're going to have to repeat this entire journey of education and changing guidelines in that all over again, starting in 2026 and moving on through 2027, so this is a long journey that we're going to be on, but it's going to be driven by clinical evidence, and it's going to be driven hopefully by successful trials. We already know EARLY TAVR. If PROGRESS is successful, this provides a long-term catalyst for TAVR. Now, the other thing that we have is an exciting opportunity that's completely different, which is aortic regurgitation.
Everything that we've done to date has been about aortic stenosis, which is a narrowing of the valve. Regurgitation is a completely different disease. It's a completely different etiology that affects patients differently. There's so much less evidence on aortic regurgitation than there is on aortic stenosis, and the only option that exists for patients today is surgical. And when you look at the data, the medical management group, they have about a 24% mortality rate at a year. So this is also a deadly disease that doesn't get as treated, even as aggressively as aortic stenosis, which we know is terribly under-treated. And we believe a catheter-based option could open up a huge opportunity for patients. So we've embarked on acquiring two technologies that we think can be complementary and fill this gap. The first is J-Valve. We've closed that transaction, and we've started the Journey trial.
We've enrolled our first patients in that trial, so that is now underway. And then the second transaction is JenaValve, which is currently in the review process, and we expect that transaction to close mid-2025. So what do we think this journey is going to look like? Well, we think it's going to look like something very familiar. We think it's going to look a lot like the AF opportunity, which is going to be this technology evolution of devices that get better and better. We address profile. We address leakage issues. We address ease of implantation, and that'll be a journey that will happen over time. The second part of it is going to be evidence generation.
We're going to have to run a series of trials where we learn what patients benefit and what is the optimal time to intervene, and we'll do a tremendous amount of education and bring our high-touch model and all of the case support, all of the things we've done to make the TAVR market what it is today. We'll be bringing all of those things into play. So our 2025 outlook, we think our growth rate is going to be between 5% and 7%. Some of the things that should drive us to the lower end of the range, if we continue to have capacity challenges and there's a lagging investment in hospitals or if there were more competitive product launches, those are things that could drive us to the lower end of the range.
But if we had earlier impact from the asymptomatic patient population, if capacity improves like we believe it will, those things could drive us towards the higher end of the range. So that's just sort of how we bracket the range. But if you look at 2026 and beyond, once we have new guidelines for asymptomatic, once we have the Target AS be socialized in centers all trying to achieve that 90-day metric, we have hopefully a successful PROGRESS trial. There's just a lot of catalysts that we believe can drive us to a mid-high single-digit grower for the foreseeable future. So it's a very exciting time to be in this business, and I'm very excited to lead it, and I'm very proud of the team and all of the things that we've been able to accomplish.
So with that, I'd like to turn it over to my good friend, Daveen Chopra, who's going to provide an update on TMTT.
Millions of patients suffer from mitral and tricuspid valve disease. There's a great need for transcatheter valve repair or replacement solutions to take care of these patients. Both mitral and tricuspid regurgitation affect survival and affect quality of life. It's imperative to have a portfolio simply because of the diversity of the patient populations. There's only one company that is really moving forward with these technologies, and that's Edwards. Today, TMTT is pioneering the treatment of tricuspid regurgitation. The EVOQUE transcatheter tricuspid valve replacement is an excellent therapy to virtually eliminate tricuspid regurgitation. We're seeing the quality of life completely change in people within 30 days. It reminds me of what TAVR was in 2006. And expanding the treatment of mitral regurgitation.
The PASCAL Precision system was really a big leap forward in mitral edge-to-edge repair. It allowed us to treat a broader range of patient anatomies in a more seamless and safe manner. Edwards is the only company offering a portfolio of repair and replacement therapies to meet patient needs. We're really seeing a proliferation of patients who before were untreated. The ratio of patients that are now being referred with significant mitral and especially tricuspid valve disease is huge, and it's growing exponentially. TMTT is leading and transforming treatments for patients with mitral and tricuspid valve disease.
Good morning. Good morning. It is a real pleasure to be here and a real pleasure and honor to talk about the mitral and tricuspid therapies business. As you just heard, there are millions of patients around the world who are suffering from mitral and tricuspid disease, and these patients have many symptoms.
They may have difficulty breathing, fatigue, painful swelling in their legs. But more importantly than their symptoms, the patients are not able to do the things they want to do: go for a walk with their friends, play with their grandchildren. And the different medical and surgical options are often suboptimal. So what does help look like for these patients? We know that both repair and replacement, transcatheter repair and replacement, are needed to treat the greatest number of patients for both the mitral and the tricuspid valve. So if you look at the care of tricuspid patients, we see that tricuspid care is accelerating.
We see right now in the U.S., there are two different modalities of treatment, both repair and replacement, and we see now that there have been three randomized controlled trials showing the benefit of intervention, which is causing a catalyst of the treatment of tricuspid patients. If you look at the mitral space and mitral patient care, we see that mitral care is continuing to expand. Very different than tricuspid, mitral repair technology is now over 10 years old, and we see continuously improving repair outcomes. But we're also seeing increasingly new evidence along with these great outcomes driving additional patient referrals and additional patient treatment. And we also see that in the very near horizon, replacement will be an option for patients. And we believe that replacement can really extend care to new groups of patients who are unsuitable for repair technology today.
We believe that Edwards is the only company that's able to transform care with this portfolio of transcatheter options. And right now, we are in the middle of rolling out repair and replacement options for each valve. We've already started with PASCAL mitral, moving on to EVOQUE, and we'll continue going forward. But each of these four different therapies requires a lot of work, requires what we believe work around each of three strategic pillars to ensure that each therapy really can reach the maximum number of patients. First, it requires innovation, not just the initial innovation, the initial invention, but continuous iteration because you learn after you bring a product to patients that there's opportunities to keep making that product better and help more patients.
Second, it requires evidence, big evidence, pivotal studies, pivotal studies that can change how physicians look at what should be the treatment for those patients. And finally, it requires great real-world outcomes. It requires comprehensive support, comprehensive support from the Edwards team to ensure with the physician that the patient outcomes each and every day are the same as what the results have come from a clinical trial. So you look first, and let's deep dive a little bit into tricuspid patient care. We believe in TMTT that we are helping pioneer treatment modalities for these patients. We believe that both repair and replacement technologies will help meet many of the needs for these tricuspid patients. And we believe that both EVOQUE and PASCAL tricuspid innovations are really going to be creating a new standard of care. So first, starting with EVOQUE, the EVOQUE replacement product truly is revolutionary.
It eliminates tricuspid regurgitation, and it does so in about a 60-minute procedure time. That's very predictable. It's very repeatable. You know what you're getting into, and you know when the case is going to end. We continue to invest in EVOQUE, not only in new iterations and new technologies, but even most recently, we came out with a new larger valve size that's now approved. This new larger valve size can add 25% more patients to the pool who were previously excluded because of valve size. In addition, or beyond the clinical feedback that we've seen, we really have deep confidence in EVOQUE because of the evidence that's been generated by the TRISCEND II study. This study, which had 400 patients followed up one year, was recently presented at TCT meeting and had a simultaneous New England Journal of Medicine publication.
What we saw from this study was that EVOQUE technology is superior to medical management. But what really got us excited were two different facts. One is that we saw in this trial about the dramatic quality of life improvement that patients felt. They had massive improvements in their KCCQ. It could start doing things again that mattered to them. Secondarily, we saw reductions in both mortality and heart failure hospitalization in the study, which was fantastic. So we believe that this is practice-changing evidence. But let's hear from some physicians on what the TRISCEND II data means for their patients.
We're really seeing a lot of patients on optimal medical therapy. They're still miserable, and the diuretics are not easy. So I think the EVOQUE device and therapy is really transformational for patients with tricuspid regurgitation.
The TRISCEND II study, with the first randomized trial with tricuspid valve replacement, it showed that we can effectively eliminate TR in the majority of patients. The aggregate health status improvement after the EVOQUE transcatheter tricuspid valve replacement system is really impressive. If we have a treatment option that's able to essentially eliminate TR, we're seeing this marked impact on health status. And that's what patients are looking for. They want to feel better. My energy is back. This has allowed me more time to do the things that I want to accomplish. I just went right back into my life. Now I know I can do it. The EVOQUE procedure is a very reproducible procedure. We had a large number of sites enrolling in this trial, and yet the procedure times were about 56 minutes.
I think it's been amazing to see the floodgates of referrals open with the introduction of the EVOQUE valve. I think tricuspid could be one of our largest treatment areas. I think that reflects the excitement and anticipation to finally have a therapy that has such a profound positive impact on these patients and their quality of life.
As you just heard, physicians are seeing that EVOQUE is really helping their patients, and that's creating a strong and growing demand from both physicians as well as patients. For instance, in the U.S., we have our next couple of months of physician training spots all filled up with a waiting list for physicians who want to get access to this amazing technology.
What we're seeing now, that is, in the real world, we're getting outcomes with the help of our commercial support organization that are very similar to what we saw in the clinical trials. Right now, as you can imagine, we're in the process of scaling our commercial capabilities. It's so important that in Edwards, we help support physicians and patients from the pre-case planning process all the way through case support. With us, we need to continue to grow and build the resources to help scale this technology to more and more patients across the world. Finally, we think it's really important to support our customers with reimbursement. In the U.S., the National Coverage Determination is on track to be completed by the end of Q1 2025.
Additionally, in Germany, the largest country in Europe, there already is a new technology funding process already in place. In addition to EVOQUE for replacement, we believe that PASCAL Tricuspid is really important for a repair technology to also help patients. PASCAL Tricuspid has actually been launched in Europe since 2020, and patients actually love to see the differentiation for this technology based on its features, especially for the tricuspid space. We're very excited to bring this technology to the U.S. In 2025, we would have finished up the one-year follow-up on our pivotal Class II TR study, the randomized trial of PASCAL versus medical treatment, and then we'll soon afterward bring it to the U.S. market. We believe that together, both PASCAL and EVOQUE, we have two complementary technologies that are really able to activate the untreated tricuspid patient.
Outside of tricuspid and now moving to mitral, as you also heard earlier, here, the diverse population in the mitral space also requires both repair and replacement technology. We have in this space the PASCAL mitral product, which really achieves excellent results in a broader group of patients. Additionally, we're on the cusp of bringing the SAPIEN M3 product to market, which will provide an additional option to patients beyond TEER. First, with PASCAL, we believe that innovation is key to continuously improving a technology. So we've already in our third generation of the PASCAL product, and we'll have our next generation product coming in 2026 that will continue to enhance ease of use and improve outcomes. And we think it is so important to have this cadence of robust and rapid innovation to ensure that we have clinical differentiation with our product.
Outside of technology, there is a broad and a growing body of evidence of clinical data supporting the PASCAL product. And what we see is that we've had two now large studies, the CLASP II randomized trial and its registry, along with the MiCLASP study, a core lab adjudicated European post-market study that has showed really interesting results. They've showed that PASCAL is very predictable. It's very durable. When you put the device in, you know exactly what kind of results you're going to get. We also see that it's great for both simple and more complex patients. And finally, we see that it has great results in both functional as well as degenerative mitral regurgitation patients. So now let's hear from some other physicians about sharing how the differentiated PASCAL system is enabling treatment for a broader range of their patients.
In our experience, PASCAL works the best in even the most challenging anatomies that historically we would not treat. The special feature of the PASCAL device and the Precision system enable physicians to place the devices exactly where it needed to be for targeting the pathology of the mitral valve. I think it's more reliable and more predictable, and now we have two-year excellent data that is increasing the confidence of the referring providers, which ultimately encourages them to continue to refer even more challenging cases, and equally important, increasing your confidence as a treating physician that you're going to get a durable and sustainable result.
so as you just heard from physicians, we believe that these differentiated features not only improve but also allow treatment for more complex patients.
