InspireMD's CGuard RX Approved in Europe, 6-Month CARENET Data Presented

January 27, 2015—InspireMD, Inc. announced that it received European CE Mark approval for the CGuard RX rapid exchange system for the company’s MicroNet covered carotid stent technology. The company also announced that positive 6-month follow-up data from its CGuard CARENET (Carotid Embolic Protection Study Using MicroNet) trial were presented at LINC 2015: The Leipzig Interventional Course in Leipzig, Germany.

InspireMD stated that the new RX delivery system will enable clinicians to place the CGuard technology using an easy-to-use delivery system; the CGuard MicroNet mesh-covered carotid stent remains unchanged. The CGuard embolic protection system (EPS) has received European CE Mark approval but is not approved by the US Food and Drug Administration for sales in the United States, advised the company

At the LINC meeting, Prof. Piotr Musialek, MD, Coprincipal Investigator for the CARENET study, presented the CARENET 6-month data at a late breaking trial session. Prof. Musialek is from Jagiellonian University Medical College at John Paul II Hospital in Krakow, Poland.

According to the company, the CARENET data showed that at 6 months, there was one major adverse cardiac and cerebrovascular event, which was not device related. The duplex ultrasound analysis performed at 6 months confirmed widely patent carotid arteries, which were stented with the CGuard as determined by flow measurements indicating no sign of vessel narrowing. The external carotid artery showed unimpeded flow in 100% of cases, demonstrating that the MicroNet allows excellent blood flow into bifurcated arteries.

The reduction in both the incidence and volume of new ischemic lesions, the 6-month data showing minimal restenosis concern, and the 100% patent internal and external carotid arteries all indicate that the therapeutic benefits of the CGuard MicroNet technology may extend well beyond the acute procedural period, noted InspireMD.

InspireMD’s CGuard EPS uses the same MicroNet technology featured on the company’s MGuard and MGuard Prime coronary EPS devices. The MicroNet technology is a single-fiber-knitted mesh wrapped on an open cell stent platform designed to trap debris. The 150-µ to 180-µ aperture of the MicroNet pore is designed to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery, stated the company.