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 ...

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...

The FDA has issued an emergency use authorization for left-sided Impella heart pumps to support to COVID-19 patients suffering from heart and lung issues. The authorization allows clinicians to use ...

The US Food and Drug Administration (FDA)-approved labeling for the Impella 5.0 and Impella LD heart pumps (Abiomed) has been expanded to allow for longer support time in critically ill patients, the ...

Impella heart pump upgraded to Class 2a in ACC/AHA treatment guideline for cardiogenic shock secondary to STEMI DANVERS, Mass., March 27, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, the global ...

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 ...

PHILADELPHIA (KFSN) -- When a patient has a heart attack, doctors are working against the clock. Often their heart is too weak to pump enough blood. Cardiologists in major U.S. medical centers are ...