- Over 60% of cardiac valve devices implanted in children were only FDA approved for adults.
- The study cohort included 9,608 valve implant procedures in 8,971 patients who were younger than 18 years.
- Only 8.9% of the implanted devices were FDA approved for pediatric use.
- Pulmonic and mitral valve positions had the highest frequency of pediatric-approved devices.
- The findings reflect limited availability of FDA-approved, pediatric-specific devices and a continued reliance on off-label use of adult cardiac valve devices in pediatric populations.
Source: JAMA Pediatrics
