EmStop Completes CAPTURE-1 Trial for Integrated Embolic Protection During TAVR
Key Insights
EmStop (search), Inc. has concluded its CAPTURE-1 early feasibility trial, evaluating the safety and performance of its embolic protection system during TAVR (search) procedures.
The trial involved 15 subjects undergoing TAVR (search) with the EmStop (search) system, designed to capture and remove thrombus, potentially reducing the risk of stroke (search).
Results are being prepared for regulatory submission, with plans for future data publication and additional clinical trials to further assess the technology.
Minneapolis, MN – EmStop (search), Inc., a cardiovascular medical device company, announced the completion of the CAPTURE-1 early feasibility clinical trial. This trial assessed the safety and performance of the EmStop Embolic Protection System (search) during transcatheter aortic valve replacement (TAVR (search)) procedures. The successful completion of CAPTURE-1 marks a significant step in developing the next generation embolic protection platform.
CAPTURE-1 Trial Details
The CAPTURE-1 study was a prospective, multi-center, single-arm clinical trial involving fifteen subjects. These individuals underwent TAVR (search) using a currently marketed TAVR device in conjunction with the EmStop (search) system. The primary goal was to evaluate the device's ability to capture and remove thrombus (debris) during TAVR procedures.
Integrated Embolic Protection System
The EmStop Embolic Protection System (search) is designed to provide full cerebral protection during left-hearted catheterization procedures. Its integrated design aims to mitigate the risk of stroke (search) and other embolic events without compromising procedural efficiency or requiring additional vascular access.
Clinical Implications
"Stroke (search) is a well-known and feared complication of TAVR (search)," said Dr. Michael Chenier, Interventional Cardiologist and CAPTURE-I primary investigator, Mission Hospital, Asheville, North Carolina. "EmStop (search) 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."
Future Directions
EmStop (search) plans to submit the CAPTURE-1 results for regulatory review and is preparing for future data publication. The company also intends to initiate additional clinical trials to further evaluate the embolic protection technology. Phil Ebeling, EmStop President and CEO, expressed gratitude to the healthcare professionals and the EmStop team for their support in advancing this platform technology.