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CytoSorbents Receives Full FDA Approval of Investigational Device Exemption (IDE) for U.S. STAR-T Trial on Ticagrelor Removal During Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., July 6, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO) announces the full approval of its Investigational Device
About this update from Cytosorbents Corporation
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., July 6, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO) announces the full approval of its Investigational Device Exemption (IDE) application to conduct the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) double-blind, randomized, controlled trial (RCT) in the United States to support FDA regulatory clearance. This study is being performed under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiothoracic surgery with CytoSorbents' proprietary polymer adsorption technology. \n\n \n \n \n \n \n \n\n \nCytoSorbents Receives Full FDA Approval to Commence STAR-T Trial in the U.S., Expects Enrollment to Start this Summer Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, \"We are pleased to announce the FDA has granted full IDE approval for the randomized, controlled, double-blind STAR-T trial designed to support regulatory clearance of the newly designated DrugSorb-ATR™ Antithrombotic Removal system for intraoperative ticagrelor removal during cardiothoracic surgery. STAR-T will enroll up to 120 patients across 20 U.S. clinical sites and is expected to begin enrollment this summer. The primary endpoint of the study will evaluate whether the use of DrugSorb-ATR with standard of care in patients on ticagrelor undergoing cardiothoracic surgery reduces the risk of peri-operative bleeding complications compared to standard of care alone. The trial will also evaluate reductions in ticagrelor blood levels and a number of additional outcomes to capture the full potential clinical and cost-economic benefits of DrugSorb-ATR. We believe the study can be completed in 2022 based on the high level of excitement and engagement we are seeing from participating sites. Finally, we will continue to collaborate closely with the FDA to leverage the priority review associated with our ticagrelor removal application in the spirit of the granted Breakthrough Designation.\"\nMichael Mack, MD, Chair of Cardiovascular Service Line at Baylor Scott & White Health, President of Baylor Scott & White Research Institute, and Principal Co-Investigator of the STAR-T study stated, \"Performing cardiac surgery in patients while on antithrombotic agents such as ticagrelor is a major ...