Edwards Shares Leap on FDA Panel NodThursday, June 14, 2012
Shares of Irvine-based device maker Edwards Lifesciences Corp. surged Thursday after a Food and Drug Administration panel recommended approval of its less-invasive heart valve for wider usage.
Edwards’ shares closed up 7% for a market value of about $11.1 billion.
The FDA panel voted 11-0 with one abstention to approve the Edwards Sapien replacement heart valve for high-risk patients with symptomatic aortic stenosis. The agency generally follows the advice of its panels when it comes to approving devices.
Edwards Sapien has been sold in Europe since 2007 and in the U.S. since last November.