CytoSorbents Corporation Pursues Resolution with FDA for DrugSorb-ATR to Address Critical Bleeding Risks in CABG Patients
CytoSorbents Corporation, a leader in blood purification therapies, has provided a regulatory update on its Breakthrough Device, DrugSorb-ATR. The device is designed to mitigate bleeding risks in patients undergoing coronary artery bypass grafting (CABG) surgery who have recently discontinued the blood thinner Brilinta®. The U.S. Food and Drug Administration (FDA) issued a denial letter for the De Novo Request, highlighting remaining deficiencies. CytoSorbents is actively engaging with the FDA to resolve these issues and, if necessary, plans to file a formal appeal within 60 days. The company remains committed to bringing DrugSorb-ATR to market to address this critical unmet medical need, aiming for a final regulatory decision in 2025.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CytoSorbents Corporation published the original content used to generate this news brief via PR Newswire (Ref. ID: NY78383) on May 01, 2025, and is solely responsible for the information contained therein.
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