Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock
ABIOMED, Inc. (ABMD)
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Source: GlobeNewswire
DANVERS, Mass., Feb. 13, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5®, Impella CP®, Impella 5.0® and Impella LD® heart pumps to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock. This approval expands the previous FDA indication for acute myocardial infarction (AMI) cardiogenic shock and post-cardiotomy cardiogenic shock (PCCS), received in April 2016. The Impella® heart pumps are the only percutaneous temporary ventricular support devices FDA-approved as safe and effective for cardiogenic shock in the setting of cardiomyopathy, as stated below: The Impella 2.5, Impella CP, Impella 5.0, and Impella LD Catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for
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