Weidman talks us through the long road to getting Symplicity Spyral™ renal denervation system ready to help patients with hypertension

December 1, 2021

In this episode, Jason Weidman SVP and President, Coronary & Renal Denervation at Medtronic, says he’s doing exactly what he set out to do when he became an engineer over 20 years ago, creating lifesaving medical devices. Weidman is leading Medtronic’s push to secure FDA approval for Medtronic Symplicity Spyral™ renal denervation system. Medtronic’s clinical trials of Symplicity Spyral are among the most closely watched in the industry. Learn more about the investments Medtronic is making for patients with hypertension.


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Tom Salemi (00:00):

Hey, everyone this is Tom Salemi of DeviceTalks. Welcome to our newest member of the DeviceTalks podcast, family it's called MedtronicTalks. Our constant search to find new ways to bring new insights in the MedTech industry led us to the fine, fine folks in Medtronic. They've agreed to make their senior leaders available to us and to you.

Tom Salemi (00:20):

In each episode we'll discuss the opportunities and challenges facing one of MedTech's clear leaders. So you'll have an inside view on what makes Medtronic go. We'll ask the questions. Medtronic will provide the answers and our great network of sponsors makes it all possible. So sit back, hop on a treadmill, take the dog for a walk, whatever you do when you listen to a great podcast and let's listen to how Medtronic is getting the job done, let's go.

Tom Salemi (00:45):

Hey everyone. This is Tom Salmi of DeviceTalks. Welcome back to the MedtronicTalks podcast. I released my inner fan boy this week, I spoke with Jason Weidman. He is Senior Vice President at Medtronic and President of Coronary and yes, Renal Denervation at Medtronic. I've never hidden my fandom for Renal Denervation (RDN). I've been following the story for a long time and happy to see it's in the hands of Jason Weidman, who is really expressive in his belief, in the therapy and in Medtronic’s commitment to the therapy.

Tom Salemi (01:17):

So had a great time talking with Jason about his started MedTech and all also his and the company's commitment to Renal Denervation. So I know you'll enjoy this conversation with Jason Weidman. But before we begin this conversation, I want to bring in Sean Campbell. Sean is Vice President and General Manager of Freudenberg Medical, minimally invasive surgery in the US. Sean, tell us about Freudenberg Medical.

Sean Campbell (01:41):

Sure, Tom. We're a global design and contract manufacturing partner for OEMs that support a true product life cycle from early stage development out all the way through manufacturing. We have 11 strategic global locations and our expert design capabilities cover early stage ideation and concept development, rapid prototyping and iteration and full scale development of both product and processes. Our manufacturing capabilities range from high precision model components, medical tubing, drug coatings, catheter shafts, handles, [inaudible 00:02:11] tubes and overall finished devices for minimally invasive surgery. For many years, we've been a key partner for Medtronic and we continue to build this relationship by consistently adding value to what they're trying to achieve. And we look forward to continuing to build this partnership in the future.

Tom Salemi (02:25):

That's great. We'll hear more from Sean and Freudenberg Medical a little later in the episode. If you'd like to find out more about Freudenberg Medical, you can go to Freudenberg Medical.com. Freudenberg is spelled F R E U D E N B E R G. That's Freudenberg Medical.com. Now let's start this interview with Jason Weidman of Medtronic. Well, Jason, Weidman, welcome to the podcast.

Jason Weidman (02:53):

Thank you, Tom. Happy to be here.

Tom Salemi (02:55):

So you're going to learn that I'm a huge Renal Denervation fanboy. I've been following the story for a long time. So I'm excited to talk to you about the program and where it's headed. But before we get into that, I always like to find out a little bit about your path into MedTech. Looking at your background it seems as if you jumped into MedTech right at a time when you probably could have joined a company selling cat food online or something like that during the dotcom boom. What brought you to our humble sector?

Jason Weidman (03:26):

Yeah, it's funny. I guess the first thing I'll say since you mentioned that is when I was about a year or two out of grad school, and I had breakfast with a bunch of my friends, I was the only person of the group of five that wasn't worth over a million dollars on paper from all of those dotcoms. So there was that brief period of time where I thought maybe I had gone into the wrong industry, but didn't really work out for any of them. But I've listened to a lot of these other podcasts that you've done with my colleagues and it's been really interesting to see and hear about the different paths. And I think I'm probably the anomaly where I'm actually that odd person that's working in the industry that I aspired to work in since high school.

