The FDA has issued an emergency use authorization for left-sided Impella heart pumps to support to COVID-19 patients suffering from heart and lung issues.
The authorization allows clinicians to use Abiomed's Impella heart pumps to provide left ventricular unloading for COVID-19 patients undergoing extracorporeal membrane oxygenation treatment who develop pulmonary edema, an abnormal buildup of fluid in the lungs, or myocarditis, an inflammation of the heart muscle.
The Impella heart pumps first received FDA clearance in 2008. It has been used to help treat ECMO patients — that is, patients on life support — in cardiogenic shock. The emergency use authorization expands its use for COVID-19 patients receiving ECMO treatment with pulmonary edema or myocarditis.
This is the second emergency use authorization Impella has received from the FDA during the COVID-19 pandemic. On May 29, the FDA issued an emergency use authorization to expand the use of Impella RP to include patients suffering from COVID-19-related right ventricular complications, including heart failure or decompensation.
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