Hello, thank you for joining us. My name is Mike Mussallem, I'm the Chairman and CEO of Edwards Lifesciences, on behalf of the entire company, we are excited to welcome you to our headquarters in Irvine, California. We really appreciate you taking the time to learn more about Edwards. I'm here at one of our new facilities on our campus, as you can see, it's still under construction, nearly complete, we're excited to be expanding our labs and capabilities to support our innovation and growth. I can't think of a better backdrop to kick off our annual investor conference. We welcome the opportunity to bring our innovations to life and to outline our 2021 and longer-term outlook. We will also spotlight several of our patients, clinical partners, and incredibly talented employees.
It's obviously a little different without all of you here. I hope you enjoy our attempt to give you some unique glimpses into Edwards while we update you on what's ahead, and finally, look forward to taking your questions at the end of our program. With that, welcome to One Edwards Way. Let's head on in as we're excited to take you on this journey with us. First, it all begins with our company's credo. Edwards Lifesciences was established 20 years ago. At that time, we committed to living the values outlined in our credo. I'm extremely proud to say our employees continue to do so every day. It's our rock. We keep it in mind with everything that we do.
Our credo closes with the statement, "Helping patients is our life's work, and life is now." What that signifies is the focus and urgency of our work. Even with our successes, we know there are many underserved patients. They need help, and they can't wait. It's what motivates us every day, and this focus remains central to our long-term success. While COVID changed the world in many ways, it didn't stop us from living our credo and being inspired by our aspirations. We believe that if we're successful in this, all of our stakeholders will benefit greatly. Our aspirations are led by transforming patient lives with breakthrough medical technologies. It's easy to say but hard to do and very motivating. We continue to remain steadfast in our commitment to behaving as a trusted partner through distinguished quality and integrity.
I'm also extremely proud of the inclusive culture that we have at Edwards, where all employees can grow and thrive. In this regard, 2020 has been a year of reflection. We recognize that actions speak louder than words. While we believe that Edwards has an excellent track record of valuing diversity, we challenge ourselves to keep improving. Beyond diversity and inclusion, our team is passionate about strengthening the communities where we live and work. As we strive to achieve these aspirations, we know that when we get them all right, we will deliver exceptional shareholder value. Now, for those of you who are newer to Edwards, I want to provide a brief overview of who we are. Our employees are at the center of our company, and they're the key to our success.
During the pandemic, we prioritized protecting jobs. In fact, we added more than 1,000 new employees around the world in 2020. We have an extraordinarily diverse and talented team who share the same focus on helping patients. As the global market leader in our field, we're a critical member of the healthcare infrastructure. During the pandemic, we never stopped. This was especially noteworthy for those in our supply chain and those who support patient treatment in hospitals who never stopped going into work. We sincerely appreciate the dedicated efforts of our entire team. Our patient-focused innovation strategy is unwavering. You'll hear more about it from each of our leaders today. It's a differentiated strategy and one that guides us regardless of the environment or geography that we're operating in. One of the unique aspects of our strategy is the focus.
At a time when medtech companies are diversifying, Edwards has remained laser-focused on innovations for structural heart disease and critical care monitoring. There's an incredible amount of growth possible within this space, and these patients are vastly underserved. By staying focused, we're able to bring our decades of expertise and clinical knowledge, more resources, and understand the patient's journey to better advance potential solutions. The other key element of our strategy is bold innovation, and we are pursuing a rich pipeline. We're focused on innovations that change the practice of medicine, supported by rigorous clinical trials and achieving best-in-class outcomes. We know that change doesn't come easily and must be backed up with big evidence. While some evidence collection was slowed as a result of the global pandemic, Edwards and the clinical community continued to be committed to delivering.
Finally, leadership is the third key component of our strategy. We think that when you go first, you have the opportunity to learn faster than others and get a seat at the table with thought leaders. Simply put, you are a key contributor to shaping the way value gets created. This strategy has delivered results for many years. In an unprecedented year like 2020, we're pleased that we're on track to grow sales over our impressive 2019 sales growth. Looking ahead to 2021, we anticipate returning to strong double-digit revenue growth, which Scott will detail later. Furthermore, we'll outline why we believe we're on track to achieve our long-term global market opportunity for TAVR and TMTT. This consistency of growth demonstrates how much patient demand exists for the work that we do and the power of the triple win.
Those innovations that extend life, improve the quality of life, and are more efficient for the healthcare system. This is an inspirational goal and the ultimate payoff for our long-term investments. We know that Edwards is valued on the outlook for a bright future, and while we expect the pandemic to have a lingering impact on the global healthcare system, we are very optimistic about 2021. Over the next 12 - 18 months, we see numerous opportunities to drive shareholder value, including exceptional sales growth, highlighting the importance of treating structural heart patients even during this pandemic. Progress on expanding large, underappreciated, and underserved transcatheter opportunities. Strong tailwinds from groundbreaking clinical trial results and clinical trial expansions, and a rich pipeline of bold innovations. Our aggressive R&D spending allows us to fuel this progress, which we will demonstrate through the achievement of significant milestones.
Today, you'll hear from many members of Edwards' executive leadership team. Each of our leaders is special. I'm really proud of this team. They bring a tremendous amount of diverse experiences and a collective passion to our company every day. Together, as a team, we develop our long-term strategies, we work through operating challenges and opportunities. This group really gets along together, respects each other, and has some fun together at the same time we deliver on our commitments. I'm grateful that we have such a talented leadership team. I'm pleased that you're going to have the opportunity to learn more. With that, let's transition to Larry Wood, who leads our Transcatheter Aortic Valve Replacement or TAVR business globally. Larry recently celebrated his 35th anniversary with our company. He's been the leader of this technology from the very beginning, 20 years ago.
He knows and cares deeply about these patients, this therapy, the science, and the value that it delivers. This therapy has continued to grow rapidly in the years after it was first introduced and distinguished itself from other medical innovations. We're proud of this leading platform and are confident that the growth will continue for a long time. I'm excited to have Larry share what's ahead.
Welcome. It's always an honor and a privilege to talk about our transcatheter heart valve program. I wish we could all be together, but I think we have a great story to share with you virtually. As we look back to 2019, we had amazing uptake in TAVR procedures. When we started this year, the first 10 weeks of the year, we were doing very well. Actually better than our initial plans were. 10 weeks in, the pandemic hit, and I think all of us know what happened then. It deeply affected our Q2, and while we've seen a strong recovery in Q3, we're not back to where we were originally. When we look at this period of Q2 and Q3, I think it's important for us to look at what happened during that period of time. Some things slowed down.
Clinical trial enrollment slowed down, training of new centers slowed down, and proctoring new indications also slowed down. Some things never stopped.
We did it.
Congratulations.
Thank you.
Aortic stenosis is deadly disease, we had to go on treating that.
We realized that our patients who have severe AS cannot wait.
We launched the TAVR program after the pandemic had started. Our average length of stay has been 21 hours.
The satisfaction's been so positive, and the compliments have been endless.
Our volume went up by 20%. 2020 is going to be our busiest TAVR year ever. In Bologna, we were able to go on performing procedure at the same pace of the previous year, thanks to this streamlined procedure.
When you compare a five to seven-day hospital stay with a 21-hour hospital stay, the resource utilization is significantly lower.
With the SAPIEN 3 and SAPIEN 3 Ultra, we can achieve these results and minimize the procedure complications, and we will be able to treat more and more patients.
Edwards and the Ultra valve offered us the best pathway. What we have learned is how strong the TAVR therapy is in a time when everything else failed.
I was very fortunate. From the bottom, or actually from the top of my heart, thank you.
I couldn't be more proud of our team, I couldn't be more grateful for all of the healthcare workers, the heart teams, the physicians, the valve clinic coordinators, and the nurses that cared for these patients during this pandemic. Looking forward, we're excited about the recovery and how the recovery's been going. While we may not get all the way back to our original trajectory, we believe we can get pretty close, we believe that sets us up for a great 2021. Some other things that didn't stop during the pandemic were FDA. FDA continued to review submissions and work on various approvals. One of the things that happened is the bicuspid precaution was removed from our label. Bicuspid was never off-label, there was just limited data on bicuspid, there was a precaution letting the operators know that.
We've submitted additional data to FDA that was compelling, and now the precaution has been removed from the labeling. We also got approval for TAVR in TAVR. This isn't important now because TAVR valves rarely fail. Should a TAVR valve fail in the future, we will have the opportunity to replace it with another TAVR valve. I think this opens up a range of possibilities for patients. Right now, the paradigm is often to treat with surgery first and then with TAVR second. With the TAVR in TAVR approval, perhaps the paradigm should be TAVR first, and then we can do a TAVR in TAVR. One of the other things that happened is we just got approval in China. This is very exciting for us. We're the first multinational company to have a TAVR approval in China, and we're excited to get the launch started.
Switching gears from aortic stenosis for a moment, congenital pulmonic valve disease is a serious congenital issue for many patients. These patients either get a valve replacement or they get a very customized repair. We now have SAPIEN 3 approved for these pulmonic patients that have had their valve replaced. That's only about a third of the patients. The rest of the patients have had a complex repair, we've been working on a pre-stent called Alterra. With Alterra, we can address about half of the patients that have had a complex repair. We're very excited, we expect that approval in 2021. Behind every one of these valves and every one of these indications is a patient. I'd like to talk about one at random, my Aunt Marilyn. My Aunt Marilyn is quite a woman. She lives on a ranch in Oklahoma.
She owns a chainsaw that she uses regularly, and she's a very, very robust woman. About 15 years ago, she had valvular heart disease, and she actually got an Edwards aortic surgical valve and an Edwards ring and had a mitral valve repair. For 15 years, she's enjoyed an amazing quality of life and has remained very active. My cousin Julie called, and my Aunt Marilyn wasn't doing well. She was actually going into heart failure, and my cousin was very scared. So was I and our entire family, as are all families that have a family member with valvular heart disease. Fortunately, there's a guy named Chris Baker and Dr. Chehab, and they were available to take care of my aunt, and gratefully, they're joining us here today. Hey, guys.
Hey, Larry. Thanks for having us, and it was our pleasure.
Hey, Larry. Good to see you.
Chris, when I first called, what happened? What'd you put into motion?
Well, when I got the phone call from you on Tuesday morning, I immediately reached out to Dr. Chehab and his team, by Tuesday afternoon, they had made contact with your aunt. Even though she lives four or five hours away, they were able to help her get to the hospital.
We got the work-up done on her on Wednesday and Thursday. She got her TAVR therapy on Friday morning. She spent the weekend, and by Monday, she was discharged, and her symptoms had significantly improved. She was out of the danger zone. Her heart failure complaints were gone, and she was feeling much better.
It was truly remarkable what you guys did for her. She looks and feels so much better than she did before. Dr. Chehab, how do you think your experience with my aunt and TAVR in general during COVID informs the future of this therapy?
Well, we learned a lot about the TAVR therapy in the last six months. Patients with aortic valve stenosis, if left untreated, actually have a double risk of dying. They would die twice. They would die first by us being shut down and not doing cases because they're, some people say, non-essential. They would die again when we reopen, and we have a massive backlog, and they would die waiting on that list again.
The deadliness of severe aortic stenosis was really brought to light during the pandemic. What else did you learn in the last few months?
We really learned a lot how to stretch the TAVR therapy. We learned about how to minimize resources and really the awake conscious procedure versus anesthesia-driven procedure was a big thing for us. We learned how to do very early next-day discharges, and even on certain patients, same-day discharges. That's a feature that is really unique to the ultra Edwards system. Your aunt, Larry, was one of the lucky people who got the SAPIEN 3 Ultra TAVR from Edwards.
I'm so grateful for our Ultra platform and that it was available for her.
That valve came to us as a godsend because the inner characteristic of that technology is it allows us to take care of patients and get them home very fast with same-day discharge and/or early next-day discharge. One of the biggest features of that is the minimal pacemaker need, the excellent hemodynamics, the very low stroke rate, and all these characteristics merged together for us to get your aunt home in less than five days.
It's truly amazing, Dr. Chehab. I'm sure you're ready for 2020 to end, as all of us are. What word would you use to describe it?
It was really a year of learning, and I think the learning points we had will help us for the next few years, if not for the next decade, and possibly the next pandemic.
Such great learnings. Chris, the field never stopped. What's it been like for you to be supporting hospitals during this pandemic?
I didn't even think about it. Dr. Chehab needed me there, and so I was there. It was a no-brainer for me. That's just what we do. We treat patients.
Chris, thank you so much for what you do every day for patients. By the way, Dr. Chehab, what was the most challenging part of my aunt's procedure?
Well, to be realistic, the most challenging part was you, Larry, calling the team and calling everyone every 20 minutes asking questions and telling us how to do our job.
