An international trial of the Impella heart pump in patients with ST elevation myocardial infarction (STEMI) and cardiogenic shock has been stopped by the sponsor Abiomed, Inc. The termination ...
DANVERS, Mass. – October 28, 2024 – Results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference from the first completed pivotal trial on patients supported with Impella ...
There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump's ...
After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall ...
Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...
DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart ...