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CytoSorbents Gets Second FDA Breakthrough Device Designation for DrugSorb-ATR

By Colin Kellaher

 

CytoSorbents Corp. on Thursday said the U.S. Food and Drug Administration granted a second breakthrough-device designation for its DrugSorb-ATR antithrombotic removal system.

The Monmouth Junction, N.J., provider of blood-purification technology said the new designation covers the removal of the direct oral anticoagulants apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.

The FDA last year granted breakthrough designation to DrugSorb-ATR to remove ticagrelor for the same application.

The FDA's breakthrough-devices program aims to expedite the development and review of technology that offers significant advantages over existing approved products.

Shares of CytoSorbents, which closed Wednesday at $7.80, rose more than 15% in premarket trading Thursday.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

August 12, 2021 08:27 ET (12:27 GMT)

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