CytoSorbents’ Antithrombotic Removal System Named FDA Breakthrough Device Again

CytoSorbents has received a second Breakthrough Device designation from the FDA for its DrugSorb-ATR antithrombotic removal system.

The blood purification device is used to reduce the risk of life-threatening bleeding in patients who have been taking oral anticoagulants and who need urgent surgery.

The new designation is for removal of the anticoagulants apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious bleeding during cardiothoracic surgery.

The company previously received a Breakthrough Device designation from the agency in April 2020 for use of the device to remove the blood thinner ticagrelor during cardiothoracic surgery.