Johnson & Johnson MedTech (J&J MedTech) has received the US Food and Drug Administration (FDA) approval to expand the indications for Impella heart pumps.
The US health regulator has granted premarket approval (PMA) for Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps.
Impella CP with SmartAssist was initially approved in the US to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI).
Also, Impella CP with SmartAssist and Impella 5.5 with SmartAssist were approved for treating heart attacks or cardiomyopathy patients in cardiogenic shock.
The current FDA approval expands their indication to include specific paediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock.
J&J MedTech said the expanded approval provides physicians a new option to treat paediatric patients with heart failure and cardiogenic shock.
Johnson & Johnson MedTech heart recovery R&D, ECP, and paediatrics platform senior director Sonya Bhavsar said: “The opportunity to treat the hearts of paediatric 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.”
Impella CP and Impella 5.5 heart pumps represent the world’s smallest heart pump platform.
The devices unload the heart’s left ventricle, enabling the heart to rest while also delivering oxygenated blood throughout the body.
The expanded approval enables the usage of left-sided Impella devices for specific paediatric patients weighing more than 52kg for Impella CP and 30kg for Impella 5.5.
J&J MedTech said its dedicated team will develop and refine training and education programmes designed specifically for paediatric patients.
Also, the medical device company has partnered with the ACTION network to support the use of Impella heart pumps in children with symptomatic ADHF and cardiogenic shock.
ACTION is a global healthcare network comprising patients, families, clinicians, researchers, and industry representatives, to improve outcomes for patients.
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.”
