EmStop announced today that it kicked off the CAPTURE-2 FDA investigational device exemption (IDE) study of its embolic protection system (EPS).
CAPTURE-2 evaluates the safety and performance of the EPS, an investigational device for cerebral embolic protection designed to capture and remove debris that includes thrombus during commercially available transcatheter aortic valve replacement (TAVR) procedures. The first cases in the study took place at Mission Hospital in Asheville, North Carolina.
Minneapolis-based EmStop aims to develop and commercialize the first integrated embolic protection system for TAVR. Its study evaluates the device against Boston Scientific’s Sentinel, a currently available cerebral embolic protection device for TAVR. The company said CAPTURE-2 builds on successful results from CAPTURE-1, an early feasibility study…