The FDA has granted an emergency authorization to a blood purification system to treat patients with the most severe cases of COVID-19.
The device is designed to strip out an excess of immune system-triggering proteins from blood and plasma before returning them back to the patient—including those that fuel cytokine storms, the harmful, cascading activation and release of white blood cells as the body overreacts to the infection.
Cytokine storms can cause severe inflammation, tissue damage and rapidly progressive shock, according to the agency, leading to fatal organ and respiratory failure. The reaction has also been seen following CAR-T infusions and other therapies.
The system, designed for use in intensive care units, includes Terumo BCT’s Spectra Optia apheresis device and specific filters developed by Marker Therapeutics AG. The FDA’s authorization is for adult patients with imminent respiratory failure.
The Spectra Optia system is typically used for a variety of cell collection and processing procedures, including white blood cell and platelet depletion as well as red blood cell and plasma exchanges.
Marker Therapeutics AG’s Depuro 2000 cylindrical adsorption cartridges include activated charcoal granules and resins that help remove cytokines from plasma, with procedures lasting up to four hours per day. It is also used for blood detoxification following a drug overdose, poisonings or liver failure as well as sepsis and septic shock.