The Food and Drug Administration (FDA) has issued an Emergency Use Authorization to Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge (Terumo BCT Inc. and Marker Therapeutics AG) for the treatment of 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 to reduce proinflammatory cytokines levels.
Cytokine levels are typically elevated during infections and can be associated with a cytokine storm in some COVID-19 patients. The Agency believes that the ability to manage the cytokine storm associated with COVID-19 may decrease patient morbidity.
The Spectra Optia Apheresis System is a blood purification system that operates in conjunction with Depuro D2000 Adsorption Cartridge devices. The authorized product uses continuous flow centrifugation and optical detection technology to separate plasma from whole blood, removing cytokines and other inflammatory mediators, and returning the filtered blood to the patient. Plasma filtration may be run for up to 4 hours and may be repeated as needed.
“With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease,” said FDA Commissioner Stephen M. Hahn, MD. “Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”
For more information visit fda.gov.