FDA approves size-adjustable pulmonary heart valve for pediatric patients

Revision 1 · Health · United States · Record prepared

Prepared through Iliyn’s AI-assisted editorial workflow. Source statements are not independent audits of underlying events.

FDA announced approval of the Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for pediatric patients with congenital pulmonary valve disease.

What the record says

FDA says the valve can later be expanded using a balloon catheter as a child grows; the agency also says experience with expansion is limited and longer-term studies are underway.

Attribution: Food and Drug Administration. Supporting location: Approval opening; expansion description; longer-term study limitation. Source details.

Practical next step

Discuss treatment options and the device’s intended use, risks and availability with the child’s specialist.

Limits and what is not established

Approval is not a guarantee that further surgery will be avoided or that the device is suitable for every child or every valve condition. This is not personal medical advice.

Sources checked October 7, 2026. This record reflects the information reviewed then; later notices may change instructions or arrangements.

Original sources

Food and Drug Administration: original information

Corrections and history

Read correction history

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