Some of the key features to allow for this, we believe, are first, one is the elongation feature of the PASCAL product. That means in the dense cords of the mitral tricuspid valve, if the device gets caught on some of the cords, you're able to just elongate and pull out of it in an easy way and then redeploy. Additionally, we have independent atraumatic clasping. What this means is that if you clasp the device and have both arms and you're not quite getting the MR reduction you want, you can essentially unclasp either arm, readjust, then reclasp, and do that several times as needed to ensure that you get the optimal MR reduction. In addition to the device features, we believe part of the PASCAL differentiation is actually over the procedure continuum.
What that means is we at Edwards really try to provide exceptional heart team support, working very closely with the physicians, not only on physician training, but then pre-case planning and then intra-procedural support to ensure the maximum or the best possible patient outcomes. As you can tell, we're incredibly confident with our mitral repair technology, but we're still lacking a mitral replacement option. And that's where we're very proud to lead again with the SAPIEN M3 product. SAPIEN M3 will be the world's first transfemoral transcatheter mitral replacement therapy. This is a product that's been built off the SAPIEN platform that you heard. The SAPIEN platform is actually being used in valve-in-valve in the mitral space now in over 6,000 patients. And this provides the opportunity to now treat patients who repair is unsuitable for.
Built off a 29 French system, we believe that this technology will really offer a new option to many patients. We expect European approval in mid-2025, and we expect U.S. approval to follow in the first half of 2026. And building the body of evidence in support of the SAPIEN M3 product is happening through the ENCIRCLE study. This is a U.S. pivotal study that has already enrolled 300 patients in the main arm of TAVR and surgically unsuitable patients, as well as another additional 100 patients in a mitral annular calcification arm. We believe the completion now and with the one-year follow-up expected to be presented in TCT 2025, that we believe this data set really sets the stage for the commercial approvals of SAPIEN M3.
So in conclusion, on the mitral space, as with tricuspid, we really have two complementary technologies that we think will help treat the broadest set of patients. So as we move into 2025 and look at kind of our revenue range of 50%-60% of revenue growth or $500 million-$530 million of revenue, we would expect that on the low end, headwinds we're facing are largely associated with the introduction and adoption of first-in-the-world therapies. There's simply no precedent. But on the tailwind side of things, we really see that potentially robust evidence can really help our innovative therapies. Whether it's emerging contemporary clinical trials in the mitral space or great real-world outcomes in the tricuspid space, we believe that both can continue to unlock referring and interventional physicians to treat more patients to get to the high end of our range.
We are incredibly proud of our innovative solutions and the impact that's happening on the lives of patients, so as I close out, I think it's always important to come back to that patient need, that important patient need, and we believe in TMTT, we're now on a multi-year journey of different therapy catalysts that are really going to enable rapid procedure growth for many years into the future. This started with PASCAL mitral that extended TEER into a broader patient population. Right now, we're pioneering tricuspid replacement with EVOQUE. We're on track to expand the treatable mitral population in the near future with the SAPIEN M3 product, and we'll finally further amplify treatment of tricuspid patients with the U.S. approval of PASCAL tricuspid.
I am so proud to say that Edwards is the only company able to meet the broad and diverse needs of many of the mitral and tricuspid patients out there in a portfolio that includes both repair and replacement technology. And we believe that as we move forward into the future, this will lead to a business that can reach $2 billion in revenue in 2030. But I think also, and more importantly, we plan to increase our contribution to Edwards' growth. I'm so excited for what the future holds for many patients. With that, I'm actually very excited to announce our next presenter, Dr. Michael Mack, a very world-renowned cardiac surgeon from Baylor Scott & White in Texas. Thank you so much.
Thanks, Daveen.
I've been involved in the structural heart space for over 20 years now, and I'm grateful to have the opportunity of kind of sharing what I think the next 20 years is going to look like. This is the current status of TAVR in the United States from the TVT registry. There were over 100,000 procedures done in 2023. The growth has been constant and steady, and I anticipate that the 2024 numbers are going to be the same this year. If we look at the whole universe of treatment of aortic stenosis, and this includes both surgery and TAVR, you can see that the number of TAVR procedures now eclipsed the number of surgical aortic valve replacements in 2018. And after that, the number of surgical aortic valve replacements fell off.
What's important to note over the last three years is both surgery and TAVR are growing. To me, this says that the growth of TAVR is not from cannibalization of surgical aortic valve replacement any longer. It's the whole space growing and growing for a number of reasons, including more awareness and earlier diagnosis. The way I think of TAVR or surgery for that matter is at the bottom of a funnel, and there's a whole lot of things that happen in that funnel above that impact the number of patients that get through to treatment. It's the demographics of the population. It's the indications. It's how early the diagnosis is made, and it's health system process improvement. I'm going to go through each of these factors and how I think it impacts potential growth of TAVR.
If we look at the U.S. population, this is from 2022, and orange is the baby boomer population. This is just now beginning to move into the TAVR treatment stage. I'm on the leading edge of this baby boomer, and there's the majority of baby boomers behind me that will be favorable for patients receiving aortic that have aortic stenosis and will be in need of treatment. I think if nothing else happened, just the demographics of the aging baby boomer population will foster TAVR growth. Expanded indications. You heard a little bit about this from Larry earlier. The asymptomatic from the EARLY TAVR trial, moderate AS, the PROGRESS trial, and there's two other proposed trials. One, a young TAVR trial in younger patients down to 60 years old, and then two proposed trials for bicuspid aortic valve disease, the Navigate trial and the Believers trial.
If we look at the EARLY TAVR trial, as Larry showed in the slides, treatment with TAVR was superior to clinical surveillance. But to me, the real takeaway from this was how many patients converted to symptoms and treatment in such a short period of time. So a quarter of patients within six months, half of them within a year, almost three quarters within two years. So this to me says, why wait? There's a penalty for waiting. There is not a penalty paid for going early. It is going to take a while to change coverage and change guidelines, but this is compelling data. How about earlier diagnosis? Well, I think there's four factors here that are going to allow us to diagnose aortic stenosis earlier. One is using artificial intelligence for ECG interpretation that I'll go into in just a minute.
The second is the use of a digital stethoscope. Listening to heart murmurs is a lost art in medical practice nowadays, and the fact that I have a digital stethoscope that can be used by mid-level providers, I think, is going to increase the diagnosis of the awareness and diagnosis of treatment of the aortic stenosis. Point-of-care ultrasound is widely used in the emergency room nowadays for a whole host of symptoms that patients that come in, and a number of patients with aortic stenosis are incidentally diagnosed when they came into the emergency room for something else, and the last is genomics. When you move into the areas of chronic diseases like COPD, diabetes, rheumatoid arthritis, and, yes, aortic stenosis is a chronic disease. It's due to multiple mutations of genes.
It hasn't been possible until now to find the multiple genetic mutations that occur that lead to these chronic conditions. So there's two large efforts, one by Tempus AI, the other by Regeneron, that are doing genomic assessment of millions of patients and then tying them to clinical databases so that we'll be able to tie genetic genotype to phenotype, and I think this over the next number of years is going to allow us to identify patients who are at risk for developing aortic stenosis as well as other chronic diseases. Now, this is use of ECG for the diagnosis of aortic stenosis. It's already been shown it can do it. It's capable of being able to diagnose a number of other conditions such as amyloidosis and left ventricular dysfunction.
This is the most scalable, least expensive way of being able to detect early aortic stenosis in large populations. And then the last is health system process improvement. I think everybody has experienced our own healthcare system, and I don't think anybody will argue of the inefficiencies that exist. I think there are four things that can happen to improve processes of care in the U.S. healthcare system. One is improve the accuracy of diagnosis. The second is identification of diagnosed but untreated patients. Third is timely treatment, and fourth is expansion of institutional capacity. So this is an AI algorithm that independently assesses echoes. It's called PanEcho, and there's a number of these AI technologies that do this now. And this is the assessment, and this is the mechanism by which you do it. Now, why is this necessary?
This too frequently is the echo reports that we see right now. In our hospital, we have 77 different cardiologists that read echoes. And if I see this report, how confident am I that this patient doesn't have aortic stenosis? I can't wait till I get a report like this from AI interpretation of echo that I have confidence that that patient does or does not have valvular heart disease. I mentioned diagnosed but untreated. You may say, how does that happen? How do patients fall through the cracks? This is a study from 24 hospitals, over 1.6 million echo reports, 600,000 that were available to assess the severity of aortic stenosis. And it was found there were almost 16,000 untreated patients with moderate or severe aortic stenosis with a mortality at four years of 60%.
Now, some of these, it was likely that it was appropriate not to treat because they had other end-stage disease, et cetera, but it speaks to the inefficiencies in the healthcare system, so there are a number of initiatives to help address these inefficiencies, and one is the Target Aortic Stenosis Program by the American Heart Association that its focus is on applying quality improvement upstream of the procedure, and it focuses on four upstream areas. One is awareness, second is detection, third is diagnosis, and fourth is referral, and this is in 55 centers across the U.S. now, and the goal is to decrease the timeline from the initial diagnosis to treatment to 90 days. Now, that still sounds like it's a long time, but compared to the way it is now, this is a significant improvement.
The other proposal that's coming out of this is for the EHR to have an alert that comes up every time you log in to do a patient record that says you have a patient with significant aortic stenosis. And this will help decrease the leakage of patients that are diagnosed, but it's unrecognized by the ordering physician. And lastly, I'd like to talk about our own program in Dallas and the opportunities to expand institutional capacity. So this is a specialty heart hospital. This is our annual TAVR procedures performed. We started with commercial approval in 2012, and you can see our growth over the last couple of years is a 19% annual growth rate, which is twice what the national average is. So how are we growing? Well, one of it is we happen to be in the most favorable demographic area in the country.
Dallas-Fort Worth has been the most rapidly growing population for five years in a row. If you're going to start a heart hospital, you'd put it right smack where we are. We're benefiting from that. What we're not benefiting from is reimbursement. From a Medicare reimbursement standpoint, we sit in the worst area of the country, in the south and midwest. This gives an idea of what our financials are. 479 patients in the last fiscal year, average length of stay 2.2 days. The payer mix is 90% Medicare, 7% managed care, which is increasing. The net revenue is $44,000 per case. The direct cost is $39,000, and the contribution margin is $4,600. Anybody that says TAVR is a money loser in the south, I'm here to say that has not been our experience.
What's not accounted for in this is the halo effect that occurs because of the TAVR procedure. All the additional stress tests, pulmonary function tests, echoes, caths, and surgery that comes off of this. If we look at the overall contribution margin of our hospital, 25% comes from cardiac surgery and 25% comes from structural heart disease. So this is an area of growth that we are focused on because it is so favorable revenue. Now, there's a number of issues that are constraining us. One is we're limited by the number of licensed beds. We're limited by clinical space and time available for clinics. We're limited by imaging capacity, not enough CT scanners. And the growth of other structural heart procedures, especially left atrial appendage occlusion, is creating capacity issues on this.
Now, the worst word that I can send to our CEO is, "I need CapEx dollars." It just isn't going to happen. It's the dirtiest word in healthcare today. So what we've come up with was solutions: satellite clinics that we have imaging along with them. We're moving straightforward same-day interventional procedures to ASCs, namely straightforward PCI, peripheral vascular disease, and potentially left atrial appendage occlusion. And now we're opening satellite TAVR programs. So this is where our heart hospital is in the northern suburbs of Dallas-Fort Worth. We have both all our clinics here as well as our TAVR and structural heart programs. It's the fifth largest cardiovascular program in the country. But we saw four years ago that we were running out of space, and for all the limitations I mentioned, not able to expand.
