The EUA status will allow to use the blood purification system to treat patients aged 18 year and older with confirmed COVID-19 disease
The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for a blood purification system to treat COVID-19 disease.
The EUA status will enable to use of the blood purification system for the treatment of patients aged 18 years and older with confirmed COVID-19 disease admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
Terumo BCT and Marker Therapeutics have secured EUA status for their Spectra Optia apheresis system and Depuro D2000 adsorption cartridge devices.
The authorised product enables to decrease the amount of cytokines and other inflammatory mediators
Moreover, the authorised product decreases the amount of cytokines and other inflammatory mediators such as small active proteins in the bloodstream, which control a cell’s immune response by filtering the blood and returning the filtered blood to the patient.
The proteins, which are removed are commonly inflated during infections, can be linked with a cytokine storm that occurs in some COVID-19 patients. It may lead to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
The FDA commissioner Dr Stephen Hahn 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.
“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.”
Recently, Becton, Dickinson and Company (BD), along with BioGX, has secured the EUA status from the FDA for a new COVID-19 diagnostic test.
The new diagnostic helps hospitals screen patients for SARS-CoV-2 virus on-site and deliver results within three hours.