FDA Panel to Review Sapien Valve for High-Risk Patients June 13

 

April 12, 2012

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.

The high-risk cohort compared outcomes after treatment of 699 patients with either surgical valve replacement or the 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 Session and published in the New England Journal of Medicine in June 2011.

The 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.

For more information: www.edwards.com