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. The goal of CytoSorb® treatment is to reduce inflammatory mediators and proteins such as cytokines and plasma free hemoglobin generated during surgery that can lead to serious post-operative complications.
Dr. Robert Bartlett, Chief Medical Officer of CytoSorbents, and Dr. Greg Di Russo, Senior Vice President of Clinical Development at CytoSorbents said in a joint statement, "Intra-operative use of CytoSorb® represents an innovative new strategy to improve the safety of complex cardiac surgical cases, and to reduce inflammation generated during the surgery. Currently, there are no practical alternatives approved in the U.S. or Europe to address this significant problem. We believe the proposed trial protocol, designed with significant input from our cardiac surgery advisory board, is well-designed to be effectively conducted by our clinical trial sites which include many of the leading cardiac surgery centers in the country. With approval, we will begin the clinical trial as soon as possible."
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "The submission of this IDE application represents a major milestone for the Company, initiating the clinical trial process needed to seek approval of CytoSorb® in the United States. With approximately half a million cardiac surgery procedures such as valve replacement and coronary artery bypass graft surgeries each year in the U.S. alone, and another one million in the rest of the world annually, we believe this represents a significant potential commercial opportunity for the Company."
All investigational medical devices require IDE approval before they can be used in U.S.-based clinical studies to evaluate safety and efficacy. This is a similar concept to the Investigational New Drug (IND) path for drug trials. CytoSorb® is currently approved in the European Union as an extra-corporeal cytokine adsorber, and installs easily and quickly into a bypass circuit in a standard heart-lung machine.
CytoSorb® has been used safely intra-operatively in well over 100 cardiac surgeries in Europe to date.
Source : CytoSorbents Corporation