So we opened a satellite clinic in a further northern suburb, and that has increased our capacity significantly. We did it to relieve expansion, but it's also promoted growth because patients that don't want to come as far into the city, and two years ago, we opened a TAVR program there using the same folks that we have in our home program. Now we're maxed out there, so we've opened another satellite clinic in another suburb that is about two years away from us opening another satellite program, and then we have another program in the eastern suburb right now. So we've solved to some degree our capacity issues by building satellite programs, so in summary, TAVR continues to grow.
There are multiple upstream factors that can affect the number of patients treated from the particular demographics to the undiagnosed and untreated patients to the diagnosed but untreated patients, earlier diagnosis, misdiagnosis, and healthcare system capacity. And addressing these factors will foster further growth. So with that, I would like to present Carrie Reddick. Carrie runs the interventional cardiology and structural heart disease service line for Atlantic Health System across the river in Morristown. Carrie?
Thank you, Mike. It's a pleasure to be here with you this morning, and I'm going to tell you a little bit about some of the capacity constraints that we're facing. So as Mike mentioned, I'm from northern New Jersey at Atlantic Health System, and Morristown Medical Center is our tertiary care center and also the flagship for our system. And that is where our structural heart program is seated. This year, we are on track to do 1,170 structural heart cases and 798 TAVR cases, which shows us that a 54% growth over a three-year period. As a team, we know that we are experiencing capacity constraints, and we're stretching to the best of our abilities. And we are anticipating, as we're very heavy into research and innovation in our facility.
We're aware of what's going on and probably more aware than most programs in the U.S. of what's coming in the future. So as Larry mentioned, the EARLY TAVR with treating patients that are asymptomatic is going to be giving an indication. And also, trials for the tricuspid and mitral space are coming, and we eventually will see these devices come to market. As a leadership team in the cardiovascular service line, we have to look at other things and other ways to look at what type of projections are happening in the space. So first, we start out talking to our docs as they are expert clinicians and find out what their thoughts are on where we're going to be growing. We also look at healthcare industry experts such as SG2 and the Advisory Board. SG2 is sharing that they see a silver tsunami coming in the cardiovascular space.
As Mike mentioned, with the burgeoning boomers, key cities on the leading edge, I'm on the trailing edge of being a baby boomer. Additionally, at Atlantic Health, we've invested in an AI platform which identifies patients through natural language processing in the echocardiogram results. We are looking at the predictive modeling on disease progression. It was really interesting to me. We rolled this out in February of 2023, and it was interesting to me that a year later, we're looking at the data, and they're saying that up to 50% of those patients that were identified most likely have moved on to severe AS. How are we going to tackle those about 400 patients? We haven't begun to tackle that group of patients yet.
So as I mentioned earlier, I think across the country, we're all facing these capacity constraints to treat these patients with aortic stenosis and other structural heart diseases. We're very acutely aware in our heart team of trying to work with other departments to get our patients through. We often think of our cardiovascular space, our procedural rooms, our cath lab staff, but are we thinking about the registration desk where just last week we had to have a meeting because they couldn't get our patients through fast enough for us to start our 7:00 A.M. cases? It's just continuing to grow and grow and grow. Our medical director, Dr. Philippe Généreux, and myself went to our leadership and finance team and explained to him where we see the projections and the capacity constraints of meeting the needs of our community and our patients.
And we were able to get a nod to move that up the chain and go to the hospital's CEO and president, where we put together a business plan with a very robust ROI. So not only were they interested in helping patients, but of course, that bottom line has to be met, right? So at that point in time, we were given the nod to go ahead and take this to our corporate executive leadership and also to our finance board, which is actually going to happen in the next couple of weeks. But our pre-meetings and preliminary meetings with them have suggested that this is going to be approved. And I'll talk a little bit more about what that means in a minute. So you can see that in addition to the growth, we're also going to need a 35% increase in full-time healthcare professionals.
But that doesn't include those registrars, or that doesn't include maybe the radiology CT scan people. So these constraints are real, and organizations across the country are facing them, and they're unable to treat TAVR patients in a timely manner. And we've already shown through the early burden of mortality that it's a problem. So as I suggested, we have a what are we doing in the short term? Because this year, we have 22% growth in structural heart cases. So how are we getting these patients through? It's been a lot of cajoling and begging to get additional time in the procedural rooms. We have asked for and been granted gap staffing to get us through until the next budget cycle to get these patients treated.
We've looked at pre and post-procedural efficiencies, and I believe that most TAVR programs are really focusing on how they can be more efficient and doing a good job with that, so longer term, with this significant investment, which I was talking to you about, we would like to add two additional procedural rooms, and in doing so, that would allow us to meet the needs we feel for at least five years, if not a little bit longer. The procedural area holding we're building a whole new procedural post and recovery area to support this growth, and this is going to bring in an additional staffing of at least the 22 this is just for the cardiovascular space, the 22 RNs. And you can see so on the types of people that we're going to have to have to meet the capacity of the patients in our area.
As I mentioned before, I think our program, being one of the highest volume in the U.S., is very aware of what's going on in the space. And I have a bit of a concern that we, Dr. Mack and myself, are with programs that are very on the forefront of looking at the future. And even so, I think it's going to be a short amount of I mean, about two years before we really get the resources that we need in place. So we're having to look at some of the shorter-term things that we're doing to get there, that gap staffing and things. But I'm concerned for the other programs that aren't as aware as maybe Baylor Scott and White as Atlantic Health. And where are those patients going to go? We're seeing increasingly longer wait times for patients to get into our facility and be treated.
Right now, we're booking up, as you saw, Atlantic. I mean, the American Heart Association is recommending 90 days from diagnosis to treatment. And we're booking out almost that amount of time just to get them on the table, even when they've been screened and ready for treatment. So the capacity constraints are real. I feel privileged to be a part of the structural heart space and to have a leadership team that sees the value and knows the importance of getting these patients treated. And they feel good about it too because of the robust ROI. So on a national level, I speak with a lot of other programs, and a lot of programs are facing some of the same issues that we are.
But I really feel like they're going to need a lot of support in the future to meet the demands of the patients that are going to be in need of a structural heart procedure. Thank you.
That's great. Thank you very much, Carrie. Thank you too, Mike. It's not every day we get Carrie and Mike in the same room together, and so we wanted to take advantage of that by giving you a chance to ask them some questions. So we're going to take 10 minutes here to do some Q&A with Carrie and Mike. I'll ask you to come back up as well. I'd ask that you limit yourself to one question, and please focus on their presentations. We'll have the rest of the Edwards team back up here later this morning for a more in-depth Q&A session. But for now, welcome Mike and Carrie back on stage. And thanks again for participating this morning. We appreciate it. We've got 10 minutes, so maybe we'll start with Rick Weiss here.
Thank you and thank you to you both for interesting comments. Carrie, you talked about capacity constraints are real. Dr. Mack, you made similar comments. I'm just curious to a reasonable level. You all are being very proactive in multiple ways in terms of investing and workarounds that you talked about, Dr. Mack. I'm just curious, does this sustain the kind of growth you're both talking about in your centers? Does it accelerate and meet the demand? I mean, what's our takeaway from your thoughtfully aggressive initiatives here on that front? Thank you.
So it's like a Tetris game, right? So every day, we're trying to get the patients through and treated. And I would say the short-term solutions are just that. They're just a Band-Aid and that we need to really be looking at how we are going to meet those needs by investing into the space and building additional procedural rooms, building additional CT scanners, and as Baylor Scott and White have said, and just expanding more into the community to do some of the testing. Initially, our echocardiograms needed to be done at Morristown because it was a protocol echo. Now, we can have those echocardiograms. We've invested in educating those sonographers in other areas so they're able to go out into the community, into closer areas for the patients. But no, we're not going to be able to meet those needs.
I made that clear when I spoke with our leadership team. We won't be able to meet the needs if we don't start now.
So we did it to be able to treat patients that we already had existed. But the unanticipated consequence of that was further growth for two reasons. One is that patients don't want to come into the city. And if you can treat them closer to home or at least diagnose them initially closer to home, it's a less heavy lift, and there's more patient satisfaction from that. And secondly, it's decreased timelines. The patient waited. We lost patients because they didn't want to wait three weeks to get their CT scan, three weeks to make their appointment after that, and then another three weeks to the procedure. The fact that we shortened those timelines has definitely promoted further growth, possibly at the expense of our competitors. Who knows?
Accelerated, it sounds like, for most of them.
Yes, very definitely.
Thank you. Shawna.
Dr. Mack, Carrie, to what extent are these AI technologies and other initiatives being adopted more broadly? What are the barriers to broader adoption as you talk to your colleagues across the U.S.? And just in terms of practice volumes, what kind of growth have you seen in those volumes? Any numbers you can put out there?
So I think that anybody that dismisses AI as the current buzzword is very not attuned to what's going to happen. AI is impacting all areas of healthcare. We're still in the very early stages of it. The initial impact is all in backroom operations and now beginning to be in patient-facing aspects of this. I see everything from improved diagnosis of imaging to treatment algorithms to identifying at-risk populations as huge applications of AI going forward. They're still early stage and aren't widely accepted yet. And one of the problems is getting new AI technology into healthcare systems because of the IS and IT firewalls that exist. Healthcare systems, of course, are very, very sensitive to breaches security. And just to be the timeline to get any of these in, where there's PHI or patient health information involved, is a significant obstacle. So it's going to happen.
It just takes long. It's going to take longer than all of us wanted. Carrie?
Yeah. So through November, we had 192 patients identified through our AI software platform and with an ROI of seven figures. So our team's pretty happy with that. I think that I get a lot of phone calls from other programs across the country asking us about the AI software program, and I think it is really starting to take off.
Anthony.
Thank you, Anthony from Mizuho. Dr. Mack and Carrie, maybe can you define how many patients are actually being lost today and how large your backlogs are for TAVR and all of these efforts, whether it be AI, added imaging, pilot sites, what length of time will it take to get the dropouts back in and address the entire backlog? Thanks.
We do track our referral to treatment times and report it out on a monthly basis. I think the AHA is really going to help, just like it did for STEMI care, heart attacks back in the day when they rolled that out. I think this is going to be a good initiative to help get people to meet that metric. Right now, we're at least four months to get people on the table just based on some of our constraints. We're looking at all of the barriers, which is stopping us from moving forward to the next step as you talk about the GATE theory, right, when you're speaking about it. Yes, there is a backlog of patients. I would have a difficult time defining how many were lost. Do people die waiting? Yes, they do.
Those numbers that I mentioned before, three weeks, three weeks, three weeks, I mean, those are real numbers. It takes that long. We think we have an incredibly efficient operation, a machine. But it still takes three weeks from the time the referral happens to you get your first imaging study, another three weeks to get a clinic appointment, then another three weeks to get the procedure. Now, you don't know what you've lost during all that. I suppose I think you've done a better job of capturing the initial referrals and what you lost. But we don't know what we've lost during the way, so I can't quantitate that for you.
Suraj?
Suraj.
Oh, hold on for a moment. Suraj.
There you go. Carrie, question for you. You brought up the 192 number that were captured for TAVR using AI. I guess a multi-part question. How many people were diagnosed using the AI from which 192 were identified positively? Were there any diagnoses that resulted in a disagreement between the physician and the AI? And the reason I ask is just knowing at least about the current AI models out there and how they're built and the accuracy thereof, I'm curious what gives you all the confidence that you'll get your positive predictive value right on? And how do you resolve any disagreements, liability or otherwise?
So, to clarify, the AI program that we're using uses natural language processing in the report of the echo. So, it's looking so the echo actually was the report was generated by a physician. And then it. And then the patients get identified. What we're seeing are patients that have had an echo, and it might be from a primary care physician, not a cardiologist, and that patient doesn't get referred. So, the program is identifying those patients that have had an echo with severe AS but have not had any referral to a Heart Team for evaluation. And so, there was 192 of those patients that were identified in that manner.