I'm pretty sure that's not true. I gave you at least 25 minutes between calls. Thanks you guys for everything that you did for my family, for my aunt, for my cousin, and for all of the TAVR patients that you've treated during this very difficult pandemic. Like Dr. Chehab said, there were a lot of learnings in their institution. I think all of us learned a lot. One of the things I think we learned is that hospitals can't just stop treating patients with structural heart disease. These patients simply don't wait well. There was a couple of studies that came out that really supported that.
One of the studies was in New York, where it showed that one out of 10 patients went from going to have an elective procedure to actually having to have an emergent procedure by delaying their therapy when elective procedures were stopped. The news out of Europe and Switzerland was even worse. One in five patients actually died waiting for the aortic valve procedure. I think another thing we learned is how hospitals manage during this pandemic. When it first occurred, so many hospitals just completely shut down, regardless of what their COVID-19 levels were. Hospitals now have learned so much, and they've learned how to treat their structural heart patient, even in the face of the pandemic. This is where TAVR really shines.
We have a procedure now, if you look at our PARTNER 3 data, 99% of our patients were alive and well at a year, 96% of our patients were discharged home, and 90% of our patients were free from rehospitalization at two years. We have very low pacemaker rates, very low rates of paravalvular leak, and it gives these hospitals tremendous confidence that they can treat their patients, get them out of the hospital safely, and get them home while still managing all of the other challenges the hospitals face. Now, economics always play a role, and I think we've always been at the forefront of studying the cost-effectiveness of transcatheter heart valves. Rather than me talk about it, I'd rather bring in a world expert, Dr. Suzanne Baron, and she's going to update us on what's the latest on economics regarding transcatheter heart valves.
Thanks, Larry. I'm really pleased to be here, especially because in today's healthcare environment, understanding the value of a particular technology and what that technology can bring to our patients, as well as the healthcare community as a whole, is of the utmost importance. When we think about cost-effectiveness, the name really says it all. We want a treatment that will be effective, but it has to come at a reasonable cost. In terms of effectiveness, the PARTNER 3 trial showed that patients at low surgical risk with aortic stenosis who were treated with TAVR had lower rates of death and disabling stroke at one year when compared with surgery. Patients don't just think about will I live longer after a procedure. They want to know will I feel better? Will my quality of life improve?
To answer this question, we performed a sub-study alongside the PARTNER 3 trial where we compared health status in patients at low surgical risk who received either TAVR or surgery. Not only did we find that TAVR was associated with significantly better health status at one month when compared with surgery, we actually found a small but persistent benefit of TAVR even out to one year. What this means is that not only do TAVR patients recover faster, but there's likely a subset of patients who will see an even greater benefit of TAVR as compared with surgery, even in the long term.
When you think about the low-risk patient population, in particular, many of whom are still working or running households, being able to get back to their previous level of functioning and maybe even better than their prior level of functioning is incredibly important, and it certainly may factor into their decision to choose TAVR over surgical AVR. TAVR is certainly as effective as surgery in the treatment of aortic stenosis for the low-risk patient population. At what cost? Prior studies have shown that the majority of cost associated with an AVR procedure can be traced back to the index hospitalization. One of the drivers of cost for the index hospitalization is length of stay.
With advancements in the TAVR technology as well as operator proficiency, the vast majority of procedures are being performed through the leg, and many of these are being done under conscious sedation as opposed to general anesthesia. What this means is that patients are recovering faster, and they're spending less and less time in the hospital. In the PARTNER 3 trial, patients who were treated with TAVR spent on average three days in the hospital as compared to seven with surgery. What this should all translate to is lower index hospitalization costs associated with TAVR when compared with surgery. Now, the formal cost-effectiveness analysis of the PARTNER 3 trial hasn't been completed yet, but I think we can make some predictions.
Given the known effectiveness of TAVR, as well as lower rates of some of the major cost drivers, I would expect that the cost-effectiveness of TAVR versus surgery in the low-risk patient population will mirror what we've already seen in the intermediate-risk population. That TAVR will be an economically dominant strategy when compared to surgery for the treatment of severe symptomatic aortic stenosis in the low-risk patient population.
Thanks, Suzanne. Looking forward, we believe the fundamentals around TAVR have only been strengthened. We continue to expect the global opportunity to exceed $7 billion by 2024, and we think there's growth drivers beyond that planned horizon as well. Looking at where we are today, we have the low-risk approval, but we were still in the process of launching that in the U.S. and in Europe when the pandemic hit. There's still a lot to be done in those markets to make sure that people are aware and getting aortic stenosis patients off the sideline. Looking to Japan, they currently only have a high-risk indication. Our low-risk approval should occur in late 2021. To talk more about Japan, I'd like to invite Huimin Wang, who's our leader of Japan and Asia Pacific, to talk about his region and what he sees for the future.
Thanks, Larry. I'm really passionate about the future of Edwards TAVR in the Japan and Asia Pacific region. Japan in particular remains an exciting opportunity for TAVR, with its aging population increasing rapidly and a mature government-funded healthcare system. We expect approval of SAPIEN 3 for low-risk patients in Japan by the end of 2021. Given the significant undertreatment of patients, indication expansion, and disease and therapy awareness will be key to unlocking the TAVR opportunity in Japan. We are also starting a new chapter in China with the launch of SAPIEN 3. Our focus in China is to establish an efficient pathway to treatment and to become the trusted clinical partner along that pathway. Outcomes are the top priority for us, and offering a new standard in TAVR for Chinese patients includes not just the best products, but best practices in patient screening and procedural techniques.
We expect other countries, including Australia, New Zealand, and others in Southeast Asia, to also offer opportunities for growth in the future. To date, more than 30,000 patients have received an Edwards TAVR valve in Japan and Asia Pacific. We're proud to say we have over a 99% procedural success rate with SAPIEN 3.
Thanks, Huimin. We continue to try to create strong clinical evidence to further expand indications. We talked at last investor conference about our EARLY TAVR trial, which is focused on asymptomatic patients. Now, this trial was directly affected by COVID-19, and it did slow enrollment. We're still optimistic that we can complete enrollment of this trial in 2021 and potentially change how patients with aortic stenosis are treated by not waiting for the symptoms and signs of heart failure, by treating them when the disease is diagnosed. Beyond that, we're looking to start a trial for moderate aortic stenosis. Rather than wait till patients are severe and damage is actually happening to their heart, we think treating them earlier when they have moderate disease might be a way to treat patients more effectively.
To talk more about that, I'd like to invite Dr. Martin Leon, and there's nobody better to speak about clinical trials than him.
Thanks, Larry. We've been studying TAVR and aortic stenosis for about 15 years. In essentially all the studies that we've done, we have largely studied patients who have severe aortic stenosis, and the trigger point for therapy has been the presence of symptoms. What we're learning now is that we have a new therapy that's very powerful. Transcatheter AVR, which provides extremely low event rates, 1% stroke and mortality at a year, that opens up the possibility of new studies in different and broader patient populations. We've also learned over the past five years that patients who don't have severe but have moderate aortic stenosis, which occurs at a frequency about equal to severe AS, that these patients have a high frequency of cardiac damage. Close to 90% have some degree of cardiac damage associated with their valvular heart disease.
If you wait too long to treat these patients, many times, that degree of cardiac damage is not reversed. We're now exploring the idea of looking at a population of vulnerable moderate aortic stenosis patients who might be candidates for early TAVR in a large randomized trial. It would open up a whole new dimension of how we approach the disease of aortic stenosis, thinking of it more as a continuum than a binary yes/no severe aortic stenosis in managing these patients with earlier valve replacement than the traditional mode, which is watchful waiting, active surveillance. We think this has the likelihood to be the next big breakthrough clinical trial in aortic valve disease.
Thanks, Marty. We're very excited about starting a moderate AS trial, and we anticipate being able to get an FDA approval to start that trial in 2021. Moving on to technology. One of the challenges of developing our next-generation platforms is how well our current platforms are working today. We enjoy 99% freedom from death and disabling stroke at a year in our low-risk trial. Next-day discharge is very routine at many hospitals around the country, and we have exceptionally low rates of paravalvular leak that's moderate or severe. We also have low pacemaker rates, and we preserve coronary access for the future. We believe all of these features are very important, and any platform we develop in the future has to maintain those. Where do we look for opportunities? One is paravalvular leak.
While we've eliminated moderate and severe to a large degree, patients still have mild PVL occasionally, and we need to be able to address that. I think there's an opportunity for us to virtually eliminate mild PVL, and if we can do that, then we really put TAVR performance on the same level as surgical valve performance because they also don't have much paravalvular leak. We also believe that there's opportunities to simplify the procedure. There's a lot of pre-procedure planning that goes into a patient in terms of all of the imaging and all the workup that has to be done. We believe through technology, there's ways that we can make the procedure more forgiving and actually make it easier for patients to go through the screening process.
When we look at our portfolio, we have SAPIEN 3, we have SAPIEN 3 Ultra, and we have some enhancements planned for that platform. We also have our next-generation valve, which is our SAPIEN X4. We anticipate starting a clinical trial on SAPIEN X4 in 2021. These platforms take a long time to develop, so even beyond X4, we have a revolutionary new platform that's under development. We're never going to stop innovating, and we're never going to stop trying to figure out how to make the perfect device and have the perfect procedure every time. Now turning to 2021, overall healthcare spending and competition are always headwinds. This year we have also the unique challenge of the COVID recovery. At the same time, in terms of tailwinds, we have a spectacular procedure that's popular with patients and reduces overall healthcare spending in addition to resource utilization.
We think the benefits of TAVR are still underappreciated and have the opportunity to grow and expand. Overall, we've set our 2021 sales guidance at $3.2 billion-$3.6 billion, which implies an underlying year-over-year growth rate of 15%-20%. Despite all the current challenges, we're very excited about 2021 and how the recovery's gone so far. We look forward to a time when the world gets to be a little bit more normal. Thank you very much and please stay safe.
Thanks, Larry. It's a powerful message. I'm convinced the best is yet to come. When I think about how far this therapy has come in this period of time and the number of patients around the world that deserve access, I am very optimistic about the future. Behind me is a special group of people that are handcrafting heart valves. This group has incredible dedication and expertise. They have an opportunity to meet patients routinely. Trust me when I say they put patients first. This group never stopped working in 2020. They knew what was at stake. This group is crafting the transcatheter heart valves of tomorrow. It's the same group that was part of the foundation of this company when it was founded 60 years ago on the first surgical heart valve.
With that, I'll transition to Daveen Chopra, who leads our global surgical effort. He's an experienced medical technology innovator, and he brings an energy and an enthusiasm to his team that I think you're really going to enjoy. Daveen.
I'm excited to share with you our strategy for surgical structural heart and how we're executing it as the innovation partner of choice for cardiac surgeons. We believe the current $1.8 billion surgical structural heart market will grow mid-single digits through 2026. This is driven by the fact that global cardiac procedures are projected to grow in the mid-single digits as the population ages. We see surgical aortic valve replacement procedures in the developed markets declining, equally offset by growth in the emerging markets. The surgical mitral market continues to grow, bolstered by an increased diagnosis, awareness, and referrals of this undertreated disease. In addition, there are several other therapy areas in surgical structural heart that continue to grow strongly. We've extended our leadership with three new product launches in 2020. We have more launches planned in 2021, including the launch of our new surgical mitral valve.
We're continuing our commitment to bringing life-saving innovation to patients best treated surgically. In developed markets, we believe that surgical cases for patients with severe symptomatic aortic stenosis who receive an isolated or simple combined procedure will decline due to TAVR. However, we believe multiple patient segments will continue to best be treated surgically and will grow. Specifically, younger active patients who don't want their lives limited by anticoagulation. Patients that need complex combined procedures such as SAVR with multivessel CABG. Finally, patients with aortic regurgitation where TAVR is contraindicated. In the emerging markets, we expect all SAVR patient segments to grow as surgery remains the predominant option. We view our valve tissue technology as an incredibly important patient differentiator, both in surgical and transcatheter therapies, because longer tissue durability leads to better overall valve performance.
Our newest RESILIA tissue technology delivers extended durability through enhanced anti-calcification properties and improved hemodynamics. This revolutionary technology is based on the cumulation of our 40 years of experience of working with bovine pericardial tissue. We're proud to share clinical data of zero structural valve deterioration out to five years from our European feasibility study of 133 patients and out to four years from our COMMENCE U.S. pivotal trial. Five-year data from this trial will be released at the end of January. One of our leading R&D tissue experts, Angela De La Fuente, is here to tell you more.
