The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices, two blood purification systems to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19).

The authorized product should be only used in patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. According to the FDA, the blood purification systems work by reducing the number of cytokines and other inflammatory mediators, i.e., 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. They also informed 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.

The Spectra Optia system is an industry-leading therapeutic apheresis, cell processing and cell collection platform that allows operators to spend more time focusing on patient care. This advanced system uses continuous-flow centrifugation and optical detection technology, providing operators the ability to perform a wide variety of apheresis procedures on a single platform. Terumo BCT Inc

"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, M.D. "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."

Spectra Optia Apheresis System
Spectra Optia Apheresis System has been authorized under an Emergency Use Authorization (EUA) for emergency use for treatment of patients with confirmed COVID-19 who are showing certain severe symptoms (including high fever, persistent cough, developing more difficulty breathing) indicating that they are likely to get more ill within the next 1-24 hours. These devices have the potential to remove substances in your blood that are not allowing the immune system to function normally. Spectra Optia Apheresis

Potential benefits of these two devices include:

  • Removal of substances from the blood that are causing your immune system to not function properly

Potential risks of these two devices include:

  • Very low blood pressure and reduced delivery of blood to vital organs
  • Abnormal heart rhythm
  • Bleeding
  • Clotting
  • Stroke from the air in the bloodstream
  • Infection
  • Damage to blood cells
  • Reduction in blood cells (platelets and white blood cells)

The FDA issued this emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.