FDA Approves Edwards' Autus Valve, a Pediatric Pulmonary Valve That Can Be Expanded

The FDA has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for children that can be widened by balloon catheter as they grow, the agency announced on October 1. Edwards Lifesciences holds the approval for the device, which was developed by Autus Valve Technologies.

The FDA said the Autus valve is 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 US to use polymeric material rather than animal-derived tissue for its leaflets. "This is the first time the FDA has approved a valve that uses polymeric leaflet material for any indication," the agency said.

What was approved

The FDA's premarket approval database lists PMA P260007 for the Autus Size-Adjustable Valve from Edwards Lifesciences, received February 9, 2026, with a decision date of October 1, 2026. The generic name is "Heart-valve, polymeric," product code SJL. According to the approval order, the valve is indicated for pediatric patients weighing at least 10 kg who need surgical pulmonary valve replacement for a dysfunctional native or surgically repaired right ventricular outflow tract, with severe pulmonary stenosis, at least moderate pulmonary regurgitation, or a combination of moderate stenosis and moderate regurgitation as measured by echocardiography.

According to the FDA, the valve can be implanted as small as approximately 13 millimetres in diameter and later widened with a balloon catheter, eventually reaching up to 22 millimetres, comparable to an adult pulmonary valve. Traditional animal-tissue valves tend to harden and break down faster in children, the agency said.

"The Autus Size-Adjustable Valve gives doctors the option of far fewer trips to the operating room, which may result in better quality of life for these children and their families," said Michelle Tarver, director of the FDA's Center for Devices and Radiological Health.

The study and its limits

The approval is based on a study of 62 pediatric patients at 12 US sites, the FDA said. Healio reported that the patients were aged 18 months to 16 years and that the study was single-arm. The FDA record links the approval to trial NCT05006404.

At six months, the first 60 patients had acceptable hemodynamic performance and no more than mild leakage back through the valve, according to the FDA. All procedures were successful, with no deaths, strokes or clots requiring additional treatment. Three patients had a fracture in the valve frame and two had reduced movement of a leaflet, but none had symptoms, the agency said.

Valve performance began to deteriorate in two patients who started to outgrow the device; both had their valves expanded without surgery. "Both patients had their valves successfully expanded without an invasive surgical procedure, but the experience is limited," the FDA said, adding that longer-term studies are under way.

Howaida El-Said of Mary Bridge Children's Hospital, writing in a perspective for Healio, said the most important questions for a pediatric valve are long-term ones, including durability and "how the valve performs after serial expansion as children grow."

Regulatory path

The FDA had previously granted the valve breakthrough device designation, and said it is the first pediatric approval to come out of its Total Product Life Cycle Advisory Program, a voluntary program meant to speed development of new devices. The device was approved through premarket approval, which the agency described as its most stringent type of device marketing application.