FDA Panel Backs Wider Use of Sapien Valve
An FDA advisory panel has voted 11-0, with one abstention, to recommend expanding the indication for the Sapien Transcatheter Heart Valve to include high-risk patients with severe aortic stenosis.
The FDA's Circulatory Systems Advisory Committee agreed Wednesday that Edwards Lifesciences' Sapien valve is safe and effective for patients who are candidates for aortic valve replacement but who have an open-heart surgery mortality risk of 15% or more.
The Sapien was approved in 2011 for inoperable patients, but Edwards is seeking the broader "high-risk" indication, which would allow the device to be a treatment option for a greater number of patients.
The earlier approval was based on "Cohort B" of the company's PARTNER trial, which was the first trial to compare transcatheter aortic valve implantation (commonly referred to as TAVI) with surgery.
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