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The BioLogic-DTPF System™ uses a single lumen 10F venous catheter and combines a hemodiabsorption system using 2 l of sorbent suspension, flowing through the dialysate side of a parallel plate cellulosic dialyzer with whole blood perfusion on the blood side (the BioLogic-DT™ System), in series with a push-pull pheresis system (BioLogic-PF System™). Bidirectional plasma flow (80–100 ml/min) across the 0.5 micron PF membranes provide direct contact between plasma protein and powdered sorbent suspension of either charcoal or charcoal and silica. In vitro tests using whole blood have demonstrated that the BioLogic-DTPF clears cytokines (TNF-α, IL-lβ, and IL-6) at a rate of 15–25 ml/min, without evidence of saturation of sorbent during 90 min run times. Systemic Inflammatory Response Syndrome (SIRS) is the most common manifestation of cyrokine mediated disease in ICU patients. A Food and Drug Administration-approved Investiganonal Device Exemption permits a phase I preliminary safety and efficacy study of a single 6 h BioLogic-DTPF treatment of 8 patients with SIRS and organ failure due to sepsis. |
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