FDA Approves Autus Size-Adjustable Valve, First Pulmonary Valve Designed to Expand With Pediatric Growth

The FDA has approved the Autus Size-Adjustable Valve (Edwards Lifesciences), a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. Edwards Lifesciences received the approval for the device, which was developed by Autus Valve Technologies Inc.

According to the FDA, the device is the first heart valve designed for expansion after surgery to accommodate a child's growth and the first valve approved in the US to use polymeric rather than animal-derived tissue for its leaflets. It can be implanted as small as approximately 13 mm in diameter and later widened with a balloon catheter to as much as 22 mm, a size the agency described as comparable to an adult pulmonary valve. The FDA said the device may reduce the need for repeat open-heart surgeries.

The approval was based on a clinical study that enrolled 62 pediatric patients at 12 US sites. At 6-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance with no more than mild regurgitation, the agency reported. All patients had a successful procedure, with no deaths, strokes, or blood clots requiring additional treatment.

Three patients had a valve frame fracture, and two had reduced movement of one leaflet; none of these events caused symptoms. Valve performance began to deteriorate in two patients who were starting to outgrow the device. Both underwent successful expansion without invasive surgery, although the FDA noted limited experience.

The valve was approved through the premarket approval pathway, used for certain Class III devices, and previously received Breakthrough Device designation. It is also the first pediatric approval from the FDA's Total Product Life Cycle Advisory Program. Longer-term studies are underway, according to the FDA, and Edwards said it will follow patients for 10 years.

Sources: US Food and Drug Administration. FDA approves first heart valve designed to grow with children. Press release. US Food and Drug Administration; October 1, 2026. Accessed October 2, 2026.

Edwards Lifesciences. Edwards Lifesciences receives FDA approval for AUTUS valve, the first surgical pulmonary valve for pediatric patients. Press release. Edwards Lifesciences; October 1, 2026. Accessed October 2, 2026.