Cardiac Surgery continues to bring life-saving technologies that give damaged hearts time to heal

December 15, 2021

In this episode of MedtronicTalks, John Mack, president of cardiac surgery, reflects on his 26-year career at the company and the portfolio of  technologies that support and repair damaged hearts. Mack discusses advances in CABG, ablation and extracorporeal life support as well as his work in the heart patient community.

 

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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.

Tom Salemi (00:09):

Our constant search to find new ways to bring new insights in the medtech industry led us to the fine, fine folks of Medtronic. They've agreed to make their senior leaders available to us and to you. 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 (00:46):

Hi everyone. This is Tom Salemi of DeviceTalks. Welcome to the final episode of MedtronicTalks, at least for the year 2021. We will be back in 2022. I'm currently working with the Medtronic communications teams on what that will look like. So please do stay tuned, expect a full-fledged return, I think in February, but we hope to have a few episodes in between now and then to tide you over. I'm very pleased to bring you this conversation with John Mack, the president of cardiac surgery. This is literally a life-saving business at Medtronic and we talked with John about how the cardiac surgery industry has changed, what technologies it's seeing to help sustain the life of patients and how it was impacted during COVID-19. We'll end the conversation will with a discussion about a few important causes that John's involved in. So, please enjoy this episode of MedtronicTalks and before we start this week's interview, I'd like to bring in our sponsor, Nordson Medical. I'm speaking with David Zgonc, he's a vice president at Nordson Medical. David, tell me about Nordson Medical. What are your capabilities and where are you located?

David Zgonc (02:09):

Nordson Medical is a global expert in the design development and manufacturing of complex medical devices and component technologies. We serve interventional, surgical and specialized medical markets as the engine of innovations that help our OAM customers save and enhance patient's lives. Today's Nordson Medical has more than 50 years in the making. Since the first Nordson Medical facility opened in 1968, we've been strategically building our capabilities to offer customers a complete solution to their medical device development needs. This strategic build-out of capabilities has led Nordson Medical to have a global footprint of 14 development and manufacturing locations spanning the US, Mexico, Europe, and Israel, allowing us to work directly with our customers where they're located.

Tom Salemi (02:55):

All right, we'll hear more from Davis Zgonc at Nordson Medical a little later in our episode. Well, John Mack, welcome to the podcast.

John Mack (03:05):

It's great to be here, Tom.

Tom Salemi (03:06):

It's wonderful to talk about such a big business. I need to understand more about this area. So, I'm glad we have this opportunity, but first I always like to understand how folks found their way the medical device sector. What was your entry point? How'd you get here?

John Mack (03:22):

I started my career actually as a CPA and I was with a public accounting firm.

Tom Salemi (03:28):

Wow.

John Mack (03:29):

Yeah, and with that, I had a lot of clients that were very involved in mergers and acquisitions. And in 1996, I had the opportunity to come out to Medtronic and support mergers and acquisitions from a financial perspective, as well as our external reporting. Then had the privilege of assisting the company as Bill George really diversified the company through mergers and acquisitions throughout the late '90s.

Tom Salemi (03:57):

So what was it about the opportunity that stuck with you? Was it Medtronic the company, was it the field? What made you stay?

John Mack (04:07):

What really inspires me every day, Tom, is the Mission of our great company, the ability to work for a global enterprise that has such a big impact, the privilege of working with great teammates around the world. And within Medtronic, we're serving upwards of 72 million people per year. Just within my business in cardiac surgery, we serve over 1.1 million patients per year. Just the honor and privilege of doing that has really kept me around for going on 26 years now.

Tom Salemi (04:37):

Did you see yourself as being the president of cardiac surgery? From that start 25 years ago?

John Mack (04:44):

Absolutely not. It's been just fantastic and to the support I've had from the company and again, all of my teammates around me, has just been truly remarkable.

Tom Salemi (04:55):

That's excellent. So let's talk about the business. We've talked to a number of people at the company. Medtronic obviously has a lot of different products touching the heart and heart health. Tell me though about cardiac surgery. This sounds like it would be a primary way to treat the heart.

