TAVI: Edwards wins FDA approval to begin clinical studies of next-gen Sapien 3 valve
Edwards Lifesciences lands FDA approval to launch a 500-patient clinical trial of its next-generation Sapien 3 transcatheter aortic valve implantation system.
Medical device giant Edwards Lifesciences (NYSE:EW) is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.
The FDA granted Edwards conditional IDE approval to enroll up to 500 high-risk and inoperable patients with severe symptomatic aortic stenosis in a study delivering Sapien 3 via either transfemoral, transapical or transaortic implantation. The medical device maker expects to gather data for a 1-year composite endpoint comparison to its 1st-generation Sapien valve, according to a press release.