Product safety matters. CytoSorb is CE Mark approved under the Medical Devices Directive, is ISO 10993 biocompatible, and is manufactured in the United States under ISO 13485 certification. CytoSorb is the only specifically approved extracorporeal cytokine adsorber in the European Union. Over 56,000 treatments been performed in more than 800 clinical departments around the world have shown the safety of the therapy. The device is considered safe and well-tolerated.
The setup and application procedures of this device are simple, and technicians require little training. CytoSorb has standard dialysis connectors that allow seamless integration with hemodialysis machines, CRRT machines, and heart-lung machines found in most hospitals today. Treatment is easier than dialysis, and there is no need for additional equipment, dialysate, replacement fluid, or ultra-filtrate waste disposal. CytoSorb is compatible with either systemic heparin or regional citrate anti-coagulation, with the same anti-coagulation requirements as for dialysis or on-pump cardiac surgery.
Based on the Company’s European Sepsis Trial, there is no adverse removal of leukocytes or red blood cell hemolysis during treatment. As with most extracorporeal therapies, some platelets are removed during therapy but the amount was less than 10% per treatment and was not clinically significant. Average albumin removal was less than 10% after 7 days of CytoSorb therapy and not clinically significant. (Ref: 1-5)
Furthermore, the safe use of the CytoSorb therapy has been described in a number of case reports from various clinical fields of application.