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Next-Gen Aortic Valve Approved
The FDA approved Edwards' Sapien third generation transcatheter aortic valve, designed to limit paravalvular leakage by incorporating a skirt at the base of the valve. The approval was based on results of the PARTNER II S3 study, which demonstrated improved rates of paravalvular leakage at 30 days (<4%) compared to 10% to 20% rates for other valves.