FDA Approves First Heart Valve Designed to Grow with Children

The U.S. Food and Drug Administration (FDA) has approved the Autus Size-Adjustable Valve from Edwards Lifesciences, marking the first heart valve designed to expand after implantation to accommodate a child's growth. This innovative device is approved for pediatric patients with congenital pulmonary valve disease and has the potential to reduce the need for multiple open-heart surgeries as children age. The valve can be implanted at a small diameter and then widened with a balloon catheter to reach an adult-sized pulmonary valve.