EmStop Completes CAPTURE-1 Early Feasibility Trial of Embolic Protection System for TAVR

November 25, 2024—EmStop, Inc. recently announced the completion of the CAPTURE-1 early feasibility clinical trial in support of the company’s integrated embolic protection system (EPS) for transcatheter aortic valve replacement (TAVR). The EmStop device is designed to provide full cerebral protection for left heart catheterization procedures.

According to the company, the CAPTURE-1 study was designed to assess the safety and performance of the investigational EmStop EPS to capture and remove thrombus during TAVR.

As summarized in EmStop’s press release, the prospective, multicenter, single-arm clinical trial was composed of 15 patients who underwent treatment with a currently marketed TAVR device and the EmStop system. The patients were evaluated under the approved clinical protocol.

EmStop advised that future plans include submitting the CAPTURE-1 results for regulatory review, publishing the study data, and initiating additional clinical trials based on the early results.

Michael Chenier, MD, an interventional cardiologist at Mission Hospital in Asheville, North Carolina, serves as primary investigator of CAPTURE-I.

“Stroke is a well-known and feared complication of TAVR,” commented Dr. Chenier in the company’s press release. “EmStop offers patients a potential alternative to reduce the likelihood of stroke and other embolic events. Due to the novel integrated filter design, physicians can perform TAVR, and potentially other procedures, while providing patients complete embolic protection and without loss of procedural efficiency or requiring additional vascular access.”