2nd Breakthrough Device Tag to CytoSorbents for Antithrombotic Removal System

  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 that the Company has been granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System by the U.S. Food and Drug Administration (FDA). This Breakthrough Device designation covers the removal of the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery. It follows the Breakthrough Designation received in April 2020 to remove ticagrelor for the same application.

Dr. David Cox, Vice President of Global Regulatory Affairs of CytoSorbents remarked, "The U.S. Prescribing Information for apixaban and rivaroxaban, two leading DOACs taken to reduce the risk of blood clots and associated complications, clearly warns that dosing should be stopped prior to a surgical procedure to reduce the risk of bleeding. Unfortunately, in unexpected urgent cardiothoracic surgery, this is often not possible, posing the risk of life-threatening bleeding in these patients. We are pleased that the FDA has recognized the potential of our DrugSorb-ATR Antithrombotic Removal System to reduce levels of these drugs in a patient's blood, potentially decreasing the risk of life-threatening perioperative bleeding. The achievement of two Breakthrough Designations in these situations where no approved or cleared alternatives exist is a major Company milestone that is expected to expedite our regulatory and clinical goals."

https://finance.yahoo.com/news/second-u-fda-breakthrough-device-110300782.html