The FDA has opened up the use of Johnson & Johnson’s miniaturized heart pumps to certain pediatric patients, including those suffering from acute heart failure and cardiogenic shock.
The agency expanded its previous premarket approvals for the catheter-based Impella 5.5 and CP pumps developed by Abiomed, for children weighing at least 30 kilograms and 52 kilograms for each model, respectively.
They cover the temporary support of a damaged heart’s left ventricle in the days after patients have undergone open surgery or have had a myocardial infarction, or in specific cases of an enlarged or inflamed cardiac muscle, known as cardiomyopathy and myocarditis.
“This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied,” said Angela Lorts, M.D., and David Rosenthal, M.D., co-founders of the Advanced Cardiac Therapies Improving Outcomes Network, or ACTION, which helped provide the real-world data used to obtain the FDA’s blessing.
“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,” Lorts and Rosenthal said in a statement.
The minimally invasive Impella 5.5 and Impella CP are designed to be threaded up through the blood vessels into the heart, where a spinning pump assists with the flow of blood and takes some of the load off the working cardiac muscle. The CP was first cleared in 2012, while the 5.5 received an FDA green light in 2019.
Earlier this year, J&J presented clinical results showing its Impella CP was able to improve six-month survival rates among adults after what are known as widowmaker heart attacks, caused by a blocked coronary artery.
For use in pediatrics, J&J said that a team will be tasked with developing training and education programs for physicians treating this specific group of patients in collaboration with ACTION and partner hospitals.