FDA approves first heart valve designed to grow with children
The FDA approved Edwards Lifesciences' AUTUS Size-Adjustable Valve on October 1, 2026, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The valve can be implanted at about 13 mm, sized for a toddler, and later widened with a balloon catheter to about 22 mm as the child grows, and it is the first FDA-approved heart valve to use polymeric leaflets instead of animal-derived tissue. The company says its pivotal study met its primary safety and effectiveness endpoints, with 100% of patients free of device-related complications through 30 days and no valve reinterventions through six months.
Why it's notable: Children with congenital heart defects have typically needed repeated open-heart surgeries to replace fixed-size valves as they grow; a valve that expands in place without replacement could cut the number of operations these patients face over a lifetime.