Edwards Lifesciences' AUTUS Valve Gets FDA Approval for Pediatric Heart Patients
Edwards Lifesciences announced its AUTUS Size-Adjustable Valve has received U.S. FDA approval. The valve is the first surgical pulmonary valve designed specifically for pediatric patients with congenital heart disease requiring pulmonary valve replacement.
S. Food and Drug Administration (FDA) has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for pediatric patients with congenital heart disease who need pulmonary valve replacement. The company said the valve is intended specifically for pediatric patients.