Russo et al., Journal of the American College of Cardiology, 2019: This meta-analysis examined the efficacy and safety of left ventricular unloading strategies during ECMO in patients with cardiogenic shock and found left ventricular unloading was associated with decreased mortality.
The FDA EUA for Impella left ventricular support systems reads as follows:

Emergency Use Authorization

Emergency Use Authorization (EUA) for emergency use of the Impella Left Ventricular (LV) Support Systems¹ intended for use by healthcare providers (HCP) in the hospital setting for providing temporary LV unloading and support to treat critical care² patients with confirmed Coronavirus Disease 2019 (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.


1 For purposes of this EUA, the term “Impella LV Support Systems” refers to the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems, which are a family of miniaturized percutaneous circulatory support systems for the left ventricle.

2 For purposes of this EUA, “critical care” patients refer to patients in the intensive care unit (ICU) who have confirmed COVID-19 infection.


ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to reopen blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP® is U.S. FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery. The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID-19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. Impella Left Ventricular (LV) Support Systems are also 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 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 authorized Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella RP and Impella LV Support Systems have been authorized for the above emergency use by FDA under an EUA and 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.

Cardiology Homepage