The expanded indication covers the Impella 5.5 with SmartAssist and Impella CP with SmartAssist for pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock.
Both platforms are among the world’s smallest heart pumps. Johnson & Johnson MedTech partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to provide the real-world data needed to support the on-label use of Impella 5.5 and Impella CP for pediatric patients. ACTION is a global healthcare network comprised of patients, families, clinicians, researchers, and industry representatives who collaborate to improve patient outcomes.
“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 and David Rosenthal, 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.”
Impella CP and Impella 5.5 heart pumps help unload the heart’s left ventricle. They allow the heart to rest while also ensuring the delivery of oxygenated blood throughout the body. The expanded approval expands the use of the left-sided devices to specific pediatric patients weighing 52 kg (114 lb) or more for Impella CP and patients weighing 30 kg (66 lb) or more for Impella 5.5.
“The opportunity to treat the hearts of pediatric patients with our life-supporting technology is incredible and fills us with gratitude,” said Sonya Bhavsar, senior director of R&D, ECP and the pediatrics platform in the heart recovery division of J&J 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.”
