Twelve-Month CARENET Data Presented for InspireMD's CGuard Carotid EPS

November 20, 2015—InspireMD, Inc. announced positive 12-month follow-up data from the CARENET trial, which evaluated the company’s CGuard carotid embolic protective stent system (EPS) featuring MicroNet technology. The data were presented by Prof. Piotr Musialek, MD, coprincipal investigator for the CARENET trial, at the 42nd annual VEITHsymposium in New York, New York.

Prof. Musialek’s lecture, entitled “MicroNet Covered Embolic Prevention Carotid Stent System: From CARENET And PARADIGM Studies To Routine Clinical Practice,” was presented during the New Techniques, Technologies, and Concepts session at the conference. Prof. Musialek is from Jagiellonian University Medical College at John Paul II Hospital in Krakow, Poland.

The new data demonstrated zero strokes or stroke-related deaths at 12 months. Additionally, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. These findings indicate that there is no sign of vessel narrowing, which is consistent with the durability of carotid artery treatment seen using CGuard, stated the company.

According to Prof. Musialek, the previously demonstrated reduction in both the incidence and volume of new ischemic lesions, as well as the 12-month data that show minimal restenosis concern, suggest that the therapeutic benefits of the CGuard technology may extend well beyond the acute procedural period.

In the company’s press release, Prof. Musialek commented, “It is very exciting to present the 12-month follow-up data from the CGuard CARENET study, which continues to validate the use of the MicroNet-covered CGuard, with zero strokes at 12 months. In addition, the 12-month data showed no change in peak systolic velocity between 6 months and 12 months, suggesting no restenosis concerns.”

He added, “These findings, combined with the results from our recent all-comer single-center PARADIGM trial, continue to show the increased therapeutic benefits of the CGuard technology in treating patients with carotid artery disease. This technology is a game changer in today’s practice of carotid revascularization, and my colleagues and I look forward to continued use of this unique technology in routine clinical practice.”

The PARADIGM trial, for which Prof. Musialek serves as principal investigator, is an investigator-initiated prospective evaluation of all-comer percutaneous carotid revascularization in symptomatic and increased-risk asymptomatic carotid artery stenosis, using the CGuard mesh-covered embolic prevention stent system. The trial indicated that the CGuard system is appropriate for use in an all-comer carotid revascularization population and is associated with an extremely favorable angiographic and clinical outcome. 

The CGuard EPS has received European CE Mark approval. It is not approved for sale in the United States, advised InspireMD.