FDA Grants IDE for Trial of Edwards' Sapien 3 Transcatheter Valve

August 5, 2013—Edwards Lifesciences Corporation (Irvine, CA) announced that it has received conditional investigational device exemption approval from the US Food and Drug Administration to initiate a clinical trial of its Edwards Sapien 3 transcatheter aortic heart valve and accessories.

According to Edwards Lifesciences, the trial will study the Sapien 3 valve in the treatment of high-risk and inoperable patients with severe symptomatic aortic stenosis. The trial will enroll up to 500 patients treated with one of three delivery techniques: transfemoral, transapical, or transaortic. Edwards anticipates that the trial will have a 1-year composite endpoint compared to previous Sapien valves.

The Edwards Sapien 3 valve—which is an investigational device and is not available commercially in any country—builds on the Sapien platform with new features that include a lower profile, a fabric cuff intended to reduce paravalvular leak, and new delivery systems, according to the company.