RESILIA tissue targets the extension of tissue durability due to the primary failure mode of bioprosthetic valves, calcification. RESILIA targets one of the main contributors of calcification, residual aldehydes. They can attract calcium. The process is to stably cap, which means we bind it or cover these residual aldehydes with a small molecule, and then we stabilize it so it's permanent. This benefits younger active patients whose primary option today is a mechanical valve, which requires reliance on an anticoagulant for a lifetime. There's a story that really sticks out for me and the benefits of RESILIA. This young woman waited for the INSPIRIS valve. Her only other option was a mechanical valve, therefore not allowing her to have children. With the RESILIA tissue, she now has that ability to do it. We're really giving back that quality of life to these patients.
Thanks, Angela. We're excited about how this tissue technology can improve durability and greatly help patients. With RESILIA tissue technology, we have introduced a new class of RESILIA innovations, the INSPIRIS aortic valve, the KONECT aortic valve conduit, and soon MITRIS, our new mitral valve. INSPIRIS is our flagship surgical aortic valve, and I'm pleased to say now is the leading surgical aortic valve in the world, featuring RESILIA tissue for enhanced durability and our unique VFit technology, which enables the valve diameter to expand for future potential transcatheter valve-in-valve cases. These features make INSPIRIS the valve of choice for younger, active patients who want to continue to live life to the fullest without the burden of anticoagulation. Our patient, Daniel Colgan, is a great example of someone who lives life to the fullest.
It's Daniel. I'm 31 years old. I have a INSPIRIS RESILIA tissue valve. Before my operation, I remember spending months researching into what valve is going to let me live this let's-push-the-boundaries type lifestyle. When I laid my eyes on the INSPIRIS RESILIA valve, I went, "That is the valve." It's now two and a half years after my operation, and I'm back doing all the things I used to love doing. If I'm not on my mountain bike, I'm out playing some golf or I'm at the gym. Still doing running. I did my first 10K race last year. I'm so thankful that I'm still here. I'm so thankful because it gave me a second chance at life.
Wow, what an inspiring story. We're encouraged by the growth and adoption of INSPIRIS for patients like Daniel in the U.S., Japan, and Europe, and we're eager for its launch in China in 2021 to extend patient impact. Our second RESILIA offering is KONECT, the first preassembled, ready-to-implant aortic tissue valve conduit. Launched in the U.S. earlier this year, KONECT is built on our trusted valve design with RESILIA tissue and a leading aortic surgical graft and is designed for complex aortic valve procedures which require replacement of the aortic valve, root, and ascending aorta. With roughly 7,500 patients in the U.S. undergoing this procedure each year and growing at the high single digits, KONECT addresses a key unmet patient need and drives growth in the U.S. in 2021. Physicians who are implanted KONECT are enthusiastic about it.
Dr. Joseph Bavaria, who is Vice Chief of Cardiac Surgery at Penn Medicine in Philadelphia, will tell you more about the benefits of KONNECT.
This is the KONNECT device, a new graft specifically and specially made for BioBentall operations. We have a beautiful sewing ring. We have the Valsalva graft made for both an intra-annular as well as a supra-annular replacement. I think that the bottom line here is that we have a new device that will make aortic root procedures, and specifically BioBentalls, a little easier and a little bit more predictable and not as variable. My experience so far has been very positive, and put a kudos out to Edwards for developing this new graft for us.
As we shift our focus from aortic valves to mitral valves, we see significant undertreatment in those with mitral disease, where less than 2% of those with the disease are treated. We see this as a strong opportunity for growth in both surgical and transcatheter therapies. If we segment the surgical mitral patients today, we believe that many will continue to best be treated surgically and will grow, specifically surgical low-risk degenerative patients, where surgery will remain the gold standard for years to come, patients with complex disease who require multiple procedures in one surgery, younger patients with rheumatic disease, and finally, patients with endocarditis or infection of the valve where surgical resection is required. Surgical mitral valve replacement will continue to be needed for many of these growing segments. I'd like to introduce our third offering in the RESILIA family, a new mitral valve, MITRIS RESILIA.
MITRIS RESILIA features our trusted valve design, RESILIA tissue for enhanced durability, which is even more critical on the mitral side, as well as several ease-of-use advancements and compatibility with minimally invasive approaches. Patients remain unsatisfied with the lifestyle compromises they must make if they receive a mechanical valve. We estimate that 60% of surgical mitral valves implanted globally are mechanical. With a large opportunity to convert mechanical valves to tissue valves globally, MITRIS RESILIA is well positioned for success and adoption. We'll be launching MITRIS RESILIA in the U.S. and Japan in 2021, and we'll continue to extend our leadership. Beyond MITRIS RESILIA, we aspire to transform how surgical mitral repair is performed. In patients with degenerative mitral regurgitation, the recommended treatment is valve repair with an annuloplasty ring as opposed to valve replacement because valve repair is associated with improved event-free survival.
Mitral repair is a complex art and often varies greatly from surgeon to surgeon in how it's performed and in patient outcomes. We're addressing this unmet need with HARPOON. By standardizing the procedure, HARPOON helps to transform mitral repair from a complex art performed well by a few to a repeatable science performed by many. HARPOON is performed beating heart without sternotomy or bypass and done under Echo guidance so surgeons can confirm real-time that mitral regurgitation has been eliminated before the patient leaves the OR. We believe this will help improve the overall patient experience through fewer adverse events and faster patient recovery. We launched HARPOON in Europe this year and have seen excellent acute outcomes to date. While we're early in this journey, our experience has been positive.
We estimate that there are approximately 20,000 patients across the U.S., Europe, and Japan who receive surgical treatment that are eligible for HARPOON. We believe that many of these patients can benefit from a less invasive beating heart repair that HARPOON provides. Pivoting to HARPOON in the U.S., I am pleased to announce that we have started our RESTORE pivotal trial, which is a unique non-randomized study with a one-year endpoint utilizing the STS database as our safety comparator. A study from the cardiothoracic surgical network as our efficacy comparator. We believe this novel approach will enable us to complete the study more quickly and effectively than a randomized trial, bringing this technology to the marketplace sooner for patients. Overall, the RESTORE trial will enroll up to 360 patients at up to 40 centers across the U.S., Canada, and Europe. For more information, you can visit clinicaltrials.gov.
Looking into 2021 and beyond, we see HARPOON as a true platform technology. We'll be launching in additional international countries, are working on a next generation, and are exploring expanded indications. As we look to the future, we believe our innovations will continue to drive balanced growth within our surgical structural heart portfolio by lowering our relative contribution from SAVR, increasing growth contribution from mitral, our strongest growth driver over the next several years, and finally, providing solutions for unmet needs in surgical structural heart for surgeons and their patients. Now turning to our sales outlook for 2021. We see continued TAVR impact in the U.S. and Europe, as well as healthcare spending pressures as our main headwinds. Our main tailwinds are increased adoption of our newest premium innovations and accelerated mechanical-to-tissue valve conversion.
Overall, we've set our 2021 sales guidance at $800 million-$900 million and are excited for a successful year of increased patient impact. As our time comes to a close, I want to leave you with three reasons to be excited about Edwards Surgical in the years to come. The surgical structural heart market is forecasted to grow in areas with unmet patient needs. Our strategy is focused on transforming patients' lives by advancing surgical structural heart innovations. Finally, we're committed to bringing life-saving surgical innovations to those best treated surgically. Mike?
Thanks, Daveen. I hope you enjoyed that look at some of our new therapies. For some patients, surgery is going to be the best option, and for us to have innovations available for them can truly be life-saving. Now I'd like to introduce Dr. Todd Brinton. Many of you may know him from Stanford University, the School of Medicine, and the School of Engineering. He also led the Biodesign program, really world-class in medical technology innovation. He is a true thought leader in structural heart disease and a valuable member of our team, and I hope you enjoy hearing from him how Edwards goes about pursuing breakthrough innovations.
Thanks, Mike. Innovation is at the heart of Edwards Lifesciences, beginning with the first mechanical heart valves, advancement of biomechanically engineered tissue valves, and pioneering the development of the first percutaneous transcatheter aortic valves. Just recently, we rolled out the Transcatheter Mitral and Tricuspid Therapies organization as a portfolio of products targeted at the large number of patients suffering from mitral and tricuspid disease. These are great examples of how the combination of internal and external innovation helps bring meaningful technologies to our patients. We usher in the next generation of innovative therapies, let me take you inside our needs-driven process and our journey to deliver on our patient-focused innovation strategy. Healthcare innovation is complex, with many stakeholders, including patients, physicians, hospitals, regulatory agencies, medical societies, along with payers. Each stakeholder is our customer, simply put, their voices are essential in the development of these technologies.
We've developed an ecosystem to address the most critical clinical needs, which in turn helps us to identify the best solutions for patients. At the center of our needs-driven innovation process are Edwards multidisciplinary innovation teams, where we bring together diverse groups of talented engineers, marketeers, and clinicians working side by side. They work to identify the richest needs through direct clinical observations, in-depth interviews, and deep scientific research. Recently, we set up the Edwards Lifesciences Innovation Fellowship to bring in the best and brightest early career physicians in the field of structural heart disease onto these teams. This work serves as the foundation for new concepts leading to breakthrough solutions in collaboration with our experienced R&D organizations. Integral to the R&D effort are the capabilities offered by our technology centers of excellence.
The COEs, as they're called, are organizations designed to go deep in the fundamentals of science related to structural heart disease. One example is our tissue COE, which developed the RESILIA technology, a breakthrough process to increase the durability of our tissue heart valves. Beyond the development of these novel technologies, we seek to develop the evidence. Our clinical trial organizations, working with physician partners, conduct a wide array of studies, ranging from early feasibility through randomized clinical trials to demonstrate value. In the future, innovations will come from therapies incubated inside Edwards and through external exploration opportunities. We will continue to partner with key opinion leaders and early-stage companies to deliver breakthrough innovations, and we continue to innovate even during the COVID-19 pandemic. Innovation continues to thrive. In fact, we've never stopped. Innovation can't be scheduled, and we've built the right environment at Edwards to collaborate.
Because let's face it, we're better when we're together. Right here in Irvine, we're expanding, increasing our talent, capabilities, and capacity. Expansion is also happening in Israel, home to the Edwards Israel Innovation Center. Together we're investing in innovations that bring global impact. In fact, as a company, we're continuing to invest significantly in research and development, including the evidence of value for patients. At Edwards Lifesciences, it's not just about technology, it's about the impact we can have on patients. We are innovating the future. Back to you, Mike.
Thanks, Todd. I hope you can see why we consider R&D such an important element of our strategy and a source of pride for our company here at Edwards. Now, on to the next chapter, our transcatheter mitral and tricuspid therapy program. It's important to us, and I know interesting to you. Despite what happened in COVID, this group continued to make exceptional progress during 2020. Bernard Zovighian leads our TMTT group, and he has assembled a team of world-class innovators. They also have a remarkable culture that is patient-focused, driven, and committed to success, and also have the agility to learn very fast. Bernard.
Hello, everyone. I'm very excited to give you an update today on TMTT strategy, the progress we have made, and our plan for next year and beyond. As you know, mitral and tricuspid patients are very diverse and complex. Today, very few are diagnosed and treated, with many patients experiencing a very poor quality of life. This is why in TMTT, we are guided by our vision, a very inspiring vision, to lead and transform treatment for patients with mitral and tricuspid valve disease, with the goal of changing the practice of medicine. This is what we want for patients. More patients diagnosed and treated with earlier referral by a general cardiologist, with access to a full toolbox of treatment options, treated in less than an hour, and returning home the next day with no complications, and sustained benefit for years to come.
We believe we can achieve this by focusing on three key value drivers. A portfolio of differentiated therapies, positive results from our pivotal trials, and favorable real-world clinical outcomes. Progress across these three key value driver will result in more patients diagnosed and treated, and in turn, a $3 billion mitral and tricuspid opportunity by 2025, with significant growth beyond 2025. Let me tell you how we are progressing towards achieving our vision, starting first with our mitral therapies. In mitral, we have a comprehensive portfolio of innovation based upon Edwards' more than 60 years of experience in the space, blended with recent important clinical learnings with our TMTT transcatheter mitral platforms. These platforms include leaflet repair with PASCAL, two transfemoral valve replacement therapies with SAPIEN M3 and EVOQUE, and annular reduction with Cardioband. I will tell you more about Cardioband when we discuss tricuspid therapies later. Starting with PASCAL.
This highly differentiated platform is delivering exceptional results to patients. This year we added PASCAL ACE. This new implant has a more narrow profiling spacer, providing physicians the ability to achieve optimal outcomes for more of their patients. Both PASCAL and PASCAL ACE share the same important elements, including a nitinol design to allow for a strong and yet flexible closure, a central spacer to bridge the coaptation gap and prevent backflow across the valve, the ability to elongate the device to safely navigate dense chords, and independent clasp which can be used without restriction to optimize MR reduction. Clearly, PASCAL has further advanced leaflet repair technology, and we are not done yet. Next year, we expect to introduce a new innovation, our next-gen delivery system, followed by a regular cadence of additional advancements to this platform in the years to come.