John Mack (05:13):

So cardiac surgery is a business that really touches almost all of the therapies and disease states across our cardiovascular portfolio. It is obviously an end-stage treatment. as I always tell somebody, it's not necessarily what you want to have done, but it's better than the alternative. We've been in the business within cardiac surgery, really going back to Earl Bakken's days with Dr. Lillehei down at the University of Minnesota.

John Mack (05:44):

Back in the day, Earl was in Dr. Lillehei's cardiac OR supporting him both with services and solutions. And today we continue to do that within the cardiac OR, spending time with our surgeon customers, understanding their needs and trying to fulfill those needs with products and services.

Tom Salemi (06:04):

So review some of the larger pieces of your portfolio, what falls under cardiac surgery?

John Mack (06:10):

So within cardiac surgery, we have essentially all of the companies' equipment that's used in the cardiac OR. So we've got everything from products that are used to operate as the patient's heart and lungs during cardiac surgery. So, full lines of oxygenators, blood pumps and products that are used to treat the patient's blood. We also have products that are used to replace or repair a patient's heart valves, either their aortic valve, their mitral valve, or the tricuspid valve. We've got products that are used to cannulate that blood, in other words, connect the patient from the heart lung machine, to the oxygenator, so we've got a full line of cannula products.

John Mack (06:51):

We've got products that are used to perform coronary artery bypass procedures. Then finally, we've got a full line of surgical ablation products. So, really anything in the cardiac OR are within the cardiac surgery business within Medtronic.

Tom Salemi (07:08):

We're seeing, as I mentioned at the top, so many different ways of treating the heart, of replacing valves without open surgery, how has it impacted the cardiac surgery business? What is the evolution of the technology in heart surgery? How has it impacted what you do?

John Mack (07:25):

So, maybe going back to me personally. In the mid 2000s, Medtronic really spent some time thinking strategically, and we wanted to extend our cardiac surgery business into a structural heart business. We went and acquired CoreValve as well as Ventor in Israel to move to a transcatheter space. We've always had the philosophy that if we can treat patients with the same outcomes, less invasively, that's good for the company and that's good for patients.

John Mack (07:57):

What we're seeing on a global basis Tom, is globally, cardiac surgery continues to be quite healthy. We see in markets, in what we call emerging markets, procedural growth in the mid to high single digits and we see procedures in developed markets, the US and Western Europe essentially flat. But there's still about 1.8 million cardiac surgeries that are done on a global basis and there's about 320,000 that are done here in the United States.

John Mack (08:33):

We've seen within cardiac surgery, a movement to more complex procedures of where these isolated procedures can be treated through a catheter. So, the complexity of what's being done within cardiac surgery continues to increase.

Tom Salemi (08:48):

You were vice president of business development in 2006 to 2014, the business development strategy and portfolio management. Were you involved in the CoreValve acquisition? Was that part of your job?

John Mack (09:00):

Yes, yes. So, my career started in corporate, then I moved to become part of the cardiac surgery business. I then left, after leading marketing to lead business development and strategy, as we were looking to create the structural heart business and was involved in both the acquisition as well as the integration of CoreValve.

Tom Salemi (09:21):

And how's it played out?

John Mack (09:24):

It's really interesting. It's played out very well, but it's also played out, really as we anticipated, as we set forth the strategy, of where patients with isolated AVR, that can be treated less invasively through a catheter-based procedure, are being treated that way today, which is what we anticipated.

Tom Salemi (09:44):

Are you seeing more patients come into your sphere having already been treated through ... having had valves replaced through TAVR or other means? Are the patients who are coming your way, are they different than they were perhaps 10 year or 15 years ago when that sort of technology wasn't available?

