Edwards Lifesciences (Irvine, California) is in a peculiar state of affairs, having won over an advisory committee recommendation for its Sapien transcatheter aortic valve, but watching its shares lose 5% or more of their value in mid-day trading last Friday. The incidence of stroke was an issue during the hearing, but FDA is looking for two post-approval studies, one of which is sure to require a lot of additional money and time (Medical Device Daily, July 22, 2011). (Medical Device Daily) Read More
