New heart valve can grow with children, potentially reducing repeat surgeries

Clinical takeaway: For children with congenital pulmonary valve disease who require valve replacement, the newly approved AUTUS Size-Adjustable Valve can be expanded through a transcatheter procedure as the child grows, potentially reducing the need for repeat open-heart surgeries.

FDA has approved the AUTUS Size-Adjustable Valve, the first heart valve designed to be expanded after implantation to keep pace with a child’s growth. The surgically implanted pulmonary valve is intended for pediatric patients with congenital pulmonary valve disease.

The design could address a longstanding challenge in pediatric valve replacement: Children may outgrow a prosthetic valve and require additional surgery. AUTUS can be implanted at a diameter as small as approximately 13 mm and later expanded with a balloon catheter to as large as 22 mm, comparable to an adult-sized pulmonary valve.

The valve also represents another first. Its leaflets are made from polymer rather than animal-derived tissue, which FDA says tends to harden and break down faster in children.

Approval was based on a study of 62 pediatric patients at 12 US sites. Among the first 60 patients evaluated at 6 months, valve hemodynamics were acceptable and pulmonary regurgitation was no more than mild. All procedures were successful, with no deaths, strokes, blood clots requiring additional treatment, or other thromboembolic complications. Three patients had valve-frame fractures and 2 had reduced leaflet movement, none associated with symptoms.

Among patients completing 1-year follow-up, all had an RVOT mean gradient ≤40 mm Hg, less than moderate pulmonary regurgitation, and no valve reinterventions, according to Edwards Lifesciences. Patients will continue to be followed for 10 years. Two children whose valve performance began deteriorating as they outgrew their valves underwent successful expansion without invasive surgery, although the FDA emphasized that experience with expansion remains limited.

“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time,” said Emile Bacha, MD, surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving Medical Center and an investigator in the trial. “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.”

Sources: US Food and Drug Administration. (2026 Oct 1) FDA Approves First Heart Valve Designed to Grow with Children; Edwards Lifesciences. (2026 Oct 1) Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients