GAITHERSBURG, Md.—The FDA’s Circulatory System Devices Panel, which evaluated the Sapien transcatheter heart valve (Edwards Lifesciences) today at a well-attended regulatory meeting, voted to recommend that the FDA approve the technology. The panelists voted on three items, including: safety, effectiveness and whether the benefits outweigh the risks, on which the respective votes were seven to three, nine to two and nine to zero (with one abstention).
The Pleasanton, Calif.-based company is seeking from the FDA that its Sapien heart valve, sizes 23 mm and 26 mm, and its Retroflex 3 delivery system be indicated for transfemoral delivery in patients with severe symptomatic, native valve aortic stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis.
During the course of the day, both the FDA and Edwards agreed to add “symptomatic, native valve” to the previously defined indication request.
After more than nine hours of presentations and discussions, much of which focused on stroke and vascular complications in the PARTNER trial, as well as appropriate procedure volume for the facility and the individual, "indication creep" and the design of post-approval studies, the majority of the panel came to the conclusion that the Sapien heart valve demonstrated a "reasonable assurance" of overall safety and effectiveness in this patient population. Unlike previous panels, the members did not have an opportunity to alter the questions and re-vote.
If the FDA accepts the panel’s recommendations, transcatheter aortic valve implantation (TAVI) procedures would be available to U.S. patients, even though it is already approved and commonly used in Europe. The FDA is not required to adopt the recommendations of the panel, but the agency often does.
Watch for more news from Cardiovascular Business on the FDA's panel review of TAVI tomorrow.