FDA Schedules PMA Review of Edwards Sapien Valve for High-Risk Patients

April 9, 2012—Edwards Lifesciences Corporation (Irvine, CA) announced that a US Food and Drug Administration (FDA) advisory panel has proposed a review of the premarket approval (PMA) application for the Edwards Sapien transcatheter heart valve for the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery. The proposed review is scheduled for June 13, 2012.

According to Edwards, the PMA application was based on data from the high-risk cohort (Cohort A) of the PARTNER trial, which compared outcomes after treatment of 699 patients with either surgical valve replacement or the Edwards Sapien valve via transfemoral or transapical delivery. The PMA application was submitted in April of 2011.

As reported in Cardiac Interventions Today, the 1-year Cohort A results were presented in April 2011 at the American College of Cardiology's 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 United States and is awaiting approval.