FDA Expands Impella Heart Pump Labeling for Pediatric Heart Failure

• The FDA has expanded the labeling for Johnson & Johnson MedTech's Impella Support System to include treatment for children with heart failure.
• This expansion was made possible through collaboration between Johnson & Johnson MedTech and the ACTION network of medical institutions.
• The collaboration also focuses on developing pediatric-focused educational materials about heart failure for families and caregivers.
• This approval marks a significant advancement in improving heart failure outcomes for children, an area historically underfunded and understudied.

In a significant advancement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech's Impella Support System to include the treatment of certain children suffering from heart failure. This expands the original approval, which was for adults with heart failure.

The approval is the result of a collaboration between Johnson & Johnson MedTech and ACTION (Advanced Cardiac Therapies Improving Outcomes Network), a network comprising over 60 medical institutions. The collaboration focuses on building real-world data to support FDA approvals.

Impact on Pediatric Heart Failure Treatment

Previously, the Impella Support System was only approved for use in adults. ACTION's clinical providers gathered essential data and enhanced the clinical understanding of ventricular assist devices (VADs) for pediatric use. This expansion provides families, caregivers, and medical providers with improved access to a potentially life-saving technology.

"This announcement marks a monumental achievement for children with heart failure," said Angela Lorts, MD, MBA, and David Rosenthal, MD, Co-Founders of ACTION. They emphasized the historical lack of funding and research in pediatric heart failure, noting that the Impella Support System's approval represents a significant leap forward in improving outcomes. ACTION is proud to have collaborated with Abiomed on this crucial FDA process and looks forward to further partnerships that will enhance care for these vulnerable patients."

Educational Resources for Families

The collaboration between ACTION and Johnson & Johnson MedTech extends beyond evidence generation to include the development of pediatric-focused educational materials about heart failure. These resources, including animations, infographics, and articles, will be available on the ACTION education site, MyACTIONEducation.org. The aim is to help children, parents, and caregivers better understand heart failure and explore their treatment options.

With this collaboration, ACTION and Johnson & Johnson MedTech are paving the way for innovative therapies, offering renewed hope to thousands of children living with heart failure and their families.