InspireMD has announced positive results from the CARENET (Carotid embolic protection study using microNET) trial for its CGuard embolic protection system. This trial demonstrates that the MicroNet covered CGuard may offer important clinical benefits for patients undergoing carotid artery stenting.
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 ischaemic 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 ischaemic 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,” states 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 organisation in anticipation of a full market release in early 2015.”
“This CARENET study shows that the CGuard reduces the incidence, as well as the total volume of ischaemic lesions,” states Joachim Schofer, a principal investigator for the CARENET study, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. “The results from this study seem to confirm that the small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The DW-MRI follow-up data confirmed that the MicroNet covered CGuard offers unique benefits for patients undergoing a carotid artery stenting procedure.”
Piotr Musialek, co-principal investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland, comments, “My experience using the CGuard device has been extremely positive. The CARENET study involved an all-comer spectrum of patients and lesion types, making it truly reflective of the carotid artery stenting population we treat today. While compatible with all types of embolic protection devices, the CGuard may provide an increase in the safety of carotid artery stenting irrespective of the type of protection used due to the ability of the MicroNet to prevent plaque protrusion and late embolisation. I have seen the benefit of this device past 30-days, when the carotid stent can safely heal, in absence of any plaque protrusion through the stent struts. The 50% decrease in the incidence of new ischaemic lesions as compared to traditional carotid non-mesh covered stents was impressive. I look forward to the continued use of the CGuard in my daily practice.”