DevicePMAs@therightstef:P140003_S018 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P140003_S018","sourcedb":"DevicePMAs@therightstef","sourceid":"P140003_S018","text":"Approval for the Impella Ventricular Support Systems. The device is indicated for the treatment of ongoing cardiogenic shock that occurs: 1) immediately (\u003c48 hours) following acute myocardial infarction or open heart surgery; or2) in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis. As a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella Support Systems therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.*Optimal medical management and conventional treatment measures include volume loading and use of pressors and inotropes, with or without 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