In addition to PASCAL, given the complex and diverse patient population, we believe transfemoral replacement is key to unlocking the full mitral opportunity. Our two-platform strategy position us for leadership in the mid to long term. SAPIEN M3 is based on the proven SAPIEN valve paired with a novel docking system. While this transseptal technology is best in class today, we are committed to further innovating this platform. We are also continuing to invest in the next-gen of our EVOQUE mitral platform. I expect to share more details about this innovation with you next year. We are proud that both the SAPIEN M3 and EVOQUE delivery system are sub-30 French, which has benefits for femoral puncture and septal crossing, contributing to ease of use and patient safety.
In addition to our dedicated efforts to further develop our multiple mitral innovation, we are also encouraged by the clinical evidence supporting these therapies, as demonstrated by the strong cadence of podium presentation and publications. Let me start with PASCAL. Our CLASP IID all-in data reflects U.S. physician first PASCAL use and demonstrated great patient outcome. Our centralized core lab adjudicated CLASP CE mark study showed excellent result at six months and one year. Equally as impressive is our real-world experience for the first 1,200 patient in Europe where procedural outcome match clinical trial result with a short learning curve. I am very proud about what we achieved so far. Whether it is a CE mark study, a pivotal trial, or commercial use, we are seeing consistent high rates of MR reduction from physician earliest experience with PASCAL. Now on to mitral replacement and our two-platform strategy.
We are building upon both the SAPIEN mitral valve-in-valve experience, now over 3,000 patients, and the great safety and significant MR reduction from SAPIEN M3 and EVOQUE. This give us great confidence as we continue enrolling the M3 pivotal study in ENCIRCLE, which is designed to demonstrate strong safety and efficacy, support approval, and promote therapy adoption. We are also planning to initiate our first clinical experience with the next-gen EVOQUE mitral system next year. Now, to hear more about our mitral portfolio, here is one of our key physician partner, Dr Raj Makkar.
There are millions of patients in the U.S. and globally who have damaged mitral valves. In fact, this affects their survival. We also know that currently only minority of patients, a very small minority of patients with mitral regurgitation are being treated. Unlike the aortic valve, the mitral valve is complex. The strength of the Edwards mitral program is the diverse portfolio it contains. Starting from PASCAL, which allows the edge-to-edge repair in a reproducible, simple fashion in the cath lab, to annuloplasty using the Cardioband device. For some patients with mitral regurgitation, repair will not be adequate, and a mitral valve replacement will be needed. Edwards portfolio is nicely positioned to use either the SAPIEN 3 valve as an M3 platform using a dock system. This procedure is done transeptally. The early experience has been excellent and reliable and quite effective.
As well as the early experience with the dedicated EVOQUE platform has been very encouraging. There is further excitement about the next generation EVOQUE system. To be able to treat a wide range of patients percutaneously and be able to discharge them as soon as the next day is tremendous for clinicians in terms of making a real impact in our patients' lives.
Thank you, Dr. Raj Makkar. Clearly, patient need is substantial and it requires a portfolio, and we are confident in our toolbox of mitral therapies and the opportunity to transform patient care. Now let me turn to tricuspid therapies. Tricuspid disease is even less understood than mitral, we know it is very prevalent. Treatment is limited mostly to medical management, with patients experiencing high mortality and a very poor quality of life. Our early experience with transcatheter tricuspid therapies is very promising, and we see a large emerging tricuspid opportunity. We also recognize there is still a lot to learn. With our three tricuspid platforms, PASCAL, Cardioband, and EVOQUE, we are very well positioned to learn rapidly and transform how patients will be treated in the years to come. Let me talk a little bit more about these therapies, starting with PASCAL.
Earlier, I described to you the unique feature and benefit of PASCAL and PASCAL ACE, both of which were approved in Europe for tricuspid patients earlier this year. As with mitral, we see PASCAL remaining the primary therapy option for these patients in the near to mid-term, and we will continue to bring the next generation of innovation to these patients. Turning to Cardioband. The Cardioband repair system continues to show strong and durable outcomes. This therapy is particularly effective for patients with severely dilated valves, and we continue to believe annular reduction is an important part of our transcatheter tricuspid portfolio. Adoption in Europe today is limited due to the long procedure times. This is the primary focus of our investment in the development of a more advanced next generation Cardioband. Now I'm pleased to introduce EVOQUE Tricuspid, which is expanding further on our tricuspid portfolio.
Our EVOQUE Tricuspid replacement platform consists of three valve sizes to accommodate the tricuspid anatomy. All three valves utilize the same SUD30 French transfemoral delivery system, bringing excellent patient safety and ease of use. As you can see, we made a lot of progress on the technology front. We have now three best-in-class therapies, and we are committed to building evidence for the treatment of tricuspid patients. Our focus on clinical evidence across the tricuspid portfolio has already delivered important data to the clinical community. First, from our pre-market study with PASCAL in the tricuspid position, we see high degrees of safety and efficacy, including TR reduction and quality-of-life improvements at 30 days. Second, with Cardioband, we recently published a two-year follow-up of our CE mark study demonstrating sustained reduction in TR severity and in addition to sustained improvement in quality of life.
Third, with EVOQUE Tricuspid, early experience demonstrate excellent safety with 88% of patients achieving mild or less TR. All of this with a very short procedure time of about an hour. Building on this positive early experience with EVOQUE Tricuspid, our single-arm TRISCEND study is enrolling rapidly, and we are going to initiate the TRISCEND II randomized pivotal study based on the FDA's breakthrough pathway designation. To hear more about our tricuspid portfolio, let me bring in another one of our close clinical partners, Dr. Stefan Von Bardeleben.
Knowing that tricuspid valve regurgitation is one of the valve diseases with a very high prevalence. The experience in bringing many different strategic therapies, ranging from the direct annuloplasty of Cardioband TR, the leaflet approximation with the PASCAL and PASCAL ACE system, and a complete valve replacement with the EVOQUE TR, has given us the advantage not only to treat more patients and more pathologies than ever before with transcatheter methods, but also to increase the efficacy in reducing tricuspid regurgitation. Having all these four options simultaneously in your toolbox expands dramatically the number of patients that you are able to treat in a one-stop shop.
Thank you, Dr. Stefan Von Bardeleben. We are energized by this emerging tricuspid opportunity and looking forward to learning more about these patients and how our breakthrough therapies can best serve them. Before ending our tricuspid section, I would love to share a story from one of our very first patients treated with EVOQUE Tricuspid, so you can hear firsthand the way this therapy is improving lives for these patients.
I had lot of medications, 12-15 tablets I was taking. I'm just reaching the end. I was very afraid that I'm going to be losing my dad.
When I first met Hassan, it was obvious he had a problem. Instead of his tricuspid leaflets being this close, they were this far apart. We needed something different. During the procedure, the feedback between the implanting team, the image guiding team, and the Edwards team was pretty flawless, actually. Such that after that procedure, we felt, well, we should have booked two of these cases.
After seven to 10 days, his health was significantly improved. Today, I'm feeling so healthy.
Having the EVOQUE valve to treat patients with tricuspid regurgitation is basically giving patients hope. This is really a revolution in the treatment of valve disease.
Wow. This is an amazing story. We could only accomplish this great outcome for patients with an outstanding and dedicated team. I am very proud to lead our TMTT team of 900-plus people, and I am confident that this is the team to lead and transform mitral and tricuspid treatment for patients. No one knows this better than Jean-Luc Lemercier, who leads Europe and other global regions and can speak to our early TMTT commercial experience in Europe.
Thanks, Bernard. To realize the mitral and tricuspid opportunities, we have built a dedicated TMTT European organization. This team is executing our high-touch model, which is particularly important given these patients' complex anatomies. The high-touch model provides exceptional physician training, both initially and ongoing, and a comprehensive support with full case coverage from our highly trained clinical specialists. I am very proud that this year our European team, together with our physician partners, have enabled the continuation of excellent patient care in this challenging COVID environment. I am pleased with TMTT's growth this year, we are looking forward to doubling our revenue next year. With our strong pipeline of TMTT therapies, we are committed to transforming care for mitral and tricuspid patients. Thank you again to our team. Now back to you, Bernard.
Thank you, Jean-Luc. We are proud to partner with you to advance care for patients in Europe. As a wrap-up now, we view this mitral and tricuspid opportunity as one with substantial unmet patient need and the potential to drive significant growth for the company. We are making meaningful progress with all of the platforms in our portfolio, having progressed from early-stage development to clinical use, something that is unprecedented in the structural heart space today. As a reminder, here are our three leading indicators of long-term success. A portfolio of differentiated therapies, positive results from our pivotal trials, and favorable real-world clinical outcomes similar to our pivotal trial results. Turning to the short term, this is what to expect from TMTT in 2021. First, introducing additional innovation to the portfolio with initial clinical experience of the next-gen EVOQUE mitral and the next-gen PASCAL delivery system.
Two, expanding our body of clinical evidence, including continued enrollment in our five pivotal trials and presenting and publishing meaningful follow-up data across our portfolio. Three, aiming to double global TMTT revenue next year by expanding PASCAL and PASCAL ACE for both mitral and tricuspid while maintaining excellent real-world patient outcomes. As we think about 2021, there are possible impacts that could affect revenue and clinical enrollment. Let me start with headwinds. First, the COVID situation is still fluid, and we may have to navigate COVID hotspots. Second, there is the possibility of increasing competition across our clinical trials. Regarding tailwinds, we could benefit further from increasing awareness of the PASCAL and PASCAL ACE differentiation, which could lead to a faster pace of site activation in Europe and acceleration in the CLASP IId trial.
Finally, let me give you a preview of two exciting things coming in 2022, the U.S. approval for PASCAL DMR and the European approval for EVOQUE Tricuspid, both expected in late 2022. As you have come to expect from Edwards, TMTT is committed to a consistent cadence of differentiated innovation coupled with world-class clinical evidence to drive leadership and provide optimal therapies for mitral and tricuspid patients. We are proud to be making significant progress for patients around the world. Thank you for listening, and I will welcome any questions during the Q&A sessions. Now back to you, Mike.
Thanks, Bernard. That team is closely collaborating with thought leaders around the world in developing deep insight into the needs of these tricuspid and mitral patients, that is going to turn out to be enormously valuable as we innovate. Now let's turn our attention to Katie Szyman and our Critical Care business. Katie has vast experience across medical technologies and a lot of success. She is involved in transforming Critical Care into an area of medicine that is most important. This is this digital world. Imagine what they're pursuing. Innovative sensors along with artificial intelligence that can improve decision-making when it matters most. You may know that Edwards' technologies are tested in our hybrid ORs like the one just behind me. Now to hear more about Critical Care, here's Katie.
Hi, everyone. I'm so excited to share an update about our critical care business and our focus on Smart Recovery, and most importantly, our focus on improving the quality of care for millions of patients around the world. First, let me share some background on our business. Hemodynamic monitoring is an essential part of caring for critically ill patients. When you look at our business today, our more mature core monitoring products include our gold standard Swan-Ganz catheters that are used in cardiac surgeries and our TruWave pressure transducers, representing 60% of total revenue. On the other hand, our faster-growing products are in Smart Recovery and capital. As COVID-19 spread globally, we saw increased demand for core pressure monitoring products.
We are grateful that our products have been able to monitor and help hundreds of thousands of patients during the pandemic, and we are so proud to have been part of the stories where patients were able to leave the isolation of the ICU and get back home to their families. Our core monitoring products have helped us weather the storm, and they provide stability for our business. As we look to the future, we aim to shift our mix towards Smart Recovery, which will lead to our high-growth areas becoming the largest part of our portfolio. Now, I often get asked, what is Smart Recovery? Smart Recovery is about providing advanced hemodynamic monitoring information to help clinicians make better decisions for their patients in order to reduce complications, and most importantly, help patients get home to their families faster.
Our Smart Recovery sensors are less invasive, and they include our FloTrac sensor , our ClearSight non-invasive cuff, and our latest Acumen IQ sensor, which enables our artificial intelligence algorithms. Our broad portfolio of sensors allows physicians to choose the right sensor for the right patient. Rounding out our sensor portfolio is our ForeSight tissue oximetry sensor. Adding this to the HemoSphere platform enables clinicians to monitor both the heart and the brain on one monitor. Think of it as the Tin Man and the Scarecrow coming together. There are approximately 14 million patients today that could benefit from Smart Recovery, but the majority of these patients are currently only receiving core monitoring through arterial lines. We see a significant opportunity here. We are taking a multi-step approach to increase the number of patients monitored with Smart Recovery products.
