Impella 5.5 and Impella CP are left-sided, minimally invasive temporary mechanical circulatory support options for pediatric patients with symptomatic ADHF and cardiogenic shock.

Summary: The FDA has expanded the indications for Johnson & Johnson MedTech’s Impella CP and Impella 5.5 with SmartAssist heart pumps, granting premarket approval for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. The decision follows data supported by the Advanced Cardiac Therapies Improving Outcomes Network (ACTION), addressing a long-standing gap in pediatric heart failure treatment.

Key Takeaways:

  1. New Pediatric Indications – The FDA now permits the use of Impella CP and Impella 5.5 devices for pediatric patients weighing ≥52kg and ≥30kg, respectively, in treating acute heart failure and cardiogenic shock.
  2. Device Functionality – The Impella devices assist by reducing strain on the left ventricle and maintaining circulation, potentially improving recovery for pediatric patients.
  3. Data-Driven Approval – The expanded approval was informed by clinical data from the ACTION network, highlighting the potential benefits of these devices in pediatric care.

Johnson & Johnson MedTech (Abiomed Inc) announced today that 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, granting premarket approval for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. 

A premarket approval is the highest level of approval granted by the FDA for the safety and efficacy of medical devices.

Impella 5.5 and Impella CP enable heart recovery as part of the world’s smallest heart pump platform. 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 pediatric 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 pediatric care has been underfunded and understudied,” says Angela Lorts, MD, MBA, and David Rosenthal, MD, co-founders of ACTION, in a release. “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 premarket approval amendment expands the usage of left-sided Impella devices to specific pediatric patients weighing ≥52kg for Impella CP and ≥30kg 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,” says Sonya Bhavsar, PhD, senior director, R&D, ECP & Pediatrics Platform, Heart Recovery, Johnson & Johnson MedTech, in a 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.”

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, according to a release from Johnson & Johnson MedTech. 

New Indications

The FDA indication for use of Impella CP with SmartAssist has been expanded as follows:

  • The Impella CP with SmartAssist Catheter, in conjunction with the Automated Impella Controller, (collectively the Impella System Therapy) are temporary ventricular support devices intended for short-term use (≤4 days) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without intra-aortic balloon pump) in adult patients and in pediatric patients weighing ≥52 kg. 
  • The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

The FDA indication for use of Impella 5.5 with SmartAssist has been expanded as follows:

  • The Impella 5.5 with SmartAssist System is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP) in adult patients and in pediatric patients weighing ≥30 kg. 
  • The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

Photo caption: Impella 5.5 (left) Impella CP (right)

Photo credit: Johnson & Johnson MedTech via PR Newswire