WASHINGTON, D.C. — The U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease, creating the first U.S. heart valve designed to expand after implantation as a child grows and potentially reduce the need for repeat open-heart surgery.
Edwards Lifesciences received approval for the device, which was developed by Autus Valve Technologies Inc.
The surgically implanted pulmonary valve can initially be placed at about 13 millimeters in diameter and later expanded with a balloon catheter to as much as 22 millimeters, allowing physicians to adjust the device as a pediatric patient grows.
That approach is intended to address a longstanding limitation of pediatric valve replacement: fixed-size valves can become too small as children grow, creating the need for additional procedures.
“The Autus Size-Adjustable Valve gives doctors the option of far fewer trips to the operating room,” Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said.
The device is also the first heart valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its leaflets, the flaps that regulate blood flow.
Traditional tissue valves can harden and deteriorate more quickly in children. One-year follow-up data cited by the FDA indicated the synthetic leaflets continued to function, though longer-term studies are underway.
The approval was based on a clinical study involving 62 pediatric patients at 12 U.S. sites.
At six months, the first 60 patients had blood-flow performance within acceptable limits and no more than mild pulmonary regurgitation, according to the FDA. All patients underwent successful procedures, with no deaths, strokes or blood clots requiring additional treatment.
Three patients experienced fractures in the valve frame and two had reduced movement of one valve leaflet, though the agency reported that none of those events caused symptoms.
Two patients began to outgrow their valves as performance deteriorated. Both devices were subsequently expanded without another invasive surgical procedure, although the FDA characterized experience with expansion as limited.
Longer-term studies are continuing to evaluate durability, the risks associated with the device and whether repeated expansion can maintain valve function while reducing additional surgeries.
Congenital heart defects affect about one in every 100 U.S. births. Pulmonary valve atresia and stenosis together affect about 4,200 babies annually, according to the Centers for Disease Control and Prevention.
The Autus valve became the first pediatric device approval to emerge from the FDA’s Total Product Life Cycle Advisory Program, a voluntary initiative intended to accelerate medical-device development and regulatory review.
The FDA had previously granted the device Breakthrough Device designation. It was approved through the premarket approval pathway, the agency’s most stringent review process for medical devices.
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