CytoSorb to be Used to Take out Anti-platelet Drug, Ticagrelor – Approval is Obtained and Gets Ready for Use at the Time of Cardiopulmonary Bypass in the E.U.

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Feb 06, 2020, 18:18 EST

Feb 06, 2020, 18:18 /Comserve / -- The only approved therapy, CytoSorb becomes ready for use, as Ticagrelor, the Anti-platelet Drug can now be removed during Cardiopulmonary Bypass in the E.U.

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CytoSorb, a therapy developed by CytoSorbents Corporation that specializes in critical care immunotherapy focusing primarily on blood purification has recently obtained the regulatory approval in the European Union and can be used for removing the anti-platelet agent, Ticagrelor at the time of surgery that would require a cardiopulmonary bypass.

Ticagrelor is an anti-platelet drug that has been used for the purpose of lowering the risks associated with heart attacks, cardiac related deaths and strokes suffered by patients who have been victims of heart attacks earlier. It is also used in cases where those persons who are undergoing percutaneous coronary intervention that involves stent placement to be used for acute coronary syndrome or sometimes in case of heart attack. Nevertheless, those patients on whom the drug require emergency coronary artery bypass graft surgery or a cardiothoracic surgery procedure, the risk of life-threatening bleeding has been reported at 65 percent. As CytoSorb removes Ticagrelor from blood quickly, the usage of CytoSorb during the times of emergency cardiac surgery has helped reduce bleeding complications that arise post operation as per a landmark observation study. Additionally, it has helped save additional cost of USD 5000 for every single patient that also includes cost of the device.

According to Vincent Capponi, who is the COO of CytoSorbents, he had commented that CytoSorb has been the only therapy that is approved and which would be able to remove Ticagrelor. He stated that currently, all the nations in the European Union, as well as in the 58 countries where CytoSorb is being distributed have had CytoSorb only as the approved therapy. Cardiothoracic surgeons in these countries would now be able to use CytoSorb on-label at the time of surgery that involves cardiopulmonary bypass, in order to remove Ticagrelor from the body within a period of 1-2 hours, instead of 3-7 days where it is naturally cleared. This has also been mainly intended to lessen perioperative bleeding complications that are caused by this anti-platelet agent and in the process, restoring natural hemostasis. CytoSorb can be installed into a side circuit of the heart lung machine at the time of cardiopulmonary bypass and has also been applied safely for thousands of surgeries related to cardiac problems that have occurred for various other reasons till date.

The patients who have been suffering from acute coronary syndrome or who have been known to have a history of heart attack have been the most common users of Ticagrelor, with the rate of cardiac surgery being higher among such patients than the general population. About 250,000 CABG procedures are being conducted every year in the European Union alone. Germany has alone conducted about 1,00,000 CABG procedures annually.

Astra Zeneca has been marketing Ticagrelor and has been selling it under the trade name Brilique in the European Union and Brilinta in the United States. The projected value of sales globally has crossed about USD 1.5 billion in the year 2019, with Europe, developing markets, including the rest of the world accounting for more than half of the sales globally.

CytoSorb will normally be used during the periods when the patients suffers from an acute heart attack and is being checked in the hospital by providing dual anti-platelet therapy. He would be also administered with aspirin and Ticagrelor before entering the catheterization lab for percutaneous coronary intervention. However, due to multi-vessel coronary artery disease or persistent ischemia, the patient may need open heart CABG surgery on an emergency basis, which due to Ticagrelor may be faced with the risk of bleeding that would not stop. Such patient may have to be administered with a postoperative transfusion of packed red blood cells and platelets, as he has had blood loss and surgical drainage and may have to be admitted for surgery by re-opening his chest for checking the source of bleeding which puts him to higher chances of facing death. CytoSorb would be used intraoperatively at the time of cardiac surgery, so that the Ticagrelor can be removed quickly and ensure that such severe and costly bleeding complications can be lowered to a great extent.

Independent Writer

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Jackie Hurtado

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