The U.S. Food and Drug Administration (FDA) granted its first emergency use authorization (EUA) for a blood purification system to treat patients at risk for respiratory failure due to COVID-19. The authorization was granted to Terumo BCT Inc. and Marker Therapeutics, authorizing the use of their Spectra Optia Apheresis System and Depuro D2000 Absorption Cartridge devices to filter cytokines and other inflammatory proteins’ blood.
Death by Cytokine Storm Must be Stopped
Many of the deaths from COVID-19 occur from the so-called ‘Cytokine Storm’—an incredibly dangerous situation that appears to be a trademark of SARS-CoV-2. In a horrific ending, COVID-19 patients are dying in isolation—with no family members allowed nearing them. With failing lungs (and other organs) patients last grasp for air terminates. This kind of horror has been faced by too many thousands of people around the world—and must be put to an end.
A New Device
Hence the new device. Its device is limited to the use of patients 18 or older that admitted to an intensive care unit with confirmed or imminent respiratory failure. The EUA specifies that the devices should only be used for patients with early acute lung injury, early acute respiratory distress syndrome, or other specific severe or life-threatening symptoms or conditions. Stephen Hahn reported the hope of this medical technology noting “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.”
Serious Warnings in UK
This technology comes with great risks as well. The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning of serious risks using hemofiltration systems to treat COVID-19 patients.
The Emergency Authorization
The Spectra Optia Apheresis System with the D2000 Adsorption Cartridge has been neither cleared nor approved for the indication to treat patients with COVID-19 infection; it has been authorized by the FDA under EUA 200148 for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels pursuant to the Section 564 of the Federal Food, Drug, and Cosmetic Act.
The products are made by Terumo BCT, a U.S.-based leader in blood component therapeutic apheresis and cellular technologies, and Marker Therapeutics AG, a Swiss-based diagnostics and therapeutics venture. The two formed the collaboration to combine existing technologies to offer an innovative approach to deal with extremely dangerous situations arising out of severe respiratory symptoms, against often associated with the cytokine storms associated with COVID-19.