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CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for the U.S. Clinical Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., Sept. 10, 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., Sept. 10, 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, announces the filing of an Investigational Device Exemption (IDE) application to gain FDA approval to conduct the clinical study, \"Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants (STAR-D),\" in the United States to support FDA marketing approval. This is being performed under the previously announced FDA Breakthrough Device Designation granted to DrugSorb-ATR® for the removal of apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.\n\n \n \n \n \n \n \n\n \nCytoSorbents Files IDE for U.S. Clinical Trial on Apixaban and Rivaroxaban Removal During Urgent Cardiothoracic SurgeryDr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated \"The investigational plan set forth in this IDE filing comes approximately one month after the FDA granted Breakthrough Designation for this application, demonstrating the operational efficiencies of our clinical and regulatory teams and the leveraged synergies with the previously approved and currently active U.S. STAR-T pivotal trial to remove ticagrelor during urgent cardiothoracic surgery. We expect discussions with FDA on the current IDE application to conclude in the fourth quarter of 2021 and if approved, plan to commence study initiation activities for this second DrugSorb-ATR trial immediately thereafter. We plan to provide more details on the STAR-D trial, designed to support U.S. FDA marketing approval for this additional application, in the near future.\"\nIn August 2021, the FDA granted CytoSorbents Breakthrough Device Designation to remove the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the risk of serious bleeding during urgent cardiothoracic surgery, recognizing this major unmet medical need. Apixaban (Eliquis®, Bristol Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Jansen/Bayer) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to redu...