FDA Expands Indication for Impella Heart Pumps to Include Pediatric Patients

The FDA expanded the indications for the Impella 5.5 with SmartAssist (Abiomed) and Impella CP with SmartAssist (Abiomed) heart pumps, granting the devices premarket approval (PMA) for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. PMA is the highest level of FDA-granted approval for the safety and efficacy of medical devices.¹

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Both devices unload the heart’s left ventricle to enable heart recovery as part of the smallest heart pump platform. This PMA amendment expands the usage of left-sided Impella devices to specific pediatric patients who weigh at least 52 kg and 30 kg for Impella CP and Impella 5.5, respectively. Real-world data is necessary to support the on-label use of the Impella pumps for pediatric patients with symptomatic ADHF and cardiogenic shock.^1-3

Impella 5.5 is a heart pump that helps deliver full cardiac support, allowing the heart to rest and achieve its natural pumping function without additional support. The pump is designed for long duration support and allows patient mobility and optimizes recovery by using real-time intelligence. Impella 5.5 is specifically for patients with cardiogenic shock, a life-threatening condition that occurs when the heart’s inability to function begins to cause other organs in the patient’s body to fail, that occurs immediately (<48 hours) after acute myocardial infarction or open heart surgery in the setting of cardiomyopathy (includes peripartum cardiomyopathy or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures). During this shock, Impella 5.5 helps provide blood and oxygen to important organs throughout the body.^1,2

Impella CP is a heart pump that is designated as safe and effective by the FDA for use during high-risk percutaneous coronary intervention (PCI) procedures and for patients with cardiogenic shock. The pump is a minimally invasive ventricular support device intended for short term use (≤4 days), and like the Impella 5.5, uses real-time intelligence associated with an improved survival and heart recovery. It helps reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.^1,3

“This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied,” Angela Lorts, MD, MBA, and David Rosenthal, MD, co-founders of Advanced Cardiac Therapies Improving Outcomes Network, said in a news release.¹

According to experts, potential adverse events (AEs) for both devices include the following: acute renal dysfunction; aortic valve injury; bleeding; cardiogenic shock; cerebral vascular accident or stroke; death; hemolysis; limb ischemia; myocardial infarction; renal failure; thrombocytopenia and vascular injury.^2,3

“The opportunity to treat the hearts of pediatric patients with our life-supporting technology is incredible and fills us with gratitude,” said Sonya Bhavsar, PhD, senior director, R&D, ECP & Pediatrics Platform, Heart Recovery, Johnson & Johnson MedTech, in the news release. “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.”¹

REFERENCES

1. Johnson & Johnson. U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients. News release. December 12, 2024. Accessed December 13, 2024. https://www.jnj.com/media-center/press-releases/u-s-fda-expands-indication-for-impella-heart-pumps-to-treat-pediatric-patients#:

2. Impella 5.5. Explore the Minimally Invasive Impella 5.5® with SmartAssist® Heart Pump for Heart Recovery. Accessed December 13, 2024. https://www.abiomed.com/en-us/products-and-services/impella/impella-55-with-smartassist

3. Impella CP. Explore the Minimally Invasive Impella CP® with SmartAssist® Heart Pump for Heart Recovery. Accessed December 13, 2024. https://www.abiomed.com/en-us/products-and-services/impella/impella-cp-with-smartassist