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The US Food and Drug Administration (FDA) has approved a surgically implanted pulmonary heart valve designed to expand as a child grows, potentially reducing the need for repeat open-heart surgeries in paediatric patients with congenital heart defects.
Edwards Lifesciences received approval for the Autus Size-Adjustable Valve, developed by Autus Valve Technologies Inc. The device can be enlarged after implantation through a minimally invasive transcatheter procedure, allowing it to accommodate a growing child’s needs.
According to the FDA, the Autus valve is the first heart valve designed to be expanded after surgical implantation to keep pace with a child’s growth. It is also the first valve approved in the US to use polymeric material, rather than animal-derived tissue, for its leaflets — the flaps that open and close to regulate blood flow.
“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, J.D.
“Today’s landmark approval is a historic turning point and reflects the Trump Administration and the FDA’s commitment to help bring innovative, life-changing devices to the patients who need them most.”
Edwards Lifesciences CEO Bernard Zovighian said the AUTUS valve represents an advancement for children who have historically had limited treatment options.
“Our commitment extends beyond innovation to generating clinical evidence and collaborating with physicians, medical societies and patient groups to help address the evolving needs of patients with congenital heart disease,” he added.
Addressing the challenges of congenital heart defects
Congenital heart defects are among the most common birth defects, affecting approximately one in every 100 babies born in the US, according to the FDA. These conditions include pulmonary valve stenosis, in which the valve is narrowed, and pulmonary valve atresia, in which the valve does not form properly. Both can restrict blood flow from the heart to the lungs.
According to the US Centers for Disease Control and Prevention (CDC), pulmonary valve atresia and stenosis together affect approximately 4,200 babies in the country each year.
Although treatment can improve blood flow and help repair these abnormalities, some children develop pulmonary regurgitation, a condition in which blood leaks backwards through the pulmonary valve. Over time, this can weaken or enlarge the right ventricle, potentially making valve replacement necessary. For many paediatric patients, pulmonary valve replacement is not a one-time event
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said, “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.”
“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,” she added.
How the Autus Size-Adjustable Valve works
The Autus Size-Adjustable Valve can initially be implanted at a diameter of approximately 13 mm, making it suitable for a toddler or preschool-aged child. As the child grows, the valve can be widened using a balloon catheter, eventually increasing to as much as 22 mm, which is comparable to an adult-sized pulmonary valve.
Another distinguishing feature is its use of polymeric material for the valve leaflets. Conventional bioprosthetic valves often use animal-derived tissue, which tends to harden and break down faster in children, often requiring repeat surgery for replacement.
One-year follow-up data suggest the Autus valve’s synthetic leaflets hold up well over time.
Clinical study findings
The FDA’s approval was supported by data from a clinical study involving 62 paediatric patients across 12 sites in the US.
At the six-month follow-up, the first 60 patients demonstrated acceptable haemodynamic performance, indicating that blood flow through the right side of the heart remained within acceptable limits. Valve leakage was no greater than mild.
All patients in the study underwent successful procedures. No deaths, strokes, blood clots requiring additional treatment or other clot-related complications were reported.
However, three patients experienced fractures in the valve frame, while two had reduced movement of one of the valve leaflets. None of these events caused symptoms in the affected patients.
Valve performance also began to deteriorate in two patients as they outgrew their implanted valves. Both valves were successfully expanded without another invasive surgical procedure. However, the FDA noted that experience with valve expansion remains limited.
FDA added that further studies are underway to assess the device’s longer-term safety and performance and determine whether expansion can maintain valve function and reduce the need for additional surgeries.
Regulatory pathway
The Autus Size-Adjustable Valve is the first paediatric device to receive approval through the FDA’s Total Product Life Cycle Advisory Program (TAP), a voluntary initiative designed to support the development of high-quality, safe and effective medical devices.
The FDA had previously granted the Autus Size-Adjustable Valve Breakthrough Device designation, which is intended to expedite the development and review of devices that may offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.
The valve received approval through the FDA’s premarket approval pathway, the agency’s most stringent medical device marketing application process. The pathway applies to certain Class III devices, which generally pose the greatest risk and require scientific evidence demonstrating that their benefits outweigh their known risks.
