EmStop™ Announces Initiation of CAPTURE-2 IDE Clinical Trial

The trial will generate critical clinical evidence and discovery for the novel medical device.

MINNEAPOLIS, May 18, 2026 /PRNewswire/ -- EmStop, Inc., a cardiovascular medical device company, announced the initiation of the CAPTURE-2 Investigational Device Exemption (IDE) clinical trial in support of the company's mission to develop and commercialize the first integrated embolic protection system for Transcatheter Aortic Valve Replacement (TAVR). The first clinical cases were completed at Mission Hospital in Asheville, North Carolina.

The CAPTURE-2 trial is designed to assess the safety and performance of the EmStop embolic protection system, an investigational medical device. The device is being evaluated for use as a cerebral embolic protection device to capture and remove debris that includes thrombus during commercially-available TAVR procedures. This study is a prospective, multi-center, randomized clinical trial comparing the EmStop device against the currently available embolic protection system.

"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," said Phil Ebeling, EmStop President and CEO. "On behalf of the entire EmStop team, we look forward to working with our clinical research partners in advancing the science around stroke in TAVR patients and ultimately improve patient outcomes."

The CAPTURE-2 clinical trial builds on the successful results of the CAPTURE-1 early feasibility clinical study, first published and presented in March 2025 at the Cardiovascular Research Technologies (CRT) meeting in Washington, D.C.

"Although stroke is a relatively low-incidence event in TAVR, it remains a serious and high-impact complication for patients, their families, and care teams," said Dr. Stanley J. Chetcuti, National Primary Investigator of the study and Structural Heart Medical Director at University of Michigan Health. "The EmStop embolic protection system represents an important step forward in advancing the science of cerebral protection and is designed to help better understand how we may address neurological risk during TAVR."

EmStop™, currently under active clinical investigation, is designed to provide full cerebral protection for left-heart catheterization procedures. It is the world's first integrated embolic protection system for protected TAVR. TAVR is a minimally invasive procedure to replace an aortic valve that fails to open and close properly. Additional information about the CAPTURE-2 study can be found at the NIH clinical trials website: https://clinicaltrials.gov/study/NCT07276711.

About EmStop

EmStop, Inc. is a Minnesota-based, cardiovascular medical device company focused on the development and commercialization of a novel, integrated embolic protection solution for patients undergoing TAVR and other left heart, catheter-based procedures. EmStop's proprietary technology platform is designed to meet the ongoing, unmet need of stroke mitigation while offering key, differentiated features that enable ease of use improvements without interrupting standard clinical workflows. For more information, please contact: [email protected]

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SOURCE EmStop