CytoSorbents announces 'positive' data from REFRESH I cardiac surgery trial
CytoSorbents announced positive top-line safety data from its recently completed randomized, controlled REFRESH I cardiac surgery feasibility and safety trial. Following a detailed review of all reported adverse events in a total of 46 enrolled patients, the independent Data Safety Monitoring Board found no safety concerns related to the CytoSorb device, achieving the primary safety endpoint of the trial and fulfilling a key requisite to move forward with a larger, definitive pivotal study. In addition, the therapy was well-tolerated and technically feasible, implementing easily into the cardiopulmonary bypass circuit without the need for an additional external blood pump. This study represents the first randomized controlled trial demonstrating the safety of intra-operative CytoSorb use in patients undergoing high risk cardiac operations.