The FDA approved a heart valve that can be widened as a child grows

The Food and Drug Administration said on October 1, 2026, that it approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease. Surgeons can implant it at about 13 millimeters, a size meant for a toddler or preschooler, and later widen it with a balloon catheter up to about 22 millimeters. It is also the first valve the agency has approved with inner flaps made of a polymer instead of animal tissue.

The decision uses a study of 62 children at 12 sites in the United States. At six months, the first 60 had blood flow the FDA called acceptable, with no more than mild leakage back through the valve. Every procedure succeeded. There were no deaths, no strokes, and no blood clots that needed more treatment. Three valve frames fractured and two flaps moved less than they should. None of those events caused symptoms. Two children began to outgrow the valve, and both had it expanded without another open-heart surgery. The FDA said that experience is limited and that longer studies are still going. The valve may mean fewer open-heart operations. The study has not shown that yet.