John Mack (10:01):

So, they tend to be sicker and more advanced in their disease progression. So if you look in the United States right now, of the 320,000 procedures that are done in the US, slightly over half of those are isolated CABG. So this has had no impact with TAVR, and these are patients that have coronary artery disease that needs to be traded through open heart surgery. We see about 8% of procedures being isolated aortic valve replacement. That's about half of what it was back when we first launched TAVR. About 8% are isolated mitral repair replacement and the remainder are complex procedures. So we're seeing a continued increase in the complexity of patients that are treated for cardiac disease in the surgical suite.

Tom Salemi (10:54):

And what has innovation been like for cardiac surgery, specifically in this space as you offer valves or replacement valves? What sort of innovation have we seen there? What sort of advances have we seen there technically?

Tom Salemi (11:10):

We going to take a break from this conversation to bring in our sponsor Nordson Medical. Once again, I'm visiting with David Zgonc, vice president. David, tell me, what type of medical device companies do you work with?

David Zgonc (11:21):

We work closely with customers to develop primarily interventional med device solutions that enable procedures such as transcatheter valve replacement, cardiac ablation, kyphoplasty, stent deployment, among many other therapies. Our solutions include both finished devices, including delivery systems, balloon catheters, and cannula, as well as component offerings that include engineered shafts, medical balloons, extrusions, heat shrink tubing, and complex medical components. With expertise ranging from finished devices to individual component optimization, we are uniquely positioned to partner with a broad range of customers covering the entire med device lifecycle.

Tom Salemi (12:00):

And how do you help your OEM customers?

David Zgonc (12:03):

Typically, we start at the front end of the device development process, working with customers to understand the problem and develop a unique solution. Once a design solution is reached, we leverage advanced modeling and proprietary testing to verify that the design meets performance requirements, ultimately taking the product into mass production through our rigorous transfer and validation process. Nordson Medical makes a device and the differentiated components in the device, elevating us in the market through a highly configurable manufacturing platform, providing our customers with significant design freedom and flexibility from a single source.

Tom Salemi (12:39):

Finally, it sounds like you have a long history of success and a great record of growth. Tell us, where do you see Nordson Medical going in the future? What kind of growth do you see happening?

David Zgonc (12:48):

Here at Nordson Medical, we're constantly looking to expand our capabilities and ways that add value to our customers, continually evaluating new technology, equipment and processes to enable new solutions that make the devices better and more cost effective. A prime example of this was the addition of FluroTech business to our portfolio last year. This competency in flouropolymer extrusion and PTFE allows us to offer a more comprehensive line of solutions, and when combined with our other proprietary technologies, it allows us to increase our responsiveness while providing unique solutions that only Nordson can deliver.

David Zgonc (13:22):

Additionally, we are always looking to optimize our footprint with the right capabilities and the right locations. Along these lines, an exciting new step for Nordson Medical is the new state of the art manufacturing facility opening at Tecate in Mexico. We've been manufacturing in Mexico for the last 16 years and the new Tecate facility reflects a commitment to provide our customers with a cost optimized solution for full device manufacturing.

David Zgonc (13:47):

Combined with our US locations, we provide rapid development and manufacturing options from our US sites and as a product transitions into greater market acceptance, we can readily transfer the production into our cost-optimized Tecate site. This is a real win for our customers because we can provide rapid development at launch and a defined path to an enhanced cost position.

Tom Salemi (14:08):

Thanks for joining David Zgonc and thanks for sponsoring this episode, Nordson Medical. You can find more information on their website nordsonmedical.com. What sort of innovation have we seen there? What sort of advances have we seen there technically?

John Mack (14:24):

Sure. So, it goes back, Medtronic's leadership in the cardiac surgical area goes back to 1977. We were the first company to launch, what we call the Med Hall tilting disc valve, and this was a valve that had a singular frame that provided enhanced durability and performance. That was followed by us entering the tissue valve market back in the mid 80s, and we've gone from having our standard Hancock™ product to our Hancock II™, to our Mosaic™ and Freestyle™ product lines, to, we just recently launched our Avalus™ pericardial surgical valve that we're quite proud of.

