Edwards Lifesciences up 8% on Positive FDA Panel Vote

Edwards Lifesciences

is trading higher on the session after the announcement last night that the FDA panel recommends the approval of the company's transcatheter valve for high-risk patients. The FDA panel voted 11-0 with one abstention. Michael A. Mussallem, Edwards' chairman and CEO. "We are very encouraged by the Advisory Panel's strong recommendation for approval to expand the current indication for the Edwards SAPIEN valve to patients at high risk for surgery. A broader indication for high-risk patients would enable multi-disciplinary Heart Teams to choose the approach best suited to their patients' needs, including for the first time a transapical delivery option. We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis of The PARTNER Trial results." Edwards Lifesciences is currently trading at $97.74, a gain of $7.20 or 7.95%.