CARENET 30-Day Data Presented for InspireMD's CGuard EPS

September 16, 2014—InspireMD, Inc. announced positive results from the CARENET trial for its CGuard embolic protection system (EPS). This trial demonstrates that the MicroNet-covered CGuard may offer important clinical benefits for patients undergoing carotid artery stenting (CAS). CARENET principal investigator Prof. Joachim Schofer, MD, presented the data at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

According to the company, CARENET was a multispecialty trial that assessed the periprocedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The CARENET trial recruited 30 patients and achieved its primary endpoint with 0% major adverse cardiac events (ie, 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 CARENET data indicate that the CGuard EPS with InspireMD’s MicroNet technology may provide patients with an improved treatment for carotid artery disease, stated the company.

InspireMD advised that given the positive results from the trial, it will immediately initiate a limited market release of the CGuard in Europe through its direct sales organization in anticipation of a full-market release in early 2015.

In the company’s press release, Prof. Schofer commented, “This CARENET study shows that the CGuard reduces the incidence, as well as the total volume, of ischemic lesions. 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 CAS procedure.” Prof. Schofer is from the Hamburg University Cardiovascular Center in Hamburg, Germany.

CARENET coprincipal investigator Prof. Piotr Musialek, MD, added, “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 CAS 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 embolization. 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 ischemic 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.” Prof. Musialek is from Jagiellonian University Medical College at John Paul II Hospital in Krakow, Poland.

In March 2014, InspireMD announced the commencement of enrollment in the CARENET trial. The CGuard EPS had received European CE Mark approval. The CGuard is not approved by the US Food and Drug Administration at this time and is not commercially available in the United States.