CytoSorbents wins German gov ’ t funding for CytoSorb endocarditis trial

CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis. The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said. The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays. “We are very grateful to the German government for their commitment to fund the Remove trial in its entirety, and to Prof. Dr. med. Frank Brunkhorst, the Center for Clinical Studies Jena, and Jena University Hospital for sponsoring the study.  Infective endocarditis, or infection of a heart valve, can destroy the valve in hours to days, and can rapidly lead to emergency open heart valve replacement surgery in very sick patients that suffer from both sepsis and heart failure.  Patients are often unstable before, during, and after the surgery, and are prone to a high risk of complications and deat...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Business/Financial News Cardiovascular Clinical Trials CytoSorbents Corp. Source Type: news