InspireMD has received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet covered carotid stent technology. Concurrently, the company announced positive six-month follow up data from its CGuard CARENET (Carotid embolic protection study using MicroNet) trial at the LINC meeting in Leipzig, Germany.
InspireMD says that the RX delivery system, designed for use with the CGuard MicroNet, will enable clinicians to place the CGuard technology using an easy-to-use, and familiar, delivery system. The CGuard MicroNet mesh covered carotid stent remains unchanged.
Piotr Musiaâek, Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, and co-principal investigator for the CARENET study, presented the six-month data at a late breaking trial session at the LINC meeting. There was one major adverse cardiac and cerebrovascular event reported at six months which was not device-related. This six-month adverse event rate is substantially lower than rates reported in other conventional carotid stenting trials. The duplex ultrasound analysis performed at six months confirmed widely patent carotid arteries, which were stented with the CGuard as determined by flow measurements indicating no sign of vessel narrowing, consistent with historical data of conventional carotid artery stenting. Importantly, 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 the volume of new ischaemic lesions, as well as this six-month data showing minimal restenosis concern, and 100% patent internal and external carotid arteries, indicates that the therapeutic benefits of the CGuard MicroNet technology may extend well beyond the acute procedural period.
Alan Milinazzo, chief executive officer of InspireMD, commented, “Physicians continue to be impressed with the superior clinical data and our six-month results further validate that CGuard with MicroNet may represent a superior next generation of stenting technology. We plan to use the new clinical data and the RX approval to expand our commercial launch activities starting immediately.”