First Patient Enrolled in U.S. STAR-D Pivotal Trial Evaluating the DrugSorb™-ATR Antithrombotic Removal System to Remove Apixaban and Rivaroxaban During Cardiothoracic Surgery

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[{"type":"text","content":"MONMOUTH JUNCTION, N.J., April 29, 2022 /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-Direct Oral Anticoagulants (STAR-D) double-blind, randomized, controlled clinical trial designed to support FDA marketing approval of the DrugSorb™-ATR Antithrombotic Removal System for intraoperative removal of apixaban and rivaroxaban during cardiothoracic surgery. The STAR-D trial is being performed under the auspices of an FDA Breakthrough Device Designation and is expected to enroll up to 120 patients across 30 sites in the United States. The first patient was enrolled at Virginia Commonwealth University's Pauley Heart Center by Principal Investigator Dr. Patricia A. Nicolato, D.O, Cardiothoracic Surgeon and Associate Professor in the Department of Surgery, Division of Cardiothoracic Surgery, Director of the Extracorporeal Life Support Program.\n\n \n \n \n \n \n \n\n \nCytoSorbents Enrolls First Patient in U.S. STAR-D Pivotal TrialDr. Nicolato stated, \"We frequently encounter patients on direct oral anticoagulants, such as apixaban and rivaroxaban, who need urgent cardiac surgery and are at very high risk for serious bleeding complications. Currently, there are no available solutions to help our team manage this complex clinical scenario and reduce the significant associated morbidity and excess costs. We are pleased to enroll the first patient in the pivotal STAR-D trial investigating the ability of DrugSorb™-ATR to remove apixaban or rivaroxaban during urgent cardiac surgery. If the results of STAR-D are positive, then DrugSorb™-ATR can be a safe and easy to implement solution to help cardiac surgeons around the world effectively address this important unmet medical need.\"\nDr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, \"The successful enrollment of the first patient in STAR-D represents another major executional milestone in our strategy to obtain FDA approval for antithrombotic drug removal during cardiac surgery. We continue to observe very high levels of interest from U.S. sites to participate in our STAR-T and STAR-D tri...

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