These building blocks focus on having the right technologies deployed, generating clinical evidence, and creating awareness that leads to adoption. We know that the natural growth rate of surgical and ICU patients is approximately 3% per year. As the leader, we believe we'll be able to increase the adoption of Smart Recovery from approximately 5% today to 15% by 2026. Let's talk about the first step, having the right technologies. There are three components to this. One, our HemoSphere platform, two, our leading sensor technology, and three, software that incorporates algorithms with artificial intelligence. Starting with our HemoSphere monitor, we continue to add new capabilities each year, including the addition of ClearSight this year. We now finally have a complete all-in-one platform for clinicians, which is a dream come true for all of us. Now let's take a closer look at our software.
Our Acumen Hypotension Prediction Index software, or HPI, predicts when a patient is trending towards a dangerously low blood pressure or hypotensive event. It offers the only predictive parameter for hypotension available today. The software not only alerts clinicians when their patient is trending towards a low blood pressure event, but it also has a really cool secondary screen that gives them more information into the root cause, helping them to make better decisions about what the patient needs. Our Viewfinder software will help clinicians implement Smart Recovery even on their own cell phones. We're going to be offering this capability next year. Let's talk about clinical evidence. A couple of recent highly cited clinical studies link intraoperative hypotension to unfavorable outcomes, including acute kidney injury, myocardial injury, and 30-day mortality. These studies underline the urgent unmet clinical need.
Now let's take a look at how our HPI software addresses this need. Earlier this year, JAMA published the HYPE randomized controlled trial, which showed a statistically significant reduction in the duration of hypotension when clinicians used our HPI software. Additionally, the results of our Edwards-sponsored multicenter trial showed that HPI software reduced intraoperative hypotension by a whopping 65%. It's strong clinical evidence like this that will convince clinicians to change their practice, which will ultimately benefit our patients. Obviously, we are extremely optimistic about this product and what it can do to help patients. What matters most are the opinions of our clinicians.
One day, we were fortunate enough to have access to a brand-new piece of technology, what's called the Hypotension Prediction Index.
We were very skeptical, like another new toy, another new value on the monitor.
I'm doing anesthesia for 30 years now, and I was thinking, "Okay, I can predict if hypotension occurs by just looking at the blood pressure or the changes in blood pressure over time. I don't need this fancy number.
We thought it told us what we already knew. Blood pressure goes down, HPI goes up. Really came to one moment, HPI was high, saying hypotension is going to occur. 10 minutes later, there was hypotension, and I didn't see it coming at all.
We realized that the HPI was much, much better in predicting these hypotensive events than changes in pressure could do.
We did a protocolized study using HPI, and we were able to decrease the rate of hypotension by about 50%, which is quite impressive, I think.
I thought, "Okay, this might be a game changer because now with HPI, we can look into the future.
You can see that our early adopters, although they were once skeptical, are now convinced about the clinical benefits of HPI software. We believe the increased evidence around hypotension will drive awareness. We know that changing clinical practice takes time, and it may not go as fast as we would like it to. We are gated by the number of new monitors that are rolled out in hospitals and the need for clinicians to experience and learn to trust our SMART technologies. We have found that once they try it, they love it. As an example, let's take a look at the story of Juan from Spain, a high-risk patient who was denied surgery until his anesthesiologist had access to HPI software.
He told me that he couldn't stand anymore the pain. The patient went to the operating room area. The anesthesiologist said, "No, we are not going to anesthetize this patient." Patient had severe hypotension. I treated with Acumen HPI, a new way and a better way to treat my patients and to manage my patients. I'm totally convinced that I'm now a new anesthesiologist.
We just love hearing success stories from people like Juan. This is the real reason why we all get out of our beds every morning. It makes it all worthwhile. Now that we've showcased Critical Care's strategy and aspirations, let's review our 2021 growth outlook. We have set our 2021 sales guidance at $725 million-$800 million. There are a couple of key headwinds that we're experiencing today that could continue, including reduced elective procedure volumes or continued hospital capital budget constraints due to COVID. On the other hand, if elective procedures increase and the backlog clears, or we see a greater impact of clinical evidence, this could bolster our sales growth. To sum it up, we're very excited about the future of Critical Care, and we believe our Smart Recovery strategy will transform the quality of care for patients.
This gives us confidence in our growth for not only 2021 but beyond. Thanks, everyone. Back to you, Mike.
Outstanding, Katie. It's going to be fun to watch these important advancements make progress. Now we're going to turn our attention to Scott Ullem, our Chief Financial Officer. Scott is a great partner for me. He and his team have never stopped this year as we pursue our strategy and at the same time try and maintain clear and consistent and transparent communication. Scott's steady hand has been so important as we focus on financial discipline at the same time that we pursue our big, bold breakthrough innovations that really create long-term shareholder value. Scott?
Hey, everyone. Thanks for joining us today. Now that you've had an opportunity to hear from our business leaders, we're going to bring all of that together and show you how our financial objectives are enabled by those near and long-term plans. The three main focus areas continue to be strong sales growth, healthy profitability, and robust cash flow, which yield long-term shareholder returns. Our financial objectives help guide decisions that we make inside of Edwards. We'll talk about historical performance and our plans for 2021 and beyond through the lens of that three-pillar model, the first of which is strong sales growth. Before we get into the outlook for 2021 and beyond, I'll review our expectations for the rest of this year. We still expect higher sequential sales in Q4.
On our earnings call in October, we forecasted year-over-year growth in Q4 similar to the underlying 3.7% growth we saw in Q3. At this point in the quarter, COVID is impacting our results more negatively than our earlier run rate. Current trends suggest flat year-over-year sales growth in Q4 for TAVR and total Edwards as compared to 2019's fourth quarter, when TAVR sales grew 30% and total Edwards sales grew nearly 20%. We expect full-year 2020 TAVR sales growth at the higher end of our guidance range of -5% to +5%. For TMTT, we continue to expect 2020 sales of around $40 million. We continue to expect surgical sales to resume growth in the fourth quarter, but decline 5%-15% for the full year.
We continue to anticipate that Critical Care sales will be flat to down 5% for 2020, largely due to reduced hospital capital spending in the U.S. We always provide a report card on our performance versus guidance from the prior year's annual investor conference. This year, the report card doesn't look as good as usual for obvious reasons, but we're optimistic about 2021 and beyond, which we'll talk about now. In 2021, we expect sales of between $4.9 billion and $5.3 billion, representing mid-teens underlying sales growth on a year-over-year basis. We expect sales growth across all regions in 2021. Our 2021 guidance assumes COVID will continue to stress the global healthcare system at least through the winter, with a strong year-over-year recovery later in the year. This expectation includes several considerations. First, the COVID impact lessens as we come out of the winter, consistent with normal influenza seasonality.
Second, an effective vaccine becomes widely available by mid-2021. Finally, we believe hospitals are continuing to improve their ability to treat non-COVID patients who need care for structural heart conditions such as aortic stenosis. Now I'll briefly walk through our 2021 sales expectations by product line and the factors that inform our guidance for mid-teens total company underlying sales growth. We expect 15%-20% growth in TAVR, driven by higher therapy adoption, continued innovation, and indication expansion in key regions around the world, including low risk in Japan. We believe we can successfully navigate ongoing COVID headwinds in 2021 and stay on course to grow this therapy to over $7 billion in 2024, which reflects low double-digit compounded annualized growth for the next four years. We expect growth to continue beyond that, driven by indication expansions for asymptomatic and moderate aortic stenosis patients.
Other assumptions that go into that 2021 guidance include relatively stable global share and average selling prices. For TMTT, we continue to expect that 2020 sales will be around $40 million, driven by the activation of new centers in Europe and increased commercial procedures with PASCAL and Cardioband. We believe that we'll be able to double in 2021, driven by the expansion of PASCAL and PASCAL ACE for both mitral and tricuspid patients. As Bernard discussed, we are also excited about the numerous opportunities that exist in 2022, including the U.S. approval for PASCAL DMR and the European approval for EVOQUE Tricuspid, both expected in late 2022. TMTT is committed to a consistent cadence of differentiated innovations for mitral and tricuspid patients, coupled with world-class clinical evidence to drive leadership. We expect this global opportunity to grow to $3 billion by 2025, with an even more significant opportunity thereafter.
Now turning to surgical structural heart. Despite rapid TAVR growth, our surgical core product sales have also grown over the last five years. As you heard from Daveen, we were able to extend our leadership position in 2020 with the ongoing launch of our flagship surgical aortic valve, INSPIRIS, featuring RESILIA tissue technology designed for extended durability. Looking ahead to 2021, we believe that our surgical structural heart product line will rebound significantly and generate $800 million-$900 million in sales, driven by growth from premium innovations and emerging markets, overcoming surgical aortic procedural declines in more established regions. Overall, we believe the current $1.8 billion surgical structural heart market will grow mid-single digits through 2026. Finally, for critical care, our guidance for sales next year is $725 million-$800 million.
As Katie mentioned earlier, despite the risk of reduced elective procedure volumes and continued hospital budget constraints due to COVID, we believe that 2021 sales will be lifted by growth from Smart Recovery products. We're optimistic about the future of critical care, and we believe that our Smart Recovery strategy will improve the quality of care for patients. This gives us confidence in our 2021 outlook and beyond. In summary, we have positive expectations for 2021 as we focus on three areas to create additional shareholder value across our four product groups. First, we are focused on new sales growth from opportunities such as the expansion of the PASCAL footprint in Europe. New product launches in China, including SAPIEN 3 and INSPIRIS, expanded approval of TAVR in Japan so all patients with severe AS have access to this therapy.
We're making continued progress on groundbreaking clinical trial results and clinical trial expansions. These include completing early TAVR trial enrollment, launching two new TAVR trials, one for moderate AS and one for SAPIEN X4, important clinical trial progress for SAPIEN M3, and initiating the EVOQUE Tricuspid pivotal trial. The third area is continuing our investment in a rich pipeline of important new technologies such as Alterra. We're excited about getting this therapy approved and introduced to patients with congenital heart valve disease. Enhancements for SAPIEN 3 Ultra, the next-generation PASCAL delivery system, and Critical Care Viewfinder connectivity solution. Let's transition to our second financial objective, healthy profitability. We strive to generate a strong margin profile while investing aggressively for profitable organic growth. Let's start with our gross profit margin outlook for 2021, which we anticipate will look similar to pre-COVID-19 levels of 76%-77% of sales.
As previously disclosed, COVID had a nominal impact on our GP rate in 2020 as we incurred incremental costs associated with responding to the pandemic, partially offset by improved manufacturing efficiencies. Over the past several years, we have put a lot of energy into improving the resilience and capacity of our production facilities worldwide. That paid off in 2020, and we expect similar benefits in 2021. We continue to spend on European MDR compliance, and we're already seeing our operations benefit from harmonizing systems and standards across our global plant network. In the years ahead, we will continue to gain efficiencies by more seamlessly connecting our product development, quality, regulatory, and global supply chain operations. Turning now to research and development and selling general and administrative expenses. Our plan is to invest aggressively in 2021 for future growth despite expected COVID disruptions.
As you heard earlier from Todd, our Chief Scientific Officer, we are innovating for the future and investing significantly in new technologies. History tells us that organizations that invest in innovation and employees during a crisis outperform their peers during the recovery. We also feel strongly that this approach will benefit the greatest number of patients. Planned research and development spending includes increased investments in TAVR and TMTT clinical trials, as discussed earlier. As a reminder, about 1/3 of our research and development investments today are targeted towards clinical trial activities. We're planning on higher selling general and administrative spending due to increased TAVR and TMTT field personnel and a resumption of travel. As we have previously discussed, we did not initiate any actions in 2020 as a result of COVID-19 to significantly impact our employees, nor to reduce investment plans supporting our long-term strategy.
As a percentage of sales, we anticipate that our 2021 R&D and SG&A spend will look similar to pre-COVID ratios, resulting in an estimated operating margin in the range of 29%-30%. As you know, our operating performance really does drive our EPS growth, and I'd like to quickly walk through a bridge to our 2021 earnings per share. I want to just touch on a few highlights here. Our October guidance for the full year 2020 was $1.85-$1.95. In 2021, improved operations are the biggest contributor to expected EPS growth. At current exchange rates, there would be an approximately 1% benefit to sales caused by the weakening of the US. dollar. This benefit would be more than offset by the impact of our hedging program, creating a year-over-year negative impact from foreign exchange of $0.03-$0.05 per share.
