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FDA Panel Backs Wider Use of Sapien Valve
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.