SILVER SPRING, Md., Oct. 1 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:
The U.S. Food and Drug Administration today 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 th...