FDA approves Edwards Autus size-adjustable pediatric pulmonary heart valve

On 1 October 2026, the U.S. Food and Drug Administration (FDA) approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease, as announced by the agency and by Edwards Lifesciences.

What is new

According to the FDA and company coverage, Autus is designed to be expanded after surgery via a minimally invasive balloon-catheter procedure so the valve can keep pace with a child’s growth — potentially reducing repeat open-heart operations. It can be implanted as small as about 13 mm and expanded up to about 22 mm. The FDA also described it as the first U.S.-approved valve using polymeric leaflets rather than animal-derived tissue. The device previously received Breakthrough Device designation and was the first pediatric approval under FDA’s Total Product Life Cycle Advisory Program (TAP), MassDevice reported.

Evidence base — study type and limits

Approval drew on a clinical study of 62 pediatric patients at 12 U.S. sites. At six-month follow-up, the first 60 patients showed acceptable hemodynamic performance and no more than mild regurgitation, the FDA said; Edwards reported 100% free from device-related complications through 30 days and no Autus reintervention through six months among those completing early follow-up. The FDA noted frame fractures in three patients and reduced leaflet motion in two, without symptoms in those cases, and that longer-term studies (including up to 10 years of follow-up cited by Edwards/MassDevice) continue. This is a device approval based on a clinical study, not advice for any individual patient — families should discuss options with a congenital-heart specialist.