CytoSorbents touts Refresh trial study data

CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery. Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week. The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids. The prospective, randomized trial looked to evaluate the safety and feasibility of the CytoSorb in treating deadly inflammation in critically-ill and cardiac surgery patients between 18 and 80 years. Results from the study indicate that valve replacement surgery was the highest risk procedure for peak plasma free hemoglobin, and that treatment with the CytoSorb increased reductions in peak pfHb levels by 26% at 3.5 hours and 38% at 4 hours. Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery, according to CytoSorbents The company said that the trial achieved its primary safety endpoint with a favorable adjudication of all serious adverse events, and no significant differences in the rate of adverse events or serious adverse events at 30 days. No unanticipated adverse device effects were reported. “...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blood Management Clinical Trials CytoSorbents Corp. Source Type: news