FDA OKs Edwards' Sapien 3 Ultra Transcatheter Heart Valve

Megan Brooks


December 31, 2018

The US Food and Drug Administration (FDA) has approved the Sapien 3 Ultra system (Edwards Lifesciences) for transcatheter aortic valve replacement in patients with severe, symptomatic aortic stenosis at intermediate or greater risk for open-heart surgery.

According to the company, the Sapien 3 Ultra system (valve sizes 20, 23, and 26 mm) features enhancements to the valve and a new delivery system and sheath. The valve has a heightened outer skirt designed to eliminate paravalvular leak.

The Sapien 3 Ultra delivery system consists of a new low-profile 14-French Axela expandable sheath and introduces an "on balloon" design, eliminating the need for valve alignment during the procedure.

"The advanced Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of Sapien 3 to further advance and improve patient care," Larry Wood, Edwards' corporate vice president, transcatheter heart valves, said in a news release announcing approval.

"The Edwards Sapien 3 Ultra system provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care," John Webb, MD, director, interventional cardiology and cardiac catheterization laboratories, St Paul's Hospital, Vancouver, Canada, and professor of cardiology, University of British Columbia, who is a consultant for Edwards Lifesciences, said in the release.

The company received CE marking for the Sapien 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients in November 2018.


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