FDA Approves Autus Size-Adjustable Valve That Grows With Children

The FDA approved the Autus Size-Adjustable Valve on October 1, 2026. It is the first pulmonary heart valve cleared for children that can be widened after implantation to match a child’s growth. The device is a surgically implanted valve for pediatric patients with congenital pulmonary valve disease.

The approval rests on two firsts. The Autus Size-Adjustable Valve is the first heart valve designed to be expanded after surgery. It is also the first valve approved in the United States to use a polymeric material instead of animal-derived tissue for its leaflets.

What the Autus Size-Adjustable Valve does

Surgeons implant the valve at roughly 13 millimeters in diameter, a size suited to a toddler or preschool-aged child. As the child grows, a balloon catheter widens the valve in steps until it reaches up to 22 millimeters, which matches an adult-sized pulmonary valve. Each widening step avoids a return trip to the operating room for a larger device.

Why children with congenital pulmonary valve disease face repeat surgery

Congenital heart defects rank among the most common birth defects in the United States and affect about 1 in every 100 births. Pulmonary valve abnormalities form part of this group and include pulmonary valve stenosis, in which the valve is narrowed, and pulmonary valve atresia, in which the valve fails to form normally. Both conditions restrict blood flow from the heart to the lungs. The Centers for Disease Control and Prevention reports that pulmonary valve atresia and stenosis together affect around 4,200 babies in the United States each year.

Treatment can improve blood flow and repair the defect, yet some children develop significant pulmonary regurgitation, a leakage of blood back through the pulmonary valve. Over time this leakage can weaken or enlarge the right ventricle and create a need for pulmonary valve replacement. A fixed-size device then becomes the wrong size once the child grows.

Tissue leaflets versus polymeric leaflets

Traditional valves use animal tissue, which tends to harden and break down faster in children than in adults and often leads to earlier repeat surgery. The Autus valve uses polymer for its leaflets instead. One-year follow-up data suggest the synthetic leaflets hold up well over time. This approval marks the first time the FDA has cleared a valve that uses polymeric leaflet material for any indication.

Clinical evidence behind the approval

The agency based its decision on a clinical study that enrolled 62 pediatric patients across 12 U.S. sites. At the six-month follow-up, the first 60 patients showed acceptable hemodynamic performance, meaning blood flow through the right side of the heart stayed within acceptable limits and leakage back through the valve remained no more than mild. Every patient in the study had a successful procedure. There were no deaths, no blood clots that required additional treatment, and no strokes or other clot-related complications.

Three patients experienced a fracture in the valve frame and two patients had reduced movement of one of the leaflets. None of those events caused symptoms. Valve performance began to deteriorate in two patients who started to outgrow the device. Both valves were successfully expanded without open surgery, though the FDA notes the experience remains limited. Longer-term studies continue to track these risks and to collect data on whether expansion can maintain valve function and reduce the number of surgical procedures.

TAP, breakthrough designation and the PMA pathway

The Autus Size-Adjustable Valve is the first pediatric approval to emerge from the FDA’s Total Product Life Cycle Advisory Program (TAP), a voluntary program for device developers that aims to speed development of high-quality, safe, effective and innovative medical devices. The FDA had already granted the valve Breakthrough Device designation, which is meant to expedite development and review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

Approval came through the premarket approval pathway, the FDA’s most stringent type of device marketing application. The route applies to certain Class III devices, which generally pose the greatest risk. Before approving a device, the FDA reviews scientific evidence, including nonclinical and clinical data, to establish reasonable assurance that the device is safe and effective for its intended use and that its benefits outweigh known risks. Edwards Lifesciences received the approval. Autus Valve Technologies Inc. developed the device.

Source: FDA news release, “FDA Approves First Heart Valve Designed to Grow with Children” (October 1, 2026).