The FDA approved the Autus Size-Adjustable Valve, the first implantable pulmonary heart valve designed for pediatric patients with congenital heart disease. This innovative valve expands as children grow from toddler to adult size, significantly reducing the need for multiple open-heart surgeries throughout childhood.
- About 1 in 100 babies born in the U.S. has a congenital heart defect, with approximately 4,200 annually born with pulmonary valve problems.
- The Autus Size-Adjustable Valve expands from 13mm (toddler size) to 22mm (adult size) as children grow.
- The valve uses synthetic leaflets instead of animal tissue, reducing the hardening and breakdown that traditionally required repeat surgeries in pediatric patients.
On Oct. 1, 2026, the U.S. Food and Drug Administration (FDA) approved the Autus Size-Adjustable Valve, the first implantable pulmonary heart valve for pediatric patients who have congenital pulmonary valve disease. The innovative device is designed to expand as children grow, thereby reducing the need for repeat surgeries.
“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,” said Acting FDA Commissioner Kyle Diamantas, JD, in an FDA press release.
According to the Centers for Disease Control and Prevention (CDC), about one in every 100 babies born in the United States has a congenital heart defect. This includes pulmonary valve atresia, which occurs when the valve is narrowed, and pulmonary valve atresia, which occurs when the valve develops abnormally. Around 4,200 American babies each year are born with both pulmonary valve atresia and stenosis, per the CDC.
“For children born with congenital heart disease, valve replacement timing has always been a difficult decision — wait too long and you risk harm to the child, but intervene too early and they may need multiple open-heart surgeries as they grow,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health. “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.”
The valve adjusts from approximately 13 millimeters in diameter — the appropriate size for a toddler or preschool-aged child — up to 22 millimeters, which is equivalent to an adult-sized pulmonary valve. Clinicians use a small ballon catheter to noninvasively widen the valve in accordance with the child’s physical development.
The Autus Size-Adjustable Valve is also the first FDA-approved valve of any kind to be made from polymeric material rather than animal-derived tissue for its inner flaps, or leaflets, that open and close to control blood flow. Traditional valves that use animal tissue are known to harden and break down quicker in pediatric patients, often requiring repeat surgeries. Clinical data showed the Autus valve’s synthetic leaflets held up well at the one-year follow-up.
The clinical study included 62 pediatric patients across 12 U.S. sites. All patients underwent a successful procedure for implantation, with no deaths or severe adverse events. At the six-month follow-up, 60 patients demonstrated hemodynamic performance, which was defined as acceptable limits of blood flow through the right side of the heart and mild or no leakage back through the valve. Two patients experienced valve deterioration due to growth. Both patients’ valves were successfully expanded but have limited experience.
Of the first 60 patients, three patients later experienced a fracture in the valve frame, and two patients had reduced movement in one of the valve leaflets. These events did not result in symptoms for the children. Additional long-term studies are underway to better understand these risks and to collect more data that demonstrate the valve can maintain functionality as it expands, thereby reducing the need for numerous invasive procedures.
Edwards Lifesciences received the FDA approval for the Autus Size-Adjustable Valve, which was developed by Autus Valve Technologies Inc.
