FDA approves SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients. Edwards Lifesciences

Edwards Lifesciences Corporation announced that the SAPIEN 3 Ultra system has received FDA approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery.

The Edwards SAPIEN 3 Ultra system (valve sizes 20, 23 and 26mm) features enhancements to the valve, and a new delivery system and sheath. The valve features a heightened outer skirt designed to eliminate paravalvular leak. The SAPIEN 3 Ultra delivery system, which consists of a new low-profile 14-French Axela expandable sheath, introduces an "on balloon" design, removing the need for valve alignment during the procedureediate or greater risk of open-heart surgery.