EmStop has commenced the CAPTURE-2 investigational device exemption (IDE) clinical trial, assessing its embolic protection system during transcatheter aortic valve replacement (TAVR) procedures.
The first participants in the CAPTURE-2 study received the treatment at Mission Hospital in Asheville, North Carolina, US.
The multi-centre, randomised, prospective trial will examine the EmStop system’s safety and performance as a cerebral embolic protection device.
It will also compare the device with the currently available embolic protection solution during commercially available TAVR procedures.
EmStop president and CEO Phil Ebeling said: “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.
“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 improving patient outcomes.”
The study aims to assess the device’s ability to capture and remove debris, including thrombus, during the procedure.
It builds on the encouraging outcomes from the CAPTURE-1 early feasibility study.
University of Michigan Health structural heart medical director and national primary investigator of the study Dr Stanley Chetcuti said: “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.
“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.”
The EmStop embolic protection system, now under clinical investigation, will provide comprehensive cerebral protection during left-heart catheterisation and is said to be the first integrated system designed for TAVR.
TAVR is a minimally invasive procedure intended to replace an aortic valve that has difficulty opening and closing properly.
In November 2024, EmStop completed the CAPTURE-1 early feasibility clinical study, which assessed the EmStop embolic protection system.