Tom Salemi (04:05):

Wow. So I did not know about the medical device industry in high school, or even immediately after college. I certainly knew that they existed, but I didn't know that it had this community. What was it about MedTech that drew you in at that early age?

Jason Weidman (04:19):

Yeah, so I grew up in Michigan and it's probably a little different than a lot of other places in the country, but when you're good at math and science people immediately and at an early stage kind of push you on that engineering track. And that's probably the influence of the auto industry. But for me, unfortunately, I had a really close friend in high school who was terminally ill. And I spent a lot of time going with him to treatments and seeing how that was going for him. And it wasn't necessarily a happy place. You could see how treatments could get better, how healthcare could be better. And so it was really at that point where I thought, if I'm going to be on this engineering path, I want to direct it towards medicine and trying to make healthcare better.

Tom Salemi (05:04):

Well, that's a terrible reason to have that inspiration, but it's good that you acted on it and remain at it today.

Jason Weidman (05:13):

Thank you.

Tom Salemi (05:14):

Now you're probably leading up, I don't think it's a stretch to say it's one of the most high profile, or we could say highest profile, new therapeutic areas in the business. I mean, we've been tracking Renal Denervation since when Ardian started up over a decade ago and of course, Medtronic famously bought it before that. I know you weren't involved at that point, but it has been one of these stories that has kind of come and gone in anticipation. But I think people are excited to see what it can become. And Medtronic has the highest profile program in the space. How did you come to lead this group? Then maybe we can talk a little bit about what Renal Denervation is.

Jason Weidman (05:56):

Yeah, sure. So I actually do have a pretty long history with it because I've been with Medtronic vascular side of the businesses almost my entire time here at the company. So about 15 years. So I was part of the original team at Medtronic that identified Ardian as a separate small company. And that drove that acquisition.

Tom Salemi (06:17):

Oh, interesting.

Jason Weidman (06:18):

Yeah, after we acquired Ardian, we kind of had it separate and it was running as a separate, independent business up until Hypertension 3 clinical trial. But then after we had the Hypertension 3 efficacy failure in 2014, that's when I really got involved with the program the first time. Then kind of went through my Medtronic career, spent some time away from RDN for a few years. Then last year with our operating model change I came back to lead the Coronary and RDN operating unit and to bring it over the finish line.

Tom Salemi (06:53):

That's great. Well, let's take a moment and just kind of circle back and tell folks, for folks who don't know what it does and how it works, give us the two-minute overview of what you're trying to do.

Jason Weidman (07:04):

Yeah. So at the very core of how blood pressure works kidneys are part of the body's blood pressure control mechanism. So communication two, and from the brain on how to regulate the kidney's activity, it happens via the nerves, obviously. And as those nerves near the kidney, they travel in the walls of the renal artery, or the artery that leads to the kidney.

Jason Weidman (07:31):

So patients with high blood pressure, they often have overactivity in these nerves. So if we can interrupt that overactivity kind of get rid of the noise, we can bring down blood pressure. So Renal Denervation is a minimally invasive outpatient procedure. And in a lot of respects, it's quite similar for the patient to a coronary stent procedure, except there's no permanent implant. So through femoral access or a tiny incision in your leg, a small device is inserted up through the arteries. Then to that renal artery that leads to the kidney, and then our Medtronic Symplicity Spyral™ device delivers energy, and we use radio frequency or RF energy. So we deliver energy to the wall of the artery to impact those nerves and try to calm that overactivity that I spoke about earlier. So this can simply help to lower blood pressure.

Tom Salemi (08:25):

Interesting. So at the time, and it's good to know that you were part of the team that identified Ardian because RDNwas the highest profile project out there, but there were many. The numbers of how many vary from four to 36, every major company seemed to have a program. Every venture capital firm seemed to have one in their company and their portfolio. What was it about Ardian's approach, I assume you looked at many, what was it about Ardian's approach and the approach you currently have that really stood out for you?

Jason Weidman (08:54):

Oh, well, I think Ardian was first. First and foremost, they had a strong IP position. I think we believed in the science, they had the most in depth science of all the companies out there. We just, like any small company that you're evaluating, you look at the science, you look at the technology and you look at the management team and all of the, those things were really strong. And we felt good about that acquisition.

