FDA approves Edwards Lifesciences' pediatric AUTUS valve

Edwards Lifesciences announced on October 1, 2026, that the U.S. Food and Drug Administration approved its AUTUS Size-Adjustable Valve. The device is a surgical pulmonary valve designed specifically for pediatric patients with congenital heart disease who require pulmonary valve replacement.

The AUTUS valve is the first FDA-approved surgical pulmonary valve designed for pediatric anatomy that can expand as a child grows. The expansion is performed through a minimally invasive transcatheter procedure, which can reduce the need for repeat open-heart surgeries. The technology previously received the FDA Breakthrough Device designation.

The regulatory approval was supported by data from a pivotal trial. In the study, 100% of patients remained free from device-related complications through 30 days, and no patients required AUTUS valve reinterventions through six months. Among patients completing one year of follow-up, 100% maintained an RVOT mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation, and no valve reinterventions. Enrolled patients will be tracked for 10 years.

The product adds to Edwards Lifesciences' congenital treatment portfolio, which includes the SAPIEN 3, the Alterra Adaptive Prestent, and pediatric atrioseptostomy catheters. Bernard Zovighian, CEO of Edwards, noted that the device represents a meaningful treatment advancement for pediatric structural heart patients who previously faced limited alternatives.