The FDA has issued emergency use authorization (EUA) to Terumo BCT (OTC:TRUMY;TYO:4543) and Marker Therapeutics for a blood purification and oxygenation system to treat patients with COVID-19.
Lakewood, Colo.-based Terumo’s Spectra Optia apheresis system works with the Depuro D2000 adsorption cartridges made by Marker Therapeutics to reduce the number of cytokines and other inflammatory blood proteins that control a cell’s immune response, filtering the blood and returning it 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, according to the FDA.
The agency has begun relaxing its regulation of blood-filtration devices during the coronavirus pandemic. It issued new guidance this week to help expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to treat COVID-19 patients. Extracorporeal circuits and accessories for long-term respiratory/cardiopulmonary failure, including devices used for ECMO therapy, provide assisted extracorporeal circulation and physiologic gas exchange of a patient’s blood for more than 6 hours.
In February, Fresenius (NYSE:FMS) announced that it had gained a 510(k) clearance for its Novalung system, which reduces or eliminates the need for mechanical ventilation by pumping a person’s blood through an oxygenator for gas exchange.
Fresenius boasted that the Novalung is the first extracorporeal membrane oxygenation (ECMO) system cleared to provide more than six hours of outside-the-body life support. The company is planning a U.S. launch in mid-2020.
“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 agency commissioner Stephen Hahn in a news 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.”
