Dr. Wesley Pedersen is one of Minnesota's new medical pioneers. Last month, he implanted a locally designed mitral heart valve through a small tube in the beating heart of a patient, becoming the first doctor to do so in the United States. The valve was made by Roseville-based Tendyne and implanted at the Minneapolis Heart Institute Foundation, where Pedersen is principal investigator on a feasibility study of the new device. Even though many medical devices are invented domestically, such "first-in-human" experimental work has become rare in the United States. Although the Food and Drug Administration may be softening its stance and allowing more cutting-edge human research to take place in the U.S., observers like Pedersen say the agency's onerous approval process still injects too much time and uncertainty into the process, scaring away the investments that drive innovation.
Q: How did the transcatheter mitral valve implant go?
A: It went very smoothly. We have two more on the docket already. It's very gratifying, and it's huge for our foundation. It builds on itself. The more you do that, the more companies want to go to you and do it with another device. We all know that.
Q: How did you get the chance to do the first U.S. human implant?
A: First and foremost, it is highly advantageous to be in Minneapolis and be an interventional cardiologist or vascular surgeon because of all the major vendors and, more importantly, the start-up ventures that are here. Access to physicians and availability is obviously much easier when you are right across town.
The engineers [at Tendyne] knew me from the Myocor business [a Maple Grove company that developed a mitral-valve leakage therapy 10 years ago]. They certainly knew that Abbott and the foundation were excellent, but I had a little bit of an added opportunity because of my relationship with them.
Q: Have you seen changes in how medical technology makes it to market?
A: It's been very difficult to raise money. The timelines are very long. They are 10 to 15 years, no longer five years. And the amount of money you need is no longer $20 million or $30 million. It is $100 million. One of the issues, and probably the biggest issue, has been the FDA.
Q: Isn't the FDA allowing more first-in-human work, like the Tendyne trial?
A: They're getting a little bit of credit now for diving in earlier, but I don't want to give them too much credit. The FDA now has softened on first-in-man stuff, but they have not softened on their approach for FDA approval ultimately.
Q: What's driving the changes at FDA?
A: I think it's been a culmination of getting hammered by physicians over the last 10 years. It is very difficult to develop this technology and to go overseas and have your first in-man done by [the University of] Leipzig in Germany or one of the big groups in Europe, the U.K., or Australia.
Q: What do you tell patients about getting experimental treatments?
A: You get sick of this stuff. Because the patients come up to you, and they ask you, I hear that they have this type of valve. And then you have to go through the rendition where you say, yes, in fact they developed it right here in Minneapolis, but if you want it, you have to go overseas and participate in a trial.
Q: And the rules for U.S. device trials can be very strict?
A: The worst trial I can think of ever having to do was the PARTNER trial [on transcatheter aortic valves], where we randomized people to death. It was very difficult to tell someone they're not going to get … the transcatheter valve, knowing that the mortality is 50 percent at one to two years [for severe aortic stenosis]. That is a devastating thing to do.
And the FDA is a stickler on that. They want science. So you don't know how long these trials are going to take. That inability to know what the timeline is going to be, and generally have expenses that you can't control, has certainly made the venture capitalists sort of withdraw for the most part from this market. More frequently now, money is raised at least initially through angel investors. And you go from there.
Q: How do you decide who gets the new device, and who is in the control group?
A: They have randomization centers. Often it is Harvard that does this. … Patients oftentimes need to be told two and three times that you have absolutely no control over that. It is literally like tossing a coin.
Q: What do you think will be the impact of the Tendyne study for the device field?
A: I think this is an absolutely fantastic opportunity for Minneapolis, and I think they should continue to build on this. I hope this represents somewhat of a turning point, and people will be more willing to open their wallets.
