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 email@example.com
(END) Dow Jones Newswires
August 12, 2021 08:27 ET (12:27 GMT)Copyright (c) 2021 Dow Jones & Company, Inc.