FDA Approves Impella for LV Unloading Emergency Use With ECMO in COVID-19

August 05, 2020

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The US Food and Drug Administration (FDA) has granted emergency-use authorization (EUA) for Abiomed's percutaneously delivered Impella heart pumps to provide left-ventricular (LV) unloading support with extracorporeal membrane oxygenation (ECMO) in patients with COVID-19, the company has announced.

The EUA specifically covers temporary use of the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist systems for LV unloading in patients with heart failure who develop pulmonary edema or late decompensation from myocarditis while on ECMO support, the Abiomed statement says.

The FDA decision follows its June 1 Impella RP EUA for use in patients with COVID-19 and right-sided heart failure from pulmonary embolism or other causes.

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