According to the news release, the FDA said the blood purification device works by seeking to reduce the cytokines burden and other inflammatory mediators by filtering the blood. The filtered blood would then be returned to the patient with a reduced level of cytokine and other inflammatory mediators.
The FDA explained that "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."
Stephen M. Hahn, the FDA Commissioner, said the administration is working to develop several potential preventive methods by authorizing emergency use, to the extent that is allowed.
"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," Hahn said.
"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," Hahn said.
The emergency use authorization is issued to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices, according to the news release.