US FDA Approves First Heart Valve Designed to Grow with Children
United States, Oct. 5 -- The U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. This innovative device may reduce the need for repeat open-heart surgeries in children with heart defects, reflecting the Trump Administration's commitment to bringing breakthrough medical technologies to market as quickly and safely as possible.The Autus Size-Adjustable Valve is the first heart valve designed to be expanded after surgery to keep pace with a child's growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its inner flaps (called leaflets). Congenital heart de...
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