- Trial completion marks an important milestone in the development of the next generation, embolic protection platform
MINNEAPOLIS, Nov. 21, 2024 /PRNewswire/ -- Cardiovascular medical device company, EmStop, Inc., today announced the completion of the CAPTURE-1 early feasibility clinical trial in support of the company’s mission to develop and commercialize the first integrated embolic protection system for protected transcatheter aortic valve replacement (TAVR).
The CAPTURE-1 study was designed to assess the safety and performance of the EmStop Embolic Protection System, an investigational medical device. The device is currently being investigated for use as an embolic protection device to capture and remove thrombus (debris) during TAVR procedures. This investigatory study was a prospective, multi-center, single armed clinical trial. A total of fifteen subjects underwent treatment with a currently marketed TAVR device and the EmStop system and were evaluated under the approved clinical protocol.
“The successful completion of the CAPTURE-1 clinical trial marks yet another important milestone in the development and clinical understanding of this novel embolic protection technology,” said Phil Ebeling, EmStop President and CEO. “I am thankful for the many healthcare professionals and the entire EmStop team who have supported the advancement of this platform technology.”
In addition to submitting the CAPTURE-1 results for regulatory review, EmStop is looking ahead toward future data publication and the initiation of additional clinical trials based on the totality of these results.
“Stroke is a well-known and feared complication of TAVR,” said Dr. Michael Chenier, Interventional Cardiologist and CAPTURE-I primary investigator, Mission Hospital, Asheville, North Carolina. “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.”
EmStop™, currently under active clinical investigation, is designed to be the ideal embolic protection device with full cerebral protection for left-hearted catheterization procedures. It is the world’s first integrated embolic protection system for protected TAVR. TAVR is a minimally invasive procedure to replace an aortic valve that fails to open and close properly. Additional information on the CAPTURE-1 study can be found at https://clinicaltrials.gov/study/NCT06103591.
About EmStop
EmStop, Inc. is a Minnesota based, cardiovascular medical device company focused on the development and commercialization of a novel, integrated embolic protection solution for patients undergoing TAVR and other left hearted, catheter-based procedures. EmStop’s proprietary technology platform is designed to meet the ongoing, unmet need of stroke mitigation while offering key, differentiated features that enable ease of use improvements without the interruption of standard, clinical workflows. For more information, please contact: info@emstopeps.com
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SOURCE EmStop
