Cytosorbents (CTSO) Announces Filing of an Investigational Device Exemption (IDE) for U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery

March 16, 2021 3:16 PM EDT

News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.

CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to conduct the clinical study, "Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)," in the United States to support an initial 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.

Dr. Efthymios Deliargyris, MD, 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 enrollment in the second half of 2021 across multiple leading U.S. 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."



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Corporate News, FDA

Related Entities

Twitter, FDA