CytoSorbents, a critical care immunotherapy leader commercializing its flagship CytoSorb blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announces the launch and initial sales of its new CytoSorb Cardio-Pulmonary Bypass (CPB) Procedure Pack for cardiac surgery.
This new product provides all of the necessary components, including the CytoSorb cartridge, to rapidly and seamlessly integrate CytoSorb into the majority of heart-lung machines used in open heart surgery today.
CytoSorb has been used intra-operatively in thousands of heart operations in Europe to either help stabilize unstable patients during surgery or to prophylactically treat patients at risk of severe inflammation caused by the surgery.
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "The CytoSorb CPB Procedure Pack was developed by our product management and engineering teams with key input from cardiac surgeons and perfusionists.
It is the first of a series of value added procedure kits that we plan to introduce into the market in 2017 to improve the end-user experience."
Mr. Capponi continued, "We are also delighted to count our partner, Terumo Cardiovascular Group, among the first customers to have ordered the CytoSorb CPB Procedure Pack. We have worked closely with Terumo, a global leader in cardiac and vascular surgery, to finalize all documentation, marketing material, and sales force training, and are pleased that they have now officially launched sales of CytoSorb in their exclusive market territories of France, Denmark, Sweden, Finland, Norway, and Iceland."
The CytoSorb CPB Procedure Pack is now available for volume purchase by direct customers and distributors worldwide.
CytoSorbents is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb is approved in the European Union with distribution in 42 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy.
These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.
CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial – a multi-center, randomized controlled study that has demonstrated the safety of intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery.
In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 17,000 human treatments to date.