FDA Authorizes Blood Purification Device for COVID-19
The system can be used among adult patients with COVID-19 who have been admitted to the ICU and are currently experiencing or will experience respiratory failure.
The US Food and Drug Administration (FDA) has granted emergency use authorization for a blood purification system to treat adult patients with coronavirus disease 2019 (COVID-19). The system can be used among patients 18 years or older who have been admitted to the intensive care unit and are currently experiencing or will experience respiratory failure.
The authorization was granted to the Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices by Terumo BCT Inc. and Marker Therapeutics AG.
The products reduce the amount of cytokines and inflammatory mediators by filtering the patient’s blood and returning the filtered blood back to the patient. According to the FDA’s statement, the device will filter out the proteins that become elevated during infection and may be associated with a “cytokine storm.” It is the elevated levels of these proteins that can lead to severe inflammation, shock, respiratory failure, organ failure, and death in some COVID-19 patients.
“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, in the announcement. “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.”