FDA issues EUA for Impella heart pumps - Verdict Medical Devices
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FDA issues EUA for Impella heart pumps

04 Aug 2020 (Last Updated August 4th, 2020 16:09)

Abiomed has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its left-sided Impella heart pump. The pump can now be used to provide left ventricular unloading and support to Covid-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) and develop pulmonary edema or myocarditis.

University of Pennsylvania surgical director Christian Bermudez said: “The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”

This is the second EUA Abiomed has received concerning the Impella pump. The device has been approved since April to include patients suffering from Covid-19-related right ventricular complications, including right ventricular dysfunction associated with pulmonary embolism.