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COVID-19, the respiratory disease caused by the new coronavirus, causes widespread inflammation which could impair or damage the left ventricle of the heart and lead to heart failure or excess fluids in the lungs.
Impella, part of a family of invasive heart pump devices manufactured by Abiomed, provides circulatory support to patients who develop left side ventricular failure and is authorized to be used by healthcare providers in the hospital setting.
It was approved for use in the United States in 2015.
This is the second EUA that the FDA has granted for Impella during the COVID-19 pandemic. In May, the FDA issued an EUA to expand the use of Impella RP to include patients suffering from COVID-19-related right ventricular complications.
