June 14, 2012 — A U.S. Food and Drug Administration (FDA) advisory panel voted in favor of recommending expanding the indication for the Edwards Lifesciences Sapien transcatheter heart valve for the treatment of high-risk patients. Currently, the Sapien is only indicated for patients who are too sick to undergo valve replacement surgery for severe, symptomatic aortic stenosis. The panel voted 11-0, with one abstention, that the benefits of the heart valve outweighed the risks for these patients.
If the FDA clears the additional indication, it will further expand the use of transcatheter aortic valve replacement (TAVR) therapy to more patients. Many experts predict TAVR will eventually replace the very invasive gold-standard therapy of open-heart aortic valve replacement surgery in the coming years.
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 Sapien valve via transfemoral or transapical delivery. In November 2011, the FDA approved the Sapien valve 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 Sapien valve is currently an investigational device for the treatment of high-risk operable patients in the United States.
For more information: www.edwards.com
August 19, 2025 