We are modeling a similar tax rate to 2020 in the range of 11%-15%. The underlying tax rate without the accounting for stock-based compensation would be about 16%-20%. Since the stock-based compensation accounting results from our future stock price performance, that's a highly uncertain estimate. All in, our 2021 guidance is $2-$2.20 per share. The third financial objective is robust cash flow. At Edwards, we have a long history of generating dependable cash flows and maintaining a very strong balance sheet. From 2016 - 2019, we generated nearly $4 billion in cash from operations and opportunistically deployed it in the form of share repurchases, capital expenditures, and early-stage strategic acquisitions. Our robust cash flows, combined with our net cash position, enables us to continue funding various internal and external opportunities despite COVID-related headwinds.
Also in 2020, consistent with our practice of opportunistically repurchasing shares, we purchased 9 million split-adjusted shares for approximately $600 million during the first quarter. We still have over $600 million in share repurchase authorization remaining. Additionally, we implemented a three-for-one stock split back in June. We ended the third quarter with nearly $2 billion in cash and investments. In addition, we have an undrawn line of credit of up to $1 billion. Our public bonds of approximately $600 million don't mature until 2028. In 2021, we expect to continue growing our cash flows. We are also planning on spending about $350 million on capital expenditures as we continue to expand our facilities around the world. Finally, putting all this together, this is a summary for our overall 2021 financial guidance.
Because the tax rate is difficult to predict with accuracy, we are also providing our operating margin expectation, which is 29%-30% for 2021. This estimate is slightly down from full year 2019, and this reflects our intentional decision to continue to grow our expense base in 2021 prior to realizing a full recovery in sales growth due to COVID-19. The other thing I'll mention is these are all non-GAAP numbers, and the tax rate does not assume any impact from potential future corporate tax legislation. Finally, we'll provide some elements of our longer-term financial plan. For sales growth, which is the first financial objective, we expect to continue to invest aggressively to have top-line growth that exceeds the med tech sector. Any potential acquisitions will likely be smaller in size, and typically, we acquire pre-revenue and early-stage companies, so this sales outlook reflects organic sales.
We expect that mix and production efficiencies will continue to benefit the long-term gross margin, even as we introduce new technologies that typically start with a lower gross margin until we reach higher volume production. We're going to continue to invest aggressively in research and development. We're seeing so many attractive opportunities to create value and help patients through innovation and clinical evidence generation that we're going to continue to invest. For SG&A, we're actively controlling general, administrative, and overhead expenses and achieving some benefits of scale as we grow globally. At the same time, we're growing our field-based teams around the world to support growth of the therapies we provide.
Overall, we are fortunate to have flexibility in managing our operating expenses, and we'll continue to prioritize investing in top-line growth while also gradually expanding operating margins over time. We are also expecting upward pressure on tax rates over time, and we'll continue to opportunistically look for ways to reduce share count as we've done successfully for many years. With that, I'll wrap up discussions about the financial forecast and turn it over to Mike for closing remarks.
Thanks, Scott. We appreciate your insightful analysis and the dedicated effort of your team. Those of you that know him recognize Scott as a highly principled and engaged strategic partner, and we are proud to have his leadership at Edwards. In summary, I hope you found the discussions today valuable, and that they gave you additional insights into the exciting work happening at Edwards, and more importantly, what we envision for the future of patient care. We have a strong track record of delivering results, and our team is committed as ever to deliver results in the years ahead. Being focused is very powerful and allows us to be deep, agile, and expert in our areas of focus. There's an incredible opportunity to help many underserved patients around the world, and we're going to continue to be aggressive investors in innovations that change the way that medicine is practiced.
As leaders, we will boldly set the path. We are energized and motivated by our strategy and committed to delivering. I'd also like to highlight several important aspects of Edwards Lifesciences that are a source of pride. Our board of directors, our commitment to corporate citizenship, and our focus on giving back to our communities. I'm very proud of our committed board of directors who bring diverse perspectives and experience to our company and are dedicated to value creation. Navigating through the challenges brought by the global pandemic, they maintain their commitment and focus on their service to Edwards. Our board constantly modernizes our corporate governance, and they drive our performance-based compensation programs and make sure that those of us in leadership have a long-term perspective. They're each passionate about their responsibilities and are big believers in our culture and strategy.
2020 saw the addition of two strong new directors, Ramona Sequeira in May and Paul LaViolette in July. Martha Marsh, a board member since 2015, assumed the role of Lead Independent Director. I'm very proud of our board. They are accomplished leaders and outstanding directors. With respect to corporate citizenship, Edwards is fortunate that we're in the kind of business that naturally harmonizes with being a good corporate citizen. For the last 20 years, operating in a responsible manner with respect and engagement among our stakeholders has become central to who we are as a company. We are inspired by our work. Our purpose and our drive to improve the lives of patients is at our core. We know we can't help patients unless we have positive, productive, long-term relationships with all our stakeholders, which includes our employees, customers, suppliers, shareholders, and communities.
We recognize that Edwards' wellbeing is tied to the wellbeing of the communities in which we live and work. That's why we work hard to build stakeholder relationships and be a positive influence in those communities. Our citizenship and sustainability efforts are aligned to our aspirations. They're integrated into our overall strategic planning process. We're pleased to have been recognized for our efforts in these areas. We don't do these for awards. We do them because they're the right thing to do and essential for our bright future. We're also fortunate to be a profitable company. We're committed to giving back. This past year has been one of unprecedented global challenges. We've remained focused on our goals. We've listened to our trusted partners, employees, and communities to help pivot our philanthropy to help those facing the greatest needs.
The spirit of giving is ingrained in the Edwards culture and as strong as ever. We continue to be humbled by the number of employees asking, "How can I help?" From supporting local nonprofits to dedicating their personal time, the generosity of our global employees during the pandemic continues to lift our spirits. We also recognize an extraordinary milestone for Every Heartbeat Matters, the centerpiece of our philanthropy. Earlier this year, we honored more than 60 cardiac and patient-focused nonprofit organizations that have partnered with us to impact the global burden of heart valve disease by educating, screening, and treating more than 1.7 million underserved patients around the world over the past five years. We are proud of this accomplishment, and we've established an even bolder goal for 2025, and we look forward to sharing our progress with you.
I want to thank you again for taking the time to learn more about Edwards. I'm pleased that we've been able to share more about our team and our patient-focused work. We hope you came away as enthusiastic as we are and confident that we are poised extremely well for long-term value creation built on a track record of credibility and trust. Our patient-focused culture drives everything we do and motivates our 15,000 employees around the world every day. The large populations of patients that we're focused on are underserved. Our innovative R&D targets breakthrough therapies that drive strong organic sales growth and exceptional shareholder returns. Putting patients first has never been more important than it is today.
As we stand together with the global community, I'm grateful for our extraordinary partners and team, and I am optimistic about the future of delivering innovations to even more patients around the world.
Welcome back. I'm Mark Wilterding, Head of Investor Relations at Edwards Lifesciences. On behalf of everyone at Edwards, we hope you enjoyed watching that presentation as much as we enjoyed putting it together. One housekeeping note, if you haven't already accessed them, I'd like to call your attention to the slides that coincide with the presentations you just heard. They are available on the Edwards Investor Relations website. With that, let's transition to Q&A.
To help facilitate that, we've assembled a panel of many of the business leaders you heard from earlier today, including Mike Mussallem, Chairman and Chief Executive Officer of Edwards Lifesciences, Scott Ullem, our Chief Financial Officer, Katie Szyman, who leads our Critical Care business, Larry Wood, the Head of our Transcatheter Aortic Valve Replacement business, Bernard Zovighian, who leads our Transcatheter Mitral and Tricuspid Therapies business, and Daveen Chopra, the Head of our Surgical Structural Heart business. As a reminder, our panelists may make forward-looking statements. Our disclaimers regarding those statements and our non-GAAP disclosures that we showed at the outset of the presentation continue to apply. Finally, I want to mention the steps we've taken to ensure safety of our participants today while we provide you with a valuable virtual experience. We're here in our new 10,000 sq ft conference room. We have a lot of space.
We've physically distanced our team on stage, and they are separated by large plexiglass partitions. Each of us has also tested for COVID-19 by PCR testing earlier this morning. The safety of our employees is a top priority for us, and we take everyone's health very seriously. Now, let's open the lines for Q&A. I would remind you that in order to get to as many participants as possible, we ask that you please limit yourself to one initial question and one follow-up. I would also ask that you please mute the volume on your computer to avoid the risk of any feedback while your line is open. At the conclusion of the Q&A session, I'll ask Mike to make some brief closing remarks before signing off at half past the hour. With that, let me pause while our operator, Diego, compiles the list of callers.
As a reminder, please press star one to queue yourself up for a question. It looks like our first question is from the line of Bob Hopkins at Bank of America. Bob, please go ahead.
Great. Thanks, Mark, and thanks everybody for hosting today. Much appreciated. I have one kind of short-term question and one longer-term question. On the short-term question, you guys nicely talked about 2021 and 2021 growth drivers, and you mentioned China and Japan. You also mentioned an enhancement to SAPIEN 3 Ultra. I was just wondering if you could talk about, to start, each one of those three a little bit in terms of how they impact 2021 over the course of the year. Just a little bit more on timing and then a little bit more on the enhancement you spoke about in terms of SAPIEN 3 Ultra and when that rolls out. Thank you.
Sure. I'll get started here and then turn it over to Larry because I think it sounds like most of your questions are really around transcatheter heart valves, the aortic valves, even though you know we are going to get a contribution from TMTT as well. All three of those are drivers. I'll also remind you, Bob, that we're on a pretty good growth there just because of the influence of our low-risk data, and we expect to get back on that as a key driver to ourselves. Larry, why don't you provide some more clarification to Bob's points?
Sure. We hope as we get into next year that we're getting back on a similar trajectory to what we had originally planned. As the vaccine rolls out, I think certainly the first half of the year or certainly the first quarter and first half are going to be a little bit more challenging. I think all of our hospitals and all of our heart teams that we partner with, I think everyone's anxious to get back to business as usual, and I think that that's going to be a positive for us. As it relates to Japan, we expect the low-risk approval to come late next year. We think that that's going to be something that maybe helps us a little bit late in the year. Japan is still really under-penetrated, so we think there's a lot of opportunity there.
China is we're really just getting started, and it's just scaling, and that's more of a long-term opportunity. In terms of the enhancements to SAPIEN 3 Ultra, for competitive reasons, I'm not going to go into details on those. We do have some things planned. They're not going to be revolutionary. They're going to be more incremental, but we think they're meaningful, and they will be valuable, and we think they'll be well-liked by our clinicians.
Thanks. Okay. Fair enough on those. The other thing I wanted to talk about, Larry, and this might be for you as well, is just on the moderate AS trial that you say you're now going to start. That sounds like a tremendous amount of progress was made in the last year because you had a presentation that was interesting last year, but it all sounded very early. Obviously, you've made enough progress to start a trial. Could you just, as much as you're willing to disclose in terms of the design of that trial, enrollment criteria, timelines, as much as you're willing to share, I'm sure there'd be a lot of interest in that study among investors, and thank you for taking the questions.
Sure. Well, I'm glad that you think it went fast because Mike's been yelling at me saying I'm taking too long. It's a complicated thing. I think the first thing that enabled us to even consider doing a moderate AS trial was just really the strength of our low-risk data. I think once we saw that data that at a year 99% of our patients were alive and well, meaning freedom from death and freedom from disabling stroke, that was just really encouraging. We've had doctors who've been passionate about this for a while. Aortic stenosis is an interesting disease in the standpoint that we don't treat it like we do other diseases. Nobody would wait until you got Stage IV cancer before you would treat it. We normally treat things earlier to prevent later damage, and I think that's really the concept between a moderate AS trial.
It's complicated. This isn't on guidelines, and so there's been a lot of learning and a lot of analysis trying to figure out who the right patient population is that's going to benefit most from it. We're just in that early process now of getting the protocol done. We have some really definitive ideas, and we've worked it out with our KOLs, and I think we know where we want to go with it. We need to engage with FDA. We need to get their buy-in. I can't really speak to the details of it at this time, but we're confident that we're going to be able to get the approval next year to start the trial. This trial, kind of like the PARTNER series, I don't know that one trial is going to be the end all be all. It might take multiple evidence buildings.
We're really excited to go after this because there's probably more patients with moderate AS than there are with severe. Again, it's going to be about picking who those right patients are and understanding when and how to intervene and how to do it in the highest quality way possible.
Thanks for that, Larry. Yes, it's certainly true. I have been bugging him and saying, "Hey, let's get going on this one." He was right, and that team did a lot of work with our clinical partners to try and come up with a pivotal trial that can really make a difference.
Thanks for the questions, Bob. Looks like our next question is from the line of David Lewis at Morgan Stanley. David, please go ahead.
