InspireMD Announces Presentation of Interim Data from Investigator-Initiated Study

InspireMD (NYSE:NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced the presentation of positive interim results from an investigator-initiated study of CGuard EPS.

As quoted in the press release:

Dr. A. Karpenko and Dr. P. Ignatenko from the Siberian Federal Biomedical Research Center, Russia, presented interim data from their first 50 patients in an independent, randomized clinical trial designed to ultimately include 100 consecutive patients with symptomatic and asymptomatic carotid artery disease. The patients are randomly assigned (1:1) into two treatment groups: 50 patients will receive the CGuard™ EPS MicroNet® mesh covered stent and 50 patients will receive a conventional carotid stent. The primary endpoints are the incidence and volume of new lesions within the brain after carotid stenting using diffusion weighted magnetic resonance imaging (DW-MRI) peri-procedurally and at 30 days.

At the protocol-mandated interim analysis, after recruiting the first 50 patients in the study, the results at one month show that, despite having patients with higher risk factors in the CGuard™ group compared to the conventional carotid stent arm, the CGuard™-treated patients had a significantly lower incidence of multiple lesions in the brain (16% vs 44%), and a lower incidence of large cerebral lesions (24% vs 40%). Finally, major adverse clinical events after 30 days occurred in the conventional carotid stent arm but not in the CGuard™ EPS-treated patients (12% vs 0%).

Click here to read the full press release.