Get the Care
Delays in cardiac treatment may be detrimental to one’s health
Due to these uncertain times, many people have forgone the care they need, putting themselves at risk of a major heart event. Your physician’s office and hospitals have implemented protocols to safely care for heart failure patients during COVID-19; avoiding care isn’t one of them. Don’t take unnecessary risks when it comes to your health. Talk to your doctor about treatment options for your heart and if a Protected PCI with the Impella® heart pump may be an option for you.
Is Impella Right for Me?
Impella heart pumps in the time of COVID-19
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.
Under FDA emergency use authorization (EUA):
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.