Tom Salemi (09:18):

And talk a bit about the challenges that have come. We'll talk a bit about the 8k you issued a little bit ago. We'll talk about that a little bit later. But in January 2014, obviously the first results came out from the earliest Symplicity trial. I think it was Symplicity, if I'm forgetting the name of the trial, please, correct me.

Jason Weidman (09:39):

Hypertension 3.

Tom Salemi (09:40):

Hypertension 3.

Jason Weidman (09:40):

That was the big, that was a doozy.

Tom Salemi (09:43):

Yeah. That was a doozy and however many Renal Denervation programs that were prior to that, there were almost zero after that. It seemed to really shake this therapeutic area to its core. Can you speak to what happened with that clinical trial and what happened after the results came out? It would've been easy, and I think a lot of people walked away thinking Medtronic wasn't going to be pursuing this anymore. I don't think that was ever the case. Are you able to sort of talk us to through what happened after...?

Jason Weidman (10:17):

Yeah, sure.

Tom Salemi (10:18):


Tom Salemi (10:20):

We're going to take a break from this conversation to bring back Sean Campbell. He's Vice President and General Manager of Freudenberg Medical, minimally invasive surgery in the US. Sean, tell me what sets Freudenberg Medical apart from other contract manufacturers?

Sean Campbell (10:36):

It's around four key things. Number one, we're a truly full service partner through the entire product life cycle. From early concept development, prototyping and iteration, product development, process development, and validation all the way in and through manufacturing. Number two, we have a high degree of vertical integration, which allows us to collaborate across multiple sites around the globe and provide the best solution for our customers. If it can't be done at one of our sites, it can be done in another.

Sean Campbell (11:03):

Number three, we have a significant horsepower and design for both product and processes. We have a large pool of engineering resources across the globe that can address a wide range of customer needs. And number four, and most important, is our proprietary technology platform. Our it around our platform, technology allows customers a quicker time to market. It's both modular and customizable and allows our customers to start on second base, let the customer focus on their area of expertise and allow us to provide them with a customizable solution for their clinical application.

Tom Salemi (11:36):

Finally, Sean, let's look ahead as a contract manufacturer, what changes are you noticing in the industry?

Sean Campbell (11:42):

That's a great question. Some of the industry-wide changes have been discussed for a while now, and that's a continuation of supplier consolidation and more specialization coming from customers. Another trend that we're seeing on our end is the continued push towards miniaturization and the challenges associated with integrating more functionality into less space, especially in the fields like cardiovascular, neurovascular, and gastroenterology, where customers are coming to us with intricate sensors and asking for help and integrating these critical and delicate components. We've been able to determine what the requirements are to maintain continuity of signal transfer and connectivity from proximal to distal and how to manipulate the architecture when these components experience both strain and compression simultaneously. Our experience with sensor integration has helped us find solutions for how to best cope with the stacking and tolerances and the refinements needed to make processes more repeatable and better fine tune for full scale manufacturing.

Tom Salemi (12:40):

Fantastic. Thanks again, Sean. And thanks again, Freudenberg Medical for joining us on this episode of the MedtronicTalks podcast. For more information, go to Freudenberg Medical.com.

Tom Salemi (12:55):

Are you able to sort of talk us through what happened after...?

Jason Weidman (12:58):

Yeah. Sure. So I think that's almost two different questions.

Tom Salemi (13:03):

It certainly is. I would've asked a third if you hadn't stopped me, so thank you.

Jason Weidman (13:07):

Maybe 10 different questions. So I think the first is what happened, or maybe what did we learn from Hypertension 3. So for those who weren't familiar, there were two earlier studies, larger studies, Hypertension 1 and Hypertension 2 that were single arm studies that were very, very positive showing a blood pressure lowering effective of RDN.

Jason Weidman (13:33):

Hypertension 3 were as the large randomized sham controlled study in the US. What happened was we missed the efficacy endpoint. What we saw was, even though the device seemed to have an effect, we also saw an effect from the control arm. So there wasn't a difference or a statistically significant difference. So at that highest level, I would say what we learned is that variability is absolutely the enemy of running a successful clinical trial. So blood pressure trials in particular are super hard to run because there are so many outside variables that affect blood pressure and they're hard to control. So in short, what we found in Hypertension 3 was that we had too much variability to measure a clean signal from the device. Does that make sense?

