FDA Grants Edwards IDE for US Trial of SAPIEN 3 Transcatheter Valve

Transcatheter valve pioneer, Edwards Lifesciences Corporation has received conditional Investigational Device Exemption (IDE) approval from the U.S. FDA to initiate a clinical trial of its new Edwards SAPIEN 3 transcatheter aortic heart valve and accessories.

Background

The trial will study the SAPIEN 3 valve in the treatment of high-risk and inoperable patients with severe symptomatic aortic stenosis. It will enroll up to 500 patients treated with one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route between the ribs or the transaortic approach through a small incision in the chest and aorta. Edwards anticipates that the trial will have a one-year composite endpoint compared to previous SAPIEN valves.

The speed with which the FDA has granted this new IDE approval is being seen as reflective of moves within the agency to respond to pressure from physicians. Cardiologists in the United States are likely to have been influential in initiatives to speed the PMA approval process up, as they look across the water at a European market where transcatheter options have been CE mark approved for some time. At present only Edwards’ original Sapien valve is available for marketing in the U.S.

Company comments

“We’re very excited to have the opportunity to initiate a U.S. study of the SAPIEN 3 valve. 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,” said Larry L. Wood, corporate vice president, transcatheter heart valves. “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.”

Regulatory status

The Edwards SAPIEN 3 valve is an investigational device and is not available commercially in any country.

Source: Edwards Lifesciences Corporation