John Mack (15:07):

This valve just had its five year performance and presented at the European Association of Thoracic Surgery meeting in Barcelona earlier this year and the product has had excellent hemodynamics, stable hemodynamics, no structural valve deterioration and we're just really continue to be quite proud of that product's performance. So that's in the area of heart valves, Tom. We've also seen significant innovation in the treatment of extracorporeal life support. This is a product line that we've just recently re-entered and this is something of where patients who need long-term treatment for their either lungs or cardiac disease, we put these patients on a device that operates as the patient's heart and lungs for a much longer period of time than would be standard cardiac surgery.

John Mack (16:03):

We've recently launched a series of both catheters as well as oxygenators in this market, that we're quite proud of. Certainly the performance of these products throughout the COVID pandemic has been really strong.

Tom Salemi (16:16):

I was going to ask about that. What is the clinical setting where the extracorporeal life support systems are used? Is it ICU or is it elsewhere?

John Mack (16:24):

Yeah, these are used in the ICU and as they said, these are products that act as a patient's heart and lungs for an extended period of time. About half the patients that need support of this type of device, Tom, are patients that have advanced respiratory disease. Certainly COVID being one of those and about half of the patients have advanced cardiac disease and need some sort of stabilization before it's determined what type of additional treatment they would need on the cardiac side.

Tom Salemi (16:58):

Well, let's drill down on the COVID part for a second. What does the last two years, unfortunately, or year and nine months, what kind of impact has that had on this business?

John Mack (17:09):

We've seen significant growth, unfortunately in the utilization of these devices. And in fact, the FDA because of the potential need, allowed all device manufacturers to file for an extension of their indication for products that were used in the cardiac OR. This is something Tom, of where the oversight that is needed to treat these patients is quite substantial. So, this tended to be limited for patients who were quite young and otherwise healthy, but that did get COVID.

Tom Salemi (17:42):

And what are some of the other uses for this system? I mean, we're seeing arise in respiratory disease, I imagine that would be a big ... I'm trying to understand where this is used in the treatment spectrum.

John Mack (17:55):

From a respiratory perspective, these would be patients who are not responding to ventilator treatment, and need an opportunity of where their lungs can actually just rest. So, we have an external oxygenator that act as the patient's lungs to both provide the critical organs oxygen, as well as remove CO2. So from a respiratory perspective, this would be beyond ventilation.

Tom Salemi (18:21):

Is there a treatment that this is bridged to, or is the hope that just the patient will have the time they need to recover on their own?

John Mack (18:26):

On the respiratory side, this would be a treatment that they would recover on their own. On the cardiac side, this would be a bridge to an additional treatment, whether that be a ventricular assist device, a transplant, or some sort of advanced cardiac surgery, but allows this patient to be stabilized and have all of their organs remain healthy as the healthcare system can make the determination as to what that next treatment step should be.

Tom Salemi (18:57):

So, extracorporeal life support. This would seem to be a different market, a different customer than your other products. Is that right? Or is it in alignment?

John Mack (19:07):

It's in alignment, primarily. The perfusionist is one of the customers in the space, as well as the cardiac surgeon. The cardiac surgeon does a lot of the cannulation of these patients, but certainly the treatment setting in the ICU is outside the cardiac OR.

Tom Salemi (19:24):

Let's talk about cardiac ablation, that also falls into your purview as well. What is the state of that area?

John Mack (19:34):

So we're seeing, pre-COVID, on a global basis, cardiac ablation grow in the 5% to 7% area. We're seeing stronger growth outside the US than in the US. We've got a full line of products Tom, that we've been in since the mid '90s. We've got an irrigated RF product that has saline, that provides RF energy to a patient to create a transmural lesion on their cardiac tissue. Then we also have a full set of cryo devices.

John Mack (20:10):

The business has been doing quite well for us, especially outside the US and we are currently enrolling in a clinical trial called Terminate AF, to get an indication to treat AF within the United States.

Tom Salemi (20:26):

Let's talk about innovation in this space as well. I mean, we've seen ablation technology being paired with imaging, with mapping and things like that. What advances are you seeing in your ablation line?

