The U.S. Food and Drug Administration (FDA) has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve intended for pediatric patients with congenital pulmonary valve disease. The agency announced the approval on October 1, 2026, describing the device as the first heart valve designed to be expanded after surgery to keep pace with a child's growth.
The Autus Size-Adjustable Valve is the first valve approved in the United States to use polymeric material for its inner flaps, known as leaflets, rather than animal-derived tissue. This synthetic material is intended to hold up better over time in children compared to traditional tissue valves, which often harden and break down faster. The device can be initially implanted as small as approximately 13 millimeters in diameter, suitable for toddlers or preschool-aged children, and later widened using a balloon catheter as the child grows, eventually reaching a size of up to 22 millimeters.
The FDA’s approval is based on data from a clinical study that enrolled 62 pediatric patients across 12 U.S. sites. At the six-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance, meaning blood flow through the right side of the heart was within acceptable limits, and there was no more than mild leakage back through the valve. All patients in the study had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes, or other clot-related complications.
However, the data also noted some device-related events. Three patients experienced a fracture in the valve frame, and two patients had reduced movement of one of the valve leaflets. Additionally, valve performance began to deteriorate in two patients who started to outgrow the valve; both were successfully expanded without an invasive surgical procedure, though the FDA noted that longer-term studies are being conducted to better understand these risks.
The Autus Size-Adjustable Valve was developed by Autus Valve Technologies Inc. and received approval from Edwards Lifesciences. The device was granted Breakthrough Device designation by the FDA, a status meant to expedite the development and review of devices for life-threatening conditions. It was approved through the premarket approval pathway, the FDA’s most stringent type of marketing application.
