Edwards Lifesciences wins FDA approval for AUTUS pediatric pulmonary valve
EW•Edwards Lifesciences won FDA clearance for its size-adjustable AUTUS surgical pulmonary valve for pediatric congenital heart disease patients. A pivotal study showed 100% freedom from device-related complications at 30 days and no reinterventions through six months.
1. Device approval
The AUTUS valve can be expanded later through a transcatheter procedure, aiming to reduce repeat open-heart surgeries as children grow. FDA approval was supported by a pivotal study that showed 100% freedom from device-related complications at 30 days and no reinterventions through six months.
