FDA Issues 'Emergency Authorization' For Blood Purification Device For COVID-19 Treatment

The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification device to treat confirmed COVID-19 patients.

According to the PR Newswire, the system would be used to treat those coronavirus patients aged 18 or older admitted to the intensive care unit with confirmed or imminent respiratory failure.

The concept of the blood purification system was based on the activity of cytokines and other inflammatory mediators, which are small active proteins in the blood that control a cell's immune response; these proteins increase significantly during an infection and would be associated with a "cytokine storm" that occurs in some coronavirus sufferers. The result is "severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death".

The devices would filter the blood and reduce the amount of cytokines present. Then, the devices would return the filtered blood to the patient.

"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."

Hahn added that their staff would continue to work full-time to review all of the medical products to speed up the availability of treatments to aid in fighting against the disease.

The FDA issued the emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their devices Spectra OPtia Apheresis System and Depuro D2000 Adsorption Cartridge.