November 20, 2015 7:36 AM EST--InspireMD shared positive 12 month follow-up data from its CGuard CARENET (CARotid Embolic protection Study using microNET) trial at the 42nd Annual Symposium on Vascular and Endovascular Issues (VEITH) in New York. Prof. Piotr MusiaBek, Co-Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, presented the 12-month follow-up data, an industry first on a mesh-covered carotid stent technology.
At the New Techniques, Technologies and Concepts session, Prof. Musialek presented the new data on the InspireMD CGuard Mesh Covered Carotid Stent Program. His lecture, entitled "MicroNet Covered Embolic Prevention Carotid Stent System: From CARENET And PARADIGM Studies To Routine Clinical Practice," focused on the CARENET 12-month results, which demonstrated zero strokes or stroke-related deaths at 12 months. Further, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. This indicates no sign of vessel narrowing and is consistent with the durability of carotid artery treatment seen using CGuardTM. According to Prof. Musialek, previously demonstrated reduction in both the incidence and the volume of new ischemic lesions, together with the 12 month data that show minimal restenosis concern, suggests that the therapeutic benefits of the CGuard technology may extend well beyond the acute procedural period.
Prof. Piotr 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. 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."
Alan Milinazzo, CEO of InspireMD commented, "Twelve month CARENET results further validate that the CGuard represents a superior next generation stenting technology, supporting broader application in carotid artery disease treatment, with physicians steadily impressed with its superior clinical data. We plan to leverage compelling CARENET and PARADIGM clinical evidence to expand upon our ongoing, active CGuard commercial activities."
PARADIGM, led by principal investigator Prof. Musialek, is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard" Mesh-covered embolic prevention stent system, 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.