J&J MedTech’s Impella 5.5 & CP Heart Pumps OK’ed for Pediatric Use

The U.S. Food and Drug Administration has granted Johnson & Johnson MedTech expanded approval for its Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps. The company won premarket approval (PMA) for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock.

The company partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to provide the real-world data needed to support on-label use of the new indications. ACTION is a global healthcare network comprised of patients, families, clinicians, researchers and industry representatives that collaborate with ACTION leadership to improve outcomes for patients.

Impella CP and Impella 5.5 heart pumps unload the heart’s left ventricle, allowing the heart to rest while also ensuring delivery of oxygenated blood throughout the body. The PMA amendment expands the usage of left-sided Impella devices to specific pediatric patients weighing ≥52kg for Impella CP and ≥30kg for Impella 5.5.

“This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied,” said Angela Lorts, MD, MBA, and David Rosenthal, MD, Co-Founders of ACTION. “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 be optimized to help improve outcomes and the quality of life for these pediatric patients.

“The opportunity to treat the hearts of pediatric patients with our life-supporting technology is incredible and fills us with gratitude,” said Sonya Bhavsar, Ph.D., Senior Director, R&D, ECP & Pediatrics Platform, Heart Recovery, Johnson & Johnson MedTech. “This milestone motivates us to continue innovating solutions to increase the number of life years that these patients have and can spend with their families and loved ones.”