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Mitral and tricuspid valves may not take the same research path or see the same delays between European and U.S. adoption as with transcatheter aortic valves, if the early feasibility trials process achieves its aims. Efforts to draw early device development back to the U.S. could speed clinical access -- and ultimately help patients, as Vinod H. Thourani, MD, of Emory Heart and Vascular Center in Atlanta, discusses in this exclusive video interview.
Following is a transcript of his remarks:
The revolution that we saw in the United States for transcatheter aortic valve therapy for aortic stenosis had a certain pathway where a lot of the work was done outside of the United States and consequently came to us later in its progression of device technology. In fact, we were not even in the top 10 countries in the United States who received transcatheter valve therapies for aortic stenosis.
So it's been quite interesting to see what's happened with mitral valve and tricuspid valve technology. That's been quite illuminating as what's happened. I think with a lot of the U.S. companies actually going outside of the U.S., there was somewhat of a discussion pathway with the FDA to say, "Do we really need to go outside of the U.S. to work on our device technology?" So it was a great relationship that industry and the FDA in the U.S. had in thought process that we would actually start to do early feasibility trials (EFS), for mitral and tricuspid technology in the United States instead of going OUS [outside the U.S.] and then coming here for the pivotal trials.
So what's happened over the last 2 to 3 years in very close collaboration with the FDA, there have been design trials for mitral valve technology. So there are now three to four early feasibility trials in the U.S. with Edwards Lifesciences, Tiara, and also Medtronic looking at mitral valve replacement techniques in the U.S. So they're choosing three to four sites in the EFS program which allows really physicians in the U.S. to really start honing in on early usage of this technology, which allows us to work with the FDA earlier. So, therefore, when the pivotal trials come forward, there will have already been an engagement of industry and the FDA and U.S. investigators to make a very thoughtful progression towards pivotal trials.
This will make it not only easy for the FDA to go to pivotal trials, but I think that it will bring technology to U.S. citizens much quicker, and I think that's really what our goal has been. It hasn't just stopped with mitral regurgitation. It's also occurred for tricuspid regurgitation. And so really the non-aortic stenosis patients -- MR, TR -- are going to see an interesting use of this technology in the U.S. in this EFS program. There are now two trials for tricuspid regurgitation in the EFS program, so we're really getting to work with industry and with the FDA in finding these technologies or bringing these technologies to our citizens.
I think that's phenomenal. We've been talking about this for over 10 years now and we're seeing the fruition of it. And so, this could only have been done with the collaboration of industry and the FDA and the governments. We're really happy that this has come to fruition.