Benzinga | Sep 10, 2021 07:13AM EDT

CytoSorbents Announces Filing Of Investigational Device Exemption For US Clinical Trial On Apixaban And Rivaroxaban Removal By DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

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(r) for the removal of apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.