CytoSorbents' Antithrombotic Removal System Scores Second FDA Breakthrough Device Tag

  • The FDA has granted a second Breakthrough Device designation to  CytoSorbents Corporation's CTSO DrugSorb-ATR Antithrombotic Removal System. 
  • The designation covers removing the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of severe perioperative bleeding in cardiothoracic surgery. 
  • It follows the Breakthrough Designation received in April 2020 to remove ticagrelor for the same application.
  • Apixaban (Eliquis, Bristol Myers Squibb & Co BMYPfizer Inc PFE) and rivaroxaban (Xarelto, Johnson & Johnson JNJ) are two of the most commonly prescribed anticoagulants.
  • Based on CytoSorbents' estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent cardiothoracic surgery on an annual basis.
  • In July, the FDA signed off the STAR-T trial for ticagrelor removal during cardiothoracic surgery using CytoSorbents' DrugSorb ATR system.
  • Price Action: CTSO shares are up 1.64% at $7.96 during the market session on the last check Thursday.
  • Related content: Benzinga's Full FDA Calendar.
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