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FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
DrugSorb™-ATR is an FDA Breakthrough Device eligible for priority review with an FDA decision anticipated in 2025 PRINCETON, N.J., Oct. 22, 2024 (GLOBE
About this update from Cytosorbents Corporation
[{"type":"text","content":"DrugSorb™-ATR is an FDA Breakthrough Device eligible for priority review with an FDA decision anticipated in 2025\nPRINCETON, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced the U.S. Food and Drug Administration (FDA) has accepted its De Novo medical device application for DrugSorb™-ATR and initiated substantive review. The goal of DrugSorb-ATR, an investigational medical device, is to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company anticipates an FDA decision in 2025. Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “We are pleased to achieve this important milestone and to enter the substantive review phase with FDA of our De Novo application. We believe DrugSorb-ATR represents a breakthrough solution that will allow patients to proceed with their much-needed CABG surgery in a safe and timely manner rather than risking serious, potentially life-threatening complications and consuming costly hospital resources while waiting in the hospital for multiple days for ticagrelor to be naturally eliminated from their system. We are committed to working closely with FDA throughout the review process.” Ticagrelor is a blood thinning drug frequently administered in the hospital to patients suffering a heart attack. If patients are not eligible for a coronary stent, they will often require CABG surgery to restore blood flow to heart muscle. Current guidelines recommend the delay of surgery by three to five days to allow “washout” or natural elimination of the drug to reduce the high risk of serious and potentially fatal perioperative bleeding from the use of the blood thinner. The 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial evaluated the safety and efficacy...