Autus Pulmonary Valve

U.S. Food and Drug Administration Approves Expandable Heart Valve for Children from Edwards

Edwards Lifesciences' Autus valve has received FDA approval, with the possibility of later expansion using a balloon catheter as the child grows, potentially reducing the need for repeated open-heart surgeries. The decision was based on a study involving 62 children, with follow-up planned for 10 years.