An FDA Advisory Panel is scheduled to review Edwards Lifesciences' premarket approval (PMA) application for its Edwards Sapien transcatheter aortic heart valve on July 20.
Irvine, Calif.-based Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort (Cohort B) of the PARTNER trial, for approval of this therapy in the treatment of inoperable patients with severe aortic stenosis.
The inoperable cohort compared outcomes after treatment with either standard therapy or the Edwards Sapien valve in 358 patients. The results of this study were published in the New England Journal of Medicine in September 2010.
The Edwards Sapien heart valve is an investigational device in the U.S. and not yet available commercially.