ARTICLE SUMMARY:
The mega opportunity in transcatheter mitral valves is deceptively simple—large market, serious disease, unmet clinical need, and a successful model in TAVR. But everything about mitral valve anatomy, disease, and device development is complicated. Have next-generation companies learned enough from the pitfalls of first-generation companies?
“Mitral valve disease is messy,” said prominent interventional cardiologist Martin Leon, MD (Columbia University and NY Presbyterian Hospital) in a recent presentation at the Cardiovascular Research Foundation’s (CRF) THT conference. He addressed why the field of transcatheter mitral valve repair and replacement is progressing so much more slowly than anticipated a decade ago, when, after the success of transcatheter aortic valve replacement (TAVR), mitral became the next and biggest frontier in structural heart disease. To start with, Leon said, mitral valve disease is a heterogeneous collection of patients both from the standpoint of their anatomy and disease.
That goes a long way toward explaining the disconnect between the enthusiasm of 2015, the year that kicked off a string of mitral valve device strategic acquisitions worth $2.5 billion, and the fact that today, there are only three companies with minimally invasive mitral valve repair devices on the market for the treatment of functional mitral regurgitation. (See “Transcatheter Mitral Devices: The Dam Finally Bursts with a Flood of Deals,” MedTech Strategist, August 31, 2015.) Several companies in the space—Viacor and Mitralign, to name just two—went out of business, while other acquired projects were abandoned or repurposed for the tricuspid valve.
