April 10, 2020: The U.S. FDA issued an emergency use authorization for 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 approved product works by reducing the number of cytokines and other inflammatory mediators, i.e. small active proteins in the bloodstream which control the immune response of a cell by filtering the blood and returning the filtered blood to the patient.
The proteins that are removed are usually elevated during infections and may be associated with a “cytokine storm” occurring in some COVID-19 patients, resulting in extreme inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M. Hahn, M.D. “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. 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.”
“The FDA issued this emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.”
The FDA, a United States department Health and Human Services Agency, protects public health by ensuring the quality, effectiveness, and protection of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the health and protection of the food supply, cosmetics, dietary supplements, products that give off electronic radiation, and to regulate tobacco products in our country.