FDA Panel Recommends Approval of Edwards Transcatheter Valve for High-Risk Patients
GAITHERSBURG, MD, June 13, 2012 -- Edwards Lifesciences Corporation announced today 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.
"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," said Michael A. Mussallem, Edwards' chairman and CEO. "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."
The Edwards SAPIEN valve is currently an investigational device for the treatment of high-risk operable patients in the U.S.