FDA Approves Edwards Lifesciences' Autus, the First Heart Valve Designed to Grow With Children

A First-of-Its-Kind Approval

On October 1, 2026, the U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve. It is a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.

Autus is the first heart valve designed to be expanded after surgery so it can keep pace with a child's growth. Until now, a valve implanted in a growing child could not get bigger as the child did.

The Problem It Addresses

Congenital heart defects affect about 1 in every 100 births in the United States. Pulmonary valve conditions make up a significant share of them. According to the Centers for Disease Control and Prevention, pulmonary valve atresia and stenosis together affect around 4,200 babies in the U.S. each year.

For these children, a fixed-size valve can become a lasting problem. A valve implanted in infancy or early childhood can eventually be outgrown. The Autus valve is meant to change that. According to the FDA, the device may reduce the need for repeat open-heart surgeries in children with congenital heart defects.

How the Autus Valve Works

The idea behind Autus is simple: the valve grows with the patient.

• The valve is first implanted surgically, like a conventional pulmonary valve.
• As the child grows, physicians can expand it using a minimally invasive transcatheter procedure. A balloon catheter is threaded to the valve to widen it.
• This adjustment lets the valve keep pace with the child's growth, so it does not need to be replaced through another open-heart operation.

Swapping a full open-heart surgery for a catheter-based procedure could be a meaningful change for young patients and their families.

A Material Milestone: Polymeric Leaflets

Autus also breaks new ground in what it is made of. It is the first valve approved in the U.S. to use polymeric material for its leaflets. Leaflets are the flaps that open and close to control blood flow.

Many replacement valves use animal-derived tissue for their leaflets. Autus uses polymer instead, which makes the approval notable for valve design in general, beyond its benefits for pediatric patients.

Regulatory Path and Clinical Results

The valve had previously received the FDA's Breakthrough Device designation, according to Cardiovascular Business.

The same outlet reported these results from the valve's pivotal study:

• The valve met its primary safety and efficacy endpoints.
• 100% of patients were free from device-related complications through 30 days.
• There were no valve reinterventions through six months.

These results supported approval of a device that could change how surgeons and cardiologists manage pulmonary valve disease in growing children.