FDA approves a heart valve that is expanded as a child grows

The US Food and Drug Administration approved the Autus Size-Adjustable Valve on 1 October 2026, calling it the first heart valve designed to grow with children. Edwards Lifesciences received the premarket approval for the device, which was developed by Autus Valve Technologies.

The valve replaces the pulmonary valve in young children with congenital pulmonary valve disease. It is implanted surgically at about 13 millimetres. As the child grows, doctors widen it from inside the body with a balloon catheter, up to 22 millimetres, close to adult size. Children with conventional replacement valves outgrow them and face repeated open-heart operations to fit larger ones. It is also the first FDA-approved valve with leaflets made of a synthetic polymer rather than animal tissue.

The approval rests on a study of 62 children, from toddlers to preschool age, at 12 US sites. All procedures succeeded, with no deaths, blood clots or strokes. Of the first 60 patients assessed at six months, all showed acceptable blood flow with no more than mild leakage. Three patients had fractures of the valve frame, and two had reduced leaflet movement without symptoms. Two showed early valve deterioration and were treated by expanding the valve, without surgery.