The device can also be used for embolic protection in symptomatic CAD due to a discrete de novo or restenotic lesion in a native coronary artery or a culprit lesion in a saphenous vein graft. The device is indicated for improving luminal diameter in vessels from 2.5 to 4.0 mm, having lesion length less than 38 mm, and providing embolic protection, in patients undergoing primary or rescue PCI for acute STEMI or with lesion having atherothrombotic appearance in non ST-elevation acute coronary syndromes (unstable angina and non-STEMI). MGuard Prime EPS is a dual layer (Cobalt Chromium L605 and PET MicroNet) mesh stent designed to trap and seal thrombus and ruptured plaque, prevent distal embolization, and optimize flow while offering superior performance compared to standard ST-segment elevation myocardial infarction ('STEMI') therapy without requiring any change in current physician practice. The Company’s 2Q-2021 results show an increase in market demand for the device. Safety & efficacy compared to CEA is similar at 30 days, and clinically superior at 1y FU ĬGuard is clinically superior, to all First-Gen carotid stents (open- and closed-cell) at 30 days, and to all other (1st and 2nd generation) Carotid Stents at 1y FU. Normal healing and lack of thrombosis/ISR concern over 12 months įavourable cerebral and clinical outcomes in moderate-risk population ĬGuard superiority in ↓brain embolism in randomized controlled trial vs First-Gen workhorse Minimized intra-CAS embolism, abolished post-CAS embolism Ĭlinical results superior to conventional stents ĬGuard is superior to, and has mechanical advantages over Casper / RoadSaver in preventing plaque protrusion (Image: CGuard development timeline source: company website)ĭata from 12 multi-specialty clinical studies, including 7 multi-centric, and up to 5y follow-up ('FU'), available since 2015 through 2021 demonstrated: ProductsĬGuard EPS is a novel, dual-layer (nitinol and PET MicroNet) mesh carotid stent designed to support accurate vessel wall apposition, and improve patient safety through sustained embolic protection for up to 48 months.ĬGuard EPS is indicated for improving carotid luminal diameter in patients at high risk for adverse events from CEA who require carotid revascularization and are patients, with neurological symptoms having more than 50% stenosis OR without neurological symptoms having more than 80% stenosis, of the common or internal carotid artery by either ultrasound or angiogram and are patients having a vessel with reference diameters between 4.8 mm and 9.0 mm at the target lesion. The Company is also developing products for treatments in peripheral artery and neuro procedures, and accessory and delivery devices for carotid procedures. Regulatory submission is anticipated in 1H-2022, followed by U.S. Up to 315 patients are expected to be enrolled in the trial. registrational IDE clinical trial “C-Guardian” of CGuard EPS in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting. The Company in July 2021, initiated a U.S. The Company’s commercialized products CGuard EPS and MGuard Prime EPS are CE mark approved but not approved for sale in the U.S. The MicroNet is a key differentiator of the Company’s commercial products in the field of vascular stenting. The MicroNet is attached and secured to the proximal and the distal crowns of the stent, and expands with it, without affecting the procedure. Woven from a single strand of 20 μm Polyethylene Terephthalate ('PET'), the MicroNet is a bio-stable mesh with a typical pore size between 150 – 180 µm, designed to prevent embolization by trapping and sealing thrombus and plaque against the vessel wall. The Company also intends to pursue applications of its MicroNet technology in other indications such as peripheral artery procedures. InspireMD seeks to change the standard of care ('SoC') in the treatment of carotid artery disease ('CAD') from surgical carotid endarterectomy ('CEA') and conventional carotid artery stenting ('CAS') to the Company’s minimally invasive CGuard EPS Carotid Stent System. The Company has developed proprietary stent designs with integrated embolic prevention systems ('EPS') using a proprietary mesh, MicroNet, for delivering neurovascular protection and stroke prevention. ( NASDAQ: NSPR) is an Israeli commercial-stage medical device company that was founded in 2005.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |