New Valve May Mean Fewer Repeat Heart Operations for Children, FDA Says

The US Food and Drug Administration (FDA), the American agency that approves medicines and medical devices, has approved the first heart valve designed to grow with a child.

The Autus Size-Adjustable Valve is meant for children born with pulmonary valve disease, and the agency said it may reduce the number of repeat open heart operations these children face.

The FDA announced the approval in a news release on 1 October 2026.

Edwards Lifesciences received the approval for the valve, which was developed by Autus Valve Technologies.

Outgrowing a heart repair

The pulmonary valve is a small set of flaps that opens to let blood flow from the heart to the lungs.

In some babies it is too narrow, or it never forms properly, so blood struggles to reach the lungs.

The FDA, citing figures from the US Centers for Disease Control and Prevention, said these two problems together affect around 4,200 babies in the United States each year.

Treatment can improve blood flow, but some children are left with a valve that leaks blood backwards.

Over time this can weaken or enlarge the right ventricle, the lower right chamber of the heart that pumps blood to the lungs, and the child may then need a replacement valve.

That is where growth becomes a problem.

A replacement valve of fixed size can be outgrown, and the FDA said these children have historically needed multiple open heart surgeries as they grow.

A valve that widens

The new valve can be implanted as small as about 13 millimetres across, which the FDA described as the right size for a toddler or preschool aged child.

As the child grows, doctors can widen it using a small balloon on a thin tube, up to 22 millimetres, which is comparable to an adult pulmonary valve.

The first placement is still done by surgery, but the later widening does not need an invasive operation.

Dr Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, said the valve gives doctors the option of "far fewer trips to the operating room," which may improve quality of life for children and their families.

The valve is also the first approved in the United States to use a synthetic material for its leaflets, the inner flaps that open and close.

Traditional valves use animal tissue, which the FDA said tends to harden and break down faster in children, often forcing earlier repeat surgery.

What the study showed

The approval rests on a clinical study of 62 children at 12 sites across the United States.

At six months, the first 60 children had acceptable blood flow through the right side of the heart, with no more than mild leakage back through the valve.

All 62 procedures were successful, and the FDA said there were no deaths, no blood clots needing extra treatment and no strokes.

Some problems did appear.

Three children had a fracture in the valve frame and two had a leaflet that moved less than it should, but the FDA said none of these caused symptoms.

Edwards Lifesciences said the study met its main safety and effectiveness goals, and that no child needed another procedure on the valve through six months.

The part still unproven

The promise of fewer operations depends on the widening working over many years, and that evidence is thin so far.

Two children began to outgrow their valves, and both had them widened without invasive surgery.

Two children out of 62 is a small base for a benefit meant to last through childhood, and the FDA itself said the experience is limited.

Follow up is short for now.

The FDA said one year data suggest the synthetic leaflets hold up well, and longer studies are underway.

Edwards Lifesciences said the children in the study will continue to be followed for 10 years.

The FDA announcement covers the United States, and the sources reviewed did not say when the valve will be available elsewhere or what it will cost.

For now, the approval gives surgeons a new option for growing children, while the question of whether it truly reduces operations across a whole childhood waits on longer follow up.

Source:FDA, News Release, 1 October 2026; Edwards Lifesciences, press release, 1 October 2026