FDA Approves Edwards’ New Heart ValveOriginally published June 16, 2014 at 4:02 p.m., updated June 17, 2014 at 10:46 a.m.
Irvine-based Edwards Lifesciences Corp. said today that the Food and Drug Administration approved its Edwards Sapien XT less-invasive heart valve.
The approval covers high-risk and inoperable patients suffering from severe symptomatic aortic stenosis, or a narrowing of the body’s main artery. Edwards said in a release that the valve will be immediately available to patients.
Edwards released the Sapien XT news after the market closed. Shares were up 4% in after-hours trading after closing flat with a market value of $8.3 billion.