www.fdanews.com/articles/198365-fda-clears-abiomeds-impella-heart-pumps-for-emergency-use
FDA Clears Abiomed’s Impella Heart Pumps for Emergency Use
August 5, 2020
The FDA has issued an Emergency Use Authorization for Abiomed’s left-sided Impella heart pumps, allowing the devices to be used for support of COVID-19 patients.
The device supports individuals undergoing extracorporeal membrane oxygenation therapy, a treatment that circulates blood through an artificial lung back into the patient.
The pumps received a premarket approval from the FDA in 2015.