Blood Purification System Authorized For COVID-19 Patients
The U.S. FDA issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 disease, who have been admitted to a hospital’s intensive care unit (ICU) with confirmed or imminent respiratory failure.
The FDA issued this emergency use authorization on April 10, 2020, to Colorado based Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
Terumo BCT, a U.S. based leader in blood component, therapeutic apheresis and cellular technologies, and Marker Therapeutics AG, a Swiss-based diagnostic and therapeutics company, formed this collaboration to combine their existing technologies to provide an innovative approach to potentially treat severe respiratory symptoms caused by COVID-19.
The Spectra Optia system is a therapeutic apheresis, cell processing and cell collection platform that uses continuous-flow centrifugation and optical detection technology, providing operators the ability to perform a wide variety of apheresis procedures on a single platform.
This FDA authorized product works by reducing the number 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 proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure, and death.
FDA Commissioner Stephen M. Hahn, M.D. said in a press release, “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.”
Terumo BCT’s corporate information says ‘We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers in more than 130 countries. We serve these customers with the unique combination of blood component, therapeutic apheresis and cellular technologies.’
“The pace of this collaboration between the companies is incredible. We are leaving no stone unturned in exploring existing and new ways for our products to mitigate the impact of COVID-19,” says Antoinette Gawin, CEO and President of Terumo BCT.
“By combining our plasma adsorption cartridge with Terumo BCT’s technology, this partnership offers the potential to develop a unique global solution for treatment of acute respiratory failure in COVID-19,” says David Cohen, Chairman of Marker.
Marker Diagnostics AG also has a patented and CE marked salivary clinical concussion diagnostic test in the rapidly emerging area of sncRNA-based diagnostics using qPCR analytical technology. www.markerhealth.com.
The U.S. FDA continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. The FDA is an agency that protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
COVID-19 medication, treatment and vaccine news published by Precision Vaccinations.