The FDA has approved the Autus Size-Adjustable Valve, the first heart valve designed to expand inside the body as a child grows — a landmark decision announced on October 1, 2026, that could spare children with congenital heart defects from repeated open-heart surgeries.
The Autus Size-Adjustable Valve: How It Works
Children born with congenital pulmonary valve disease often need a replacement valve early in life — but traditional replacement valves come in fixed sizes, so growing children can outgrow them, and their animal-tissue leaflets wear out faster in young patients. Until now, that usually meant two, three or more open-heart operations before adulthood.
The Autus valve, developed by Autus Valve Technologies and approved for Edwards Lifesciences, takes a different approach. Surgeons implant it surgically at about 13 millimeters wide — small enough for a toddler or preschooler. As the child grows, doctors can widen it through a minimally invasive balloon procedure threaded through a blood vessel, up to 22 millimeters, close to adult size — no new chest incision required.
The inner flaps (leaflets) are made from a synthetic polymer rather than cow or pig tissue — the first FDA-approved valve of any kind to use this material. Animal-derived valves tend to calcify and break down faster in children.
Trial Results and FDA Review
The approval is based on a pivotal study of 62 children at 12 U.S. hospitals. All procedures succeeded, with no deaths, strokes or blood clots requiring treatment. Two children who had begun outgrowing their valves had them widened without surgery, and among patients who completed one-year follow-up, outcomes remained consistent — an FDA report also noted no device-related complications through 30 days and no valve reinterventions through six months.
"For children born with congenital heart disease, valve replacement timing has always been a difficult decision — wait too long and you risk harm to the child, but intervene too early and they may need multiple open-heart surgeries as they grow," said Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health.
Acting FDA Commissioner Kyle Diamantas called the approval a "historic turning point." The work began roughly a decade ago in a Boston Children's Hospital lab and included testing in growing lambs. It is also the first pediatric approval to come through the FDA's Total Product Life Cycle Advisory Program (TAP), and the device went through premarket approval, the agency's toughest review process for high-risk devices. Patients will be followed for 10 years.
Why This Matters
Congenital heart defects are among the most common U.S. birth defects, affecting about one in 100 babies. Two pulmonary valve conditions — stenosis (a narrowed valve) and atresia (a valve that did not form properly) — together occur in around 4,200 U.S. babies each year, according to the CDC.
"Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time," said Dr. Emile Bacha, 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."
Watch: US Health News Watch — Autus Heart Valve FDA 2026, a short video report on the FDA's October 1, 2026 approval of the Autus Size-Adjustable Valve, covering how the valve expands as children grow and the results of the 62-patient pivotal study.