A Heart Valve That Grows Up With The Patient Wins FDA Approval

Children born with certain heart defects may face fewer open-heart surgeries, thanks to a new replacement valve that grows with them.

The U.S. Food and Drug Administration (FDA) on Thursday approved the Autus Size-Adjustable Valve, the first heart valve built to be expanded after it’s implanted. 

It’s for children with congenital pulmonary valve disease, which affects the valve that controls blood flow from the heart to the lungs.

Congenital heart defects are among the most common U.S. birth defects, affecting about 1 in 100 babies. Two pulmonary valve conditions, stenosis (a narrowed valve) and atresia (a valve that didn’t form properly), together occur in around 4,200 U.S. babies each year, according to the U.S. Centers for Disease Control and Prevention (CDC).

Repairs can improve blood flow, but some children still have a leaky valve. Over time, that leak can strain and enlarge the right side of the heart, and a replacement valve becomes necessary.

Current replacement valves come in fixed sizes, so children can outgrow them. Valves are also typically made from animal tissue, which can wear out. That often means another surgery.

“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,” Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in a news release.

The Autus valve can be implanted at about 13 millimeters wide, small enough for a toddler or preschooler. As the child grows, doctors can widen it up to 22 millimeters, close to adult size, using a small balloon threaded through a blood vessel.

The valve’s inner flaps, called leaflets, are made of a synthetic material rather than animal tissue. It’s the first FDA-approved valve of any kind to use this material.

The approval is based on a study of 62 children at 12 U.S. hospitals. All procedures succeeded, with no deaths, strokes or blood clots needing treatment. Two children who began outgrowing their valves had them widened without surgery. 

Experience with expansion is still limited, and longer-term studies are underway, the FDA noted.

“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 in New York City, who was an investigator in the trial.

The valve went through premarket approval, the FDA’s toughest review process, used for the highest-risk devices. 

It previously received Breakthrough Device designation, which speeds review of promising devices for serious conditions. 

More information

Visit the Boston Children’s Hospital website to learn more about how the new heart valve was developed.

SOURCES: U.S. Food and Drug Administration, Oct. 1, 2026; Edwards Lifesciences, news release, Oct. 1, 2026