CytoSorbents has announced the filing of an investigational device exemption (IDE) application to conduct the STAR-T clinical study—Safe and Timely Antithrombotic Removal‒Ticagrelor (STAR-T), in the USA to support an initial US Food and Drug Administration (FDA) regulatory approval.
This is being done under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiac surgery.
Efthymios Deliargyris, chief medical officer of CytoSorbents, stated: “We are very pleased with the investigational plan, set forth in the IDE filing, that we believe accurately reflects the spirit of the Breakthrough Designation and are looking forward to the Agency’s feedback. We expect that our discussions with FDA will complete in the second quarter of 2021 with the goal of beginning patient enrolment in the second half of 2021 across multiple leading US institutions that have already expressed their keen interest to participate in this trial. We plan to discuss more detail on the trial upon approval of our IDE application.”