I would add to this that all of these technologies, the emphasis is on AI assistance rather than independent interpretation, and there's physician overreads for agreement or disagreement with this, but there's multiple studies in New England Journal and elsewhere that look at chest X-rays, CT scans, and echoes that show that the sensitivity and specificity in terms of diagnosis is higher with AI than it is with clinician interpretation.
I'm tempted to sneak one more in, but I want to stay on schedule, and I appreciate both of your time. Let's take a first break. We'll reconvene in about 15 minutes at 10:30 A.M. with Wayne Markowitz, the head of our surgical business. Carrie, Mike, thank you both. Again, we appreciate it. All right. Thank you very much, and welcome back. As I mentioned before we went into the break, we're going to start back up here with the surgical business. We've got a great video to show you, and then we'll have Wayne Markowitz, the head of that business, come up and run through the presentation. So with that, roll the video, please.
Having been a cardiac surgeon now for over 30 years, I can't imagine a more exciting time.
We're having to do multiple procedures on the same patient, whether it's more than one valve, AFib ablation, multiple valves, valve and bypass, all the above.
Valve disease doesn't just affect wealthy nations. It affects everybody. So how do we bring heart surgery to developing and lower-income countries?
The key is that we continue to embrace technology and to look for innovative ways to continue to improve our outcomes.
What I love about Edwards Lifesciences is they prove it with randomized trials and registries that are scientifically at the highest level.
Being able to partner with Edwards, who are committed to providing young and old patients with tailored solutions, is really important.
One thing that I've always admired about Edwards is that they haven't lost their focus.
Okay. Good morning, everyone. It's exciting to be here today to share an update and an outlook on the surgical business with all of you so in surgical, we're having a strong 2024. We're delivering above-market growth again. That's now several consecutive years in a row. We're extending our leadership in surgical structural heart, and we're doing this fueled by three key catalysts. First, we're accelerating the adoption of our premium Resilia innovations, and we're backing it up with robust clinical evidence. Next, we're increasing the pool of patients we treat beyond severe AS to other critical etiologies and we're expanding patient access to our Resilia therapies in emerging market geographies. Together, these catalysts will help support our mission to improve the lives of 2 million patients globally between 2024 and 2030. Now, our premium best-in-class Resilia portfolio is our key growth driver for the surgical business.
It consists of INSPIRIS, the leading SAVR valve globally, KONECT, the only preassembled tissue valve conduit in the world, and the most recent addition to the portfolio is MITRIS for the mitral valve position. What sets these therapies apart and really differentiates us is the Resilia tissue technology, which provides outstanding durability for patients. Now, since the Resilia portfolio was first launched, beginning with INSPIRIS back in 2017, now over 370,000 patients worldwide have benefited from our Resilia therapies to date. From this curve, you can see the adoption rate is ramping up, and we expect significant increases moving forward, exceeding 1 million Resilia patients by the year 2030. Now let's take a little deep dive into our Resilia portfolio. INSPIRIS, as I mentioned, it's the leading surgical aortic valve. It's the only SAVR valve with VFIT technology for patient lifetime management.
This enables it to expand for better hemodynamics in potential future TAVR valve and valve procedures. INSPIRIS is the primary driver of our revenue this year globally, and it's now available in over 70 countries, which is incredibly meaningful in terms of patient access. Now, the adoption for INSPIRIS has also increased globally in 2024 and accounted for a significant portion of our above-market growth. Looking forward, we expect more meaningful top-line growth for INSPIRIS in both the developed markets as well as the emerging markets. INSPIRIS continues to be supported with excellent, outstanding clinical results. Earlier this year, the outcomes from two independent real-world studies, Endure and Impact, were published. This was with 1,000 INSPIRIS patients in nearly 40 European leading centers.
The data reinforces the excellent outcomes that we've seen from our COMMENCE aortic pivotal trial when it comes to things like freedom from all-cause mortality and several other clinical measures like endocarditis, stroke, and reoperation. To date, we have exceptional data out to seven-year follow-up from our COMMENCE aortic pivotal trial. And in 2026, we plan to present the 10-year results that are eagerly anticipated by all. To date, we have unmatched outcomes when it comes to a wide range of etiologies, including aortic stenosis, bicuspid aortic valve, as well as AR. And I'll dive a bit deeper into bicuspid aortic valve as well as AR segments and how our RESILIA innovations have treated those patients. First, we'll take a look at the bicuspid aortic valve. The majority of these patients can be best treated with a surgical approach today.
Now, bicuspid aortic valve presents a challenging morphology, as you can see here from the illustrations. In the U.S., it represents about a quarter of all SAVR cases, and these patients tend to be younger, with a mean age of 61. Earlier this year, outcomes from a bicuspid aortic valve subset of our COMMENCE trial were presented at the STS annual meeting, showing zero cases of SVD at seven years. Next, we can see AR. It's a growing patient segment for SAVR globally. In the U.S., it represents roughly a third of the SAVR cases, yet it's growing at a rate twice that of AS. As you heard from Larry, the overwhelming majority of these patients that are diagnosed are untreated at one year. There's a significant opportunity for improvement here.
And for those patients that do receive treatment, three-quarters of them required concomitant procedures, and one-quarter received Bentall procedures, which actually creates an opportunity for one of the products we'll talk about next in KONECT. Earlier this year, we had five-year outcomes from a pure AR subset of our COMMENCE trial, and these were published showing excellent survival outcomes with RESILIA in these AR patients. So the next therapy that I'm going to be highlighting is KONECT. As I mentioned, it's the only preassembled tissue valve conduit in the world. And this is only made possible because of our dry RESILIA tissue technology. It combines our market-leading valve platform with the market-leading graft technology, and in the end, you get the best of both worlds. And in 2024, KONECT delivered significant growth for surgical, especially in the US, so much so that it's now become a flagship product for us.
In the US, KONECT can be applied to these Bentall procedures. This represents the fastest, meaningful SAVR segment that's growing right now. It speaks to the need for a novel solution like KONECT. It's supported by unparalleled enthusiasm that we receive from our surgeons and partners regarding the predictability and simplicity that this technology, this therapy brings to these complex procedures. Looking forward, we're going to continue the momentum, and we plan to launch KONECT in over 30 additional countries. We're currently launching in India, and we're following this. We'll have planned launches in Europe as well as in Asia-Pacific. Consistent with our approach to back up our innovation with robust, compelling clinical evidence, we are now collecting real-world data and clinical evidence on KONECT to support additional regulatory approvals as well as broaden adoption.
And recently, we collected one-year outcomes in a study at leading centers in the U.S., and these results were accepted for the 2025 STS annual meeting that's just going to be happening next month. As I mentioned, MITRIS is the newest offering in the RESILIA portfolio. It's designed for greater ease of use of implantation and with the RESILIA tissue to offer that outstanding durability in the mitral position. The global MITRIS adoption also grew significantly in 2024. So we saw this adoption accelerate, particularly in places like Europe with the ongoing launch of MITRIS throughout the year. And consistent with other geographies, we're seeing faster adoption of MITRIS than we did with INSPIRIS. This is due to the surgeon's awareness and confidence in the RESILIA platform combined with the growing evidence that we're providing them with and the experience that they're gaining with the launch of INSPIRIS.
We're excited to have recently received regulatory approval for MITRIS in China. Right now, the team's gearing up and prepping for a launch in early 2025. We're collecting real-world evidence on MITRIS through our MOMENTUM global study. It's the largest core lab-adjudicated surgical mitral valve replacement study to date. In 2024, we completed enrollment in North America, and our enrollment in Europe is well ahead of schedule. Next up is our expansion to LATAM. We expect to complete total enrollment during the course of 2025. We're very excited that our RESILIA innovations are available to treat patients in many countries across the globe. We've seen our surgical revenue grow twice that in the emerging markets than it has in the developed ones. Now, these procedures in the emerging markets represent greater than 50% of the global cardiac surgery volume, and it's continuing to grow.
We expect it could reach 60% by 2030. This is due to the population growth in these areas, the improvements in access to care, as well as affordability, and looking forward, we'll be launching our RESILIA innovations in over 20 countries in emerging markets just in 2025. These launches will be planned in places like LATAM, Southeast Asia, and China, just to name a few, and within the emerging markets, if we just focus on Asia-Pacific for a moment, it's delivering incredibly strong growth, and we expect it to continue. Why? We expect these high rates of surgical procedure growth with approximately a 10% CAGR through 2030. There's a high incidence and prevalence of rheumatic disease, which can be best treated surgically, and there's increasing rates of hypertension in this geography, which presents a significant opportunity for our KONECT product as well.
Now, to help bring this all to life, here's a video highlighting the profound impact that RESILIA had on patients across the globe.
I was really struggling. I could hear my valve and heart just whooshing, whooshing all the time. My breathing was getting harder for me, and I could hardly make it up the stairs. [Foreign language] . I was born with a bicuspid aortic valve and have significant aortic regurgitation. I find it hard doing any sort of training. [Foreign language]. We decided to go for the Edwards Lifesciences, MITRIS RESILIA, mitral valve. Having these innovative newer technologies available in our region has been a real benefit to our patients. [Foreign language] . Charlie has regained his life.
I feel so freaking good. [Foreign language]. You're in the ice in the Southern Ocean, so you're battling the huge swells and a lot of ice, and we've broken eight Guinness World Records. I'm just going to go, go, go. It's just wonderful. Edwards saved me.
So for me, it's truly inspiring to lead an organization that has that type of impact on patients across the globe. As you can see, regardless of age, wherever they may live, patients are able to live without limits thanks to the RESILIA technologies. Now, looking ahead, we will deliver mid-single-digit growth in 2025. The high end of this will be fueled by many of the drivers I just shared, including the global RESILIA adoption. And the low end could be influenced by different external factors.
Overall, I'm highly confident that surgical has a very bright future ahead and partnering with surgeons to treat the millions of patients that are in need. We will be successful and achieve mid-single-digit growth with continued adoption of our premium RESILIA portfolio and innovations fueled by the compelling clinical evidence and these upcoming global launches we're excited about. We're now addressing needs beyond severe AS to include these other critical etiologies like bicuspid aortic valve, AR, and Bentall procedures. And we can address the millions of patients in emerging markets that are in need and deserve the best-in-class surgical therapies for treatment. Thank you. And with that, I would now like to introduce my friend and colleague, Diane Gomez-Thinnes.
Heart failure is a chronic condition. Despite having excellent pharmacological or device therapies, patients are still short of breath, are still tired, and they suffer from increased mortality and repeat hospitalizations.
It has a huge burden on the healthcare providers as well. So we need new solutions. Cordella was designed with really the 21st century in mind. Having a comprehensive picture of the patient, we can make changes in their medications and give them advice without the patients being in the clinic. It opens up opportunities to see new patients. For the first time, the patient can immediately see their data, and they can understand how their condition is being managed. I can look at the readings of pulmonary artery pressure, and I can watch it go up. I can watch it go down. And that sets up the day. There is a sense of we are doing something proactive for ourselves, for Tom's life.
When we manage our patients with the Cordella system, we see our patients transmitting data six to seven days a week, and that engagement leads to better outcomes. It has really revolutionized the heart failure management. I'm really excited to see what's next.
Hello everyone, and I'm delighted to join Edwards to lead the new Implantable Heart Failure Management business, or IHFM. Implantable Heart Failure Management represents a significant patient opportunity. While there have been meaningful advances, heart failure remains a major burden to patients and the healthcare system. There are over seven million patients suffering from heart failure in the U.S., and hospitalizations are on the rise. In fact, mortality after hospitalization exceeds 75% at five years, and this represents an economic challenge. Care for these patients costs the U.S. healthcare system over $40 billion annually.
