The FDA has approved a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
Developed by Edwards Lifesciences via its recent buyout of Autus Valve Technologies, the Autus Size-Adjustable Valve may reduce the need for repeat open-heart surgeries in children with heart defects, according to the FDA.
The device is the first heart valve designed to be expanded after surgery to keep pace with a child’s growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its inner flaps (called leaflets).
“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., in a statement.
According to data compiled by the CDC, congenital pulmonary valve disease impacts 11.3 per 10,000 live births, or around 1 in 885 births. It also lists heart defects among the most common birth defects in the United States.
Pulmonary valve abnormalities—including pulmonary valve stenosis, in which the valve is narrowed, and pulmonary valve atresia, in which the valve fails to form normally—restrict blood flow from the heart to the lungs.
While treatment helps repair these congenital defects, some children may be left with significant pulmonary regurgitation, or leakage of blood back through the pulmonary valve. Over time, this can weaken or enlarge the right ventricle and create the need for other surgeries as the child grows.
“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, M.D., Ph.D., director of the FDA’s Center for Devices and Radiological Health, in a release.
“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 can be initially implanted as small as approximately 13 millimeters in diameter—the appropriate size for a toddler or preschool-aged child—and later widened using a small inflatable tube (balloon catheter) as the child grows, eventually reaching up to 22 millimeters, which is comparable to an adult-sized pulmonary valve.
While Medtronic’s Melody Transcatheter Pulmonary Valve features expandable balloon technology, it is not specifically designed for dynamic expansion that matches the growth of a child and is typically only prescribed for children and teenagers weighing at least 55lbs.
The Autus Size-Adjustable Valve uses polymeric material for its leaflets—the flaps inside the valve that open and close to control blood flow. Traditional valves use tissue derived from animals, which tends to harden and break down faster in children, often resulting in the need for earlier repeat surgery.
The FDA says that one-year follow-up data suggest the Autus valve’s synthetic leaflets hold up well over time. While other polymeric heart valves are currently in development, the Autus valve is the only FDA-approved device containing polymeric leaflet material for any indication.
The Autus Size-Adjustable Valve is the first pediatric approval to come out of the FDA’s Total Product Life Cycle Advisory Program (TAP), a voluntary program for device developers intended to spur more rapid development of high-quality, safe, effective and innovative medical devices for all patients, according to the agency.