The Priority Review

Approvals

FDA approves first pediatric heart valve built to be expanded as a child grows

Edwards Lifesciences' Autus Size-Adjustable Valve is also the first valve approved in the U.S. with polymeric leaflets instead of animal tissue.

By The Priority Review desk

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The U.S. Food and Drug Administration on October 1 approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The approval went to Edwards Lifesciences; the FDA says the valve was developed by Autus Valve Technologies Inc.

The FDA calls it the first heart valve designed to be expanded after surgery to keep pace with a child's growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its leaflets. The agency says it has not approved polymeric leaflets for any indication before.

How the valve works

Surgeons can implant the valve as small as about 13 millimeters in diameter. As the child grows, a balloon catheter widens it, up to 22 millimeters, which the FDA describes as comparable to an adult pulmonary valve. Edwards says the expansion is a minimally invasive transcatheter procedure, which could reduce the number of repeat open-heart surgeries.

The evidence

The FDA says the approval rests on a study of 62 pediatric patients at 12 U.S. sites. The Autus Valve Pivotal Study on ClinicalTrials.gov (NCT05006404) lists 62 enrolled participants aged 18 months to 16 years, with follow-up planned to February 2036.

  • At six months, the first 60 patients showed acceptable blood flow through the right side of the heart, with no more than mild leakage back through the valve.
  • The FDA reports no deaths, strokes or blood clots that needed more treatment.
  • Three patients had a fracture in the valve frame and two had reduced movement of one leaflet. The FDA says none of these events caused symptoms.
  • Two patients began to outgrow the valve, and both had it expanded without surgery. The FDA says that experience is limited.

Edwards says 100% of patients were free from device-related complications through 30 days, with no valve reinterventions through six months, and that patients will be followed for 10 years.

Pathway

The valve was approved through premarket approval, the FDA's most stringent device pathway. It previously received Breakthrough Device designation, and the FDA says it is the first pediatric approval from its Total Product Life Cycle Advisory Program (TAP).

What to watch

A continued access study (NCT07466745) started on July 27, 2026, and is recruiting an estimated 36 children, with primary completion estimated for October 2027. The FDA says longer-term studies will test whether expansion keeps the valve working and reduces surgeries.

Sources