Device Description
The Depuro D2000 Cartridge consists of a sterile, self-contained disposable Cartridge. The Cartridge is intended to assist in blood detoxification. It can be used in instances of drug overdose, hepatic encephalopathy, liver failure, in any condition which results in the release of endotoxin into the bloodstream, and in any condition which generates excess inflammatory response, such as sepsis, septic shock, or systemic inflammatory response syndrome (SIRS).
The Depuro D2000 Cartridge operates in conjunction with standard CRRT devices, or with any plasma separation device in the hospital. The Cartridge is integrated into the extracorporeal circuit, downstream from where the plasma is separated. After priming the D2000 Cartridge and assembling the inlet and outlet lines to the plasma separation extracorporeal circuit, plasma filtration should run for 4 hours, to be repeated as needed.
In bench testing, the Depuro D2000 Cartridge has been shown to remove statistically significant proportions of IL-3, IFN-gamma, IL-10, IL-1B, IL-6, IL-8, MCP-1, TNF-alpha, creatinine, bile acids, and bilirubin when compared to control. The adsorption materials used in the D2000 Cartridge have also been demonstrated to be efficacious in the treatment of drug overdose, including acetaminophen overdose, uremia, barbiturate poisoning, and in the removal of glutethimide.
Treatment duration and indication for exchange of the cartridge depend on the clinical course. The maximum treatment time per single cartridge is 4 hours.