The FDA approved the first heart valve designed to expand after surgery as a child grows.
Autus Size-Adjustable Valve is a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease, according to an Oct. 1 FDA news release. It can be initially implanted at the size of a toddler’s valve and expanded to reach comparable adult-sized pulmonary valves — approximately 13 millimeters in diameter to 22 millimeters.
The approval was based on a clinical study of 62 pediatric patients across 12 U.S. sites. At the six-month follow-up, the first 60 patients showed acceptable hemodynamic performance and had no more than mild leakage back through the valve. All patients had successful procedures, with no deaths, strokes or other clot-related complications. Three patients experienced a fracture in the valve frame, and two had reduced movement of a valve leaflet, though none had symptoms. Two patients who began to outgrow their valves had them expanded successfully without surgery.
The device may reduce the need for repeat open-heart surgeries in children, and is the first valve device approved to use polymeric material rather than animal-derived tissue for its inner flaps. It is also the first pediatric approval to come from the FDA’s Total Product Life Cycle Advisory Program, a voluntary program for device developers to increase rapid creation of high-quality, safe, effective and innovative medical devices.
Congenital heart defects affect about 1 in every 100 births, and pulmonary valve atresia and stenosis together affect around 4,200 babies in the U.S. each year, according to the CDC.
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