InspireMD announced the full market launch of the CGuard Embolic Prevention System for the treatment of carotid artery disease by its strategic distribution partner, Penumbra, at the CIRSE Annual Congress (26–30 September, Lisbon, Portugal). Penumbra leverages its direct European commercialisation team to launch CGuard distributed by Penumbra.
At CIRSE 2015, Penumbra hosted a symposium titled, “CGuard—MicroNet Covered Embolic Prevention Stent System: A Game-Changer in CAS” led by Piotr Musialek on Sunday, 27 September. Musialek is principal investigator in the all comer PARADIGM study that continues to document both the short-term and long-term benefits of using the MicroNet covered CGuard technology in patients with carotid artery disease.
Jim Pray, president, International of Penumbra, stated, “The Penumbra team believes that the CGuard technology will give our customers a new, proven alternative to traditional treatment options for patients with carotid artery disease. We have been trained on the CGuard technology and are officially launching it here at the CIRSE meeting this week. We look forward to working with our customers to provide them with this exciting new carotid embolic prevention system.”
PARADIGM 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. At EuroPCR 2015, Musialek summarised his clinical presentation of 71 CGuard procedures in unselected all-comer patients in the PARADIGM evaluation as: 1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred peri-procedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.