FDA Expands Impella Heart Pump Indication to Include Pediatric Patients
Key Insights
The FDA has granted premarket approval to Johnson & Johnson MedTech (search)'s Impella 5.5 (search) and CP heart pumps for pediatric patients with acute decompensated heart failure (search) and cardiogenic shock (search).
The Impella CP (search) is approved for children weighing at least 52kg, while Impella 5.5 (search) is approved for those weighing at least 30kg, offering temporary ventricular support.
These left-sided heart pumps unload the heart's left ventricle (search), allowing it to rest while maintaining oxygenated blood flow throughout the body, facilitating heart recovery.
Johnson & Johnson MedTech (search)'s Impella 5.5 (search) with SmartAssist and Impella CP (search) with SmartAssist heart pumps have received expanded FDA approval for use in pediatric patients experiencing symptomatic acute decompensated heart failure (search) (ADHF) and cardiogenic shock (search). This premarket approval (PMA) marks a significant advancement in treatment options for young patients with severe heart conditions.
The FDA's decision allows for the use of Impella CP (search) in pediatric patients weighing 52 kg or more, providing short-term ventricular support for up to four days in cases of cardiogenic shock (search) following acute myocardial infarction (search), open-heart surgery, or cardiomyopathies, including peripartum cardiomyopathy (search) or myocarditis (search). Impella 5.5 (search) with SmartAssist is now approved for short-term use (up to 14 days) in pediatric patients weighing at least 30 kg, also for cardiogenic shock under similar clinical conditions.
Sonya Bhavsar, PhD, Senior Director, R&D, ECP & Pediatrics Platform, Heart Recovery, Johnson & Johnson MedTech (search), stated, "The opportunity to treat the hearts of pediatric patients with our life-supporting technology is incredible and fills us with gratitude. 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."
Clinical Application and Mechanism
Impella CP (search) and Impella 5.5 (search) are designed to unload the heart's left ventricle (search), reducing its workload while ensuring adequate blood circulation. These minimally invasive, left-sided heart pumps support heart recovery by allowing the heart to rest and regain function.
Collaboration with ACTION Network
Johnson & Johnson MedTech (search) (Abiomed) partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to collect real-world data supporting the on-label use of Impella pumps in pediatric patients. ACTION is a global healthcare network comprising patients, families, clinicians, researchers, and industry representatives focused on improving outcomes for pediatric heart patients.
"This marks a monumental achievement for children with heart failure (search) 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 (search) on this crucial approval and look forward to further collaborations that will enhance care for these vulnerable patients."
Training and Education
A dedicated team will develop training and education programs tailored for pediatric patients and their physicians. Collaborating with ACTION and selected hospitals, these resources will be optimized to enhance outcomes and quality of life for young patients. This strategy aims to equip healthcare providers with the necessary skills to support these patients effectively.