FDA Greenlights First Growable Pulmonary Valve for Pediatric Heart Patients

The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve for use in pediatric patients requiring surgical pulmonary valve replacement due to congenital heart disease, the agency announced Thursday.

This innovative device represents the first pulmonary valve specifically engineered for pediatric anatomy. The Autus valve features an adjustable design that allows it to expand over time, aligning with a child’s natural growth and potentially reducing the need for repeated open-heart procedures. Available in sizes starting at 13 mm in diameter for toddlers, the valve can be incrementally enlarged through balloon catheterization up to 22 mm for adult use.

“For children born with congenital heart disease, timing valve replacement has always presented a significant clinical challenge—intervene too late and risk patient harm, but act too early and they may face multiple open-heart surgeries as they grow,” said Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “The Autus Size-Adjustable Valve offers physicians an option for significantly fewer surgical interventions, which could improve quality of life for these young patients and their families.”

The Autus valve also marks a milestone as the first FDA-approved heart valve utilizing polymeric material for its leaflets, which may offer enhanced durability compared to traditional animal-derived tissue, according to FDA officials.

Approval was supported by a pivotal study involving 62 patients, demonstrating favorable hemodynamic performance with no more than mild pulmonary regurgitation observed. All participants remained free from device-related complications at 30 days and required no valve reinterventions during the initial six months post-implant.

In patients who reached the one-year follow-up milestone, mean right ventricular outflow tract gradients remained at 40 mm Hg or below, with no valve reinterventions reported.

“Pediatric patients with congenital pulmonary valve disease have long awaited prosthetic valves capable of accommodating growth over time,” noted Dr. Emile Bacha of NewYork-Presbyterian/Columbia University Irving Medical Center, a co-author on the pivotal study. “The Autus valve introduces congenital heart teams to a transformative approach in long-term care planning for pediatric patients who might otherwise face repeated surgeries.”

A continued access study is currently underway, with patient monitoring scheduled to continue for up to 10 years.

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