WASHINGTON — The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a new pulmonary heart valve designed for children with congenital pulmonary valve disease.

The device is the first FDA-approved heart valve that can be expanded after implantation as a child grows. Doctors can initially implant the valve at about 13 millimeters and later expand it with a balloon catheter, with the valve able to reach approximately 22 millimeters.

The technology could help some children avoid repeated open-heart surgeries as they grow. The valve also uses polymeric leaflets instead of animal-derived tissue, another first for an FDA-approved heart valve.

FDA approval was supported by a clinical study involving 62 pediatric patients at 12 U.S. sites. Early results showed acceptable valve performance, while longer-term follow-up is continuing to evaluate durability and the benefits of expanding the valve over time.

The approval marks a significant development in pediatric cardiac care, particularly for children who may otherwise require multiple valve replacement surgeries during childhood.