When someone describes FDA and the Centers for Medicare & Medicaid Services as sister agencies, they may be on to something if the CMS report regarding a coverage analysis for the Sapien aortic valve made by Edwards Lifesciences (Irvine, California) is any indication. The Sept. 28 CMS memo indicates that the agency heard loud and clear the message FDA intended to send during the advisory committee hearing earlier this year, which conveyed the notion that FDA is not keen on seeing this device migrate into anything but a heavily staffed facility with personnel who are well versed in this type of procedure (Medical Device Daily, July 22, 2011). (Medical Device Daily) Read More
