FDA approves expandable Autus valve for congenital pulmonary valve disease

According to a new announcement from the US Food and Drug Administration (FDA), the agency has approved the Autus Size-Adjustable Valve (Edwards Lifesciences), a surgically implanted pulmonary valve for pediatric patients with congenital pulmonary valve disease.¹ The device is the first heart valve designed for postoperative expansion to keep pace with a child's growth.¹ It is also the first valve approved in the US to use polymeric leaflets instead of animal-derived tissue.¹

The approval gives pediatric cardiology teams a new option for children who need pulmonary valve replacement. Fixed-size valves have historically required multiple open-heart surgeries as children grow, forcing difficult decisions on the timing of intervention.¹ Animal-derived leaflets also tend to harden and break down faster in children, often prompting earlier reoperation.¹

The approval rests on data from a clinical study enrolling 62 pediatric patients across 12 US sites.¹ The FDA announcement does not name the study or provide a ClinicalTrials.gov registration number. The valve can be implanted at a diameter as small as approximately 13 mm, sized for a toddler or preschool-aged child.¹

As the child grows, clinicians can widen the valve with a balloon catheter, eventually reaching up to 22 mm, comparable to an adult pulmonary valve.¹ All enrolled patients had a successful implantation procedure.¹

The key performance measure reported by the FDA was hemodynamic function at 6 months. Among the first 60 patients reaching 6-month follow-up, the valve showed acceptable hemodynamic performance, defined as right-sided blood flow within acceptable limits with no more than mild regurgitation through the valve.¹ The announcement does not report effect sizes, P values, or confidence intervals.

Autus valve safety: frame fractures, leaflet mobility, and balloon expansion in growing patients

No deaths, strokes, blood clots requiring additional treatment, or other clot-related complications occurred during the study.¹ Three patients experienced a fracture of the valve frame, and 2 patients had reduced mobility of a single leaflet.¹ None of these 5 events produced symptoms.¹

Valve performance began to decline in two patients as they started to outgrow the device.¹ Both underwent successful valve expansion without an invasive surgical procedure, although the FDA characterized experience with expansion as limited.¹ Longer-term studies are under way to clarify these risks and to determine whether expansion can maintain valve function and reduce the number of surgical procedures patients require.¹

One-year follow-up data suggest the polymeric leaflets hold up well over time, according to the agency.¹ The approval marks the first time the FDA has approved polymeric leaflet material for any valve indication.¹

The valve was approved through the premarket approval pathway, the FDA's most stringent device marketing application, used for certain Class III devices.¹ It previously received Breakthrough Device designation and is the first pediatric approval to emerge from the FDA's Total Product Life Cycle Advisory Program (TAP).¹ Edwards Lifesciences holds the approval, and Autus Valve Technologies Inc developed the device.¹

"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," Michelle Tarver, MD, PhD, director of the FDA's Center for Devices and Radiological Health, said in the announcement.¹

For pediatricians co-managing children with congenital pulmonary valve disease, the approval adds a surgical option designed to reduce repeat open-heart procedures as patients grow.¹ Postimplant expansion uses a balloon catheter rather than reoperation, though data on expansion outcomes remain limited.¹ The announcement does not address commercial availability or patient selection criteria beyond the pediatric indication.

REFERENCE

1. US Food and Drug Administration. FDA approves first heart valve designed to grow with children. News release. October 1, 2026. Accessed October 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children