Medtechs Bet On Transcatheter Mitral Valve Repair
The success of transcatheter aortic valve replacement has generated optimism that the much larger pool of mitral regurgitation patients can be similarly served. While big strategics bet on replacement, however, other companies are betting on repair, developing less invasive devices inspired by an array of established mitral valve surgical repair techniques.
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The double-blind CARILLON trial will compare mechanical repair of functional mitral valve regurgitation with medical therapy alone in 400 patients at about 50 sites. The company is already running the REDUCE FMR randomized trial outside the US.
Amid the success of transcatheter aortic valve replacement (TAVR), strategic acquisitions of transcatheter mitral valve replacement (TMVR) companies and the success of mitral valve repair device MitraClip, a group of companies are developing a number of minimally invasive options to repair mitral valves. Whether minimally invasive repair, replacement, or some combination will emerge as the best option for patients with mitral regurgitation remains unclear, and insiders say this road will be rockier than it was for TAVR.
Amid the clinical and commercial success of transcatheter aortic valve replacement (TAVR), companies are preparing for what is predicted to be an even larger market in minimally invasive mitral valve replacement and repair technologies; in the summer of 2015, strategics made huge bets in quick succession on promising replacement valves. There is a great deal of activity on the repair side, too, and debate is ongoing about technical and regulatory challenges and which technologies are likely to be appropriate for patients with various types of mitral valve regurgitation.