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The US Meals and Drug Administration (FDA) has granted emergency-use authorization (EUA) for Abiomed’s percutaneously delivered Impella coronary heart pumps to supply left-ventricular (LV) unloading help with extracorporeal membrane oxygenation (ECMO) in sufferers with COVID-19, the corporate has introduced.
The EUA particularly covers momentary use of the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.zero, and Impella 5.5 with SmartAssist techniques for LV unloading in sufferers with coronary heart failure who develop pulmonary edema or late decompensation from myocarditis whereas on ECMO help, the Abiomed assertion says.
The FDA choice follows its June 1 Impella RP EUA to be used in sufferers with COVID-19 and right-sided coronary heart failure from pulmonary embolism or different causes.
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