FDA Approves Edwards Sapien 3 Transcatheter Heart Valve

June 17, 2015—Edwards Lifesciences announced US Food and Drug Administration (FDA) approval of the Edwards Sapien 3 transcatheter heart valve (THV) with the Commander delivery system for the treatment of high-risk patients with severe, symptomatic aortic stenosis. 

According to Edwards, the Sapien 3 THV is available in 20-mm, 23-mm, 26-mm, and 29-mm sizes. The device has an outer skirt, which is a cuff of fabric surrounding the valve frame that provides a seal to address paravalvular leak.

The company advised that it expects the United States launch to be largely completed by the end of the year. Edwards noted that the FDA approval was received earlier than anticipated and the company is accelerating the supply of the device for commercial availability in the United States. The Sapien 3 THV has been commercially available in Europe since January 2014. 

The Sapien 3 approval was based on a cohort of the PARTNER II trial, which enrolled 583 high-risk patients at 29 sites in the United States.

Martin B. Leon, MD, who served as Coprincipal Investigator for the PARTNER II trial, commented in the company’s press release, “The Sapien 3 valve sets a new standard for THV performance and patient outcomes. We have seen some of the best results to date from the PARTNER II trial in treating high-risk patients with the Sapien 3 valve. The PARTNER II study concluded that this new valve reduced several complications associated with the transcatheter aortic valve replacement procedure such as paravalvular leakage and stroke and represented a meaningful improvement over data from prior studies with earlier-generation devices.” Dr. Leon is Director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center and Professor of Medicine at the Columbia University College of Physicians and Surgeons in New York, New York.