CytoSorbents has secured approval for CytoSorb for the removal of the anti-platelet agent ticagrelor from blood during cardiopulmonary bypass in the European Union (EU).
CytoSorb, which achieved EU regulatory approval and CE Mark label expansion, can be used to meet the unmet medical need of life-threatening postoperative bleeding in cardiothoracic surgery patients.
Astra Zeneca’s drug ticagrelor can reduce the risk of cardiac death, heart attacks, as well as strokes in patients.
As part of an observational study, the use of CytoSorb during emergency cardiac surgery significantly reduced bleeding complications after the surgical operation.
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 antiplatelet agent, while restoring natural hemostasis.”
During cardiopulmonary bypass, the device CytoSorb can be installed into a side circuit of the heart-lung machine.
It is the first approved extracorporeal cytokine adsorber in the EU. It is compatible with standard haemodialysis machines, continuous renal replacement therapy machines, heart-lung machines and other blood pumps.
Astra Zeneca markets and sells ticagrelor under the tradenames Brilique in the EU and Brilinta in the US.
The European Commission approved AstraZeneca’s Brilique (ticagrelor) in February 2016 to treat patients with a history of heart attacks.