Daveen Chopra discusses Edwards’ mitral and tricuspid focus, PASCAL and EVOQUE, and patient impacts

Yeah, no that's a good one. I started MedTech actually right when I got out of business school. Before business school, I did my undergrad in biology and I was always interested in sciences and things like that. When I came to business school, I really wanted to get into the biology or the science around healthcare overall and I explored a lot of that in business school and ended up in MedTech almost by random chance. I had a friend of mine who was an intern at Medtronic at the time. He had a great time for a summer and he said hey they have some cool jobs here. We're in the San Francisco area. You should apply for one. Went out learned a little bit about the business, learned a bit about MedTech at the time and found a role and started in MedTech way back then.

This is 2005 actually.

No it wasn't. It was past the crash. So it was more the... Yeah. Trying to figure out what to do. It was really fun. It was a good starting point.

Well I love the fact that in MedTech, and again maybe I'm comparing it a little bit to pharma or biotech that I interned or worked a little bit in biotech where you had a product and you just had to almost market it and sell it but you couldn't change the product. The product's the product because you couldn't actually take feedback from physicians and change it. And that's what I loved about MedTech where when you could talk to a customer and say hey can you tweak this and can you tweak that? And you could work with an engineer and help make those changes and bring it back and actually help the customer. Reasonable timeframe. I really love that.

Yeah it was ironic that it's always a bit of a personal and it's always a bit professional. The personal component is living in northern California and we actually went through wildfires at the time and so everything in our area got kind of devastated. So I have two little boys and we were actually living in different areas and trying to find a place to even live where I was working out of an office that didn't get destroyed in. It was a good time to realize that the community probably was going to be rebuilding for a long time. And so at that point my wife and I were open to moving because before that we hadn't been. And the professional one was actually ironically enough a previous marketer for me had moved to search and she was working for a search firm that Edwards was working with. And one day she gave me a call and be like I don't call you very often but I've got a legit job for you. I got you something really interesting. It's working for Mike at Edwards. And that's opened my door to kind of realizing to learning more about Edwards and the history of this great company.

Yeah all great. I did say I said you wouldn't compare it but then you said compare the workplace. What are some similarities between the babies? All great companies really dedicated to helping patients. That's what really matters. What I love about Edwards is our focus. I love that we're focused on structural heart and that our whole organization is driven around the heart. And so in that way I can almost talk to anyone at Edwards and they know what we're talking about when we talk about our diseases or technologies because we're so focused. So to me the excitement of focus is something that really drives me and our focus and leadership at Edwards go hand in hand with that.

I have actually from a couple of customers, physicians who use our products. And I think what we've said and what people believe and what I believe is that this will just continue to allow more focus and as a result continue to be closer to those structural heart interventionalists. And again this was a physician. So from their perspective they actually took it as a positive that we're continuing to be just focused on the world that they live in. So they like that connection. And for me I think that's probably exactly what the relation is that critical care is an amazing business, one of the foundation parts of Edwards. But our ability to continue to focus on this large but relatively narrow area of structural heart really allows us to continue to innovate and lead.

Yeah no problem. This is a... TMTT is our acronym. I know there are so many acronyms. Right? So TMTT is our acronym. So as you said we are focused on transcatheter technologies for the mitral and tricuspid valves, the two valves of the heart. And they're two valves that traditionally have not been really treated as long transcatheter as the aortic valve or the TAVR business that's been around for much longer. And so we're really focused on bringing a portfolio of therapies that can either repair or replace the valve, the mitral tricuspid valve. And that's really what we're focused on, providing those new technologies to help people live longer and better.

Yeah no definitely. I think people know the aortic valve best because I think for many years the aortic valve which was treated surgically and then now treated transcatheter as well was known to have a really high mortality rate. And so people knew that they had to treat it and had to treat it aggressively. So transcatheter options were created very quickly. The mitral valve below the aortic valve started being treated a little bit later surgically and the transcatheter options have been actually harder to create, more complex. Both these valves, they're more heterogeneous in disease. So if you look at three different people with the disease, the disease all looks different. So there isn't as much as one single solution that can just solve everything. And like the aortic valve replacement does fantastic for patients. So part of it's been it's harder to treat the valve technology-wise. The other one especially I'll talk about the tricuspid valve which is on the right side of your heart. That's been not known until more recently to have as much an impact in people's lives. In a way they kind of thought well if I treat the left side of the heart or the mitral and aortic valve, the tricuspid valve would get better. Or people didn't realize that by treating this valve or diagnosing the disease and treating it that people would get much better. So they just never really realized that. So in a way for many years the tricuspid valve was called the forgotten valve. And only until the last bunch of years have people realized wow there's people suffering from tricuspid disease where if we provide a treatment for them they're going to feel a lot better which has been awesome to see.

