For many parents, a child's steady growth is pure good news. For families whose child was born with a heart defect, each new inch has also meant watching the clock on the next operation.
On October 1, 2026, the FDA approved the Autus Size-Adjustable Valve, the first pulmonary heart valve that can be widened after it is implanted.
It starts around 13 millimeters wide and can be expanded to about 22 millimeters, close to an adult size, as the child grows.
The expansion happens without opening the chest again. A doctor threads a thin tube with a small inflatable balloon through a blood vessel and stretches the valve to a bigger size.
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The device is made by Edwards Lifesciences and was developed with Autus Valve Technologies.
What the trial in 62 children showed
The approval rests on a study at 12 US hospitals. All 62 young patients were implanted successfully, and six-month results on 60 of them showed acceptable blood flow with no more than mild leakage.
No child died, had a stroke or developed a blood clot that needed treatment during follow-up.
Three had valve frame fractures and two had reduced leaflet movement, but none of these caused symptoms.
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In two cases, the valve was widened again without further surgery.
Why it matters for children with congenital heart defects
Congenital heart defects affect about 1 in every 100 babies born in the United States.
Pulmonary valve atresia and stenosis, the two conditions this device is designed to treat, together affect roughly 4,200 US babies each year.
Until now, replacement valves could not grow with the child. As the heart grew, the valve stayed the same size, which often forced families through several open-heart operations during childhood.
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The FDA announcement quoted Michelle Tarver, director of the agency's Center for Devices and Radiological Health.
The device could mean "far fewer trips to the operating room" and better quality of life for these children and their families, she said.
The valve is also the first approved in the United States to use a synthetic polymeric material, rather than animal-derived tissue, for the inner flaps that open and close with each heartbeat.
Families whose child has congenital pulmonary valve disease can ask their pediatric cardiologist whether the Autus valve is a fit for their child's case.
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This article is made and published by Mie Hermansen, who may have used AI in the preparation.