A 6-year-old Michigan child received a first-of-its-kind expandable heart valve at C.S. Mott Children's Hospital in August, marking the first such implant in the country.

The Autus Valve, a synthetic pulmonary valve made by Edwards Lifesciences, can be widened with a minimally invasive balloon procedure as a child grows. That could significantly reduce the need for repeated open-heart surgeries that children with congenital heart disease have long faced.

"This valve is a game changer," said Jennifer Romano, a Mott pediatric heart surgeon who served as primary site investigator for the device's pivotal trial. "Typically, we give these children a temporary fix, knowing they will need more surgeries down the road."

The valve could last a lifetime.

The surgery was the first implant in a Continued Access study, which allows children to receive the device while the U.S. Food and Drug Administration (FDA) reviews results from the pivotal trial, according to Michigan Medicine. Mott was one of 12 hospitals nationwide that participated in that trial and enrolled its final patient in spring 2026.

The valve is built for children ages 18 months to 16 years. It uses thin polytetrafluoroethylene (PTFE) for its leaflets instead of biological tissue. Traditional tissue valves can deteriorate and cannot keep pace with a growing child's body. The Autus Valve can also be implanted in far smaller children than other valve technologies allow.

For some children born with heart defects, surgeons have historically had to choose between relieving a blood-flow obstruction and leaving the child with a leaking pulmonary valve. That tradeoff can enlarge the right ventricle and cause problems later in life. Romano said the new valve lets doctors fix the obstruction and protect the ventricle at the same time.

Congenital heart defects affect about 40,000 births per year in the United States, according to the Centers for Disease Control and Prevention. About 1 in 4 babies with a heart defect have a critical defect requiring surgery or other procedures in their first year.

Early clinical results from the pivotal trial show favorable safety outcomes. A few children in the trial have already had their valves successfully expanded, Michigan Medicine reported. Continued Access patients will be followed for years to track long-term performance.

U-M Health is the only approved Continued Access site in Michigan, Indiana and Ohio and continues to enroll eligible patients. Richard Ohye, co-director of the Congenital Heart Center at Mott, said the effort required collaboration across the center to identify patients, coordinate procedures and support families.

Gorav Ailawadi, chair of cardiac surgery and a director of the U-M Health Frankel Cardiovascular Center, said the hospital committed to offering the treatment before commercial availability because many patients need care plans that span a lifetime.

The FDA's review and potential approval are the next steps before the Autus Valve can be offered commercially. No timeline for that decision has been announced.