Well from a transcatheter approach which we do. No not really. Actually, it's just as easy as the mitral valve. We go up the femoral vein and we enter that way. If you're doing surgery for it which traditionally is a traditional approach, this is actually a little bit of a harder of an approach from how surgery approaches occur. So. Yes but it's just because it's not the main pump of the heart. The left side of the heart's the big, the strong heart that pumps all the blood. People in a way just thought hey you can be okay with it. It doesn't have to be perfect. And only we realized that yeah you can actually get a much better quality of life when it is in better shape.

Yeah sure. So I start with the categories before I get into names. The categories are repair and replacement. And you're like wait those are two different things. Replacements obviously are putting in an artificial valve. So the body's natural leaflets for valve mobility are now smushed off to the side. They're no longer there. But we also try to repair valves. So keep the body's leaflets, the valve going but just fix them a little bit and they actually replicate more what's done traditionally in surgery for both these mitral and tricuspid valves. If I can keep the natural body's leaflets there and just tweak them a little bit. With repair, we want to do so but many many times you can't do so and you have to do a full replacement. And so for us in terms of technologies, we start off by bringing our first repair technologies, this product called Pascal which has been a great product coming in transfemorally that in the US is approved for the mitral valve. And in places like Europe, we have it approved for the mitral and tricuspid valve. So that's been very excited to bring that technology. Most recently we got approved for the first transcatheter tricuspid valve replacement. This product called Evoke which has just been a fascinating innovation. That man it's only been about five years since we had first in human and we're already approved in both Europe and US. So this is the world's first transcatheter replacement for the tricuspid valve. So it's a fascinating... So for those that can't be repaired or don't make sense to be repaired, a replacement is right for them. And that's what we have now available in the marketplace. And we're also working on a mitral valve replacement. Our first product to the market will be a product called Sapien M3 which hope to launch in the near future but we're working very hard to bring that to market as well.

Yeah. So the primary physician is the one who implants the valve and those are the traditional interventional cardiologists who really focus on structural heart disease. But in the mitral and tricuspid valve when you're putting these procedures in addition to being an interventionalist who deploys the valves, you lose a lot of imaging or echo guided imaging, echocardiography. So the other important physician is the echocardiographer which is a type of cardiologist who is essentially an imaging cardiologist who's also in that cath lab looking at the imaging screen to help guide your echo probe that goes in you to help see the heart while the interventionalist is actually deploying the product. So it becomes much more of a teamwork between an echo physician and an interventional cardiologist working together communicating with each other versus just one physician doing it on their own.

Traditionally in the aortic valve you just need fluoroscopy which is almost like an x-ray. So the person who's the interventionalist who's using the device can look at a large fluoroscopy view and just see the x-ray and move the table around as needed to or the imaging around to get the right viewpoint. When you're doing a lot of interventions of the valve now mitral tricuspid similar to what they do often in surgery you also need this other kind of imaging called echo and echo trans TEES is putting an echo probe down someone's throat. So that's why they're under general anesthesia and essentially creating an ultrasound picture of the person's heart from inside of them. And so you now have an echocardiographer who has the probe put down the person's throat and they're making adjustments to the probe to get the right viewpoint in the echo image. So the physician who's doing the interventions will see both the fluoro and the echo but they can't also control the echo's viewpoint because they're not also able to be at the patient. So you have a different physician controlling one kind of guidance of viewing the echo and the other physician controlling the fluoroscopy which is the intervention list. So it's this combination now. It's really complex and the heart's going this whole time. It's a moving object. You're not replacing a knee which is a stationary fixed. The heart is beating the entire time. And that's why these kinds of advance when you think about them they've only been online in the last decade or so. These are things that 20, 30 years ago we just didn't have the technology to do that we do now.

We do a similar amount of planning. There is. Yeah there is actually some amount of planning where before the procedure the patient will have both CTs as well as echoes done in advance. So we get a lot of imaging in advance especially for these complex procedures. And we often if we get the imaging in advance put together a pre-case plan quite a bit. We often work with the physician on this kind of plan and so we can say hey here's the approach you want to look at. Here are things we've seen in the anatomy and then we can work together and say here are some things we should watch out for in the case. So we look at the imaging, understand which device we plan to use, put together a pre-case plan and then we actually work with the physicians inside the operating room. So often in these cases some cases we might have one Edwards person in the room. Sometimes we have two or three Edwards people in the room, one working with each the imager as well as the interventionalist to help them work through the case and take our experience along with the physician's experience together hopefully get a better patient result.

I've gone through seen more than a couple of them. It's such an amazing... I am not a clinically certified person. Would I do it on my own? But watching my teammates do this it's just an amazing sight to see that kind of collaboration where the Edwards members are part of the hospital team for that case to work together to get the best patient output.

