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CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., March 16, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption
About this update from Cytosorbents Corporation
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., March 16, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to conduct the clinical study, \"Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T),\" in the United States to support an initial FDA regulatory approval. This is being done under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiac surgery.\n\n \n \n \n \n \n \n\n \nDr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, \"We are very pleased with the investigational plan, set forth in the IDE filing, that we believe accurately reflects the spirit of the Breakthrough Designation and are looking forward to the Agency's feedback. We expect that our discussions with FDA will complete in the second quarter of 2021 with the goal of beginning patient enrollment in the second half of 2021 across multiple leading U.S. institutions that have already expressed their keen interest to participate in this trial. We plan to discuss more detail on the trial upon approval of our IDE application.\"\nAbout CytoSorbents Corporation (NASDAQ: CTSO) \nCytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the \"cytokine storm\" or \"cytokine release syndrome\" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 121,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or con...