Emergency use authorization can be had.....BY Dow
Post# of 153887
(Total Views: 586)
Posted On: 04/11/2020 7:14:58 AM
Emergency use authorization can be had.....BY Dow Jones & Company, Inc.
— 9:13 AM ET 04/10/2020
The U.S. Food and Drug Administration said it has issued an emergency-use authorization for a blood-purification system to treat Covid-19 patients who have been admitted to the intensive care unit with respiratory failure.
The agency said Friday it granted the authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices. The FDA uses the authorization to help increase the availability and use of certain supplies and equipment needed during public-health emergencies.
The device reduces the amount of cytokines or other small active proteins in the bloodstream that control a cell's immune response by returning filtered blood to the patient, the agency said.
The proteins, which are typically elevated during infections in what is known as a "cytokine storm," could lead to severe inflammation, respiratory and organ failure and death, the FDA said.
"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 Stephen 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."
— 9:13 AM ET 04/10/2020
The U.S. Food and Drug Administration said it has issued an emergency-use authorization for a blood-purification system to treat Covid-19 patients who have been admitted to the intensive care unit with respiratory failure.
The agency said Friday it granted the authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices. The FDA uses the authorization to help increase the availability and use of certain supplies and equipment needed during public-health emergencies.
The device reduces the amount of cytokines or other small active proteins in the bloodstream that control a cell's immune response by returning filtered blood to the patient, the agency said.
The proteins, which are typically elevated during infections in what is known as a "cytokine storm," could lead to severe inflammation, respiratory and organ failure and death, the FDA said.
"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 Stephen 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."
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