It's fantastic when you get a great result you see the physicians and people high five each other and things like that. It's really awesome to see.

Yes I think if I think about TMTT in the new company we are one of the beach heads of the new company. Right. Ultimately my business, we have the aortic valve business, we have the surgical business and we're all just looking at different parts of the heart in a very complementary manner. So TMTT just becomes I think a more important part of the remaining Edwards because it's more focused on the areas that we want to focus on. And I think this focus on structural heart allows us to continue to not only want to invest more in this space because this is the only space we're in but it continues to deepen our knowledge in a way that I think appropriately we're ones who are willing to take more risks on because we understand the space really well. And so for us I think as an overall organization where everyone is more deeply focused and knowledgeable about structural heart it just allows us to run as a better organization.

Yeah I mean at the end of the day I think it's just... it's heart disease related not through vessel issues you know not through the plumbing issues you know you might have or the electrical issues you know like in electrophysiology or in coronary stenting or something like that but focused on the actual structures of the heart and diseases of those structures. So ours is not about an artery filling up with a plaque that needs to be popped open but actually as the structure of a heart moves and those leaflets around the valves move or other parts of the heart are moving and they have some kind of disease that prevents them from moving the way they normally do, the structures aren't quite working right. That's where we come in to kind of play and help them out.

Well I'll answer it two different ways. First even in valves where we've been treating them for over 60 years in some way shape or form there's so much more to go meaning that even today there are so many patients who never have the disease awareness, never get diagnosed, never get referred and never treated. So even severe aortic stenosis, the aortic valve which is the most established disease of the heart, we believe in the US that only 13 out of 100 patients who have this disease get treated each year.

Because there's so many people who... They're getting older they're having trouble walking up the stairs and they actually have aortic stenosis. They go to their doctor and you're just getting a little bit older. Yeah you're in your seventies. That's natural. But it's actually aortic stenosis slowing them down not just getting older. And so that's why these diseases are a little bit tricky in that the awareness referral and diagnosis... awareness referrals and treatment is still really low. So we have a lot of work to do not only on therapy awareness but also and then continue to create new treatments to get better results. Like we're working on in my division. So I think there's a lot of opportunity just in valves. But then outside of valves as we've talked about there's the space of interventional heart failure that we're starting to look into and others are starting to look into. And I say heart failure as you know is when your heart isn't quite pumping the way it should be, ultimately the walls are not quite doing what they're supposed to be doing in the pumping motion. There are ways and this affects a lot of patients around the world. There are opportunities for perhaps medical technology and interventions to help improve their lives as well. It's not quite valvular disease related to valvular disease but potentially has a lot of synergies. What we're doing. So we've talked about and are starting to work in this space along with a lot of other folks in the space.

Yeah. So similarly that's the aortic stenosis numbers. But actually in mitral and tricuspid the treatment rates are actually even lower than 13 per 100. Facts are yes many of those patients are dying at home or living quality of lives that are just below what we normally expect. And those are the many patients who unfortunately never even get to a hospital and never get diagnosed appropriately. And then even today or in the past never even got treated at least today. Now there's starting to be options for them especially as I talked about the tricuspid valve where we're starting to have options now in the US to treat these patients before you essentially just take a pill that would hopefully help reduce away some of your water weight make you feel temporarily a little bit better but just... it doesn't actually solve any of the problem and you're still feeling really bad every day. Now we have options to give you a medical device treatment that can actually rapidly and significantly improve your life and how you feel.

It's going to be a really big process over many many years. And then interestingly because in a way mitral and tricuspid therapies are so new. We see especially in tricuspid that a lot of these patients, some of these patients are already sitting at a hospital but just don't have a treatment option. So part of our initial job for the first couple of years is just essentially training physicians how to use our product, working them closely to get great clinical results and almost in a way treating some of the patients that have managed to get to them. And then what will happen in the next phase is we're going to learn that there are probably other patients at their hospital that have gotten to their hospital system with symptoms but never quite got diagnosed correctly and never got to the intervention list. So we'll spend a lot of time then working in those following years with hospitals to try to improve their diagnosis and treatment paradigms. And then at some point over time which is always harder you want to start trying to reach patients over time so that if they have those symptoms they realize they have those symptoms and they go ask their doctor about it and try to get into that pathway. But in a way for us right now where we're such in a new therapy we just got approval just months ago we're just training our first centers. We're very much focused on that interventionalist and getting them trained to use our product right. And almost attacking those patients that are already right there. They're very close to that physician versus branching out yet. But over time we're going to have to keep branching out to get to more and more patients.

