FDA Approves Abbott's Amplatzer Paraclose, the First U.S. Transcatheter Device Designed to Treat Paravalvular Leak
Abbott Park, Illinois — Abbott announced on October 28 that the U.S. Food and Drug Administration (FDA) has approved its Amplatzer Paraclose PVL Occluder, the first and only transcatheter device approved in the U.S. specifically designed to treat paravalvular leak (PVL), a backflow of blood around a surgical heart valve, giving patients a minimally invasive option instead of another open-heart surgery.
A paravalvular leak occurs when a small gap remains or develops over time between native heart tissue and a replacement valve. Abbott says such leaks occur in 7% to 17% of mitral valve replacements and 5% to 10% of aortic valve replacements, and can lead to heart-failure symptoms including shortness of breath, fatigue and swelling of the legs and feet, as well as hemolysis, in which red blood cells are damaged, causing severe anemia. The Paraclose device is implanted through a catheter inserted through an artery or vein in the leg, and its oblong, elliptical shape is designed to close a wide range of leak shapes and sizes.
The approval was supported by data from the PARADIGM study, a prospective, multicenter, single-arm study of 200 patients, which Abbott said demonstrated that Paraclose provides an effective, minimally invasive alternative to open-heart reoperation. Amar Krishnaswarmy, M.D., section head of Invasive & Interventional Cardiology at the Cleveland Clinic, said the U.S. approval addresses a significant treatment gap for people suffering from a paravalvular leak and lets many patients avoid another cardiac surgery.
Sandra Lesenfants, senior vice president of Abbott's structural heart business, said physicians treating PVL in the U.S. previously did not have an approved alternative to repeat open-heart surgery, and that the purpose-built device fills a critical unmet need. Outside the U.S., the device is known as the Amplatzer Valvular Plug III and has been approved to treat PVL in Europe since 2020.
Source: GSM · USA (original Chinese edition)
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