As indicated by the news release, the device will be used to treat patients who are confirmed to be infected by the CCP (Chinese Communist Party) virus, commonly known as novel coronavirus, admitted to the Intensive Care Unit in hospitals, confirmed with respiratory failure. Furthermore, the patients also have to be 18 years of age and older.
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.
Science Direct stated that this process, which is called an extracorporeal blood purification, allows a patient’s blood to pass through the device in which toxic material and minerals are removed.
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.
Johns Hopkins University resource center recorded a total of 475,749 confirmed cases of the CCP Virus, along with 17,925 deaths resulting from the disease, as of the time of writing.