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First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in
About this update from Cytosorbents Corporation
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support FDA marketing approval of the DrugSorb-ATR™ Antithrombotic Removal System for intraoperative removal of ticagrelor during cardiothoracic surgery. The STAR-T trial received full FDA IDE Approval in July 2021, and is being performed under the auspices of FDA Breakthrough Designation granted in April 2020. The STAR-T trial is expected to enroll up to 120 patients across 20 sites and be completed by 2022. The first patient was enrolled by Dr. Bradley S. Taylor, Chief of the Division of Cardiac Surgery and Director of Coronary Revascularization and site Principal Investigator at the University of Maryland Medical Center. \n\n \n \n \n \n \n \n\n \nFirst Patient Enrolled in U.S. STAR-T Trial Evaluating DrugSorb-ATR™ to Remove Ticagrelor During Cardiothoracic SurgeryDr. Bradley S. Taylor stated, \"Ticagrelor is an antiplatelet agent routinely used in the management of patients with acute coronary syndrome to reduce the risk of death, myocardial infarction, and stroke. However, when urgent surgery is required, patients on ticagrelor are at very high risk of serious and potentially fatal bleeding. We are very pleased to enroll the first patient in the landmark STAR-T study that is investigating the ability of DrugSorb-ATR™ to remove ticagrelor during surgery and reduce the risk of bleeding in these patients. If positive, STAR-T could establish DrugSorb-ATR as an easily implemented solution that addresses a long-standing, frequent, and critical unmet medical need faced by cardiac surgery centers around the world.\"\nDr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, \"Removing antithrombotic agents intraoperatively with the DrugSorb-ATR system in patients requiring urgent cardiac surgery has the potential to save lives, reduce morbidity and provide substantial cost savings to heart centers around the world. The FDA approved STAR-T trial has now left the station...