Market & Industry Briefs
Brief summaries of recent medtech market and industry developments. This month we cover the FDA's comprehensive new guidelines for DES clinical trial design, TriVascular's re-emergence as TriVascular2, and the European heart valve repair and replacement market.
You may also be interested in...
Over the last few years, interventional heart valve technologies have been among the most popular segments of the cardiovascular device market with venture investors. This popularity has resulted in some VCs concluding that the space has become saturated. While the market may be getting tougher to enter for newcomers, the successful financing rounds recently closed by Evalve and Mitralign show that investors--including new device investors--remain bullish on companies that can demonstrate an effective percutaneous alternative to existing surgical procedures.
Although safety concerns about drug-eluting stents have been mitigated somewhat by recent reports of more positive clinical data, there is lingering unease and confusion in the cardiology community about when, how, and in whom to use these devices. There is also a growing wave of healthy skepticism about the way stent trials are designed and conducted, and whether evidence- based medicine is well served by the current process.
Full-scale commercialization of percutaneous heart valve technology is still years away, but Evalve's new approach to mitral repair is closest to the clinic.