A blood purification device for treating certain adult COVID-19 patients received an emergency use authorization from the FDA, the agency announced Friday morning.
Spectra Optia Apheresis System with Depuro D2000 Adsorption Cartridge by Terumo BCT and Marker Therapeutics is designed for adults in intensive care units with novel coronavirus infections and "confirmed or imminent respiratory failure" the FDA said.
As explained by the FDA, the device reduces the number of cytokines, a group of proteins emitted by parts of the immune system. That is designed to cut down on the chance of "cytokine storm" in COVID-19 patients, which causes lung problems that increase the chances the patient will die.
"A cytokine storm is an overproduction of immune cells and their activating compounds _ cytokines _ which, in something like a flu infection, is often associated with a surge of activated immune cells into the lungs," according to "Cytokine Storm: The Sudden Crash in Patients with COVID-19," an article that posted to PhysiciansWeekly.com on Wednesday.
A March 31 article by doctors in China shared and posted to the U.S. government's National Center for Biotechnology Information site says, "Expeditious control of the cytokine storm in early phase might be beneficial to selective patients, and blood purification therapy is effective in our limited experiences."
"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," FDA Commissioner Dr. Stephen M. Hahn said. "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."