Thanks for taking the question. Just two for me. I'll just start with Scott and then maybe a follow-up for Bernard. Scott, just want to come back to operating margin expansion. Obviously, it's a little muted into 2021, and you're basically guiding to a lower drop through at the high end of the range in 2021 than we saw frankly in 2019. As you're probably well aware, it's going to mark five years in a row of no margin expansion. Is it safe to say if recovery is faster, we're going to see upside of these numbers? More importantly, how should we now think about the next three years relative to the prior five years as it relates to margin? Thanks.
Yeah. Thanks a lot, David. There are a couple of things going on. First of all, keep in mind, as a result of COVID, our sales are down almost a half a billion dollars a year relative to what we originally expected for 2020. As we look ahead at 2021, we see the ramp for revenues coming up, but it's going to be delayed as a result of COVID. You've heard our assumptions before around COVID, the impact coming down a little bit, coming out of the winter, the assumption that there's an effective vaccine, and that should help our revenues start to recover. Meantime, on the expense side, we're planning to continue to invest, and we're going to continue to grow both R&D and SG&A as we're building on our field teams, for example, in Europe and in the U.S.
The ratio is going to look artificially or temporarily depressed during the beginning part of the year, and it should improve during the course of the year. In terms of the next three years versus the last five years, our plan is that we're going to gradually increase operating margins over time, and it's going to really be partly just because of the law of big numbers. We're going to continue to invest aggressively in R&D. At the same time, our revenues are going to grow faster than our expenses, and that's going to improve incrementally over time our operating margin.
I just might add one thing to that, David, to keep in mind when you're talking about comparing us to the past on the operating margins. Remember the amount of investment that we're making in research and development. We're a significantly larger company, we're making significantly larger investments, we feel like the way that we create value and why we're passionate about this is to make the investments necessary to drive organic growth. Go ahead. I think you had another question.
Thanks for that, Scott and Mike. Bernard, just second question for you, just thinking about PASCAL and obviously the commercial development of PASCAL, I think for most investors has been a little labored here, obviously by COVID, but it's been labored sort of in general. You sounded, at least to me, a little more upbeat about this business in 2021. What's going to change in 2021? Is it going to be different commercial strategy, which could employ different pricing? Is it going to be Ace? Is it going to be the new delivery system, and sort of when does that come? What's driving this confidence that 2021 really is the inflection year for PASCAL? Thanks so much.
No, thanks, David, for your question. First, let me start with 2020. I'm very pleased about what we achieved in 2020. We are on track to deliver $40 million, which when you think about it, this is about 40% growth year-over-year during a pandemic. Very pleased about that. We were able to maintain the great real-world outcome. We were able to progress with so many milestones. We are finishing the year, if you look at the second part of the year compared to the first part of the year 2020, with great momentum. We have PASCAL for sure, a differentiated platform, PASCAL ACE, both approved for mitral and tricuspid. We are basically the doubling of the business next year is going to be led by PASCAL ACE, mitral, and tricuspid. We feel confident about these plans.
Just something to add here. Bernard's team has done just a great job with this. One of the things that starts happening over time is we have more and more data and outcomes available. That just wasn't there in the past. When people had a different option, why would they use PASCAL? Now you're starting to see really compelling data about how good PASCAL is. I think that's really what drives the inflection as well.
Thanks, David. We'll go to Matt Miksic from Credit Suisse for our next question. Matt, please go ahead.
Thanks so much. Two questions from me. One for either Mike or Larry, and then a follow-up for Daveen, if I could. For Mike or Larry on the TAVR opportunities in moderate and asymptomatic severe. Some investors wonder about the prospect of treating an essentially asymptomatic patient with a TAVR device, which is new or would be new. I know it's still early in these programs, but you are making significant investments here. It'd be great if you could talk a little bit about how significant you think that is as a hurdle, and maybe what, if anything, you can share about your discussions on the topic with clinicians, regulators, maybe CMS, just to give us some perspective.
Sure. Thanks for the question. I think there's two separate issues here. We have the issue of early TAVR, and then we have the issue of moderate AS. I'll probably try to answer them separately and I think hopefully get to the root of your question. Early TAVR is for patients that have severe aortic stenosis, so there's no question that they have the disease. They have severe aortic stenosis. The issue is they're not representing with symptoms yet, and this is something that's been debated a lot. When a patient's sometimes designated as asymptomatic, oftentimes that doesn't mean they don't have any symptoms. It means their symptoms are mild, or in some cases, the symptoms they're having are not associated with their valve disease.
People don't present at a doctor and say, "Doctor, my heart hurts." They present at the doctor and they say, "Oh, I'm short of breath," or, "I'm having trouble exercising," or, "I get winded with mild exertion." People don't always connect that to the aortic stenosis. Historically, when we've looked at the data, about half the patients are deemed to be asymptomatic, and about half the patients are deemed to be symptomatic or asymptomatic versus symptomatic. Where it gets tricky, though, is when you go back and actually look in those patient charts. Often in the asymptomatic group, you find patients do have some evidence of symptoms, and so that's why nailing down that number gets difficult at times. What we're trying to do with the early TAVR trial is we believe strongly that it's the disease that's the problem.
This idea of waiting from symptoms is really from, I think, a bygone era. It goes all the way back to the Braunwald curve. We just think if you have the disease and if it is severe, you deserve therapy at that point in time. That's the whole purpose of the early TAVR trial. Now, it's complicated because we have to stress test these patients and make sure that they truly are asymptomatic.
Because the trial is off guideline and certainly with COVID, it certainly slowed down our enrollment, but we still remain optimistic that we can complete enrollment hopefully by the end of next year. Moderate AS is different. This is patients that have not progressed yet to severe, and they may or may not have symptoms at this point in time. We're trying to figure out, can we do things, as Marty said in the video, about 90% of those patients have some evidence that they're doing damage to their heart. The real question is, earlier intervention, can we prevent that later damage to their heart and give patients a better long-term prospect versus waiting until the disease is severe? They're two different strategies, two different trials, and they're going to have to be managed separately, but that's really what we're trying to accomplish.
That's great. I appreciate it, Larry. The one question for Daveen, maybe if you could talk a little bit about some of the puts and takes for the surgical business, the surgical portfolio from increasing penetration in AS, and also innovation in tissue technology that drives, as you talk a little bit about increased adoption in tissue valves in younger patients. How do those crosscurrents work, and what we should expect?
Great. Well, thanks so much for the question, Matt, appreciate it. At a macro level, as I mentioned, obviously cardiac surgeries are increasing. Overall diagnosis, referral, and awareness of this disease state, aortic stenosis or aortic regurgitation, is increasing, and that provides kind of a market tailwind for our entire overall business. We're very excited by that. That kind of helps our business at a baseline. Beyond that, we continue to see that this exciting new RESILIA technology, this technology that we really think provides these anti-calcification properties for increased durability. What we see doing is we see that patients who seem to make the best sense for surgery are more attracted now to this technology.
Both patients, referring physicians, and implanting physicians say, "Hey, maybe this makes a little bit more sense for us." From our business standpoint, we see that continued kind of growth coming from moving into younger patient groups who now feel more comfortable with this tissue valve over a longer period of time. We also continue to see that across not only the developed world, but in the developing world, we see a lot more patients where that overall market growth is happening, where this kind of tissue valve really makes sense for that kind of group of patients. We're very bullish on what RESILIA and this new technology can do across our portfolio to help us provide us with a little bit of tailwind.
Matt, thanks for calling.
Super helpful. Thank you, Daveen.
No problem.
Thanks for calling in, Matt. Looks like our next question is from Josh Jennings from Cowen. Josh, please go ahead.
Thanks, Mark, and thanks to the team for taking the questions. I was hoping to just ask about the China opportunity first. You have a $7 billion+ TAM or opportunity that you're maintaining by 2024. Can you just talk about how big you see the China market over time, specifically for TAVR? I just want to get a check-in on that. I'll just have one follow-up.
Yeah. Maybe I start and turn it over to Larry to provide a little bit more to this. China's obviously a big opportunity. We've been in China for decades, but it's been there with our Critical Care business and our Surgical Structural Heart business, and TAVR is just coming. We're excited about that. This is arguably the second-biggest medical technology market in the world. We're going to come in with a typical Edwards approach, right? We're going to come in with a high level of service, and it'll be global pricing strategy, and we believe that there's an opportunity to do something important. It's a different marketplace because it's private pay. That's going to change the adoption rate, and so we think that we should be sort of thoughtful about how fast this happens. We believe that there's a great opportunity.
Larry, you might expand on this more.
Sure. What we're focused on right now is differentiation of not just our technology, but also our service model. We're bringing our high-touch model, very much the same as what we do in the U.S. and what we do in Japan. We're bringing that same service model, and we think that that's just going to lead to differentiated outcomes, and we've certainly seen this play out in other markets. How fast it ramps, as Mike said, it's a private pay market. It's really different than other places that we've been before. It's unique in that way, but we are going with a similar price strategy, a premium product offering. We're happy to be the first multinational there, and we're excited about it. I think it's going to be much more of a long-term thing than a short-term thing.
Thanks for that. Just follow-up question for Katie. Appreciate the download on SMART technology and the early evidence with HPI. Sounds like it could take a little bit to really see deep penetration. Is there anything else on the evidence generation front that could accelerate that penetration of your SMART technology, particularly the HPI algorithm? Any studies that you would pursue for specific harder endpoints? Thanks for taking the questions.
Yeah. Thank you. Thanks, Josh, for the question. Yeah, great question. As you saw from what we showed earlier, we saw a significant reduction in the duration of hypotension. The key question is: does it tie to clinical outcomes? In these studies, we saw early signals of a correlation to a reduction in acute kidney injury. Similar to Larry, Mike is currently pushing us to say, can we start a large trial that really focuses on outcomes, whether that's a registry or an RCT. It's going to be large, right? Because you're talking about a baseline AKI of two-ish %. More to come on that, but really happy with the early evidence that we see so far because, as you said, evidence is going to drive adoption and help us help more patients in the future. Thanks.
Thanks, Katie, and thank you Josh for the questions. Looks like our next caller here is Larry Biegelsen from Wells Fargo. Larry?
Good afternoon. Thanks for taking the question. It's just two for Larry Wood. Larry, on early TAVR, if you complete the enrollment towards the end of 2021, when could we see the data? I know it's a two-year follow-up on clinicaltrials.gov, but I think it's a median of two years. Second, let me just ask that first, then I have one follow-up for you, Larry.
Sure. Larry, as you said, it's got a two-year endpoint. I think one of the things that we're all looking at, I think it's true of Bernard, I think it's true of me and anybody who's running clinical trials right now. Given some of the delays we've had in COVID, when you design the trial initially, you're assuming a certain enrollment period to get the necessary number of events and the necessary number of follow-up that you have. Right now it's a two-year endpoint, and I believe it is two years from last patient in. Whether that's something we can revisit with FDA or not is probably an open discussion. Right now, we think that that trial has to have a long enough period of time to really be able to show the benefits, which is why we designed it around a two-year endpoint.
If we complete enrollment around the end of next year, you'd have two years out, and then the normal three to six months to clean up the data and put together a manuscript. That's probably the timing we'd be looking at the way that everything's designed right now.
Thanks. Larry, on SAPIEN X4, can you say anything at this point on the pivotal trial design and any clinical work you've done to date, and when we might see that, and could CE mark approval come based on the early clinical work? Thanks for taking the questions.
Yeah. I'm not going to say a lot about it just for competitive reasons. We don't have any sort of agreement with FDA. We think that trial starts probably late in the year. There's not a lot of detail that I can share on it. We have done a series of cases with the X4 valve, and we're very pleased with the valve and the performance, and we think its value proposition is very strong. That's obviously going to be important because to displace SAPIEN 3 from the market, it's going to have to be a major advance, and we're excited about it. Once we have the trial design, we have more to share, I'm sure we'll share it with you guys, but it's just too early to talk about right now.
I'll just add, Larry, thanks a lot for spacing out the questions. That makes it a lot easier. You've probably seen our act in the past, and I'm sure Larry appreciates that as well.
Yeah. Thanks, Larry.
Good questions. Next, it looks like we've got Robbie Marcus from JP Morgan. Robbie, please go ahead with your questions.
Oh, great. Thanks for taking the questions. Scott, wanted to ask you a couple guidance questions here. Just some clarifications, make sure I'm thinking about it the right way. It looks like you're guiding to gross margin 66%-67%, but SG&A and R&D pretty much in line with 2019. I'm coming up with something like 30%-31% versus 20%-29% operating margin based on that. Also, I was hoping you could clarify the rationale for flat share count and if there's a operating cash flow guidance. Thanks.
Sure. Thanks for the question, Robbie. You mentioned gross margin 66%-67%. I think you meant 76%-77% as our guidance.
