Edwards’ Sapien Ramp-Up Successful, But Medicare Policy Makes For Some Hurdles
This article was originally published in The Gray Sheet
Edwards’ rate of training hospitals on its new transcatheter valve procedure is on track with its goals but slower than the 20-site-per-month rate that the firm says it can handle, likely because some hospitals are struggling to ensure that they meet new Medicare coverage requirements.
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Direct Flow Medical announced Jan. 28 the receipt of a CE mark for its transcatheter aortic heart valve system, to compete with Edwards, Medtronic among others in burgeoning market.
Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.
New Medicare coverage policy for transcatheter aortic valve replacement is a significant step for the nascent procedure and a possible window into how the agency will address future high-profile, early-stage technologies.