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CytoSorbents Announces Filing Of An Investigational Device Exemption For US Trial On Ticagrelor Removal During Cardiothoracic Surgery


Benzinga | Mar 16, 2021 03:17PM EDT

CytoSorbents Announces Filing Of An Investigational Device Exemption For US 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 (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.






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