ACTION Centers Collaborate with Johnson & Johnson MedTech to Secure FDA Labeling for Impella Support System in Pediatric Patients | PR Newswire [Video]

, /PRNewswire/ — In a groundbreaking achievement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech’s Impella Support System to include treatment for certain children suffering from heart failure, extending the original approval for care of adults with heart failure. This significant advancement is the result of a collaboration between Johnson & Johnson MedTech and ACTION (Advanced Cardiac Therapies Improving Outcomes Network), a network of over 60 medical institutions. The collaboration is aimed at building real-world, adjudicated data to support FDA approvals.

Previously, the Impella Support System was approved for use in adults. ACTION’s clinical providers not only gathered essential foundational data but also enhanced clinical understanding of ventricular assist devices (VADs) for pediatric use. Families, caregivers, and medical providers can now benefit from improved access to this life-saving technology.

“This announcement marks a monumental achievement for children with heart failure,” said Angela Lorts, MD, MBA, and David Rosenthal…