Summary
The FDA approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease. It can be widened after implantation as a child grows, though longer-term studies are still underway.
The U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve on October 1, 2026, for pediatric patients with congenital pulmonary valve disease. The surgically implanted valve can be widened after implantation with a balloon catheter, allowing it to accommodate growth. The FDA says it is the first heart valve designed to be expanded after surgery as a child grows, and the first U.S.-approved valve to use polymeric material for its leaflets.
The approval is based on a clinical study that enrolled 62 children at 12 U.S. sites. At six months, the first 60 patients had blood flow through the right side of the heart within acceptable limits, with no more than mild leakage through the valve. Longer-term studies are underway.
How the valve is adjusted
The pulmonary valve controls blood flow from the heart to the lungs. Some children with congenital conditions such as pulmonary valve stenosis or atresia can develop significant pulmonary regurgitation—a backward leak through the valve—which may eventually lead to valve replacement.
A replacement valve that is too small for a growing child may need to be addressed again. The Autus valve can initially be implanted at approximately 13 millimeters in diameter, a size the FDA describes as suitable for a toddler or preschool-aged child. A clinician can later widen it using a balloon catheter, up to 22 millimeters, comparable to an adult-sized pulmonary valve.
The adjustment offers a way to increase the valve’s size without another invasive surgical procedure. In the study, two patients whose valve performance began to deteriorate as they outgrew the valve had it successfully expanded. The FDA describes this experience as limited, and says further studies are collecting data on whether expansion can maintain valve function and lead to fewer surgical procedures.
The valve’s leaflets—the flaps that open and close to control blood flow—are made from polymeric material rather than animal-derived tissue. The FDA says animal-derived leaflets can harden and break down faster in children, sometimes prompting earlier repeat surgery. It cited one-year follow-up data suggesting the Autus valve’s synthetic leaflets held up well over time.
What the study reported
All patients in the study had a successful procedure. The FDA reported no deaths, blood clots requiring additional treatment, strokes or other clot-related complications. Three patients experienced a fracture in the valve frame, and two had reduced movement in one leaflet; none of these events caused symptoms in the patients.
The reported six-month findings provide early clinical evidence about valve performance, while the two successful expansions offer initial experience with adjusting the device as children grow. The FDA says longer-term studies are continuing to assess risks and whether expansion can keep the valve functional over time.
The valve was approved through the FDA’s premarket approval pathway, which the agency describes as its most stringent type of medical-device marketing application. The approval is for pediatric use in congenital pulmonary valve disease.