Edwards Lifesciences Says FDA Approves AUTUS Size-Adjustable Valve, Surgical Pulmonary Valve Designed For Pediatric Patients With Congenital Heart Disease

Edwards Lifesciences (NYSE:EW) today announced that the U.S. Food and Drug Administration (FDA) has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed specifically for pediatric patients with congenital heart disease who require pulmonary valve replacement.

For many pediatric patients, pulmonary valve replacement is not a one-time event. The AUTUS valve is the first FDA-approved surgical pulmonary valve designed for pediatric anatomy, with the ability to be expanded as a child grows. Valve expansion is performed through a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries.