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Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery

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The Impella 2.5, Impella CP, Impella 5.0 and Impella LD catheters, in conjunction with the Automated Impella Controller console, are intended for short-term use (<4 days for the Impella 2.5 and Impella CP and <6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction (AMI) or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump.  The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
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Catalyst Date
Occurred on:
Apr 07, 2016
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Related Keywords Fda Approval, Cardiogenic Shock, Heart Attack, Heart Surgery, High Risk Percutaneous Coronary Intervention