EmStop has announced the initiation of the CAPTURE-2 investigational device exemption (IDE) clinical trial in support of the company’s mission to develop and commercialise the first integrated embolic protection system for transcatheter aortic valve implantation (TAVI). The first clinical cases were completed at Mission Hospital in Asheville, USA.
The CAPTURE-2 trial is designed to assess the safety and performance of the EmStop embolic protection system, which is an investigational medical device being evaluated for use as a cerebral embolic protection device to capture and remove debris that includes thrombus during commercially available TAVI procedures. This study is a prospective, multicentre, randomised 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 TAVI 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 TAVI 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 2025 at the Cardiovascular Research Technologies (CRT) meeting (8–11 March, Washington DC, USA).
“Although stroke is a relatively low-incidence event in TAVI, it remains a serious and high-impact complication for patients, their families, and care teams,” said Stanley J Chetcuti (University of Michigan Health, Ann Arbor, USA), national primary investigator of the study. “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 TAVI.”
