CytoSorbents gets CytoSorb EU approval for removal of ticagrelor during CPB

CytoSorbents has secured approval from the European Union (EU) for its CytoSorb extracorporeal blood purification therapy for the removal of anti-platelet agent ticagrelor during surgery requiring cardiopulmonary bypass (CPB).

The CytoSorb whole blood adsorber has also been given CE Mark label expansion for the indication.  It was earlier approved in the European Union for the extracorporeal removal of cytokines.

AstraZeneca’s ticagrelor (Brilinta/Brilique) is a commonly used anti-platelet drug for reducing risk in patients with cardiac problems like heart attacks and strokes.

Also patients subjected to percutaneous coronary intervention with stent placement for heart attack or acute coronary syndrome are given the drug in most cases.

However, in patients on the drug needing urgent or emergent coronary artery bypass graft (CABG) surgery or other cardiothoracic surgery procedure, the risk of major fatal/life-threatening bleeding has been reportedly high.

CytoSorb has been shown to remove ticagrelor from the blood rapidly and its use during emergency cardiac surgery considerably brought down post-operative bleeding complications in an observational study, said CytoSorbents.

Vincent Capponi – Chief Operating Officer of CytoSorbents 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 is easily installed into a side circuit of the heart-lung machine during cardiopulmonary bypass, and has been used safely in thousands of cardiac surgeries for other reasons to date.”