April 12, 2012 - Edwards Lifesciences Corp. said a U.S. Food and Drug Administration (FDA) advisory panel will review the company's request to expand the indication for the Sapien transcatheter aortic valve to high-risk surgical patients. The premarket approval (PMA) application is set to be reviewed June 13, 2012. Edwards submitted a PMA application in April 2011 based on data from the high-risk cohort (Cohort A) of the PARTNER Trial, for approval of this therapy in the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery.