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FDA Approves Heart Valve That Grows With Children

The US Food and Drug Administration has approved a heart valve that grows with the patient. The Autus Size-Adjustable Valve got the green light on October 2, 2026. It is the first heart valve built to be expanded after it is implanted.

The valve is for children with congenital pulmonary valve disease. This condition affects the valve controlling blood flow from the heart to the lungs. Current replacement valves come in fixed sizes, so children can outgrow them and need repeat open-heart surgeries.

The Autus valve can be implanted at about 13 millimetres wide, small enough for a toddler. As the child grows, doctors can widen it up to 22 millimetres, close to adult size. A small balloon threaded through a blood vessel does the widening. Its leaflets use a synthetic material, a first for any FDA-approved valve.

Approval is based on a study of 62 children at 12 US 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. Longer-term studies are still underway.

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