Tom Salemi (14:28):

That does make sense. No, and it's something I've heard from, well, another company in the space as well. Just managing the amount of meds being, taking the lifestyle, the adherence to the other meds being taken and trying to figure out what impact your device is having on the patient is difficult to quantify. So it certainly does match up. So was it immediately known to you that this is an issue with execution on a trial, let's fix that problem and then we'll find out what this technology can do?

Jason Weidman (14:58):

No, it wasn't certainly immediately known, and we really analyzed everything about the procedure, about the patient population, about the device, and really tried to figure out what went wrong. And I would say if you break it down, I would say from a procedure perspective, number one, we were likely ablating in a suboptimal place, which would create an inconsistent response. Number two, our first generation device, which was called the Flex Catheter, it was a single-point catheter. The way it was used it enabled significant variability in how the physicians placed it, and thus the type of response you got. So the post-analysis data suggested we had incomplete ablations in a huge percent of our patients. As you mentioned and probably most importantly, we just didn't have good control or even visibility to pay patient medication changes, which obviously can completely confound your results.

Jason Weidman (15:57):

So we knew if we were going to go forward with this program, we were going to need to address all of those things. As we have moved the program forward these are all things that we've addressed to the best of our ability. We changed the ablation location. We moved to this new Spyral™ device, which takes out variability and is much easier to use. And we take a lot more care in terms of patient blood pressure medications. We actually watch patients take their pills before important blood pressure measurements in the trial. We trace what drugs are in their system via urine analysis and blood samples, et cetera. So even if things go in a direction they aren't supposed to go with a patient, they're doing something they're not supposed to do. We can control for that now because we know exactly what they're doing.

Tom Salemi (16:41):

Are managing these trials, is this more difficult than other clinical specialties in MedTech? Not just in Medtronic, but is this an unusually difficult type of trial to run? I mean, you guys are swinging for the fences, so understandably could be, but...

Jason Weidman (16:56):

I would say that these are the most difficult trials I've certainly ever been involved in, the most sophisticated trials I've been involved in. And that's been echoed by people like Rick Kuntz [SVP, Chief Medical and Science Officer at Medtronic] who obviously know a few things about doing clinical trials.

Tom Salemi (17:11):

For sure. Well, what is the program? Where have you been in the last couple of years? I want to hit upon the 8k and what's coming up next. What trials have been you been running for the last, well, gosh, I'm losing track of the calendar. What's been going on since say 2015 or in 2021, where we currently are? What's the Renal Denervation program look like?

Jason Weidman (17:38):

So after really looking at Hypertension 3 and analyzing those results, like we talked about and making the determination to move forward, which I will call out, I think was a bold move by Medtronic. I think, frankly, most companies would've quit. In fact, most companies, as you pointed out, did quit. It's funny, I've actually said that it was one of my proudest moments at Medtronic when we made the decision to keep going on this. I remember Omar [Ishrak] saying, when we had the Hypertension 3 failure, he said something like, "that's why they call it a clinical trial and not a clinical guarantee." And he said, "go figure out if we can really have an impact on patients."

Jason Weidman (18:17):

And when we came back and said, we think we can solve this and we can have this big impact. People were about going forward. So this was really the Medtronic Mission in action.

Tom Salemi (18:26):

That's great.

Jason Weidman (18:27):

Yeah. So we restarted the clinical trial program and so it's been a series of clinical trials. And where we are today, if we just kind of fast forward to where we are today and look backwards, we have an enormous body of clinical evidence for RDN at this point. And we continue to demonstrate time and time again, the safety in efficacy of this device, in those trials. I've said this a few times over the past couple of months in other settings, but in my 25 years in MedTech, I don't think I've seen another therapy that's preapproval that already has this much positive evidence.

Tom Salemi (19:06):

That's a good space to be. And it would allow for all the excitement and anticipation for this product. I mean, it's been talked about in your analyst calls, Geoff Martha has mentioned it a few times as one of your higher growth areas, along with Hugo™ the robot, which is another obviously high profile project. What is it like managing a program where the expectations are so justifiably high?

