FDA receives IDE application for CytoSorbents' CytoSorb cardiac surgery trial

CytoSorbents Corporation, a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation in critically-ill and cardiac surgery patients, announced today that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb® intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine.



from The Medical News http://www.news-medical.net/news/20141231/FDA-receives-IDE-application-for-CytoSorbents-CytoSorb-cardiac-surgery-trial.aspx