Active management of heart failure reduces morbidity and mortality, thereby improving outcomes and quality of life for patients, and we believe that 1.2 million patients are at high risk for hospitalization and can benefit from better management. The Cordella pulmonary artery sensor and heart failure system has the potential to transform patient management by simplifying the approach for both patients and healthcare providers. Our goal is to reach more patients and drive adoption with a roadmap of innovation that advances the platform, compelling clinical and economic evidence to advance guidelines and influence payers and policymakers, and better insights with an intuitive and engaging platform that will empower patients and healthcare providers with data, knowledge, and better decision-making. IHFM is a dedicated business unit at Edwards, and this enables us to have a deep expertise and a focused go-to-market approach in close partnerships with providers and their patients.
And with Cordella serving as a strong foundation for the new IHFM business, we are committed to delivering upon an innovation pipeline that spans the cath lab, the home, and the cardiology clinic, with key stakeholders involved in each environment: the implanting cardiologist, patients and their caregivers, and the clinical care team. R&D investments will expand organizational capabilities across hardware, software, and data sciences. Cath lab-related projects involve simplifying the implant and calibration procedure. In the home, our plans are centered on continuous improvement in the user experience to motivate the patient. We are pleased with the very high engagement of our patients in the PROACTIVE HF study in which patients engaged with Cordella an average of six days per week, and we're pleased to be able to see their own data progress. We're excited to continue to innovate in this home environment.
Finally, the clinic will benefit from streamlined physician and care team workflows that will include automation and data insights using our advanced Cordella patient management portal. We know that the key to innovation is evidence generation. Against the backdrop of historical trials that support the use of pulmonary artery pressure in heart failure management, proactive HF results for Cordella, which led to its FDA approval, confirms this. We don't stop there. Proactive HF2, or PRO2, will be the most robust PAP-guided heart failure management trial to date, enrolling over 1,700 patients across the U.S. and Europe. This randomized control trial is poised to unlock the significant opportunity to improve heart failure management.
PRO2 will study New York Heart Association Class 2 and Class 3 patients with the objective to establish the evidence to expand indications, update guidelines, and empower patients who will engage with their own data to self-manage their condition, and we're confident that this body of evidence will reinforce the benefits of PAP-guided heart failure management and finally fuel broad adoption. 2025 is a foundation-building year for us. We're excited about the future of this new category at Edwards, but we know this is a journey, and it will take time as we go to market and gain learnings.
Next year, we can expect the following: National Coverage Determination in the first quarter, which will open up coverage for most patients and be a catalyst for adoption. Clinical progress with PRO2 as we activate sites and enroll patients across the U.S. and Europe. And commercialization with a team that is growing as we transition from an R&D and clinical organization to a commercial business. Ours is a thoughtful build with the healthcare provider and the patient top of mind. We are actively hiring as we aim to provide a high-quality and high-touch service, including professional education, patient services, and field support. This foundation will set us up for the ultimate goal, which is to drive towards a new standard of heart failure management. With that, I'll bring up Scott Ullem, our Chief Financial Officer.
All right. Thanks, Diane. Okay.
Well, I know this audience in particular is interested in the financial outlook and how it ties to everything you've heard about this morning. And so I'll take you through a presentation with guidance and other features. But I want to start by just saying how aligned our financial plan is with our corporate strategy and our corporate guidance. And so we'll talk about how everything ticks and ties strategically. There are three key focus areas for us from a financial point of view. The first one is strong organic sales growth. And you've heard earlier today us talk about 2025, 8%-10% underlying constant currency sales growth. 2026 and beyond, we're targeting 10% average annual sales growth per year. The second key focus area is on healthy and expanding margins and bottom-line profitability. And it starts with gross profit margins.
We'll talk more about this in a minute. But the gross profit margin fuels capacity to invest in R&D, in field resources, and in the other elements that really set up Edwards for long-term profitable growth. The third piece is strategic capital deployment. And our use of cash ends up being an important part of the model and how we generate outsized returns. So now let's dive into each of those. In terms of sales, we focus on large and growing patient populations. And our sales are supported by investments that we make in research and development, generating clinical evidence and helping provide all the raw material that goes into setting up for long-term top-line performance. A lot of what contributes to the sales growth is evidence that gets generated through our research and development efforts and our clinical trials specifically. But in sales, here's a quick profile.
So you can see on the left-hand side, sales from continuing operations, so excluding the businesses that were separated earlier this year, have grown to an estimated $5.4 billion in 2024. You've seen our guidance for 2025. Regionally, about 60% of our sales are in the U.S., 40% of our sales outside of the U.S. Not surprisingly, based upon what you've heard this morning, our top three fastest-growing product categories are EVOQUE, PASCAL, and SAPIEN 3 Ultra RESILIA. Just to give you a flavor for what the growth engines are in the near term. A recap of what you heard from others this morning. In TAVR, I'll just hit the highlights here. We're expecting 5-7% constant currency growth in 2025 and mid to high single-digit annual growth in 2026 and beyond.
It's really driven by things like early TAVR and opening up this therapy to patients who are suffering from severe aortic stenosis without symptoms, as well as the PROGRESS trial, which we'll read out in 2026, studying patients who have a moderate degree of aortic stenosis. For TMTT, $500 million-$530 million in 2025, growing to reach nearly $2 billion or to reach $2 billion annually by 2030. This is really supported by this comprehensive, holistic therapy collection of repair and replacement technologies for patients suffering from both mitral and tricuspid regurgitation. In surgical, Wayne just talked about mid-single-digit growth in 2025 and beyond. It's really lifted by this investment that we've made in our RESILIA tissue treatment technology that we're seeing really benefit patients in multiple different products around the world.
And then finally, you just heard Diane talk about structural heart failure and our start to structural heart failure in interventional heart failure management. We've also made an investment in aortic regurgitation. And these are both the incremental growth opportunities for Edwards Lifesciences in the years ahead. So the second focus area is on healthy and expanding margins. And again, it starts with gross profit margin. Even as we are investing in building our field clinical resources and strategically investing in new growth platforms, we're also committing to increased operating margins in 2026 and beyond. But let's start on the top margin. Gross margin 78%-79% of sales in 2025. And it's really fueled by differentiated technologies where we get rewarded in association with the high value that our technologies bring to the healthcare system. And that helps contribute to a healthy gross margin.
We've got a proven model for gaining efficiencies in our production processes, and those efficiencies are especially benefited as volumes increase. Now, it's offset by new technologies. When they come on stream, they end up being at lower volumes, and we don't get the same kind of manufacturing efficiencies until we reach those higher volumes, but the format and the strategy is in place to continue to generate high gross margins. We have made investments and put in place initiatives to have a very well-calibrated and aligned global supply chain. We have currently five production facilities around the world. We just broke ground on a new one in Spain that will be our sixth.
And together, these facilities really represent an engine of not just financial strength for Edwards, but redundancy and risk mitigation as we plan ahead to run an integrated global supply chain that can support our growth around the world. In terms of the operating margin, I mentioned before, we're planning for 50 to 100 basis points of operating margin expansion annually starting in 2026. And there are specific plans in place that are tied to primarily SG&A and R&D, where we are going to continue to invest aggressively, but the top line is going to outgrow the expense lines. And that's what contributes to the margin uplift. I should mention that in 2025, our operating expenses in total will grow in the 5%-7% range. And that's reflected in our guidance. So turning to research and development.
In R&D, about two-thirds of R&D is tied to generating scientific evidence and sustaining research and development activities that support our existing leading therapies. All of our R&D is focused on structural heart, and we make active decisions about how to prioritize investments, where we're going to accelerate investments, where we're going to deprioritize, or even combine technologies as part of our regular research and development strategy. Earnings per share. Here's a walk across of earnings per share, and I'll just take you through it starting on the left. Based upon our Q4 guidance, our earnings per share in 2024 from continuing operations would be in the range of $2.37-$2.41. A $0.35 increase is projected for 2025, just tied to our existing operating business and efficiencies that we've gained through some of the right-sizing actions that we took earlier this year.
So $2.37-$2.41 plus $0.35 gets us into the $2.74 range at the midpoint of the range. And that's a 15% increase over our estimated 2024 earnings per share. So we're pleased with the healthy performance of our existing business. Now, that's offset by approximately $0.15 of estimated operating expense that comes with the three acquisitions that we've already closed. We're expecting about a $0.10 benefit from interest income on some of the remaining proceeds from the sale of critical care, as well as the share count, which we expect to be in the 585-595 million range in 2025. Tax and FX end up being a pretty significant headwind now based upon the current FX markets and what we are envisioning for our tax position in 2025. So that costs us about $0.25.
Then out of all that, it gets to our guidance of $2.40-$2.50. Now, for those of you who are ticking and tying, which is everybody in the room, you'll notice that walking across, it doesn't add up to $2.40-$2.50. It adds up to $2.42-$2.46. That's intentional. And instead of putting a range by every box, we decided we'd just approximate. But the overall guidance for the year is $2.40-$2.50. And as always, we encourage people to model to the midpoint of the range. So the third focus area for us from a financial point of view is on strategic capital deployment. And there are three particular areas where we focus in order. Number one is continuing to invest to support the long-term growth of Edwards.
This is in areas of capital expenditures to fund our production facilities and even things like our IT systems. Number two is external investments. We're exclusively focused on structural heart. We're generally focused on smaller and earlier-stage investments. The third piece, of course, is returning capital to shareholders. Our preferred method for doing that has been share purchase. I'll talk more about our history in just a second. Share purchase in 2024 so far has been over $1 billion. We still have $1.4 billion in authorization available. You can see we've got a consistent track record of buying back stock, both to offset the dilutive impact of incentive stock awards, but also to reduce the net share count over time. You can see we've taken it down from over 700 million shares to now under 600 million shares.
We're pleased with that performance. We're going to continue to look for opportunistic times when we can buy back stock at values where we think it's beneficial to the long-term value creation opportunities for Edwards. The second priority is investing capital to support the growth of the business. We spend about $250 million a year on CapEx, most of which goes into our production facilities. This has really been beneficial and helped us set up the company for lean, efficient, flexible, and risk-mitigated production footprint around the world. Finally, before I close out, just a recap of the financial guidance overall. We've talked about all these different elements with the exception of the one on the upper right, which is the FX impact to our sales. We're estimating at today's levels of about $100 million or 2%.
So for those of you who are trying to line up the dollar guidance ranges that we've provided for our product groups and for the company and the percentage underlying growth constant currency guidance ranges, it's not perfectly aligned, and it never is. But that gives you a sense of the biggest disconnect, which is that $100 million in FX. So hopefully, that helps with the modeling. I'm happy to take questions about that during Q&A or afterwards as well. So finally, just to wrap up, a recap of our three focus areas and how closely they're tied to the company strategy. Number one is really making sure that we're exclusively focused on structural heart and generating strong organic top-line growth. The second is healthy and improving and expanding margins, specifically the operating expense line, driving 50-100 basis points of improvement in EBIT margin annually.
Finally, being smart with how we use the cash and deploying it in a way that can continue to reinforce our extraordinary returns on invested capital. I'm really excited about 2025. I'm also really excited about 2026 and beyond. With that, I'm going to turn it over to Bernard to wrap up. Bernard.
Thank you, Scott. Thank you for the amazing partnership with you. So let me recap the themes you heard this morning. Edwards is the leader in structural heart innovation. And this starts by us focusing on large, complex, big, unmet patient needs. For us, it's all about going first with big innovation, breakthrough technologies, with high-quality science, and with the goal of creating and then defining categories, and then leading these categories, and being able to deliver sustainable and long-term growth of a company. I'm very pleased to have a strong and highly qualified board of directors. They have a broad expertise. They are guiding the company. They are always here to support and to guide us and to guide me. They are actively engaged in the company and strategy. Before I wrap up, I want to update on our Edwards Foundation. We are, as a company, committed to charitable giving.
