FierceBiotech1 个月
FDA expands use of J&J's Impella heart pumps to pediatric patients
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 ...
pharmaphorum1 年
J&J bulks up before consumer health spinout with Abiomed buy
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 ...
New warnings about heart pumps linked to 49 deaths
The pumps, left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed, have been linked to more than 100 ...
Medindia1 个月
U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
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 ...
Mena FN1 个月
U.S. FDA Expands Indication For Impella Heart Pumps To Treat Pediatric Patients
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 ...