ABSTRACT

Fact Sheet for Healthcare Providers: Emergency Use of Impella Left Ventricular Support Systems During the COVID-19 Outbreak   [open pdf - 190KB]

From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Impella 2.5, Impella CP [Cardiac Power], Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems ('Impella Left Ventricular (LV) Support Systems,' in short). The Impella LV Support Systems are authorized for emergency use by healthcare providers (HCP) in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients with confirmed COVID-19 [coronavirus disease 2019] infection who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and who develop pulmonary edema while on veno-arterial (V-A) ECMO support or late cardiac decompensation from myocarditis while on venovenous (V-V) ECMO support."

Publisher:
Date:
2020-08-03
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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