So since 2004, the foundation has donated $185 million with two goals in mind: improving the life of structural heart patients in need, but also strengthening the communities where our employees are living and working, something I'm very proud of. It is what makes this company very special. So to close this prepared remark, I'm very confident about our strategy. You heard this from all of our speakers. Structural heart is large and growing. We, as a company, are uniquely positioned to bring life-saving solutions to patients. 2025 will be a strong year based upon three growth drivers: TAVR, mitral, and tricuspid. 2026 and beyond will be very exciting for the company with the addition of two emerging opportunities: AR and heart failure. And this positioned us for accelerated growth, long-term growth, sustainable profitable growth, and shareholder value creation.
So very excited about where we are and where we are going. With that, we are going to take a short break, about 10 minutes, and we are going to get back for a Q&A session. Thank you.
All right, everybody. Welcome back. We're going to kick off the Q&A portion of the discussion this morning. We've got about 40 minutes allocated for Q&A. As I mentioned earlier, we'll have the entire leadership team from Edwards on stage, those of whom presented, I should say, this morning. And we'll open it up for questions. Similar to the session we ran with Mike and Carrie, if you could limit yourself to one question, that would be greatly appreciated. We'll try to get to as many of you in the room as possible. We've got microphones going around like we did earlier. And maybe we'll start to make you walk all the way up here, but with Robbie Marcus in the front row.
Thanks, Robbie Marcus, J.P. Morgan. Appreciate the really helpful analyst day today. Wanted to start on the TMTT guidance of $2 billion. That was a lot higher than where the street is sitting for 2028, 2029 as far as it goes out, much higher than what I was thinking. So maybe just help us walk through the building blocks of that, how we get there, and your level of confidence in that. Thanks a lot.
Sure. Yeah. I'll kick that off with Sabine here. So for us, obviously, right now, as you know, our guidance next year is over $500 million. And that's really built off our first block of PASCAL Mitral. And the EVOQUE block has started this year, right? And it's going to be growing next year and the year after. And then clearly, as I showed, we've got those four different blocks, those four different therapies, where we believe that each of those therapies will continue to grow on top of each other with multi-layers of catalysts. So for us to get to that $2 billion, so it starts with block A. We're starting, obviously, EVOQUE now. We're going to move to PASCAL, sorry, to SAPIEN M3, and then eventually PASCAL Tricuspid.
So with those, we feel like when you start adding that on top of each other, we can get to that $2 billion. We can reach that $2 billion mark that we're looking for. So the patient opportunity we know is large. There are a lot of patients out there. And when you start bringing innovations that can change their life, we're seeing now with EVOQUE, there's really strong, strong demand, stronger demand than I've seen ever in my career for a new therapy. So we believe when it comes out with SAPIEN M3, we'll see that same demand and continue forward with each of these four therapies.
No, that's great to see. And maybe we'll add something about. This is truly the result of a vision we had seven, eight years ago. We came in and we said, "This patient population, very complex, very diverse, large and growing, and a portfolio will be necessary." And so we didn't go one step at a time. We went big from the beginning, having multiple therapies, bringing innovation, bringing science, having in mind the long term. And we knew it was going to take time. But I'm super excited about next year. Daveen and his team next year, it's going to be a formidable business, growing 50%-60%. That's meaningful, aiming for $2 billion by 2030. So it is truly about the result of our long-term vision.
David.
Thank you. David Roman from Goldman Sachs. Maybe if you could continue along the lines here on TMTT. Obviously, we talked about this at TCT a little bit, but mitral valve repair technologies have been around now for over a decade, and I think if you were to rewind 10 years ago, people would have thought mitral today was a multi-billion-dollar market. We're sitting at about $1 billion-ish for MitraClip today, and what is going to drive that market and really bust it wide open, and look, you're seeing 50%-60% growth. You're seeing development here, but maybe just walk us through in a little bit more detail the diagnostic pathway, how you increase referrals, and what really drives the uptake from here.
Yeah. So if we pull up and look at, first, start with Mitral Repair, just one of these many catalysts, right? As you said, it's a therapy that's been around for 10 years that we believe today is growing double-digit in both the U.S. and Europe. And what we've seen is that we continue to get contemporary evidence. We continue to get new big randomized studies, whether by us or by other physicians, that are showing the value of this technology to patients. So with that, those continue to increase awareness. They continue to increase diagnosis, and then eventually the treatment, the interventional. So it's starting to unlock and continuing to unlock. So we're seeing that strong Mitral Repair growth. Then if you look at Mitral overall, you then add in, well, there's still a lot of patients who are unsuitable for TEER.
And that's really where we believe SAPIEN M3 and other replacement technology can add patients to the pool. So just in mitral, to your point, it's over a $1 billion market today and has the opportunity to continue to unlock many more patients, both existing technology as well as new additive replacement technology.
So you're trying to look at the answer to having a pool of replacement devices? Is it what really changes going forward?
And so, sorry, just for everyone. This is a replacement. I think a replacement device now adds to the pool of patients who are unsuitable. And there are many of those patients. And as we see the results, they'll come out in the clinical outcomes. We'll figure out exactly where it fits in the practice. But with the treatment of Mitral patients, any one technology only treats a section of those patients. When you start adding multiple technologies, you start treating more and more of them. And even with multiple technologies, there's still going to be patients with unmet needs that are still going to need new technologies in the future. So it's an additive kind of effect for this large group of Mitral patients.
Pito.
Thank you, guys. Pito Chickering, Deutsche Bank. Looking at TMT guidance for 2025, can you break out PASCAL and EVOQUE in any color on sort of those two products? Is this more back half loaded due to the anticipated reimbursement for tricuspid? And any color on the awareness for TR patients?
No, great. Diving into a little bit of detail. So we try to believe it's continuous growth. So it's not back half loaded. We believe it's a continuous sequential growth that would occur over the course of the year. If you look at the business today in 2024, or if you look at the number of patients we're treating, based on the history of having PASCAL for a larger period of time, PASCAL is our largest business. EVOQUE is one year in and has this unprecedented demand, and that's growing. So we move from this year to next year, we'll see growth, both continuous growth in PASCAL, especially driven by the mitral, as well as EVOQUE. So I see kind of now two drivers moving to next year. And if you look at it a little bit more by geography, today, Europe is our largest geography.
The U.S., though, is our newer geography, but growing quicker. So you can imagine moving to next year, both Europe is a great driver, and the U.S. is a great driver. So I think we have a little bit of multi-regional kind of growth, as well as multi-product line growth from both PASCAL, mitral, and EVOQUE on the tricuspid side. So that kind of answers that it's both valves, it's both one repair and a replacement technology, and it's happening from both regions primarily, but obviously with more countries than just the U.S. and Europe.
Chris.
Thanks. Chris Pasquale and Nephron. Scott, the 50 to 100 basis points of operating margin expansion in 2026 and beyond stood out to me. That implies a bit of a change in trend in terms of the investment level in SG&A and R&D. You talked about some specific plans to achieve that. Can you give us any more color on what you guys are going to do? Because we heard about a lot of market development work, clinical programs, new products. So the need for investment doesn't seem to be changing. How do we get the leverage?
Yeah. We took some actions already in 2024 to address the changes that came with separating out critical care, which is $1 billion in sales, $250 million in operating profit. That was the start of taking action to right-size the company. We're going to grow into a company that has more profit potential than the 27%-28% guidance for 2025 represents. Specifically in the areas of SG&A and R&D, there are things that we can do more efficiently as the company grows, as the structural heart footprint grows globally, where we just get more natural efficiencies. SG&A in particular, R&D to a lesser extent, but R&D as a percentage of sales is going to decline because our top line is going to outgrow the R&D line. It's not to say that we're going to be investing less in R&D.
It's not to say we're going to be investing less in SG&A. To your point, we're going to continue to be funding patient activation initiatives. We're going to continue to fund having people in the field to support clinicians and patients who are going down this pathway of getting structural heart interventions. But we can accommodate those increasing expenses and still generate margin expansion because the top line's just going to outgrow it.
Danielle.
Hey, good morning, everyone. Thanks so much for taking the question. Danielle Antalffy from UBS. Larry, this question is for you and the long-term TAVR growth guide, or I guess the 2026 and beyond, still looking at that mid to high single digit growth rate. I mean, you will have potentially guideline changes. You're going to have progress readout in that time frame. Maybe help us understand what's baked into that 5% to 7% and how much upside there could be from things like guidelines changes and progress.
Yeah. Well, I think your question a little bit answers itself. We have the early TAVR, and we expect to get the indication around the middle of next year. I think guideline work will probably start early next year, and we'll try to accelerate that process as much as we can. But that's a society-run process, and so our ability to drive it or influence it is somewhat limited because it's a clinician-driven activity. But we'll be active in that. And I think the data is so compelling. I think it is going to lead people to try to update the guidelines sooner because I think people now fully understand the impact of waiting and that it's not benign like many people thought.
Even somebody who's as deep in the space as Mike Mack, and there's few people that are more clinically astute or deeper, prior to this data was like, "I don't know how I feel about treating asymptomatic patients." Now he sees the data, and he's like, "It's compelling. We need to change practice." But it takes time to change practice because we have to get it all starts with the general cardiologist referring these patients to the heart team to get their evaluation and stop doing this symptom acceleration. So I think the guideline changes are going to be a powerful driver. I think the other thing is it gives us the opportunity to request reopening of the NCD, and that has the potential to let us add sites, but also ensure that coverage is standardized across the country for asymptomatic patients.
So I think there's a lot of things that are catalysts. But the other thing that I would say is we've been growing pretty significantly even over the last five years, but our last major data catalyst was in 2019 with the low-risk data. This is the first major data catalyst we've had in the TAVR space in five years. And I think that's going to help re-energize. But there's a very strong case to be made now, even as hospitals are trying to plan their workflow. They now have definitive data that says severe AS patients don't wait well. And we don't have that same data for a lot of the other technologies that are competing for attention. So I think it does a lot of things for us. But as you get longer term out, certainly if the PROGRESS trial's successful, that's a big catalyst for us.
And so we just feel really, really positive about the long-term prospects of TAVR.
Josh.
Hi, good morning. Josh Jennings from TD Cowen. Great event. Wanted to ask Larry, the focus on human outcomes continues. Congratulations on the one-year SAPIEN and three-year Ultra RESILIA results presented at EuroPCR. Boston Scientific, and I think the investigators of ACURATE IDE put forward a hypothesis that the subgroup of patients that received an underexpanded neo2 had a higher mortality and stroke rate because of turbulent flow that was measured by cardiac MRI. It seems like the clinical community is beginning to focus more on flow dynamics. Can you just help us understand, one, maybe comment on that hypothesis? And then two, is Edwards doing anything in terms of using cardiac MRI to investigate flow dynamics for SAPIEN patients? Thanks.
You really hit on a lot of important points. Valve design is complicated, and there's all sorts of engineering trade-offs we make in every valve design. I think we've always been focused on trying to create a valve that has very laminar flow. If you look at the shape of our valve and the way the leaflets are designed, we do achieve very laminar flow. I think a lot of the data that's come out on echo-discordance has been really about how flow patterns can influence velocity, which therefore influences the calculated gradient by echo. It's something we've always been really fixated on, which is in terms of the flow characteristics of the valve and making sure that we get proper expansion.
But you can have all the theories you want about why something works or why something doesn't, but the bottom line at the end of the day is how good is your one-year data, how good is your five-year data? And I don't think you can focus on any singular characteristic of a valve and say that's the secret. It's really the culmination of all of the things. And that's why we're so proud of our platform. We have a million implants with it. Every case in the United States is followed in the TVT registry. We have all of these randomized trials, and then there's all of these independent country registries. And it doesn't really matter which data set you go down and you look at, even ones that we have no involvement in whatsoever. Our platform shows incredibly well.
I think it's a combination of our design, our delivery system, the way that we analyze flow, because fundamentally we're valve people. That's what we do. That's really what our strength is. So anybody that's making a valve, I think some of the take-home messages are everybody should have a lot of trepidation about using anything until they have that one-year data or those longer data subs that are followed up from an FDA trial that really has all the scrutiny and really has all of the adjudications and the CECs. And the FDA approval is still the highest bar, really, that exists. And I think we just keep learning that over and over again, that valves that might look good in a single-arm registry, when they're subjected to a really rigorous clinical investigation, maybe don't hold up quite as well against contemporary standards.
