Europe Editor

Wolfgang Goetz gave up a successful career as a cardiac surgeon to start Transcatheter Technologies (Regensburg, Germany) determined to solve a series of problems plaguing the current generation of transcatheter aortic valves with a next generation repositionable device. The results of the first-in-human clinical trial using the company's Trinity valve were presented at the most recent TCT and EuroPCR meetings. Medical Device Daily spoke with Goetz, the CEO for Transcatheter Technologies, in Paris during EuroPCR.

MDD: Why would a little start-up company get in a field where giants are playing?

Goetz: Because I am naive. Because I did not know what I was doing. Because I was so excited about what we have been able to develop that I just wanted to do it. You rarely have such chances in life, where you are inspired by an idea. You either do it or forget it. Afterwards you may regret not having done it. If I do this and it does not succeed, at least I can say I followed this passion.

MDD: How then did you convince investors to back you with over $7 million? Presumably they are not naive.

Goetz: Because I have a good story. I am a cardiac surgeon. At the German Heart Center in Munich, I performed for years every procedure a cardiac surgeon can do. There was no transcatheter interventional procedure. That came later. I was specialized in heart valves and became very interested in these valves. I did mitral valve repair, which was my main interest at the beginning. And I became interested in autologous tissue heart valve prosthesis where we take pericardium tissue from the patient's own heart and fashion an aortic valve. You take a part of the sack around the patient's heart, treat it chemically to tan it like leather, cut it to a template and suture it to the wall of the aortic valve, not to a stent. It takes 15 minutes.

MDD: How did you go from building custom-fit valves to mass production?

Goetz: You can't make money with autologous valves. It is a procedure, not a product. I did this in India and Thailand on a humanitarian basis. It is priceless for patients, but there is no market. It depends on a surgeon's skill, and for most surgeons it becomes safer to implant an industry-produced valve prosthesis. That was around the time when TAVI came out, and I thought, like other cardiac surgeons, 'oh no, they are going to start killing patients.' We could not imagine how they could implant a valve in the aortic root like that. The concern was that these devices would block the ostium, the opening of the right coronary artery. It became clear to me that such a valve would need to be repositionable because if you block the ostium you need to go back and retrieve the valve. This is where I began working.

MDD: You set out to design what you call a "truly repositionable" aortic valve?

Goetz: There were other problems with these implantable valves. We were learning from the clinical experiences of the big players. We learned there were problems with paravalvular leakage because the valves did not seal properly. Then there is a problem with the heart's electrical conduction system. The valves interfere with the conduction, depending on the valve's placement.

These became the points we have been working on: retrievability, positionability, sealing, and reducing the risk of pacemaker implant. When I look at the valves that are now on the market, the big players have not solved these problems, most especially retrievability and precise positioning. To be sure, everyone wants to do it right the first time, to go in and slowly deploy the valve. They don't want to reposition a deployed stent because it scrapes the artery wall and that creates emboli that can cause a stroke. But there are cases where they wish they could reposition. In about 30% of the cases of TAVI implants, the cardiologists are not satisfied with the positioning. The reposition-ability for the Trinity valve that we provide is not meant to be used all the time. It is a feature that allows, if there is a positioning problem, to go back and solve the problem without surgery, and without risking the life of the patient. Martin Léon compares a repositioning capability for valves to having an airbag in your car. You don't drive your car expecting to have a crash, but if it happens, you really want to have that security feature.

MDD: So you have quit cardiac surgery and are now fully engaged in interventional valve procedures.

Goetz: Yes, I gave up my job as a cardiac surgeon. We had seen the interventional surgeons arrive with a stent and the number of bypass surgeries went down. Then they came with drug-eluting stents, and bypass operations further decreased. The cardiologists were taking over the work of the cardiac surgeons. I realized this will happen again with valves. And it is happening again. They are implanting now in patients older than 75 years who cannot undergo surgery. Pretty soon these valves will get better and will go into younger patients. I was looking for something more, something exciting. Now, every day is a new experience. I am out there selling this idea, it's my baby.

Next week: Transcatheter Technologies CEO Goetz describes the market opportunities he sees for the next-generation Trinity valve, and describes its features, which include a unique configuration to avoid crimping valve leaflets and potentially extending their durability. //