FDA Panel Recommends Approval Of Edwards Lifesciences Corporation's Transcatheter Valve For High-Risk Patients

Edwards Lifesciences Corporation announced that a U.S. Food and Drug Administration (FDA) Advisory Panel voted in favor of recommending approval of the Edwards SAPIEN transcatheter heart valve via transfemoral and transapical delivery for the treatment of high-risk patients with severe, symptomatic aortic stenosis. The panel voted 11 to 0, with one abstention, that the benefits of the heart valve outweighed the risks for these patients. Edwards submitted a Premarket Application (PMA) in April 2011 based on data from the high-risk cohort (Cohort A) of The PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery evenly randomized to receive either surgical aortic valve replacement or the Edwards SAPIEN valve via transfemoral or transapical delivery. In November 2011, the FDA approved SAPIEN via transfemoral delivery for the treatment of inoperable patients with severe, symptomatic aortic stenosis. The Edwards SAPIEN valve is currently an investigational device for the treatment of high-risk operable patients in the U.S.