Jason Weidman (19:32):

I think it's fun. It's exciting, right? I mean, as I said to you, I'm a medical device guy who found his way into business, not a business guy who found his way into medical devices. So my whole career, and I think what most people are at Medtronic for is to make a difference in medicine and what better opportunity than to transform hypertension care. I really can't think of another opportunity like this. This is a once in a career opportunity, so it's all good. The expectations are fine.

Tom Salemi (20:04):

That's great. So let's talk a bit about the 8k that came out last month in, well, I think it was in October. I'm trying to remember where I am on the calendar now. I know there was hope that you'd have some positive news to share TCT then the 8k came out and the news wasn't what you expected to be. Can you talk about where things fell short and where you're going from here.

Jason Weidman (20:24):

Yeah, sure. Good question, Tom. Let me provide a little bit of context for it so that the listeners can understand. So I mentioned we have this huge clinical trial program and more specifically our clinical program for FDA approval it consists of four randomized sham controlled studies. So those were both in the presence and absence of blood pressure lowering medications. Then we also have a very large real world data set. So at this point now we have three of those four sham controlled studies are successfully complete and have shown the technology and procedure are safe and that it works. That real world data set, which we call the Global Symplicity Registry has enrolled 3,000 patients, including many of those at high risk, so with high risk patient groups. And we've seen a really strong and consistent blood pressure, lower in effect in that trial.

Jason Weidman (21:21):

And what's great is 2,500 of those patients are now out to three years. So that effect has been sustained up to three years. So everything at this point, everything so far looks great. So all that's left to finish is that final, that number four out of four sham controlled study. So that's the Spyral™ ON MED trial. So it's this trial, the ON MED trial, that was the subject of the 8k that you mentioned. So the ON MED trial is a Bayesian design. So going back to your question about complex trials, it's a super complex trial. It's a particular flavor of Bayesian that's new and novel, and hasn't been used in medical devices before. And it includes pre-specified interim looks that allow you to stop the trial early if certain criteria are met.

Jason Weidman (22:12):

So essentially if the results are better than expected or better than what we planned for when we designed the trial, you can stop it early. This was pretty widely known in the financial community that we had one of these pre-specified looks here early in October. Given that our early pilot results for ON MED were really strong there was a lot of hope that we could see better than expected results and end the trial early. Well, we heard back in October from our independent data safety monitoring board. So we don't look at the data ourselves we're completely blinded to it. What that independent board told us is that they recommended that we continue trial enrollment. That we should continue as planned and continue until the full sample size is reached. So the 8k was simply an update to the financial community on timing, and we put it out there to maintain our transparency on what's going on with the program.

Tom Salemi (23:10):

So where you go from here? Have you said when you may be able to provide the update that's necessary to sort of close a loop on the trials?

Jason Weidman (23:20):

Yeah, we have. So we expect that we'll have data some by the end of next calendar, sometime by the end of next calendar. So we just have to finish enrollment in the trial, which we're kind of on that last lap. Then there's a six month follow up period to the primary endpoint. We'll have those data sometime next year.

Tom Salemi (23:39):

How do you as a business person building this business up, what does that do for your plans in terms of ramping up for hopefully ultimately commercialization? Do you put things on hold? Do you still sort of build with an approval in mind? What's going on in that area?

Jason Weidman (23:56):

Yeah, it's a good question, Tom. I think what's most important is that the timing update doesn't impact our confidence and our high confidence in RDN at all. So this is just a trial that's not complete. So as I mentioned earlier, we have a ton of clinical evidence on this therapy already that's all pointed in the same direction and that's positive. So we're certainly not holding up things that are time sensitive. We continue to advance our plans. But there are also other things that you do only when you're very close to approval. So let's say as you're starting to supplement your field force or put particular field facing roles in place, it doesn't make sense to put those in two years in advance. So things like that we would hold off on.

Tom Salemi (24:43):

Excellent. It's a great story. As I said, up top I'm of a fanboy of the technology and I do give credits to Medtronic for sticking with it, because I think this market's future sort of hinges upon this program. There are other companies out there that are doing it, but even they're looking to you to sort of open some doors and blaze the trail. I asked you this before, and you said it's fun and I think that's great. But you've joined an industry where you wanted to make a difference, you're in position to make a huge difference if things go well, what's it like going to work every day, knowing that's sort of the likely hopefully outcome?

