FDA approves a heart valve that can be widened

The Food and Drug Administration approved the Autus Size-Adjustable Valve on October 1, 2026, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The agency says the device may reduce the need for repeat open-heart surgeries in children with heart defects.

Congenital heart defects are among the most common birth defects in the United States, affecting about 1 in every 100 births, the FDA says. Citing the Centers for Disease Control and Prevention, the agency says pulmonary valve atresia and stenosis together affect around 4,200 babies in the country each year. Those conditions restrict blood flow from the heart to the lungs. Some children are left with pulmonary regurgitation, a leakage that can weaken or enlarge the right ventricle and lead to valve replacement as the child grows.

The FDA says the Autus valve is the first designed to be expanded after surgery to keep pace with that growth, and the first valve approved in the United States to use polymeric material rather than animal-derived tissue for its leaflets. It can be implanted at about 13 millimeters in diameter and later widened with a balloon catheter to as much as 22 millimeters. One-year follow-up data, the agency says, suggest the synthetic leaflets are holding up. This is the first approval of polymeric leaflet material for any indication.

The approval rests on a study of 62 pediatric patients at 12 U.S. sites. At six months, the first 60 patients had acceptable blood flow through the right side of the heart and no more than mild leakage. The FDA says every procedure in the study succeeded, with no deaths, no blood clots that needed more treatment, and no strokes or other clot-related complications. Three patients had a fracture in the valve frame, and two had reduced movement of one leaflet. The agency says none of those events caused symptoms.

In two patients who began to outgrow the implant, valve performance started to deteriorate. Both valves were expanded without open surgery. The FDA says that experience is limited. Longer-term studies are underway to understand those risks and to see whether expansion can keep a valve working and may lead to fewer operations.

This is the first pediatric approval from the FDA's Total Product Life Cycle Advisory Program. The valve had Breakthrough Device designation and was approved on the premarket pathway used for Class III devices. Acting FDA Commissioner Kyle Diamantas said children who need a pulmonary valve replacement have had limited surgical options that have historically meant more than one open-heart surgery as they grow. Michelle Tarver, director of the FDA Center for Devices and Radiological Health, said the valve gives doctors the option of fewer operations, which may mean a better quality of life for the children and their families.