April 10, 2020

FDA issues EUA for blood purification device to treat COVID-19

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

According to the FDA, the authorized product works by reducing the amount 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. The FDA added 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. This leads to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.

“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”, said FDA Commissioner Stephen M. Hahn, M.D.

The FDA issued this EUA for the Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.

SOURCE: FDA
Popular with Other Subscribers

Popular with Other Subscribers

Click to view learning opportunity
 
Click to view learning opportunity
 
Click to view learning opportunity
View All >