CytoSorbents has submitted an Investigational Device Exemption (IDE) application to the US 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 haemoglobin generated during surgery that can lead to serious post-operative complications.
Robert Bartlett, chief medical officer of CytoSorbents, and 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 USA 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 centres in the country. With approval, we will begin the clinical trial as soon as possible.”
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.