Edwards Lifesciences Says US FDA Approves AUTUS Pediatric Pulmonary Valve

05:00 PM EDT, 10/01/2026 (MT Newswires) -- Edwards Lifesciences (EW) said late Thursday the US Food and Drug Administration approved its AUTUS Size-Adjustable Valve, a surgical pulmonary valve for children with congenital heart disease who need pulmonary valve replacement. The approval was based on a pivotal study that met its primary safety and effectiveness endpoints, with all patients free from device-related complications through 30 days and no valve reinterventions reported through six months, the company said. Among patients who completed one-year follow-up, all met the study's valve-performance criteria and had no valve reinterventions, Edwards Lifesciences said, adding that patients will continue to be followed for 10 years. The AUTUS valve previously received FDA Breakthrough Device designation, the company said.