John Mack (20:40):

Relative to some of what you're talking about would be within the EP area in our cardiac ablation business, so we're primarily focused on open surgical and patients that would have these procedures in connection with having other procedures done on the heart. From a technology advancement perspective, we're continuing to see advancements in the space, we just recently launched a new generator within our RF line, of where the same generator drives all of our cut and COAG products coming out of our MITG business, as well as drives all of our ablation products within cardiac surgery. We're currently investing in a next gen cryo device as well and we anticipate having that in the market within the next 24 months.

Tom Salemi (21:35):

No, thanks for setting me straight on that. I was a little confused as to why ... I always saw A-fib is more of a minimally invasive application, so when is ablation done in this setting?

John Mack (21:45):

So you do see some isolated treatment within the cardiac setting, but that's pretty rare. So, a majority of our cases are, you're already doing a mitral valve repair or replacement. This patient needs additional treatment, and they get it. You're already doing a coronary artery bypass. That type of a thing would be primarily what you're seeing in the cardiac surgery area.

Tom Salemi (22:11):

Interesting, okay. I mean, what is your overall feeling about advancement in this space? It seems everything we talk about is all minimally invasive and interventional, and very little of my attention seems to be given to this sort of technology. Is this an area that is still gets the attention that it did before? Or do you feel like that interventional tools are getting more of a spotlight than perhaps you feel like they should? I don't know.

John Mack (22:37):

Yeah as I said, our underlying philosophy as a company has always been, if you can provide patients a similar outcome through a less invasive method, that's a good thing for the patient. So certainly as advancements are made on the catheter side, we watch those closely. We do also though, continue to believe that patients who are undergoing cardiac surgery are going to need to continue to need these types of treatments and advances should be made in these areas as well. So, as I said, we've made advancements in our energy platform. We're making advancements in our cryo platform, and we're also closely watching some work that's being done in our catheter-based technology with pulse field ablation and seeing how that might be applicable within cardiac surgery at some time in the future.

Tom Salemi (23:26):

John, I want to circle back and we hit upon it maybe a little bit, but I want to understand more about your portfolio in CABG. What are your products here and how are you approaching that space and that procedure?

John Mack (23:40):

Sure, thanks, Tom. So when you look at coronary artery bypass procedures, which continue to be a majority of procedures within cardiac surgery globally, about 80% of those procedures are done what we call on-pump, of where you would put the patient on a heart lung machine, on an oxygenator, you would cannulate them and the surgeon would do a standard coronary artery bypass procedure. About 20% of those procedures and by far a vast majority in countries like India, in countries like Japan, but about 20% average across the world, are done what we call off-pump. In the mid '90s, Medtronic partnered with the University of Utrecht to develop a family of stabilizers that we call Octopus. That was a really another part of innovation and first within Medtronic, where we developed this line of products in partnership with the University of Utrecht and we really launched what was a new therapy in the mid '90s.

John Mack (24:46):

It reached about 30% penetration in the United States, somewhere about 30% of CABGs were done. Because of some of the complexities of the procedure, that's now moved back to about 15%. But when you look in countries like India, about 80% to 85% of procedures are done off-pump and in Japan, it's about 70%.

Tom Salemi (25:08):

Those are interesting numbers. Why is it so different from country to country?

John Mack (25:12):

Some of it is around economics and some of it quite honestly, is just around position training and position comfort.

Tom Salemi (25:21):

So going forward, I mean, where are the opportunities you see for growth in this business? And how is cardiac surgery viewed by the company? I'm talking with others, some have had a larger business with lower anticipation for growth or lower projections, where does cardiac surgery fall in that expectation realm?

John Mack (25:42):

Yeah, we think cardiac surgery can continue to grow in the mid single digit to range within the company. As I said earlier Tom, cardiac surgery is the end stage treatment for a lot of the disease states that we treat across cardiovascular. So, we're also a bridging business within the company. As I talked earlier, we partnered with the structural heart business as we entered the TAVR space. We continue to partner very, very closely with the structural heart business as they're treating transcatheter mitral valve disease, or they're looking at tricuspid disease.

