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.
"This valve builds on the Sapien platform and provides new features designed to benefit patients and enhance ease of use, such as a lower profile, a fabric cuff intended to reduce paravalvular leak and new delivery systems," Edwards TAVI vice president Larry Wood said in prepared remarks. "We appreciate the FDA’s efforts to allow initiation of this trial in a timely way, providing U.S. patients with access to our most advanced transcatheter system."
Edwards has also been making advances with its Sapien XT TAVI system, which just last month won approval for the Japanese market, making the device the 1st and only technology of its kind available in Japan. Sapien 3 is not yet available anywhere, Edwards noted.
News of the IDE trial approval have yet to make waves with Wall Street, where EW shares were up 0.2% to $72.76 as of about 12:20 p.m. today.