Fact Sheet for Healthcare Providers: Emergency Use of Impella Left Ventricular Support Systems During the COVID-19 Outbreak | NLM

Disaster Information Management Research Center | NLM

Fact Sheet for Healthcare Providers: Emergency Use of Impella Left Ventricular Support Systems During the COVID-19 Outbreak

08/03/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 8/3/2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Impella Left Ventricular (LV) Support Systems. The Impella LV Support Systems are authorized for emergency use by healthcare providers (HCP) in the hospital setting for providing temporary LV unloading and support to treat critical care patients with confirmed COVID-19 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 veno-venous (V-V) ECMO support. (PDF)