A First for Children

The FDA approved the first U.S. heart valve designed to widen after implantation as a child grows.

Expansion Happens Later

The Autus valve can start at about 13 millimeters and later widen with a balloon catheter to up to 22 millimeters.

A Different Leaflet Material

Its leaflets use polymeric material, making it the first U.S.-approved heart valve with leaflets not made from animal-derived tissue.

Who the Approval Covers

Approval covers pediatric patients with congenital pulmonary valve disease who need pulmonary valve replacement; it does not cover every congenital heart defect.

What the Study Measured

FDA reviewed 62 pediatric patients at 12 U.S. sites; at six months, the first 60 had acceptable right-heart blood-flow performance.

Reported Study Events

No deaths, strokes, or clots needing treatment were reported; three frames fractured and two patients had reduced leaflet movement without symptoms.

Long-Term Questions Remain

Two valves were expanded without invasive surgery, but experience remains limited; longer-term studies are assessing risks and performance after expansion.