Well yeah it's a multi-year process that's well underway. Meaning as I talked before the tricuspid valve is the forgotten valve. Wasn't really talked about much but in the last five, seven years you start going to medical conferences and there's a lot of conversation. There's been lots of understanding of how many patients and how bad they really are. Then you start seeing the early clinical trial results from our therapies and any other devices as well starting to make real differences. So there's been a buildup over the last couple of years. So with our approval in the US there's been a buildup of energy for this where in a way we're trying to not have to convince physicians that they need to use it but start that process of training them. And it's not quick and easy. It's not something that you pick up on a weekend for us it's one where to get really proficient and really use it. It takes months and it requires really close collaboration with Edwards where we help you in not only using the device but understanding how that imaging component works in the cath lab and it just takes time to do so. So right now because we're in the early days I think we have a lot of physicians very excited by it and we're working very closely we can with physicians to get them up and train and treat their patients.

It's all three. You kind of knew the answer didn't you already? It's a little bit of everything because for us the technology we have there's opportunities to keep making it better both in what happens inside the valve as well as the delivery huge opportunities to keep getting better there. But as I mentioned in the beginning these valve diseases they're very heterogeneous. So no two patients really look the same. So despite our valve replacements or repair treating a lot of patients there's still a lot of patients that the technology might not be quite right for because of how the disease manifests in the valve. And so for us that's why we continue to have a portfolio of solutions and keep working on a portfolio of solutions. So we're not only working on improving what we have but we keep looking at new ideas to treat some of those patients that don't even have a solution even with their new solutions out there if that makes sense.

It's the pre-placed planning so it's not during a preservation. So we know in advance quite often now that which patients make sense for our products and we have a decent sense and this is from all the clinical work done early on. And which ones? Oh it's not going to fit in quite right or it doesn't quite make sense. It's just anatomically not going to work. So we have a really good sense of that for our pre-case planning well in advance. And so the reality is there's still going to be patients who don't have a great solution. So we continue to internally work on new programs and new ideas about different ways of continuing to attack the problem. And for us as an innovative engine we look everywhere for good ideas. Right. We sometimes our engineers are working day in and day out with physicians and hearing from them about unmet needs and that's really important. We're hearing about their unmet needs and bringing some together solutions externally. There are lots of different startups in the space working in the areas who are also working with physicians understanding the need. So we believe innovation can actually come from anywhere. It can come from inside the company, come from outside the company. It's okay wherever it comes from. But our goal as a company is to make sure where the innovation starts from. We hope to then if it's going to work we want to be the one to help bring it to market and really help treat patients with that.

Oh of course there is yeah. Because if you look at these products even our Evoke valve right now takes 24 hours of sewing to sew together just one of those valves and there's all these very challenging pieces and parts to help put together. So we continue to look at how do we keep getting better and making these products easier, more robust, more durable, more manufacturable. There's a lot of continuous improvement on that.

Yeah sure. Edwards is driven around different business units and we've said that for each business unit we want a group of people who are just dedicated to the customers and patients in that specific area. So for Mitral and Tricuspid we have a group of R&D engineers, people who run clinical trials, people who design clinical trials, people who help support physicians who just focus on mitral and tricuspid. So we feel like that we can really understand the unmet needs that physicians have in the space and that patients have and we can help create solutions and create clinical data around these solutions to really help support physicians and patients in just our space. So for us we really feel that the focus of each area is really important and I think we do a lot of that is really focusing on our areas.

Yeah we have our own internal R&D team, our own internal clinical trial team, our own internal... Yeah all those kinds of parts altogether just on mitral and tricuspid.

Oh man. It's going to be... It's exciting because I think overall you're going to see patients just continue to win as the sector works in the next five years as these therapies kind of grow. I see at the end of the day patients are the big winner where more and more patients are going to get great treatments that may have not been available to them not that long ago. For us as a company though we're going to keep our commitments to things that we found really important. Like the first thing we've always said hey you got to start with amazing innovation. So we're going to stay committed to innovation in the next five years where we're going to continue to invest in new technologies. We've also said it's really important to stay continued to clinical evidence because even if you invent something amazing if you don't have the clinical evidence to support it no one's going to use it. So we're committed to continuing to do large pivotal studies working with the FDA and other agencies to really help change the practice of medicine through the clinical data around the trials. And finally we mean really committed that even after you bring the product to market you've got to have amazing real world outcomes day in and day out. So not from hundreds of patients in a clinical trial but to tens of thousands of patients in a commercial setting. So we're committed to our field teams continuing to work really really hard with physicians to continue to get great clinical outcome. So overall this product focus innovation type of structure that we're just going to stay really focused on that for the next five years. While we hope patients really win at the end of the day.

Well I just want to give a final kind of maybe shout out. And thanks to all the folks who've been working at Edwards at the TMTT space. There's an amazing group of people who are just so dedicated to the trailblazing that is the TMTT space. It is really an area of patient needs where we at Edwards really feel like we've been trailblazing in support of patients and I just really want to thank everyone for all their hard work on that.

Thanks so much Tom.