2 OCT 2026 — The US Food and Drug Administration on 1 October approved a heart valve for children that doctors can widen as the child grows, without opening the chest again. The Autus Size-Adjustable Valve replaces the pulmonary valve, which controls blood flow from the heart to the lungs, in children born with defects of that valve.
No heart valve before it was designed to be expanded after surgery, according to the FDA's announcement. Its leaflets, the flaps that open and close, are made of a polymer instead of animal tissue. The agency had never approved a polymer for valve leaflets of any kind.
The problem with valves children outgrow
Congenital heart defects affect about 1 in every 100 births in the US, the FDA says. Two of them, pulmonary valve stenosis, in which the valve is narrowed, and pulmonary atresia, in which it fails to form normally, together affect around 4,200 babies a year, according to US birth defect estimates cited by the agency.
Repairs can leave the valve leaking blood backwards, which over time can weaken or enlarge the heart's right ventricle. A replacement valve does not grow, so children have needed further open-heart operations to fit larger ones. Animal-tissue leaflets also tend to harden and wear out faster in children.
"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 Michelle Tarver, director of the FDA's Center for Devices and Radiological Health.
How the valve grows
Surgeons implant the valve at sizes as small as about 13 millimetres across, which fits a toddler or preschool child. As the child grows, doctors widen it with a balloon catheter, a thin tube with an inflatable tip passed through a blood vessel, up to 22 millimetres, comparable to an adult pulmonary valve.
Edwards Lifesciences received the approval for the valve, which was developed by Autus Valve Technologies. It went through premarket approval, the FDA's strictest route for high-risk devices, after earlier Breakthrough Device designation.
What the study showed
The approval rests on a study of 62 children at 12 US hospitals. At six months, the first 60 had acceptable blood flow through the right side of the heart and no more than mild leakage back through the valve. Every implant succeeded, with no deaths, strokes or blood clots needing extra treatment.
According to MassDevice, Edwards said all patients were free of device-related complications for the first 30 days, and none needed a repeat procedure on the valve through six months. One-year data suggest the synthetic leaflets hold up well, according to the FDA.
The problems the FDA listed
The agency also reported problems, none of which caused symptoms. The valve's frame fractured in three children, and in two, one leaflet did not move as freely as it should.
In two children the valve began to work less well as they started to outgrow it. Both had it widened without surgery, the FDA says, "but the experience is limited."
What is still unknown
That is the key uncertainty. The point of the valve is fewer operations over a childhood, yet the FDA describes expansions in only two children so far. Longer-term studies are under way to show that expansion keeps the valve working, and Edwards says patients will be followed for 10 years.
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