A First for Growing Children

The FDA approved the first heart valve designed to expand after surgery as a child grows.

Who the Approval Covers

The Autus valve is approved for pediatric patients with congenital pulmonary valve disease needing pulmonary valve replacement, not every childhood heart defect.

Why Replacement May Be Needed

Some children develop substantial backward leakage through the pulmonary valve, which can weaken or enlarge the right ventricle over time.

Expansion Uses a Balloon Catheter

A balloon catheter can widen the valve from about 13 millimeters to as much as 22 millimeters, potentially reducing repeat open-heart surgeries.

Polymeric Leaflets Mark Another First

The valve’s polymeric leaflets control blood flow; the FDA called it the first U.S.-approved heart valve using polymer instead of animal-derived tissue.

Six-Month Study Findings

In the first 60 patients, six-month results showed acceptable right-sided blood flow and no more than mild backward leakage through the valve.

Some Questions Remain

Three patients had valve-frame fractures and two had reduced leaflet movement; none caused symptoms. Longer-term evaluation is continuing.