Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death. The issue stems from a manufacturing defect in certain units’ pump driver ...
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 ...
Hot on the heels of handing down a trio of Class I recall labels this year to safety events concerning certain Abiomed heart pumps, the FDA has gone a step further in its crackdown. The agency issued ...
NEW ORLEANS – The Impella 5.0 and 5.5 left ventricular assist device failed to measure up on outcomes when used for high-risk patients undergoing ventricular tachycardia (VT) ablation therapies, ...
DANVERS, Mass., April 8, 2024 – A late breaking clinical trial, presented at the American College of Cardiology conference and simultaneously published in the New England Journal of Medicine, confirms ...
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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 ...
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