The FDA issued an emergency use authorization for a blood purification system to treat patients 18-and-older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.
The Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices work by reducing the amount of cytokines and other inflammatory mediators, which are small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient.
The system removes proteins that 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.
“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, MD. “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.”
The FDA issued this emergency use authorization to Terumo BCT Inc and Marker Therapeutics AG.