Oh, we know how you know. Simple things. It is not easy to make a valve. We have been making valves for 65 years. Surgical valves, TAVR for 20 years. We have seen a company coming and leaving, and they are all trying it. I know it is an important and meaningful segment, but we are pleased where we are. There is a reason why we have a leader.
My eyes aren't that good, so it's dangerous to sit in the back row. But David, I think I see your hand up way back there. Keep going.
Thank you. David Rescott with Baird. Maybe a question for Scott on the FX kind of implications for next year. I think in the past, when you have a headwind on FX from a revenue perspective, it tends to be a tailwind on the gross margin line. And so if you look back at 2022, you had four to five points in the top line, two to three points, or three to four points of gross margin expansion in 2022. When you think about the 200 points in the top line in 2025, should we think about that directionally being a benefit from the gross margin line, or is there a difference now with the critical care business being out of the portfolio? And if so, is that contemplated in the 78%-79% for next year? Thank you.
Thanks for the question. It's a little bit of both. I mean, part of this is we do have a different production facility footprint and different economics associated with our cost of sales and what flows through to the gross margins. So yeah, there's a little bit of hedge impact to the 78%-79% guidance for 2025. But I'd say it doesn't really change the longer-term profile of the company from a gross margin perspective. And that's a reasonable modeling assumption for 2025. And we'll talk more about what the changes could be as the FX rates unfold during next year. Remember, our hedging program is intended just to protect the gross margin or to protect earnings per share for the upcoming 2025 year. And so that's what's reflected in the 78%-79% gross margin guidance and the 240 to 250.
Matt?
Matt Miksic with Barclays. Just to follow up on margins, and maybe if you could talk a little bit about sort of the magnitude and the tail of what some of the dilution around these recent and upcoming acquisitions might be. And then also, as you get through 2025 into 2026, as you talked about margin opportunity for margin improvement, where in there do we start to see absorption of some of the stranded costs post the divestiture? Thanks.
Yeah. So there are a couple of elements to your question, Matt. I'll try to take them one by one. First, on acquisition impact. For the three acquisitions that we've already closed, you see we're estimating approximately $0.15 of EPS impact in 2025. It's an estimate. We're still in the process of completing the integration for these acquisitions, but that's a pretty good assumption. And the fourth one that we've announced is JenaValve, and we are expecting to close the transaction mid-2025. When we do, we'll talk about what the potential implications are financially, both from an expense perspective, where we're going to try to offset some of those incremental expenses from JenaValve, as well as from a commercialization perspective, where we are expecting them to be on track for a commercialized product later in 2025.
We'll be able to have a better sense of what that looks like and what the implications are under Edwards' ownership after we close the transaction. For other margin implications, we feel really good about where we are right now in terms of the operating footprint. While we took actions in 2024 relating to the separation of critical care, there are additional things we can do to continue to improve our margins in 2025, 2026, and beyond. That's why we felt comfortable with that 50-100 basis point expansion target for EBIT. Did that get to what was the third part of your question, Matt?
What's that you're both talking about that you created the year after or you're going to do both? You created the year after, duration of something, dilution?
Yeah. So I mean, I think it's reflected in our longer-term guidance, which is bottom line, we're targeting and planning for double-digit earnings per share growth and leverage P&L relative to what the top line sales will look like. And it's all in there.
Ed.
Thank you. Edward Duday, rep in Atlantic. A related question, Scott. If we could think about capital allocation more broadly, I mean, clearly you do have market-leading marginal capital. You are blessed now with an extremely strong balance sheet. But equally, can you give us some reassurance on your internal ROIC metrics that you need to look at in terms of something that's an acquisition? Because yes, we all understand you want to make the investment, but as Bernard also highlighted this morning, you have exceptional ROIC on your internal investment. So if you could talk a little bit about what IRRs you're looking for on the external work, that'll be helpful, I think.
Sure, so just to clarify, when we talked about greater than 20% ROIC, I know it was next to the R&D reference in the graphic, but that's for the company. That's corporate return on invested capital north of 20%. We look carefully at different returns metrics and estimates when we're evaluating our internal and our external investment alternatives. Early-stage med tech acquisitions are tough to value using a traditional ROIC approach, and so we combine quantitative but also qualitative considerations when valuing and paying for investments that we're making externally. If we ran TAVR based purely on ROIC, we never would have started in the business, and so we bring that same kind of careful but longer-term lens when making investments in other businesses, and sometimes the timing is just off. Sometimes we end up being able to commercialize technologies faster than expected. Sometimes it's slower than expected.
But it's one of the reasons why this key operating drivers system that we have internally, where we really reward and provide incentives for our people based upon qualitative long-term factors, becomes such an important part of the equation. If we've got an investment that is performing well, then we'll end up putting more resources behind it. If we've got an investment that is not showing the same signals of opportunity that we expected, then we may deprioritize it or defund it or combine it with another technology platform. So in terms of ongoing investments internally and externally, we're going to continue to bring that same level of rigor and bringing both quantitative and qualitative lenses to where we make decisions and trade-offs.
Thank you. Would it be reasonable to assume then, given the investments you've made and given the comments today, that you certainly have enough to work on through 2025 in terms of your current capital allocation?
Yeah. We're very focused right now on completing the integration and really accelerating the benefits that have come with these investments that we've made. We're still actively looking for other opportunities and other external investment opportunities. But as we said before, generally, we're looking at earlier-stage, small, strictly structural heart investments. And we're going to continue to do those. But we're really feeling pleased with the acquisitions that we've made in 2024, and we're focused on making sure they're successful.
Patrick.
I would say, we are laser-focused on growing TAVR, fully funding TMTT to achieve $2 billion by 2030, growing surgical, and creating these two new categories: AR and heart failure for us. What we have in mind is a company targeting 10% growth in the top line and a double-digit nice leverage in the bottom line. This is the way we are thinking about, at the high level, at least the way I'm thinking about it, at the high level about our vision, our strategy here.
Patrick.
Thank you so much, Patrick Wood, Morgan Stanley. As you showed with the early trials, we get to younger and younger patients, asymptomatic, presumably lower STS scores, things like that. Is there a chance that a chunk of those patients actually, instead of ending up in the TAVR pool, end up actually in the SAVR pool, and that you actually get better than single-digit growth there as you're going down that age curve and doing more preventative care? Is that something that's kind of been considered as part of the business?
Let's just start with that.
Sure. Look, I think as we improve diagnosis and as we improve referrals, I think it's going to be a rising tide that lifts all boats. I think it's going to benefit both the surgical business, and I think it's going to benefit the TAVR business. That said, this is still a disease of older people. It's not like when you start getting into asymptomatic patients that are all of a sudden 45. They're still going to be up in the late 60s, early 70s. And I think what you're looking at there is what the paradigm's really shifting to is what's their anatomical situation. And if they're anatomically suitable for a TAVR, it's just simply the preferred therapy for patients. It just is. And so I think that that happens first. But there's a lot of patients that aren't anatomically suitable or have other considerations.
And so those patients are naturally going to flow to surgery. But as Dr. Mack pointed out, if you look over the last four years, there's been growth in both segments. And you have a hard time looking at the TAVR growth curve and saying, "When did it all fall apart?" I mean, the growth curve has been pretty dramatic over a very long period of time. And that's the last five years haven't been with any new data or any new catalysts related to expanded indications, which are what drove us early on. So those are all the things that weigh in on why we feel good about our future. But this, again, isn't going to go into 40-year-old patients and that sort of thing.
Rick.
I thought I'd ask Diane a question about heart failure. It's one of the key new initiatives. I remember about a decade ago, St. Jude acquired CardioMEMS. Seemed like a good idea to me then. And we've had some great data. My strong sense is that the product and technology hasn't evolved, though. I'm very clear on that point. Is it enough that Cordella is new, reimagined, modern technology to get this market going again? Help us understand why the market's right. And I think I missed the slide on your 2030 contribution to dollars. Maybe you could tell us that number. Scott told me to ask.
Maybe let me start here about the rationale, why we decided to make this acquisition. We always start with looking at, is there a large patient need? We said, "Yes." Can we make a difference? We said, "Yes." So we were looking at this technology for a long time. We made an investment in the company, I want to say, seven, eight years ago. And so we were following their progress, the readout of their trial, and we became confident that this technology can make a difference, easier to use, have an impact. And then we look at, can we use our expertise, our playbook, innovating, bringing science, partnering with physicians to truly unlock this segment. So it is the reason why we decided to make the acquisition at the end of July. I want to draw a parallel though.
I don't know if you remember when we started TMTT eight years ago with PASCAL, most of the people were telling us, "Why are you going there? The TEER mitral segment is not growing. And there is one technology there forever that is not growing." And look at where the mitral TEER is going today. Growing, high single-digit, low double-digit. We believe there is an opportunity to treat even more patients with TEER mitral technologies. So at the end of the day, when you have a patient need, when you have the right technology, when you have science, you unlock the market potential. And this is truly the vision here for heart failure for us.
And if I can just add, I mean, I'm incredibly excited to join the team to lead in this effort. And as I outlined in my presentation, I mean, this is a differentiated technology today, and we're excited about applying elements of the playbooks that Edwards has had with other technologies and looking to invest in a pipeline that really spans three different environments. And it does take that level of commitment of innovation and building the evidence to support that innovation that makes us really excited about the future.
Larry.
Thank you. Larry Biegelsen's the most progressive. I wanted to give you an opportunity to comment on the PARTNER 3 Interim Six-Year Data. My questions are, is it stat-sig at this point? What's the plan going forward for you to update the data? Are you going to just let FDA continue to put out data? And why isn't it a little bit concerning to see the curves start to diverge? Thanks.
Yeah. It's actually not concerning. So one of the things that we highlighted during the five-year data is we've had a disproportionate number of withdrawals, and there's imbalances between the two groups. And one of the things that happens is when you it's easy to keep patients in a trial for one or maybe two years, and they'll come back for their follow-up visits. But you have to remember, a lot of these people come from distances. And you take a center like Mack Center in Texas. People are coming from distances. When people get the experimental device, the TAVR device, they're like, "This is a new device. We're studying it. We're doing all these things." And so people will make their follow-up visits, and they'll stay in the trial at a pretty good rate.
When you get to control therapy, the tried-and-true surgical bioprosthesis that we've run for 30 years, they're like, "I don't want to drive all the way back to Plano to get my follow-up." And a lot more patients withdraw from the trial. When patients withdraw from the trial, you lose all of their events because you're not following them anymore. And so it looked like we were seeing a separation at five years. But when we did a vital status sweep, which we couldn't do for 100% of the missing patients, but when we did a vital status sweep, the difference was, I think, slightly less than 1%, which just isn't meaningful when you're out at five years. And we had the early advantage of TAVR. So I think if you had perfect 100% follow-up, I think these things are probably pretty much flying in formation.
The other things that gave us confidence when we looked at valve dysfunction rates, they were incredibly low in each group and actually a little bit numerically lower in the TAVR group. When you end up with these imbalances over time, you're going to see curves separate, but it's not meaningful anymore once you have so much data that's no longer in the cohorts. The differences that we're seeing just aren't clinically relevant. We'll work with Martin and Mack, who are the PIs of the trial. We'll decide what the next time point is. This is really a physician-led exercise. It doesn't do a lot of good to keep putting data out when you know the integrity of the data is lessening over time because it just loses clinical context.
Adam.
Maeder, Piper Sandler. Question for Larry, just on the TAVR guidance, the 5%-7%. Was hoping you could kind of just unpack that for us. How are you thinking about US growth versus OUS, price versus volume, and just share dynamics as well? Thank you.
