EmStop Inc. Launches CAPTURE-2 Clinical Trial for Innovative Heart Device

EmStop™ Launches CAPTURE-2 Clinical Trial

EmStop, Inc., known for its focus on cardiovascular medical devices, has recently announced the commencement of the CAPTURE-2 Investigational Device Exemption (IDE) clinical trial. This initiative marks a significant stride in the development and commercialization of the first integrated embolic protection system for Transcatheter Aortic Valve Replacement (TAVR) procedures.

The initial clinical procedures were successfully carried out at Mission Hospital located in Asheville, North Carolina. The purpose of the CAPTURE-2 trial is to evaluate the safety and performance of the EmStop embolic protection system, which is still under investigation. This system is designed to function as a cerebral embolic protection device, specifically aimed at capturing and removing debris, including thrombus, throughout standard TAVR procedures.

Importance of the CAPTURE-2 Trial

This clinical study is structured as a prospective, multi-center, randomized trial which will directly compare the EmStop device with the currently available embolic protection systems. The ramifications of this study could be profoundly beneficial in improving the safety protocols associated with TAVR procedures, thereby enhancing patient outcomes.

Phil Ebeling, EmStop’s President and CEO, expressed his enthusiasm regarding the trial by stating, "The CAPTURE-2 clinical trial represents another step in the understanding and advancement of the important role that embolic protection systems can play in TAVR procedures." He emphasized that the team is eager to collaborate with clinical research partners to push the envelope on stroke prevention in TAVR patients.

Leading the charge as the National Primary Investigator of the study is Dr. Stanley J. Chetcuti, the Structural Heart Medical Director at the University of Michigan Health. He noted that even though stroke is a relatively rare occurrence during TAVR, it remains a grave risk for patients and the families involved. He highlighted that the EmStop system offers a critical advance in cerebral protection and promotes a better understanding of managing neurological risks associated with TAVR.

The CAPTURE-2 trial builds upon the foundation established by the earlier CAPTURE-1 feasibility study, which yielded encouraging outcomes and was first presented at the Cardiovascular Research Technologies (CRT) meeting held in Washington, D.C. in March 2025.

Understanding TAVR and the Role of Embolic Protection

Transcatheter Aortic Valve Replacement (TAVR) is recognized as a minimally invasive procedure aimed at replacing a malfunctioning aortic valve. This surgical approach is particularly significant for patients who may face risks associated with traditional open-heart surgery. However, TAVR does carry the inherent risk of embolic events, which jeopardize the neurological health of patients. Thus, the implementation of an effective embolic protection system is essential.

EmStop is currently reinforcing its commitment to addressing the unmet needs in stroke prevention during left-heart catheterizations. The EmStop device promises not only to provide comprehensive cerebral protection but does so without hindering standard clinical workflows, thus fostering seamless integration into existing medical practices.

For additional information about the CAPTURE-2 clinical trial, potential participants or interested parties can access details via the NIH clinical trials website here.

About EmStop

Headquartered in Minnesota, EmStop, Inc. prioritizes the advancement of innovative medical devices designed for cardiovascular applications. Their integrated embolic protection solution stands out as a tailored response to growing concerns around stroke during TAVR and other catheter-based procedures in the left heart. By focusing on stroke mitigation, EmStop aims to establish itself as a leader in this vital area of medical innovation. With a proprietary technology platform, EmStop continues to bridge the gap in cardiovascular health and safety.

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