Health Canada has granted Medical Device Authorisation for the importation, sale, and emergency use of critical care immunotherapy company CytoSorbents’ blood purification technology to treat hospitalised Covid-19 patients under Interim Order (IO) ID# 316575.
CytoSorb is used to treat fatal inflammation in critically ill and cardiac surgery patients worldwide.
It will be commercially available in North America and 67 other countries across the world for use in Covid-19 patients.
The company will partner with speciality medical products distributor in Canada, ebbtides medical, to make the treatment available rapidly and extensively.
The IO of the Canadian Government helps to make health products available to fight public health emergencies such as the Covid-19 pandemic.
CytoSorbents president and chief operating officer Vincent Capponi said: “Cases of Covid-19 have been steadily rising in Canada with approximately 600,000 confirmed cases already.
“Last month marked our first shipments of CytoSorb into Canada and we plan to work closely with ebbtides medical to deploy CytoSorb in hospitals throughout Canada to help as many patients as possible, particularly as most of the world waits for the Covid-19 vaccine.”
Furthermore, CytoSorb secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for use in critically ill Covid-19 patients who are likely to have or confirmed respiratory failure.
Last April, the technology received US FDA EUA and marketing approval in Mexico as a wide-ranging extracorporeal cytokine adsorber to be used in various critical ailments and cardiac surgery.
CytoSorbents’ purification technologies use biocompatible, highly porous polymer beads, which can eliminate toxic substances from blood and other bodily fluids using pore capture and surface adsorption method.
In January last year, CytoSorbents secured approval for CytoSorb for the removal of the anti-platelet agent ticagrelor from blood during cardiopulmonary bypass in the EU.