FDA Approves First Heart Valve to Keep Pace With Children's Growth

The FDA approved the Autus Size-Adjustable Valve (Edwards Lifesciences), the first heart valve designed to be expanded after implantation to keep pace with a child’s growth, for pediatric patients with congenital pulmonary valve disease on October 1.¹ The approval could reduce the need for repeat open-heart surgeries in children with heart defects.

The valve can be implanted at a diameter as small as approximately 13 mm, an appropriate size for a toddler or preschool-aged child. As the child grows, it can be widened with a balloon catheter, eventually reaching up to 22 mm, which is comparable to an adult-sized pulmonary valve.

The FDA previously granted the Autus Size-Adjustable Valve Breakthrough Device designation. It is also the first pediatric approval from the FDA’s Total Product Life Cycle Advisory Program, a voluntary program intended to spur more rapid development of high-quality, safe, effective, and innovative medical devices for patients.

In addition, the decision marks the first time the FDA approved a valve that uses polymeric leaflet material for any indication. Traditional valves use animal tissue for their leaflets, which tends to harden and break down faster in children, requiring earlier repeat surgery. By contrast, the Autus valve’s synthetic leaflets have held up well over time, according to 1-year follow-up data cited by the FDA.

Pulmonary Valve Defects and the Need for Replacement

Congenital heart defects affect about 1 in every 100 births, making them among the most common types of birth defects in the US. Among these conditions are pulmonary valve abnormalities. These include pulmonary valve stenosis, in which the valve is narrowed, and pulmonary valve atresia, in which the valve fails to form normally. Both defects restrict blood flow from the heart to the lungs, and they affect around 4200 babies in the US annually, according to the CDC.²

Although treatment can help repair these congenital defects and improve blood flow, some children may have significant pulmonary regurgitation, or leakage of blood back through the pulmonary valve.¹ Over time, this can weaken or enlarge the right ventricle, creating a need for pulmonary valve replacement as the child grows.

Kyle Diamantas, JD, acting FDA commissioner, called the approval a “historic turning point” that reflects both the FDA’s and the Trump Administration’s commitment “to help bring innovative, life-changing devices to the patients who need them most.”

“For far too long, children with congenital heart defects who need pulmonary valve replacement have had very limited surgical options, and those options have historically required multiple open-heart surgeries as children grow,” he said in a news release.

Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, added that the Autus Size-Adjustable Valve “gives doctors the option of far fewer trips to the operating room, which may result in better quality of life for these children and their families.”

Pivotal Trial Supports FDA Approval

The FDA’s decision was based on data from the Autus Valve Pivotal Trial (NCT05006404), which enrolled 62 pediatric patients across 12 US sites.³ All patients had a successful procedure, with no deaths, strokes, blood clots requiring additional treatment, or other clot-related complications.¹ At 6 months of follow-up, the first 60 patients demonstrated acceptable hemodynamic performance, meaning blood flow through the right side of the heart was within acceptable limits, with no more than mild leakage back through the valve.

However, 3 patients experienced a fracture in the valve frame, and 2 patients had reduced movement of a valve leaflet. None of these events resulted in symptoms. In addition, valve performance began to decline in 2 patients who were starting to outgrow the device; both had their valves successfully expanded without surgery.

Because long-term experience is limited, further studies are underway to better understand the risks associated with the Autus Size-Adjustable Valve. These studies also aim to show that expansion can maintain a functional valve over time, potentially reducing the number of surgical procedures patients need.

References

1. FDA approves first heart valve designed to grow with children. News release. FDA. October 1, 2026. Accessed October 5, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children
2. Prevalence of selected birth defects from population-based birth defects surveillance programs in the United States, 2018-2022. CDC. April 2026. Accessed October 5, 2026. https://www.cdc.gov/birth-defects/media/pdfs/2026/04/Data-Brief-Birth-Defects-National-Estimates-2018-2022.pdf
3. Autus Valve pivotal study. ClinicalTrials.gov. Updated September 28, 2026. Accessed October 5, 2026. https://clinicaltrials.gov/study/NCT05006404