Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19 | Food and Drug Administration

2021-11-25 06:15:08 By : Ms. Tina Sun

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The U.S. Food and Drug Administration has issued an emergency use authorization for the blood purification system for the treatment of coronavirus disease 2019 (COVID-19) diagnosed at 18 years of age or older, admitted to the intensive care unit (ICU) and confirmed or about to breathe Patients with failure.

The role of the licensed product is to reduce the amount of cytokines and other inflammatory mediators, that is, small active proteins in the blood, and control the cellular immune response by filtering the blood and returning the filtered blood to the patient. The protein that is removed is usually elevated during infection and may be related to the "cytokine storm" that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure, and death.

"We will continue to work in all departments to accelerate the development of many innovative potential prevention and treatment methods by providing emergency medical services to patients as much as possible and supporting the evaluation of potential therapies," FDA Commissioner Stephen M. Hahn (Stephen M. Hahn) Hahn) said. , MD "With today’s authorization of blood purification equipment, we are accelerating the provision of treatment options for ICU patients to help reduce the severity of the disease. Our employees will continue to conduct round-the-clock reviews of all medical products to speed up the availability of treatments. Help fight this devastating disease."

The FDA granted Terumo BCT Inc. and Marker Therapeutics AG emergency use authorizations for its Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge equipment.

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