FDA Expands Approval of SAPIEN XT For Valve-in-Valve Procedures

The U.S. Food and Drug Administration (FDA) expanded the approval on Oct. 15 of the Edwards Lifesciences’ SAPIEN XT transcatheter heart valve for aortic valve-in-valve procedures.

The expanded approval comes from the one-year outcomes of the PARTNER II Valve-in-Valve Registry trial, presented Oct. 15 at TCT 2015. The results showed that Valve-in-valve transcatheter aortic valve replacement (TAVR) may be a beneficial therapeutic alternative to reoperation in patients with failed aortic bioprostheses.

Read more from the FDA about the SAPIEN XT device.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve, Aortic Valve Stenosis, Bioprosthesis, Heart Valves, Registries, Reoperation, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration


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