FDA Approves Adjustable Heart Valve Designed to Grow with Children

The U.S. Food and Drug Administration (FDA) has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve developed for children with congenital pulmonary valve disease. The device has been designed to address a long-standing challenge in paediatric heart care: children can outgrow implanted valves and may subsequently require additional open-heart surgeries.

Unlike conventional replacement valves, the Autus valve can be enlarged after implantation as the child grows. It can initially be implanted at a diameter of approximately 13 millimetres, making it suitable for younger children. When required, doctors can expand the valve using a balloon catheter, allowing it to reach a diameter of up to about 22 millimetres.

The FDA said the device is also the first heart valve approved in the United States to use polymeric material for its leaflets rather than tissue derived from animals. These leaflets open and close to regulate blood flow through the valve.

The approval was supported by a clinical study involving 62 paediatric patients at 12 sites across the United States. At the six-month follow-up, the first 60 patients showed acceptable blood-flow performance and no more than mild pulmonary leakage. The FDA also reported that some device-related events occurred, including valve-frame fractures in three patients and reduced leaflet movement in two. None of these events produced symptoms.

The Autus valve was approved through the FDA’s Premarket Approval pathway, which applies to certain higher-risk Class III medical devices. It is also the first paediatric device approved through the FDA’s Total Product Life Cycle Advisory Program. Longer-term follow-up is underway to assess the device’s durability and performance as children grow.

01-10-2026