New FDA-Approved Pediatric Pulmonary Valve Can Expand as Children Grow

Congenital pulmonary valve disease affects the valve that directs blood from the heart to the lungs. Even after repair, some children develop valve leakage that can strain and enlarge the right side of the heart. Because replacement valves have fixed sizes, children may outgrow them and require another operation. A new device now offers a surgically implanted pediatric pulmonary valve that can be expanded as the child grows using a minimally invasive transcatheter procedure. 

Edwards Lifesciences has introduced the AUTUS Size-Adjustable Valve, a surgical pulmonary valve created for pediatric patients with congenital heart disease who require pulmonary valve replacement. The device is surgically implanted and engineered to accommodate growth by allowing later in situ expansion. Expansion is performed via a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries.

On October 1, 2026, the U.S. Food and Drug Administration (FDA) approved AUTUS for pediatric patients, making it the first FDA-approved surgical pulmonary valve designed for pediatric anatomy. The valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need. It is specifically designed for children with congenital heart disease who require pulmonary valve replacement. This approval expands Edwards’ congenital treatment options, which also include SAPIEN 3, the Alterra Adaptive Prestent and pediatric atrioseptostomy catheters. 

FDA approval was supported by the pivotal study, which met primary safety and effectiveness endpoints. In the study, 100% of patients were free from device-related complications through 30 days and showed favorable valve performance with no AUTUS reinterventions through six months. Among patients who completed one-year follow-up, 100% achieved a right ventricular outflow tract (RVOT) mean gradient of 40 mmHg or less, had less than moderate pulmonary regurgitation, and required no valve reinterventions. Participants will continue to be followed for 10 years.

“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time. The AUTUS valve gives congenital heart teams a new way to think about long-term care planning for pediatric patients who may otherwise face multiple surgeries,” said Dr. Emile Bacha, surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, who was an investigator in the trial.

Related Links
Columbia University Irving Medical Center
Edwards Lifesciences