A recent research letter led by Susmitha Wunnava, PhD, of the Harvard-MIT Center for Regulatory Science at Harvard Medical School in Boston, Massachusetts, evaluated the FDA approval status of cardiac valve devices implanted in pediatric patients. The study revealed that over 60% of cardiac valve devices implanted in children were only FDA approved for adults, highlighting a continued reliance on off-label use of adult cardiac valve devices in pediatric populations and a limited availability of FDA-approved, pediatric-specific devices.

Source: JAMA Pediatrics