FDA Approves Only Surgical Pulmonary Valve Fit for Growing Kids

The FDA approved the Autus Size-Adjustable Valve for surgical pulmonary valve replacement in children with congenital heart disease, the agency announced on Thursday.

The Autus valve marks the first such valve dedicated to pediatric anatomy. It is designed to be expanded over time in keeping with a child’s growth, which is believed to reduce the need for repeat open-heart surgeries. The FDA noted that the Autus valve comes in a size as small as 13 mm in diameter for a toddler and can be incrementally widened with balloon catheterization to up to 22 mm for an adult.

“For children born with congenital heart disease, valve replacement timing has always been a difficult decision — wait too long and you risk harm to the child, but intervene too early and they may need multiple open-heart surgeries as they grow,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, in the agency’s press release. “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.”

Of note, the Autus valve is the first FDA-approved heart valve to use polymeric material for its leaflets, which may be more durable than animal-derived tissue, the FDA said.

Premarket approval was based on a 62-patient pivotal study showing acceptable hemodynamic performance of the valve with no more than mild pulmonary regurgitation. All study participants were free from device-related complications through 30 days and did not require valve reinterventions through 6 months.

Among patients who completed 1-year follow-up, right ventricular outflow tract mean gradients stayed at 40 mm Hg or less and there were no valve reinterventions.

“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time,” said Emile Bacha, MD, of NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, who was an author on the pivotal study, in a press release from maker Edwards Lifesciences. “The Autus valve gives congenital heart teams a new way to think about long-term care planning for pediatric patients who may otherwise face multiple surgeries.”

A continued access study is underway, with follow-up planned through 10 years.