IRVINE, CA, Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel is scheduled to review the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on July 20, 2011. 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 in the U.S.

Source: Edwards Lifesciences Corporation