EmStop said it has initiated the CAPTURE-2 Investigational Device Exemption clinical trial of its embolic protection system for TAVR, with first cases completed at Mission Hospital in Asheville. The study is listed in CMS and ClinicalTrials.gov records and builds on earlier feasibility work at the same hospital.
EmStop said it has started the CAPTURE-2 Investigational Device Exemption clinical trial for its embolic protection system used during transcatheter aortic valve replacement, or TAVR.
The company said the first cases in the study were completed at Mission Hospital in Asheville, North Carolina. EmStop described CAPTURE-2 as a prospective, multi-center, randomized trial designed to evaluate its system against an existing embolic protection device.
The launch adds a new public milestone to a program that had already appeared in federal and registry records. CMS lists the study as NCT07276711 and shows an approval date of Jan. 14, 2026. ClinicalTrials.gov also lists the trial.
Mission Hospital said in a separate statement last year that it was the first site to test EmStop in an earlier phase of the program. EmStop and the hospital have both framed the work as part of a stepwise effort to evaluate safety and performance in TAVR procedures.
The company did not disclose enrollment totals or a timeline for opening additional sites in the materials reviewed.
What comes next
The main near-term question is how quickly CAPTURE-2 expands beyond Mission Hospital and when EmStop releases early enrollment or safety data. Those details were not included in the public announcement reviewed for this article.
Revision note
Initial automated publication.