Yeah. Sorry.
I was on the track.
It's been a long week.
Yeah. I understand. But we understand the question, which is, hey, how do you get to 29%-30% operating margin when you're starting at 76%-77% gross margin and the SG&A and R&D as a percentage of sales similar to what it was like pre-COVID? The answer is it's not a perfect science when we're dealing with ratios, partly because of what I mentioned to David's question, which is a lot of this is going to depend upon the ramp of revenues coming out of COVID. As well, how quickly we can get back to deploying investments in R&D and continuing to build out our field force.
Just round numbers, if you look at the higher end of those ranges for expenses, say 17%-18%, if you take the higher end of R&D as a percentage of sales, maybe the higher end of our pre-COVID SG&A as a percentage of sales, you'll get down to that 29%-30% operating margin, which is our guidance for the full year. In terms of the share count, 632 million shares, we think that's the right modeling assumption. We typically don't forecast what our share purchase activity would look like. We do intend to cover the dilution from employee stock-based and performance-based stock awards. At a minimum, we'll do that. We'll be active in share purchase to keep the share count where it is.
To the extent that there are opportunities to go and buy down that share count, reduce the net shares outstanding, we're going to do that, as you've seen us do pretty regularly over the last several years.
Just quickly on cash flow.
On cash flow, just for 2021, we didn't give guidance. As you know, our guidance for 2020 was $1 billion-$1.1 billion. We brought that guidance back just because of COVID. Know that as a result of business being bigger in 2021 than it would have been in 2020 without COVID, cash flow should be bigger than the 2020 original guidance as well. Beyond that, we're not in a position to give any more detail. We'll talk about that as we get into 2021.
Great. Maybe one quick follow-up. Thought it was interesting Medtronic launched a head-to-head trial in small annulus patients. We don't typically see this in devices. Just wanted to get your reaction to the trial, your confidence that SAPIEN should perform equal or better than Evolut, and any comments you have around it. Thanks.
Yeah. Maybe I start, and then we ask Larry to follow on. Overall, we do have a lot of confidence in our platform. We think our data and our performance and our leadership speaks for itself. We think that key to the success of our business, and really for patients, is expansion of this therapy. That's where we put all of our focus and really spend less time sort of pursuing strategies that are associated with market share. We think that's really what's most important from an Edwards cultural perspective. Larry, you might build on that .
Sure. Share is a byproduct of your technology and your service model and the other sorts of things, and we're really proud of our technology. We're really proud of our data. I think we were all stunned when we saw the PARTNER 3 low-risk data for the first time, and 99% of our patients were alive and well at a year, and we were superior to surgery. It was really impressive, and we're really, really proud of that. I think focusing on one particular feature, I think it's about the entire patient experience. It's about mortality rates and stroke and paravalvular leak and pacemakers and just all of the things in addition to hemodynamics. We feel great about our platform. We feel great about our position.
As Mike said, rather than focus on these share issues, we'd rather focus on groups of patients right now that we think are underserved. We think patients right now with severe symptomatic aortic stenosis are terribly underserved and undertreated, and we think there's a great opportunity to get those patients off the sideline and do a lot of educational work there, and we're really, really focused on that. You see where we're investing. We're investing on next-generation technologies, and we're investing on trials to expand into asymptomatic patients and expand into moderate patients because we just feel it's about patients, and it's about how well we treat them and making sure that everybody has an option to get the best therapy if the evidence supports it. That's just where we focus.
Thank you very much, Robbie. It's great to hear from you. Looks like our next question is from Vijay Kumar from Evercore ISI. Vijay, please go ahead.
Thanks, Mark. Congrats, guys, for hosting this analyst day virtually. I like the setup. The event was well organized. I guess maybe to start with my first question, the 15%-20% TAVR guidance you guys gave out, do you assume any share gains with Boston's exit from the market? I was curious because I think Larry had competition as a headwind. I would have thought that's a positive for 2021. Any comments?
Yeah. Maybe I begin here, and Larry, you could build on a level of specifics. I think it's inherent in that 15%-20% growth for TAVR guidance is relatively stable ASP and relatively stable share. That's what underlies the assumption, but Larry, you can get a step deeper as it relates to LOTUS.
Sure. Yeah. As it relates to LOTUS, Boston was pretty early in their launch, especially in the U.S., and with COVID, I think it restricted a lot of their activities. They weren't really that deep in the market. Their share was pretty low because they were still in an early phase of the launch. We sort of built that into this assumption. Obviously, they'd exited before we put out the guidance. That's just all built in here and is assumed that they wouldn't be in place in the market any longer.
Understood. I guess Sorry, go ahead.
After you, Vijay.
Just one on the early TAVR question. This might be more of, I guess, a bigger picture question on the trial design itself. My understanding is these are asymptomatic patients. The way the enrollment works is patients get on the treadmill, and if anyone has symptoms, they're excluded from the trial. I guess my question is the bar now really high for the trial because you're enrolling really, really healthy patients when in reality there's a lot of patients who should be in the trial but are being excluded?
Yeah. Well, it is one of the challenges because when we do put patients on a treadmill and we do stress them, we find symptoms. Heck, I had my physical this year, and they put me on the treadmill, and I thought I had symptoms. It is difficult all the time to separate whether somebody's just feeling short of breath from exertion or whether they're feeling short of breath because of a heart valve issue. We have a whole specific protocol that they have to do to go through that. If they show up as being symptomatic on the treadmill, they're no longer eligible for the trial, and they're actually eligible for commercial therapy because now they're a symptomatic severe aortic stenosis patient. The key thing, though, is don't ever mistake asymptomatic for not sick or not having the disease.
All of these patients have been evaluated by Echo and confirmed that they have severe aortic stenosis. It's just a matter of articulating these symptoms. It is one of the challenges of the trial is when you do stress test these patients, a lot of them do show up with symptoms, and then obviously they're not able to participate in the trial any longer.
Yeah. I'll just add, that's the beauty of this trial. We're going to get a chance to see on a randomized basis patients, are you better off just watchful waiting, or are you better off to get a TAVR? It'll be exciting to get that answer.
Thank you very much, Vijay. Looks like our next question is from Raj Denhoy with Jefferies. Raj, please go ahead.
Yeah. Thank you. Wonder if maybe I could start with the 7.5 , or sorry, better than $7 billion target for 2024. I guess I'm curious if you kind of run the math out on that, as you suggested. You'll still be double digits moving closer to that end period, but it is going to drop, and it'll probably be close to 10%, depending on how you do in 2021. The question is really around, is that a conservative outlook? Why would growth sort of start to trend downward, given everything you're describing about the size of these markets and your development efforts?
Yeah. Maybe I start and Larry can jump in. Remember some of the core assumptions that are in there? In that time horizon, you're really not going to see the results of an asymptomatic approval. If it did come, which we are hopeful it does, it would come very much toward the tail end of it. Not really see much lift from that. Whatever happens on moderate-risk patients would happen beyond that time horizon. We're simply providing more of a near to midterm sort of outlook, if you would. Again, you correctly assumed that, yes, we're talking about double-digit growth here, but it doesn't limit our horizon at all. Actually, we think things are going to grow for a long time. Larry might add.
Yeah. I don't have a lot to add, but I think the takeaway for me is we have the $7 billion, but again, you don't have things like a successful early TAVR trial or a successful moderate AS trial. Those things would actually be later. It's not like the $7 billion+ in 2024, that's the end of the story. The story, I think, keeps going. If we have these additional trials and they're successful, I think TAVR has legs well beyond 2024 and well beyond $7 billion+. I think that's one of the things that's so exciting about this technology. The results that we're seeing just enable us to go out and do things that I don't think you could have done in an open heart surgical world.
The idea that we can do a procedure and send patients home routinely the next day, and they're 99% are alive and well at a year, it just opens up opportunities for us to do things that even a few years ago we would have never even contemplated or imagined. I think that's what's so exciting about TAVR and why, even though in some ways people think it's a maturing market, it's also got so much left to do and so much in front of us that I'm still excited to work on it every day because there's just so much more to it.
Great. Maybe switch to the extreme short term. I just wanted to parse out the commentary on the fourth quarter that Scott gave. You mentioned COVID was having a bit more of an impact than you previously thought. What are you actually seeing? Is it that funnels aren't filling for surgery? Is it that hospitals are reducing capacity? What's causing that kind of near-term slowdown that you're experiencing?
Thanks, Raj. Things have gotten, it feels like more difficult from a COVID perspective, even since what we projected in October. We've seen sort of a fall off. It's sort of felt it globally. It's probably more predominant in the U.S. There's a lot of anecdotal stories, no common theme to this where it's one region or one size hospital. It's sort of here or there hotspots, net-net, it feels like it's having an impact on our fourth quarter, that's why we just wanted to share that with you. We expect the winter to be a tough one from a COVID perspective. We're optimistic of coming out the back end of it.
One of the things that we've learned along the way here is that physicians and hospital systems have figured out how to treat structural heart patients at the same time that they're treating COVID. We're not seeing anything like we saw in April, but we are seeing some effects. Hopefully that helps.
Raj, thank you very much for the questions. I just want to be mindful of time. We're coming up here on the bottom of the hour. Time for one more question. I think we'll go to the line of Joanne Wuensch from Citi. Joanne, please go ahead.
Good afternoon, and thank you for taking the question. I'll put them both up front. It seems to me as if the Japan market adoption has been relatively slow versus other regions. Is it possible that the introduction of low risk will help accelerate that they just really needed a broader indication label? My second question is, if I heard correctly, it seems like you might be just incrementally more excited by the tricuspid opportunity. I want to make sure I heard that right, and if so, why that might be. Thank you.
Larry, why don't you start? Yeah.
Sure. Yeah. You're right. The market adoption in Japan has been somewhat slower than maybe we would've initially anticipated. I think there's just maybe a lot of historical reasons for that, just in terms of how the hierarchy of the clinicians and whatnot. This issue of low risk, and I think the low risk is going to be really important for Japan, just like we've seen in other regions. This whole thing of risk-scoring patients is, I think, sort of from a bygone era. When we first started the trials, we didn't know how the technology was going to work. You start where you think the risk-benefit is, which was in inoperable patients. We just sort of walked down from high risk, intermediate risk to low. From a patient lens, this makes no sense.
Every patient who has severe aortic stenosis is at high risk of dying. The risk scores are just your risk of dying from having open heart surgery. Getting the low-risk approval is going to give us the ability to talk about the therapy differently. Now we don't have to go through these gyrations of risk-scoring the patients and trying to understand any patient anatomically that's suitable for a TAVR now has the opportunity to get a TAVR. I think it just changes how we talk about it. I think it changes how doctors think about it, and I think it certainly changes how patients think about it. I think getting low-risk approval is always going to be important.
Some markets adopt faster than others, and I think the challenges really are is to say, how do we get Japan adopting at a rate more similar to a Germany or a U.S. than where they are right now.
Yeah. Thanks, Larry. Bernard, why don't you speak to the tricuspid opportunity?
Thanks for your question, Joanne. We are very excited by both the mitral opportunity and the tricuspid opportunity. We need to remember that this patient population, they are underserved, very complex and very diverse, and it is why we are investing so much. We believe this opportunity is going to be a $3 billion opportunity by 2025, and will grow even faster after 2025. What you heard in my prepared remark is our excitement to our newest technology on the tricuspid side, EVOQUE. What we have seen is that our study, TRISCEND, is enrolling very fast. For sure there is a big patient need, but also if you compare it to mitral, there are less trial on the tricuspid side. There is no commercially available technology on the tricuspid side. You know what you see.
We are very excited about the result we are seeing with EVOQUE Tricuspid, also it is going faster. When I look at the opportunity overall, the global one, mitral and tricuspid, we are very excited, and we are very committed.
Yeah. Thanks, Bernard. I'll just add, there just aren't many options for these tricuspid patients, and so physicians are really anxious to have another alternative that could help them. That's what makes this really interesting to us. We keep getting reinforced by our clinicians.
Thanks so much, Joanne. Thank you all for your questions and for your interest in Edwards. We really appreciate you dialing in. I see there is a queue of some others there. I'm sorry we didn't get to everyone, but we're available for calls all afternoon. With that, let me turn it over to Mike for some closing comments.
Well, you know what? I just want to thank you all for taking your time to join us today. I hope you've gotten a feel for this very talented team that we have that's inspired by helping patients, and that's really sincere. I hope you also had a chance to feel our optimism about the future. We really think that we can deliver, that we will deliver, and that delivery will happen over years. We have an exciting lineup of innovations, and what underpins it all is a group of patients that are underserved. The medicine today is quite good, but it could be so much better, and we're committed to being part of that solution. Scott and Mark and I will be happy to take your questions after this, but thanks for joining us today.