Transcatheter Mitral Valve Therapy: Opportunities And Challenges
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.
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Starts & Stops is a regular feature highlighting Medtech Insight's monthly picks of noteworthy clinical trial announcements, initiations, completions, and suspensions. The list for December is headlined by announcements on Edwards' transcatheter valve technologies. Meanwhile, MValve, a company Boston Scientific has invested in, is not going forward with a planned trial of its MValve dock device with Boston Scientific's Lotus valve, which is currently off the market.
The Cardioband system is a transcatheter annuloplasty device for repair of mitral and tricuspid valves that should be a natural fit with Edwards transcatheter mitral valve development program. Israel-based Valtech had a deal in September 2015 to be acquired by HeartWare for $900m, but that deal fell through after HeartWare investors protested.
A look at Medtech Insight's Approval Tracker data shows that last month was a relatively active one for US FDA approvals of novel devices via the PMA, panel-track supplement and de novo routes. But 510(k) clearance totals are down so far in 2016 compared to recent years.