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 has proposed a review of the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on 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.

The high-risk cohort compared outcomes after treatment of 699 patients with either surgical valve replacement or the Edwards SAPIEN valve via transfemoral or transapical delivery. The one-year results of this study were presented in April 2011 at the American College of Cardiology's (ACC) Annual Scientific Sessions and published in The New England Journal of Medicine in June 2011.

The Edwards SAPIEN transcatheter heart valve received FDA approval for the treatment of certain inoperable patients in November 2011. It is currently an investigational device for the treatment of high-risk patients in the U.S. and is awaiting approval.

Source: Edwards Lifesciences Corporation