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Artificial Heart Valve Wins FDA Nod
The FDA has approved the SAPIEN 3 transcatheter aortic heart valve for the treatment of high-risk patients with severe, symptomatic aortic stenosis.
The decision was based on positive results from a cohort of the PARTNER II (Placement of AoRTic TraNscathetER Valves II) trial, which enrolled 583 high-risk patients at 29 U.S. sites.
“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,” said co-principal investigator Martin B. Leon, MD, professor of medicine at the Columbia University College of Physicians and Surgeons.
The new valve, available in 20-mm, 23-mm, 26-mm, and 29-mm sizes, has an outer skirt (a cuff of fabric surrounding the valve frame), which provides a seal to address paravalvular leakage, according to its manufacturer, Edwards Lifesciences Corporation. The company expects the product’s launch to be largely completed by the end of the year.
The SAPIEN 3 valve has been commercially available in Europe since January 2014.
Source: Edwards Lifesciences Corp.; June 17, 2015.