![]() ![]() 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. Its potential merits and limitations warrant further evaluation.InspireMD, Inc. In suitable patients undergoing SVG-PCI or native lesion intervention during acute MI, the MGuard stent is a viable treatment strategy. The major adverse cardiac event (MACE) rates were 11% in the native artery and 29% in the vein graft group, mainly due to respective target lesion revascularization/target vessel revascularization rates of 6% and 7% in the native vessel group and 11% and 15% in the SVG group. ![]() Mortality in the native group was 1.9% vs. Of the total number of patients, 47% had diabetes and 29% had chronic kidney disease. The clinical presentation was STEMI in 30% and non-STEMI/unstable angina in 60% of patients. The mean age was 67 years and 83% were males. The MGuard stent was used in 67% of patients who underwent SVG-PCI while 33% were treated for native coronary artery disease, the majority during ST-elevation MI (STEMI). We followed 163 consecutive patients who underwent MGuard stent deployment during the period 2009 to 2014 in a large tertiary cardiac center in central Israel. To report on local experience with patients treated with the MGuard stent until follow-up at 1 year. The MGuard™ stent (InspireMD, Tel Aviv, Israel) is a bare metal mesh-covered stent, developed to prevent no-reflow phenomenon during percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and acute myocardial infarction (MI), both associated with significant atherothrombotic lesions. ![]()
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