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Development Update: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., April 20, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its
About this update from Cytosorbents Corporation
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., April 20, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Designation to CytoSorb for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. The Breakthrough Devices Program provides for more effective treatment of life-threatening or irreversibly debilitating disease or conditions, in this case the need to reverse the effects of ticagrelor in emergent or urgent cardiac surgery that can otherwise cause a high risk of serious or life-threatening bleeding. Through Breakthrough Designation, FDA will work with CytoSorbents to expedite the development, assessment, and regulatory review of CytoSorb for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k) or premarket approval (PMA)) consistent with the Agency's mission to protect and promote public health. \n\n \n \n \n \n \n \n\n \nTicagrelor (Astra Zeneca - Brilinta®, Brilique®) is one of the most commonly used anti-platelet drugs or \"blood thinners\" to reduce the risk of cardiac death, heart attacks, and strokes in patients with acute coronary syndrome (ACS; i.e., situations where the blood supplied to the heart is suddenly blocked) or a history of a heart attack. It is also used to reduce the rate of stent thrombosis in patients who have been stented for treatment of ACS. However, when patients on ticagrelor require emergent cardiac surgery (e.g., coronary artery bypass graft surgery or CABG, dissecting aortic aneurysm repair, infective endocarditis, etc.), the risk of serious or life-threatening bleeding and complications is very high. There are no approved or cleared therapies in the U.S. to rapidly reverse the effects of, or remove ticagrelor in these patients. \nMr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, \"We are excited to receive FDA Breakthrough Designation of CytoSorb for the removal of ticagrelor during emergent and urgent cardiothoracic surgery. This breakthrough designation represents another co...