US-based immunotherapy provider CytoSorbents has secured the CE Mark approval to market its whole blood adsorber CytoSorb in the European Union, with expanded label indication.
CytoSorb has been previously approved for the extracorporeal removal of cytokines, and the current approval expands the label indication to include the removal of anti-platelet agent ticagrelor, during cardiopulmonary bypass (CPB) surgery.
CytoSorbents chief operating officer Vincent Capponi said: “CytoSorb is the only approved therapy to remove ticagrelor in the European Union and in all 58 countries where CytoSorb is distributed.
“Cardiothoracic surgeons in these territories can now use CytoSorb on-label during surgery involving cardiopulmonary bypass, to rapidly remove ticagrelor from the body in 1-2 hours, as compared to 3-7 days with natural clearance, with the intent to reduce perioperative bleeding complications caused by this potent anti-platelet agent, while restoring natural hemostasis.”
CytoSorb removes ticagrelor from the blood, facilitating cardiac procedures
Ticagrelor is marketed by Astra Zeneca as Brilinta in EU and Brilique in the US. The drug is commonly used as anti-platelet drug to reduce the risk of cardiac death, heart attacks, and strokes in patients.
The drug is mostly used by the patients with history of heart attack, or those subjected to percutaneous coronary intervention (PCI) with stent placement for acute coronary syndrome or heart attack.
Patients requiring urgent coronary artery bypass graft (CABG) surgery or other cardiothoracic surgery procedures are at the risk of fatal bleeding.
CytoSorb is said to remove ticagrelor rapidly from blood, and is used during emergency cardiac surgery to reduce the post-operative bleeding complications.
Capponi added: “Bleeding complications are the major adverse event for all three major anti-platelet drugs used in dual anti-platelet therapy for acute coronary syndrome. Of these, only ticagrelor has the distinction of being technically reversible, a theoretical safety benefit that until now has not been realized because no reversal agent had been approved in the US, Europe, or elsewhere.
“Now that we can officially market this application on-label internationally, we plan to drive CytoSorb as standard of care for the removal of ticagrelor during cardiopulmonary bypass procedures in every country we serve, supported by additional studies in the U.K and elsewhere.”
