News | January 27, 2015

CytoSorbents Submits IDE Application to FDA for U.S. CytoSorb Cardiac Surgery Trial

Trial will use CytoSorb intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine

Cardiovascular surgery, CytoSorbents, corporeal cytokine adsorber

Image courtesy of CytoSorbents

January 27, 2015 — CytoSorbents Corporation announced 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 postoperative complications.

Robert Bartlett, M.D., chief medical officer of CytoSorbents and Greg Di Russo, M.D., 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.”

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.

For more information: www.cytosorbents.com

 

 

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