EmStop Initiates CAPTURE-2 IDE Clinical Trial for Embolic Protection System in TAVR Procedures
EmStop, Inc., a cardiovascular medical device company based in Minnesota, has announced the initiation of the CAPTURE-2 Investigational Device Exemption (IDE) clinical trial. This trial aims to evaluate the safety and performance of EmStop's embolic protection system, which is designed to capture and remove debris, including thrombus, during Transcatheter Aortic Valve Replacement (TAVR) procedures. The first clinical cases have been completed at Mission Hospital in Asheville, North Carolina. The CAPTURE-2 trial is a prospective, multi-center, randomized clinical study comparing the EmStop device against existing embolic protection systems. This trial builds on the successful results of the CAPTURE-1 early feasibility study, which was presented in March 2025 at the Cardiovascular Research Technologies meeting in Washington, D.C.