University of Michigan Health’s C.S. Mott Children’s Hospital became the first U.S. hospital to implant Edwards Lifesciences’ Autus Valve during a continued-access study while the FDA reviews the device for potential commercial approval.

The synthetic pulmonary valve is designed for children ages 18 months to 16 years who need pulmonary valve replacement. Physicians can enlarge the valve through a minimally invasive balloon procedure as a child grows, potentially reducing the need for repeat open-heart surgeries. A 6-year-old Michigan patient received the first valve manufactured after Edwards acquired the technology.

Mott was among 12 hospitals participating in the pivotal clinical trial and is currently the only approved continued-access site serving Michigan, Indiana, and Ohio. Early trial results have shown favorable safety outcomes, according to Michigan Medicine, although researchers will continue evaluating the valve’s long-term durability.

FDA review and approval remain necessary before the valve can become commercially available.