FDA Approves Only Surgical Pulmonary Valve Fit for Growing Kids

FDA Approves Only Surgical Pulmonary Valve Fit for Growing Kids

(MedPage Today) -- The FDA approved the Autus Size-Adjustable Valve for surgical pulmonary valve replacement in children with congenital heart disease, the agency announced on Thursday. The Autus valve marks the first such valve dedicated to pediatric...

Edwards gains FDA approval of AUTUS pulmonary valve for pediatric patients

FDA approves Edwards Lifesciences’ AUTUS adjustable pulmonary valve for children with congenital heart disease—key study results, safety and outcomes.

Size adjustable pulmonary valve gains US FDA approval

Edwards Lifesciences has announced that the US Food and Drug Administration (FDA) has approved the Autus size-adjustable valve, a surgical pulmonary valve designed specifically for paediatric patients with congenital heart disease who require pulmonary valve replacement. The valve is designed for paediatric anatomy, with the ability to be expanded as a child grows. Valve expansion […]

Edwards Lifesciences wins FDA approval for AUTUS

Edwards' AUTUS valve wins FDA approval after a 62-child study, while longer follow-up will test durability and the value of expansion.

Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients