FDA Approves First Heart Valve Designed to Grow With Children
The Autus Size-Adjustable Valve can be widened after surgery with a balloon catheter, which may spare young patients repeat open-heart operations.
The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a replacement pulmonary heart valve for children that can be enlarged as they grow. The agency announced the approval on October 1, 2026. It says this is the first U.S.-approved valve with synthetic polymer leaflets, rather than animal tissue, for any use.
"Today's landmark approval is a historic turning point." — Kyle Diamantas, Acting FDA Commissioner
Why a growing valve matters
Children with certain congenital heart defects need a new pulmonary valve, but a fixed-size valve is eventually outgrown, which has often meant repeated operations. This valve is implanted at roughly 13 millimeters, suited to a toddler or preschooler. Later, doctors can widen it with a small inflatable balloon on a catheter, up to about 22 millimeters, comparable to an adult pulmonary valve.
The FDA says the defects behind this need affect about 1 in 100 births, and pulmonary valve atresia and stenosis together affect around 4,200 U.S. babies a year.
"The Autus Size-Adjustable Valve gives doctors the option of far fewer trips to the operating room." — Michelle Tarver, M.D., Ph.D., Director, FDA Center for Devices and Radiological Health
What the study found
The approval followed a study of 62 children at 12 U.S. sites. According to the FDA:
- Among the first 60 patients, valve performance was acceptable at six months, with no more than mild leakage.
- All procedures were successful, with no deaths, strokes or clot-related complications needing treatment.
- Two children who began to outgrow their valves had them expanded without invasive surgery.
Honest context
Experience with expanding the valve is still limited to those two patients. Three patients had a fractured valve frame and two had reduced leaflet movement, though none had symptoms. Longer-term studies are continuing to confirm that expansion keeps the valve working and reduces the number of surgeries over time.
The device was developed by Autus Valve Technologies, and the approval went to Edwards Lifesciences. It was also the first pediatric approval through the FDA's Total Product Life Cycle Advisory Program, an effort to speed promising devices to patients.
