FDA Approval of Cardiac Valve Devices Implanted in a National Cohort of Pediatric Patients, 2016-2022

Abstract: Cardiac valve abnormalities are one of the most common congenital cardiac malformations in children; however, relatively few valve implant devices have been approved by the US Food and Drug Administration (FDA) for pediatric use. Therefore, off-label use of adult valves to treat valve disease in children is a standard practice.1,2 Challenges in developing pediatric-specific devices are largely related to barriers in performing clinical trials in small patient populations and perceived low market potential by manufacturers.3 To define gaps in treatment options and support efforts to advance pediatric device research and development, we analyzed data from a large database of cardiac operations performed in the US and evaluated the FDA approval status of cardiac valve devices implanted in pediatric patients.