InspireMD, a leader in embolic protection systems (EPS), announced positive results from the CARENET (CARotid Embolic protection study using microNET) Trial for its CGuard EPS. This trial demonstrates that the MicroNet covered CGuard may offer important clinical benefits for patients undergoing carotid artery stenting (CAS).
CARENET was a multi-specialty trial that assessed the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The CARENET trial recruited a total of 30 patients and achieved its primary endpoint with 0% MACE (meaning no death, stroke or myocardial infarction) at 30 days.
Additionally, compared to published historical control groups of non-mesh covered carotid stents, the incidence of new ischemic lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) after carotid artery stenting was reduced by almost 50%.
The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than these historical control groups. The reduction in both the number of new ischemic lesions and the volume of those lesions indicates therapeutic benefits of the MicroNet technology in this patient cohort.
"The very positive data from the CARENET trial indicates that the CGuard EPS, with InspireMD’s proprietary MicroNet technology, may provide patients an improved treatment for carotid artery disease," stated Alan Milinazzo, President and Chief Executive Officer of InspireMD.
"Given the positive results from the trial, we plan to immediately initiate a limited market release of the CGuard in Europe through our direct sales organization in anticipation of a full market release in early 2015."