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# FDA Rejects CytoSorbents Bleed Reducing Device
- URL: https://www.fdaweb.com/fda-rejects-cytosorbents-bleed-reducing-device/
- Published: 2025-05-02T12:00:00.000Z
- Updated: 2026-09-14T15:10:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159109

FDA has denied a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, an agency-designated breakthrough device intended for reducing the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within two days of stopping the antiplatelet drug Brilinta (AstraZeneca’s ticagrelor). In its denial letter, FDA cited remaining deficiencies that must be addressed before the de novo request can be granted, according to the company.

CytoSorbents says it has begun discussions with the agency to better understand the deficiencies. “However, if these conversations do not lead to a resolution, a formal appeal will be filed within 60 days,” it adds.