CytoSorb® approved by the EU to remove rivaroxaban, a Factor Xa inhibitor

• Published Month : Wednesday, 13 May 2020 12:00 pm

EU approved CytoSorb® to remove rivaroxaban, a leading Factor Xa inhibitor and new oral anticoagulant, during pumping cardiothoracic surgery

CytoSorbents Corporation , a critical care immunotherapy firm specializing in blood purification, announces that CytoSorb®  is now approved and immediately available in the European Union for the withdrawal of rivaroxaban ( Xarelto® - Bayer, Jansenn / Johnson & Johnson), a widely used Factor Xa inhibitor and new oral anticoagulant (NOAC), during cardiothoracic surgery requiring cardiopulmonary bypass (CPB). With this release and the EU approval earlier this year to withdraw the anti-platelet inhibitor P2Y 12 , ticagrelorFor the same indication, CytoSorb is providing cardiac surgeons and perfusionists with a new, easy and fast treatment option to help reduce the risk of serious and potentially fatal perioperative bleeding complications caused by these two drugs, in different categories of anticoagulants.  

Vincent Capponi , COO and CEO of CytoSorbents, said: " Rivaroxaban was the # 10 best-selling prescription drug based on global revenue in 2018 , and cumulatively,  more than 40 million people worldwide have been prescribed the drug.. Given the high prevalence of coronary and vascular disease in these patients, it is not surprising that many patients require urgent or emergent cardiothoracic surgery each year, where rivaroxaban puts them at risk for serious bleeding complications. CytoSorb can rapidly reduce rivaroxaban during a typical coronary artery bypass graft (CABG) surgical procedure, so waiting 2-3 days without the drug to allow the anticoagulant to pass from the body is no longer necessary. Since CytoSorb is already being stored in many coronary care centers for use during a variety of pumped cardiac surgical procedures, we believe that the decision must be made to use CytoSorb to phase out rivaroxaban. Furthermore, as the only therapy that reduces ticagrelor and rivaroxaban, cost more than $ 20,000 per dose . We also believe that CytoSorb has the potential to become a competitive and cost-effective standard of care for anticoagulant withdrawal during cardiac surgery "_ =" _ "/>

Dr. Phillip Chan , CEO of CytoSorbents, said: "We believe this expansion of the CE Mark label could be another driver of future sales growth for CytoSorb. We plan to take advantage of the same marketing channels we are using for the removal of ticagrelor during cardiac surgery with a broader and more competitive value proposition for cardiac surgeons and perfusionists CytoSorb has a long history of safe use and support for cardiopulmonary bypass and is now the only therapy specifically approved to withdraw or reverse the effects of ticagrelor and rivaroxaban during cardiothoracic surgery in the European Union and in the 58 countries we serve. "  

Rivaroxaban  ( Xarelto® ) is a commonly used Factor Xa inhibitor and a new oral anticoagulant to reduce the risk of blood clots in common conditions such as atrial fibrillation (AFib), deep vein thrombosis (DVT), and pulmonary embolism (PE). Rivaroxaban is also approved to reduce the risk of major cardiovascular events in conditions such as coronary artery disease (CAD) and peripheral artery disease (PAD). Rivaroxaban is used globally, with approximately  $ 4.5 billion in 2019 sales outside the U.S. USA  driven by Europe and Asia , and  2019 US sales of $ 2.3 billion. Concern about uncontrolled bleeding in emergent surgery is increasing as the use of NOACs is expanding more and more. According to the documentation, it  is estimated that between 8 and 10% of patients on anticoagulant therapy will require emergent surgery at some point in their lives . Historically, in the case of cardiac surgery where the risk of postoperative bleeding is high,  a 48-hour washout period is recommended  for elective surgery. By reducing rivaroxaban during surgery, CytoSorb has the potential to eliminate the need for this delay, while reducing the pro-thrombotic risks of not having these agents, and in turn reducing bleeding complications. For example, in a series of retrospective cases of patients (n = 12) who required emergency cardiac surgery with rivaroxaban  and were unable to delay surgery, the incidence of bleeding events (eg, need for blood transfusions, rate of thoracotomy, volume drainage) and ICU and hospital admission time were lower in those treated with CytoSorb compared to those who were not.