CINCINNATI — 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, MD, Co-Founders of ACTION. “Historically, this area of care has been underfunded and understudied in pediatrics. The approval of the Impella Support System for children with heart failure represents an enormous leap forward in improving heart failure outcomes for children. We are proud to have collaborated with Abiomed on this crucial FDA process and look forward to further partnerships that will enhance care for these vulnerable patients.”
The collaboration between ACTION and Johnson & Johnson MedTech includes not only evidence generation but also the development of pediatric-focused educational materials about heart failure. These resources will be available on the ACTION education site, MyACTIONEducation.org, featuring engaging animations, infographics, and articles designed to help children, parents, and caregivers better understand heart failure and explore their treatment options.
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.
See the press release issued by Johnson & Johnson MedTech.
