The US Food and Drug Administration (FDA) has expanded the indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps (Johnson & Johnson Medtech), granting premarket approval (PMA) for use in specific paediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock.
Johnson & Johnson MedTech has partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to provide the real-world data necessary to support on-label use of Impella 5.5 and Impella CP, both left-sided heart pumps, for paediatric patients with symptomatic ADHF and cardiogenic shock.
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.
“This marks a monumental achievement for children with heart failure as, historically, this area of paediatric 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 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 paediatric patients weighing ≥52kg for Impella CP and ≥30kg for Impella 5.5.
“The opportunity to treat the hearts of paediatric patients with our life-supporting technology is incredible and fills us with gratitude,” said Sonya Bhavsar, 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.”
A dedicated team will develop and refine training and education programs designed specifically for paediatric patients alongside these patients’ doctors. In collaboration with ACTION and previously identified hospitals, these tools and resources will be optimised to help improve outcomes and the quality of life for these paediatric patients. This strategic approach will equip the best-in-class heart recovery field team and providers with the skills to best support these patients now and in the future.
