The CytoSorb adsorber is a CE-mark approved Class 2b medical device that is the only specifically approved extracorporeal cytokine adsorber in the European Union. It is approved for use in clinical situations where cytokines are elevated and is compatible with standard hemodialysis and heart-lung machines found in hospitals worldwide.
CytoSorb comprises several important features: An advanced biocompatible and hemocompatible porous polymer sorbent bead technology with extremely high binding capacity, documented ability to reduce a broad range of cytokines and other inflammatory mediators, and good safety in thousands of human treatments. The goal is to reduce, but not eliminate, cytokines to levels that are no longer toxic, while still keeping the immune system intact.
The CytoSorb adsorber is composed of biocompatible porous polymer beads, each roughly the size of a grain of salt, that act like tiny sponges to remove substances from whole blood based on pore capture and surface adsorption. Substances that are larger than the pores, such as blood cells, cannot get into the pores and go around the beads. Very small substances, such as electrolytes and other blood chemistries, are also not captured.
Appropriately sized molecules in the 5-60 kDa range, however, get trapped in the vast network of pores and channels in every bead, and are permanently eliminated from blood. CytoSorb was specifically designed to target this molecular weight range, given that the majority of cytokines and inflammatory mediators fall within this size spectrum. Because of this, CytoSorb is a broad spectrum solution to cytokine storm and inflammation. The technology is not an affinity-based sorbent and does not use antibodies, ligands, cells or drugs.
During CytoSorb therapy, the patient’s entire blood volume is recirculated continuously through the adsorber, technically similar to extracorporeal hemoperfusion. With an estimated total surface area of more than 40,000 square meters (>4 European soccer fields), an adsorber is able to decrease high cytokine levels efficiently and remain effective over an extended period of time (up to 24 hours). CytoSorb binds proteins exceptionally well, and does so in a concentration dependent manner. Very high concentrations of cytokines and other substances are removed very efficiently, while normal to high normal levels are not significantly removed. This makes it difficult to over-treat and improves the safety profile of the technology.
CytoSorb is ISO 10993 biocompatible, meeting strict standards of hemocompatibility and biocompatibility, and is not genotoxic, cytotoxic, and does not cause complement activation or acute sensitivity. CytoSorb is compatible with both systemic heparin or regional citrate anti-coagulation. The adsorber is gamma sterilized and has a shelf-life of three years at room temperature.
The goal of CytoSorb therapy is to counter the effects of high circulating levels of cytokines and inflammatory mediators, thereby modulating deadly, spiraling inflammation, and either preventing or treating organ failure. CytoSorb represents a new therapy to help physicians regain control of their patients suffering from SIRS and Sepsis.