The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Johnson & Johnson (J&J) MedTech’s Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, allowing their usage in paediatric patients with acute decompensated heart failure (ADHF) and cardiogenic shock.
The amendment of PMA specifies the use of the devices for paediatric patients who weigh at least 52kg for Impella CP providing short-term ventricular support for up to four days in cases of cardiogenic shock following acute myocardial infarction, open heart surgery, or due to cardiomyopathies such as peripartum cardiomyopathy or myocarditis.
Similarly, the Impella 5.5 with SmartAssist System is approved for short-term use of up to 14 days for paediatric patients weighing at least 30kg, also addressing cardiogenic shock under similar clinical conditions.
J&J MedTech R&D, ECP and Pediatrics Platform, Heart Recovery senior director Sonya Bhavsar said: “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.”
These left-sided heart pumps facilitate heart recovery. They are designed to unload the left ventricle, reducing the heart's workload while maintaining blood circulation throughout the body.
Johnson & Johnson MedTech (Abiomed) has collaborated with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to gather real-world data supporting the on-label use of the heart pumps for the specific patient group.
ACTION plays a crucial role in improving patient outcomes by bringing together patients, families, clinicians, researchers, and industry representatives.
ACTION co-founders David Rosenthal and Angela Lorts said: “This marks a monumental achievement for children with heart failure as, historically, this area of paediatric care has been underfunded and understudied.
“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.”
