Johnson & Johnson MedTech’s Impella 5.5 and Impella CP Receive Expanded Indications to Treat Pediatric Patients

December 12, 2024—Johnson & Johnson MedTech announced that the FDA has expanded the indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, granting premarket approval (PMA) for use in specific pediatric patients with symptomatic acute decompensated heart failure and cardiogenic shock.

According to the company, the PMA amendment expands the usage of the left-sided Impella devices to specific pediatric patients weighing ≥ 52 kg for Impella CP and ≥ 30 kg for Impella 5.5. The intent of Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function, note the company.

Johnson & Johnson MedTech (Abiomed, Inc.) advised it has partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to provide the real-world data necessary to support on-label use of the Impella 5.5 and Impella CP left-sided heart pumps for pediatric patients with symptomatic ADHF and cardiogenic shock.

ACTION is a global healthcare network composed of patients, families, clinicians, researchers, and industry representatives who collaborate with ACTION leadership to improve outcomes for patients, noted the company. Funding for this research program was provided by Abiomed to the Cincinnati Children’s Hospital Medical Center (CHMC), which is the coordinating center for the research and health care quality improvement efforts of ACTION.

“This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied,” commented Angela Lorts, MD, and David Rosenthal, MD, cofounders of ACTION, the company’s press release. “We are proud to have worked with Johnson & Johnson MedTech on this crucial approval and look forward to further collaborations that will enhance care for these vulnerable patients.”

 A dedicated team will develop and refine training and education programs designed specifically for pediatric patients alongside these patients’ doctors. In collaboration with ACTION and previously identified hospitals, these tools and resources will help improve outcomes and the quality of life for these pediatric patients, stated Johnson & Johnson MedTech.