EmStop has completed the ‘Controlled Arterial Protection to Ultimately Remove Embolic Material’ (CAPTURE-1) early feasibility clinical study which assessed the EmStop embolic protection system.
The trial will support the company’s goal of developing and commercialising the integrated embolic protection system intended for protected transcatheter aortic valve replacement (TAVR).
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The single-arm, prospective, multi-centre trial was conducted to evaluate the safety and performance of the investigational medical device and aims to capture and eliminate thrombus, or debris, at the time of TAVR procedures.
It involved 15 participants who were treated with a TAVR device alongside the EmStop system, after clinical protocol approval.
The goal of the study was to determine the feasibility and safety of the system and to investigate its performance in the participants across two US investigational sites.
Subjects will continue to be monitored for 30 days post-procedure to assess the long-term safety outcomes associated with the use of the device.
EmStop president and CEO Phil Ebeling said: “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.
“I am thankful for the many healthcare professionals and the entire EmStop team who have supported the advancement of this platform technology.”
In August, the company announced the appointment of Phil Ebeling as its new CEO and president.
The company is focused on providing an optimal embolic protection device that offers full cerebral protection for left-hearted catheterisation procedures.
Looking forward, EmStop plans to submit the results of the CAPTURE-1 trial for regulatory review. Additionally, the company is anticipating to launch further clinical trials, building on the comprehensive outcomes obtained from this current trial.
CAPTURE-I primary investigator and interventional cardiologist Dr Michael Chenier said: “Stroke is a well-known and feared complication of TAVR. EmStop offers patients a potential alternative to reduce the likelihood of stroke and other embolic events.”
