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 ...

Abiomed makes the bulk of its $1 billion-plus annual sales from its Impella range of heart pumps, which are billed as the smallest such devices available in the world and have enjoyed double-digit ...

The pumps, left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed, have been linked to more than 100 ...

Impella ECP is a technology of Abiomed, part of Johnson & Johnson MedTech, and the global leader in heart recovery. The pivotal investigational device exemption (IDE) study, which enrolled 256 ...

A spokesperson for Johnson & Johnson - which acquired Abiomed in 2022 - told Reuters: "This notification is not a device removal and Impella heart pumps remain on the market and available for ...

Impella 5.5 and Impella CP enable heart recovery as part of the world's smallest heart pump platform. Johnson & Johnson MedTech (Abiomed, Inc.) has partnered with the Advanced Cardiac Therapies ...

Impella 5.5 and Impella CP are the first left ... Johnson & Johnson MedTech (Abiomed, Inc.) has partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) 1 to provide ...

13, 2024 /PRNewswire/ -- In a groundbreaking achievement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech's Impella ... with Abiomed on this crucial FDA ...