EmStop has announced the start of the CAPTURE-2 Investigational Device Exemption (IDE) clinical trial for its investigational embolic protection system designed for Transcatheter Aortic Valve Replacement (TAVR) procedures.

The first clinical procedures in the study were completed at Mission Hospital.

The CAPTURE-2 trial is a prospective, multicentre and randomised clinical study evaluating the safety and performance of the EmStop embolic protection system. The device is designed to capture and remove debris, including thrombus, during commercially available TAVR procedures.

The study will compare the EmStop system with currently available embolic protection technology used in TAVR procedures.

According to the company, the trial builds on findings from the earlier CAPTURE-1 feasibility study, which was first presented and published at the Cardiovascular Research Technologies 2025 in March 2025.

EmStop stated that the trial is intended to support research into stroke prevention during TAVR procedures and improve patient outcomes.

The company noted that the EmStop embolic protection system is designed to provide full cerebral protection during left-heart catheterisation procedures. It is being developed as an integrated embolic protection system for protected TAVR procedures.

TAVR is a minimally invasive procedure used to replace an aortic valve that does not open and close properly.

 

Source: prnewswire.com

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