The FDA approved a heart valve on October 1 that is designed to be widened as a child grows, rather than replaced in repeat open-heart surgery. The Autus Size-Adjustable Valve is a surgically implanted pulmonary valve for pediatric patients with congenital pulmonary valve disease. The FDA says the device "may reduce" the need for repeat open-heart surgeries — not that it removes them.
What the device does
The valve can be implanted as small as approximately 13 millimeters across, the FDA says, the right size for a toddler or preschool-aged child. Later, doctors widen it using a balloon catheter, a small inflatable tube threaded in without open surgery, reaching up to 22 millimeters, comparable to an adult-sized pulmonary valve. Its leaflets — the flaps that open and close inside it — are polymeric rather than animal-derived tissue, which the FDA says tends to harden and break down faster in children. It is the first valve the agency has approved in the U.S. using polymeric leaflet material, for any indication. One-year follow-up data, it says, suggest the synthetic leaflets hold up well over time.
Who it is for
The valve is for pulmonary valve stenosis, in which the valve is narrowed, and pulmonary valve atresia, in which the valve fails to form normally. Congenital heart defects as a group affect about 1 in every 100 births in the United States, the FDA says; citing the Centers for Disease Control and Prevention, it puts those two conditions together at around 4,200 babies in the United States each year. Treatment can leave some children with significant leakage back through the pulmonary valve, which over time can create a need for valve replacement as the child grows.
The trial evidence
The approval rests on a clinical study that enrolled 62 pediatric patients across 12 U.S. sites. At six months, the first 60 patients had acceptable blood flow through the right side of the heart and no more than mild leakage back through the valve. Every patient had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes or other clot-related complications. Three patients had a fracture in the valve frame and two had reduced movement of one leaflet; the FDA says none of these events resulted in symptoms. Valve performance began deteriorating in two patients who started to outgrow it, and both had their valves successfully expanded without an invasive surgical procedure — but the agency says that experience is limited. Longer-term studies are being conducted to understand those risks and to show expansion can keep the valve working.
What the approval does not settle
The FDA approved the device through the premarket approval pathway, its most stringent review, used for certain Class III devices, which the agency says generally pose the greatest risk. Edwards Lifesciences received the approval; Autus Valve Technologies Inc. developed the device. The release does not say when the valve becomes available to patients. As of this reading, FDA's own device databases held no premarket approval order or Summary of Safety and Effectiveness Data for it, so the study figures above rest on the announcement alone.