FDA emergency use authorization for Impella in some COVID-19 patients

Unloading Therapy for COVID-19 Patients

The FDA has issued an emergency use authorization (EUA) for Impella® heart pumps to provide left ventricular unloading and support for COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.

Impella Unloading in ECMO-Treated Patients in Cardiogenic Shock is Associated With Improved Survival in Several Published Multi-Center Reports

ECpella FDA emergency use authorization data

To learn more about the EUA, visit our press release

 

Emergency Use Authorization

Impella Left Ventricular (LV) Support Systems (Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist) are authorized for emergency use by HCPs 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 (i.e. patients in the intensive care unit) with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. The Impella LV Support Systems have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

All cardiovascular procedures have risk. Potential adverse events associated with the use of Impella include: acute renal dysfunction, aortic valve injury, bleeding, cardiogenic shock, stroke, hemolysis, limb ischemia, myocardial infarction, renal failure, thrombocytopenia, vascular injury and death.

 

IMP-1560


To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: abiomed.com/important-safety-information

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