FDA gives Edwards’ Sapien 3 Ultra TAVR the nod

Edwards Lifesciences’ Sapien 3 Ultra TAVR

Edwards Lifesciences (NYSE:EW) can now market its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in the United States.

The FDA approved the device for severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered an intermediate or greater risk, the Irvine, Calif.-based company said.

For the Ultra, Edwards has added a taller skirt with sizes 20, 23 and 26 mm to the Sapien 3 design to eliminate paravalvular leak and improve TAVR outcomes. The Ultra device also introduces an “on balloon” design that the company said does away with the need for valve alignment during the procedure. The delivery system is compatible with its 14F Axela expandable sheath.

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