New Emergency Use Authorization (EUA) for a Blood Purification System

On April 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Terumo BCT Inc. and Marker Therapeutics AG for use of their Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge devices as a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The authorized product works by reducing the amount of cytokines and other inflammatory mediators (small active proteins in the bloodstream that control a cell’s immune response) by filtering the blood and returning the filtered blood to the patient.

The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure, and death.

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