John Mack (26:18):

We partner very closely with the CAS business in looking at the way that we look at surgical ablation. So we continue to be a bridging business across the enterprise, but also a business that the company views realistically. We see that on a global basis, we should be able to grow in the mid single digits. We see that that growth is going to be stronger in parts of the world that would be emerging markets, where the treatment of cardiovascular disease is much less penetrated. So we make significant investments in training and education and in our global footprint to address those patient needs but we see the markets more flat in Western Europe, the United States and Japan.

Tom Salemi (27:04):

And final area I want to talk about, I know you're involved more broadly in the heart community. You've done work with the American Heart Association. How did you become involved with those groups, and talk a bit about that experience.

John Mack (27:16):

Sure, I've been involved in the American Heart Association ever since I came to Medtronic, supporting The Heart Walk and other types of activities, going to the annual gala. But I had the opportunity to become part of the board of the American Heart Association about seven years ago. I served on the board for six years, three years as chair and really, I would just say, support in significant ways the great work of the American Heart Association. Medtronic is a Life is Why sponsor for American Heart and we're working very closely with the American Heart, both within the Twin Cities area, as well as across the country, on addressing healthcare needs and specifically healthcare disparities. With all of the things that have been happening in the world over the last several years, really spending time on addressing healthcare disparities is something that we've really partnered closely with, with the American Heart Association.

Tom Salemi (28:17):

Excellent.

John Mack (28:17):

And Tom, I would just maybe also, as long as I've got the team in the podcast, give a plug for another group I'm very involved in and that's Camp Odayin. Camp Odayin is a camp for kids with cardiovascular disease. It started in 2002 where we treated, or we helped about 50 campers, and now we support nearly a thousand campers and their families per year, and really helping these kids have a great experience and support their both physical and mental health with Camp Odayin.

Tom Salemi (28:50):

Wow, that's a great cause. I don't imagine you have any sort of pediatric applications in your business line, do you?

John Mack (29:00):

We do, we do. We have a lot of pediatric products that support cardiac surgery from oxygenator to catheters.

Tom Salemi (29:10):

Wow.

John Mack (29:10):

To all of those products.

Tom Salemi (29:12):

All right, well that's definitely a great cause, I'm glad you brought it up. Well, it's been a really informative conversation, John. I appreciate you joining us on the podcast.

John Mack (29:23):

Tom, it's been a real pleasure. Thank you.

Tom Salemi (29:25):

And that is a wrap. Thank you so much for joining us for this episode of the MedtronicTalks Podcast. And thank you for being part of the MedtronicTalks Podcast season. So excited to be working on MedtronicTalks Podcast, season two. We will be back in February. It's going to have a different look, a lot of new folks, new faces, new voices, new topics, really, really, really looking forward to bringing you those stories. So please do subscribe to the MedtronicTalks Podcast, that way you won't miss the new episodes when they come up. You can subscribe on Apple, Google, Amazon, Spotify, we are out there. Please do not miss a future episode of MedtronicTalks.

Tom Salemi (30:13):

Please do connect with me on social media. Another way to track down future episodes of MedtronicTalks. I am on LinkedIn, you can find me on Twitter @MedTechTom. You can also find these podcasts on medtronic.com on devicetalks.com, where you can also see our information about our other podcasts and our events in 2022.

Tom Salemi (30:36):

Yes, we are planning in-person events and you won't be surprised to learn that Medtronic will be an important part of those as well. So once again, I like to thank Nordson Medical for sponsoring this episode of the MedtronicTalks Podcast. I'd very much like to thank the communication professionals at Medtronic for working with us in putting together this series. It's a lot of work. It's not easy to do, but I think it was totally worth it. And again, excited to bring you season two. That's it, tune in next year for another great episode of the MedtronicTalks Podcast.