Edwards Gets FDA Approval for its Next-Generation TAVR Device

Edwards Lifesciences Corp., maker of heart valves and hemodynamic monitoring, received U.S. Food and Drug Administration (FDA) approval of its most advanced transcatheter aortic heart valve – the Edwards Sapien 3 valve with the Commander Delivery System—for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis.       

“The Sapien 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes,” said Martin B. Leon, M.D., director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center in New York, N.Y., and professor of medicine at the Columbia University College of Physicians and Surgeons. “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 TAVR (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.”

Leon was the co-principal investigator for the PARTNER II Trial. Sapien 3 approval was based on a cohort of the PARTNER II Trial, which enrolled 583 high-risk patients at 29 U.S. sites.

The Sapien 3 valve builds on Edwards’ experience in the development of tissue heart valves. The new valve, available in 20 millimeter (mm), 23 mm, 26 mm and 29 mm sizes, has an outer skirt—a cuff of fabric surrounding the valve frame—providing a seal to address paravalvular leak, which is blood flowing through a channel between the structure of the implanted valve and cardiac tissue as a result of a lack of appropriate sealing.

“U.S. physicians have been eagerly awaiting the launch of the Edwards Sapien 3 valve since it became available in Europe last year, and we appreciate the FDA’s timely and thoughtful review in making this device available to American patients,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “Based on extensive research and high quality clinical data, we believe the SAPIEN 3 valve has the potential to transform patient care in the U.S.”  

Given the earlier-than-anticipated FDA approval of Sapien 3, the company is ramping up supply and expects the launch to be largely completed by the end of the year, Edwards officials noted.

The Sapien 3 valve has been commercially available in Europe since January 2014. The Sapien family of valves has been used in the treatment of more than 100,000 patients globally.