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 BMY / Pfizer 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.