The FDA recognizes an unmet medical need and clears the path for CytoSorb® blood purification technology that helps mitigate the bleeding risk and inflammation for critically-ill and cardiac surgery patients. CytoSorb® is designed as an extracorporeal cytokine absorber to reduce the “cytokine storm” or “cytokine release syndrome” that may result in massive inflammation, organ failure and death. It is the only cleared therapy in the U.S. to rapidly reverse the effects of blood thinners in patients that require heart surgery.
The FDA granted conditional approval to begin the STAR-T Trial, a randomized, controlled clinical trial for the removal of ticagrelor (Astra Zeneca – Brilinta®, Brilique®) during cardiothoracic surgery to reduce perioperative bleeding complications. CytoSorb® blood purification technology is used during and after cardiothoracic surgery by simply placing the patient in the cardiopulmonary bypass machine blood circuit to directly remove ticagrelor from their blood.
In April 2020, the FDA granted Breakthrough Device Designation during emergent and urgent heart surgery, and FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients in certain circumstances. CytoSorb® is approved in the European Union with distribution in 67 countries outside of the US. So far, CytoSorb® has been used in more than 121,000 human treatments.
If this trial is successful, CytoSorb® is the first effective therapy for high risk cardiac patients. The conditions set forth by the FDA for the investigational device exemption (IDE) application will be addressed within the 45-day timeframe. This puts the study ahead of CytoSorbents internal schedule. If accepted, CytoSorbents will provide full details of the trial. In the future, CytoSorbents said they plan to collaborate with the FDA and the STAR-T study infrastructure for their first U.S. FDA marketing submission for label expansions.