Yeah. I think it'd be difficult to break out too definitively regionally. We have Japan and emerging markets that probably grow a little bit above. The bigger markets are going to grow a little slower. You get into the law of big numbers and those sorts of things. I think the things that do the range for us is it is going to be about you heard earlier about all the activity trying to increase capacity. I think hospitals really are understanding the wave of patients that are coming. And it's just how fast are they able to adapt that? How fast do we get the indication for early TAVR? How fast can we change clinical practice? And if those things start happening earlier or faster, then we start ending up at the high end of the range.
If those things lag and keep pressure on us a little bit, then we kind of end up on the lower end of the range. And that's just sort of where we are. But that's why we thought it was important to talk about 2026 and beyond. 2026, we believe all these things start getting better. Capacity, whatever it is today, it's going to be better in 2026. If we get an update to the national coverage decision, we can add centers. That can immediately add capacity to the system as guidelines change and all these things happen and it gets socialized. Those are all going to be long-term drivers. So that's why we feel so confident in the long term of the TAVR growth opportunity.
Anthony.
Anthony from Mizuho. I want to clarify on the $0.15 of dilution acquisitions. You have JenaValve, JC Medical. JenaValve doesn't close till mid-2025. So what acquisitions are in the $0.15? And is JenaValve, in addition to that, the dilution? And then just on the spread between 5%-7% and high single-digit growth for TAVR, how much of that is what we discussed today with Dr. Mack on systems expanding capacity versus asymptomatic patients coming in? Thanks.
Do you want to start first?
Sure. I mean, it's a combination of the two. We know that severe symptomatic patients right now, as Mack pointed out, there's a waiting list, and some patients are even getting lost there just from the time that they're waiting. So we need capacity to improve in the system. We're growing off a very large base in the U.S. So even when we're growing at the 5%-7%, it's a lot of physical number of patients that are coming into the system that we have to be able to accommodate.
I think the thing that early TAVR does is if somebody was sitting on the sideline as Carrie or Mack are going to their administrator and they're saying, "I need investment in this," people are saying, "I'm not so sure." It gives them a data set to go that's very compelling that says, "Look, this problem that we have, this backlog that we have today, it's going to get worse if we don't make these investments. We do have new indications coming. We do have new things." And I think that can be a catalyst for making some of the investments that we need to improve the capacity. But those things simply have to get better because these patients just simply don't wait well.
On part one of your question, Anthony, so the $0.15 approximate forecast for EPS headwind resulting from acquisitions is the three acquisitions that we've closed: JC Medical, JenaValve, and Endotronix, which is our interventional heart failure management business. That does not include anything from JenaValve, which we're expecting to close mid-2025. When we get to that point, we'll talk more about what the financial implications could look like. We'll topline and on the expense lines for Edwards. But at this point, it's premature to talk anymore about what that could look like.
Marie, I didn't see you earlier.
Marie Thibault, BTIG. Just a question on the potential of some of the new populations, asymptomatic, severe, and moderate. Can you give us your latest estimates for those patient population sizes here in the U.S.? And is there a reason, Dr. Mack, he discussed the profitability of TAVR, clearly very profitable procedures still for the hospitals. Is there a reason to think these procedures might be more or less profitable for the hospital in those populations? Thank you.
Sure, well, I'll start with the profitability side of it first, and I think there's going to be a very compelling economic case for treating these patients sooner, and we highlighted that a little bit in the presentation, but when these patients become emergent, the expenses for these patients go up. They're more likely to be decompensated. They might have to be in the hospital a day before to get tuned up, and remember, the hospital just gets a set amount of money, and they have to pay all their expenses and all the procedure costs out of that set pool of money. I think when centers, especially centers that participate in early TAVR, and we're going to be working with them on this, on the economic analysis, we're going to find that these patients that came in that felt well, they didn't need any tune-up.
They didn't need anything done. They could literally come in and get their TAVR and go home the next morning, I think, in an overwhelmingly high number, and that's going to be the most economically beneficial patient that the hospital can treat. So in terms of sizing the market, one of the big learnings that we had, and it was one of the things that was truly unknown going into the trial. If you would have told me that one in five patients would fail a stress test, I would have said that number would have been higher. I would have thought half the people would fail a stress test. We used to have rich debates about whether asymptomatic AS was a myth. Like, if you stress tested these people, would they all fail? And we actually found out, no, one in five.
It's a minimum of one in five, but you don't know all the patients upstream that are just being held that nobody's referring. We know when we survey general cardiologists and Samuel Myers published on this. There's a lot of patients held upstream who actually have symptoms, but they're deemed mild symptoms, and they don't feel like moving them forward. I think until you have the indication, and I remember when we started TAVR and we were looking at inoperable patients, the surgeon said, "There's no such thing as an inoperable patient." I think our first $1 billion was built on a patient population that didn't exist. You don't know what's there until you open up the referrals, and that takes the indication. It takes the technology. It takes all those things. I mean, you look at what Daveen's doing in the tricuspid space.
Nobody talked about tricuspid, and now it's the thing that everybody's talking about. And we do know for moderate, there's two moderate. There's about two moderate patients for every severe patient. But we're going to learn from the trial. I don't know that every moderate patient needs to be intervened on early. But the thing that I do know is once we have the early TAVR data, we have the whole partner series of data, and then we have the progress data set, we're going to be able to pretty fine-tune, and Mack talked about AI. You're going to be able to pretty fine-tune what's the optimal point to intervene on a patient based on certain characteristics. And I think that's going to be the next big thing for us to be able to really do.
But we're going to be the only people that have that comprehensive data set to really do that.
Rich.
Hi. Thank you. Richard Newitter from Truist Securities. I just want to make sure on what's included and what's not in the 2026 and beyond, the 10% and the double-digit bottom line, 10% top line. So you're going to close JenaValve mid-year 2025. Do we view the 10%, the double-digit guidance in 2026 and beyond as a floor such that whatever you do come to us with for the impact of JenaValve, that those are still good numbers or that could change depending on what you reassess with JenaValve and then have one follow-up?
I can start on the math and then maybe talk more about the operational integration stuff. The 10% long-term top line growth guidance is not a floor. It's a target, and it's an average annual target. By the time we get to next year and talk about all of our businesses and Jena as well, we can talk more about what that could look like on the top line.
Yeah. The way to think about it is for many years, TAVR was the main business, the main growth driver. And it is not anymore the case. TAVR is an important business. We have mitral and tricuspid, and we have two new emerging opportunities coming. So if you look back and you say, "Can we make the TAVR grow faster than what 24 and 25 is?" The answer is yes, with EARLY TAVR in progress. Therefore, the range is mid- to high-single-digit. TMTT will continue to accelerate in terms of growth contribution to the company. Surgical will continue to be a very healthy business, mid-single-digit. Heart failure and AR will provide some type of growth, 26 and beyond. It will be small initially, more later. And so obviously, also when we say 10%, we are going to have some variability year over year, correct?
So a year where we have a number of catalysts happening, a new NCD, a new indication, a new approval, we might be slightly higher than 10%. A year where we have less of all of these, maybe slightly below 10%, altogether as an average around 10%. And this is our vision for the company, and this is why we are investing across structural heart disease.
Okay. Thanks. And maybe just for Larry, we were all at TCT. We all did our doc checks and reactions to early TAVR data, and everyone commended the data and was excited about it to some degree. But the enthusiasm that you guys are projecting today is notably more significant than I think what a lot of us, or at least we picked up from our diligence the day of. I guess, what do you think the biggest disconnect is between maybe what you guys presented today in that data that you showed that one chart and where physicians just it's going to take time to come around?
Yeah. I think there are a couple of things. One, I think the people immediately went to the lack of mortality benefit. And so I think people go there. I think people, if they get deep on the trial design and they understand that all these people were pre-screened, so the minute they presented, they could immediately go in the queue for treatment. As Mack pointed out, they have a three-week to schedule your procedures three weeks out. And so these people were already at that point where they could go immediately to scheduling to get their procedure, which is why they were treated in 32 days. I think when people understand that's not the real world. And if these people were sitting and waiting longer, I think we probably would have seen a mortality benefit or it would have been much more likely we would have seen mortality benefit.
I think the other thing too is when people see rehospitalization and they don't get into the reasons why somebody was rehospitalized, if they're just thinking, "Oh, well, they just presented again and they got their valve," and that's kind of that yellow group, they're like, "I don't know that it's a big deal." But that red group is very significant. And the problem that you have with waiting is you don't know who's who. You don't know who could wait. You don't know who ends up in the yellow group and just has standard progression. And you don't know who ends up in the red group who's getting an aortic balloon pump because their ejection fraction fell below 30. You just don't know who's who. And so as Mack pointed out, there's no penalty for early intervention.
The argument against early intervention a lot was if you're using a tissue valve, you're starting the durability clock. But if somebody's crossing over in six months, the durability argument doesn't even make any sense. If you're that worried about durability, make sure you're using a RESILIA-based valve. And so I think it's just going to take education. And I think sometimes people have to see the data more than once. I think what you hear from Mack and I and Philippe and a lot of the people, we're all super deep on the data because we've lived the journey and we've lived the manuscript and we lived all those things. I think it's just going to take a little more time to socialize that broadly.
I want to sneak in one last question from Matt Taylor.
Thank you. Matt Taylor from Jefferies. So I had a question on the building blocks in TMTT. I wanted to know if you could give us any kind of high-level split between mitral and tricuspid, repair, replacement, anything to help us think about the building blocks through 2030. And then on surgical, I had a question on the growth rate there. How much pricing is assumed in the mid-single digit growth kicker?
Sure. So I'll help hit some of the building blocks. When you get up to 2030, right, we know that tricuspid is new today and mitral is established. We believe that they get closer to each other in size in 2030, right? So to give you a little bit of building blocks, at least how we're thinking about the tricuspid could be really big. Maybe it's bigger, but those are some building blocks. When you think about both repair and replacement, where we obviously offer both technologies, we think that both would be significant in the tricuspid space, right? So they're both going to be very significant as a growth driver. And the mitral space, as I mentioned, hey, repair has been established now. Replacement will add as a building block.
So when you already have something that's very big and you're adding a building block, hey, well, maybe that'll stay a little bit larger for a little bit more into the future. So that just gives you some trends, but I think if you pull back up and look about it, it's not an either/or for us. We know that there are so many patients out there who need treatment that even with repair and replacement, there's still going to be patients who are undertreated, who are suboptimally treated. But at least when the patients that can be treated, we feel like we can offer the best possible solution that may exist for repair or replacement just to help in the future, and that's how we're kind of thinking about these building blocks.
So if we trade away one building block for the other, we still feel that the patient's getting the best care and we can offer the best Edwards solution for those patients.
Then for your question on surgical, thanks for the question. Really, we always look at three different levels, right? We've got the market, we've got share, and we've got price or our mix. And at any given year, there's going to be some sort of balance between all of those three. Most recently, it's been a pretty even balance across all of those three. As we expand the new geographies and we're bringing a new RESILIA technology to some of these emerging markets, there's obviously significant upside on the premium technology, which typically comes at a premium price because of the premium value that we're delivering on it. So it really depends on geography, but there tends to be a pretty even distribution of balance between that market, share, and price level.
Great. Thank you.
So with that, I'm going to turn it back over to Bernard for some closing thoughts and a patient video, and the rest of us, I think we'll file off here. Thank you.
So I want to close this morning with thanking all of you. You spent the entire morning with us. I know you know us as a company well. I trust you are going to leave this session as excited as we are about the many opportunities we have in front of us, the kind of company we are, how we do things, and the impact we are having to society and patients. I feel very fortunate to be leading this company. We do well. We are successful. We have strong performance. But also, we do well, again, like I say, to society and to patients. And this video here is a great reminder about all what we do together. So thanks again and see you soon.