The Food and Drug Administration has authorized the first blood purification system to treat adults with very serious cases of coronavirus.
The system is for patients 18 years and older who have been admitted to intensive care with confirmed or imminent respiratory failure.
The system, approved Thursday, reduces the amount of small active proteins in the bloodstream that control a cell’s immune response — known as cytokines — by filtering the blood and returning the filtered blood to the patient.
The proteins that are removed are linked to a “cytokine storm” and are typically higher during infections, causing severe inflammation, rapidly progressive shock, respiratory and organ failure and death, the FDA said.
“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 Hahn. “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.”
The federal agency issued the emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
The FDA has issued multiple emergency use authorizations for ventilators, personal protective equipment and diagnostics during the coronavirus crisis.
