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- J&J Heart Pumps Receive F ...

First cleared in 2012 and 2019, respectively, and developed by Abiomed, the Impella CP and Impella 5.5 are miniaturized heart pumps from Johnson & Johnson. These minimally invasive devices are threaded through blood vessels into the heart, where they reduce the workload on the cardiac muscle by using a spinning pump to assist blood flow.
The pumps are typically used in patients who have undergone open-heart surgery or suffered a myocardial infarction, providing temporary support to the damaged left ventricle. They are also effective in cases of cardiomyopathy and myocarditis, where the cardiac muscle becomes enlarged or inflamed, by alleviating the strain on the heart.
The FDA has now expanded the premarket approval for these devices to include use in pediatric patients. The Impella 5.5 is approved for children weighing at least 30 kilograms, while the Impella CP is approved for patients weighing 52 kilograms or more.
The expanded approval also covers pediatric patients experiencing acute heart failure and cardiogenic shock.
The data supporting the FDA’s decision came from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION), which provided real-world data to bolster support for the pumps. ACTION will continue collaborating with Johnson & Johnson to ensure proper use of these devices by physicians.
Commenting on the approval, Angela Lorts, M.D., and David Rosenthal, M.D., co-founders of ACTION, said, “This marks a monumental achievement for children with heart failure as, historically, this area of pediatric 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.”
Earlier this year, J&J shared clinical trial results for the Impella CP in adult patients who had suffered from widowmaker heart attacks, caused by blocked coronary arteries. The device was shown to improve six-month survival rates in these patients.
To ensure a smooth transition to pediatric use, J&J plans to form a team in collaboration with partner hospitals and ACTION representatives. This team will develop training and education programs for healthcare practitioners treating pediatric patients with the devices.