FDA Approves Growable Artificial Heart Valve for Children

The US Food and Drug Administration (FDA) has approved the Autus Size-Adjustable Valve, the first artificial heart valve designed to expand post-surgery and grow with pediatric patients. Developed by Edwards, this artificial pulmonary valve aims to eliminate the need for multiple surgeries in children born with certain congenital heart defects.

Congenital heart disease affects approximately 400,000 children annually in the United States, with about 30 percent of these cases impacting heart valves. Specifically, abnormalities of the pulmonary valve, such as stenosis (narrowing) and atresia (failure to form normally), affect around 4,200 babies in the US each year, according to the Centers for Disease Control and Prevention. While artificial pulmonary valves have been implantable for a long time, they traditionally necessitated a series of replacement surgeries as the child grew.

What makes the Autus valve a significant advancement is its ability to be expanded inside the body using a balloon catheter. It can be implanted as small as 13 millimeters in toddlers and preschool-aged children and expanded to a maximum of 22 millimeters, comparable to adult-sized artificial valves. This innovative feature reduces the risks associated with repeated surgical interventions for young patients.

Furthermore, the Autus is the first adjustable heart valve to utilize polymeric material for its flaps. Conventional implants often employ synthetic flaps derived from animal materials, which tend to harden and break down more quickly in children, thus requiring more frequent surgeries. The FDA's follow-up data after one year suggests that the Autus valve demonstrates improved durability compared to existing models, promising better long-term outcomes for pediatric patients.

What to watch: Long-term efficacy and broader adoption of the Autus valve.

Editor's note: review unavailable