Jason Weidman (25:24):

It is, like I said, exactly what I've wanted to do. It's exciting for me to get up every day. I actually wish there were maybe 36 hours in this day instead of 24 hours a day because there would be more time to spend on it. I just really get super excited about the prospect of, like I said earlier, about transforming how hypertension is treated. I think it's because, you and I were talking about this, it's such an enormous problem. So you look at the facts more than a billion people worldwide have high blood pressure. It costs our healthcare systems about $400 billion annually. It's the largest contributor to death. However, despite all of this, what we have today just isn't working.

Jason Weidman (26:11):

So less than one in five people have their blood pressure under control. So it's less than 20%. This is just so sad because small, small reductions in blood pressure make a big difference on health outcomes. So a drop of just two millimeters of mercury in systolic blood pressure. So when you go to the doctor and you get that cuff and they measure it and they give you those two numbers, that top number, if that goes down by just two points, that results in a 10% reduction in stroke and a 7% reduction in ischemic heart disease mortality over a patient's lifetime.

Tom Salemi (26:47):


Jason Weidman (26:47):

So contemplate that. It's such an opportunity for us and what's also sad about this is that drugs do work. It's just people don't take them. So if you look at the data and there's tons and tons of studies out there on drug compliance, only about half of people are fully compliant with their blood pressure drug regimen at a year, and a full 20% of them don't take anything at all.

Jason Weidman (27:20):

So we desperately, desperately need more tools to treat high blood pressure and so do patients. I truly believe, as does our organization, that RDN is one of those potential answers. It has the possibility to fill that void because we think of it as always on. There's no need to worry about taking pills every day. It's just a one time procedure. It appears that it's durable. It's not going to get rid of medications for all patients, but it's going to serve a great purpose for many.

Tom Salemi (27:51):

That's fantastic. And, and just final question and sort of circling back to my question about your path into MedTech. You are an engineer, you went to Stanford, at like 97. I joked about the dotcom thing. I wonder if you could speak to other engineers out there. I mean, you have a lot of engineers who go into industry where they don't have to deal with an FDA and clinical trials and everything you need to do to prove that the work you're doing is effective. What is it about, for you as an engineer, that has made work in the medical device field so worthwhile? And what would you tell future engineers like my son who's 16 and looking at this industry, or looking at a technical industry, what would you say to young people who want to apply their technical skills? What would you say about the medical device industry?

Jason Weidman (28:35):

Yeah, it's a good question, Tom. I think it kind of comes back to some of the earlier things we talked about. Which is, you want to pick a career, whether it's engineering or anything else, in an industry that gets you excited to wake up and come to work every day. I think what better place to do that when you can bring your inventiveness and your ingenuity and your technical skills to improve people's health and you can see that directly. You can see that direct impact of what you're and what you're designing on people's health.

Tom Salemi (29:08):

That's fantastic. Well, this is a great conversation. Now I'm a fan of you as well as Renal Denervation.

Jason Weidman (29:15):

Thanks, Tom.

Tom Salemi (29:16):

I appreciate the insights and we'll be tracking this story. I'm sure we'll be talking again next year. I'm sure to talk about some positive news. So thanks for joining us on the podcast Jason.

Jason Weidman (29:26):

Okay. Thanks so much, Tom.

Tom Salemi (29:29):

Well, that is a wrap. Thanks again to Freudenberg Medical for sponsoring this episode of the MedtronicTalks podcast. Thanks. Of course, to Jason Weidman for joining us on the podcast. I really enjoyed that conversation. And thanks of course, to you for being part of this conversation. Continue your role in this conversation by sharing this episode on social media. Please share it on Twitter where you can find me @MedTechTom, or on LinkedIn. I would love to connect with you there. Please also do yourself a favor and subscribe or follow this podcast. You can do that on every major podcast application. That way you will not miss a future episode of MedtronicTalks. You can also find MedtronicTalks on medtronic.com and devicetalks.com. Go to devicetalks.com for information about our other podcasts and our in person and digital events. Once again, go to devicetalks.com. Thanks again for joining us tune in next time. We'll have another great episode of the MedtronicTalks podcast waiting for you.