CGuard™ Embolic Prevention System (EPS) to be Randomized Against
Abbott’s RX ACCULINK® Carotid Stent System
Tel Aviv, Israel—October 9, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in Embolic Prevention Systems (EPS) / thrombus management technologies and neurovascular devices, today announced the start of patient enrollment in an investigator initiated trial in Russia, entitled: Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus CGuard™EPS. The objective of the trial is to assess the neuro protection and clinical superiority of the minimally invasive interventional procedure with the CGuard™ EPS versus Abbott’s RX ACCULINK® Carotid Stent in subjects at high risk for Carotid Endarterectomy (CEA), a surgical procedure.
The trial is a single center randomized trial with two interventional arms comparing CGuard™ EPS to Acculink™. The trial will enroll 100 consecutive eligible patients with 50 patients in each arm. The primary endpoint of the trial will be new ischemic areas in the brain within 24 to 48 hrs post procedure, and new lesion permanence at 30-days as determined by Diffusion-Weighted Magnetic Resonance Imaging (DWMRI). Each patient will receive clinical and ultrasound follow-up at 1 year. The trial will be conducted at the Center of Vascular and Hybrid Surgery within the Scientific Research Institute of Circulation Pathology in Novosibirsk, which is associated with the Novosibirsk State University, one of Russia’s top three universities (QS World University Rankings® 2016). The research will be lead by Professor Andrei Karpenko, the head of the vascular surgery department.
Professor Karpenko commented, “Having been aware of the very impressive data supporting the use of CGuard EPSTM for the treatment of carotid artery stenosis, we are excited to now have the opportunity to evaluate this system versus Abbott’s RX ACCULINK® which is widely used in Russia today.”
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are honored that Professor Karpenko and his team have elected to study CGuardTM EPS in this Vascular Surgeon led clinical trial at the Center of Vascular and Hybrid Surgery within the Scientific Research Institute of Cardiovascular Pathology in Novosibirsk. We understand the first patients have been enrolled and treated in the trial and we look forward to the results at the conclusion of the trial. Once again, we believe that this trial will reinforce our current CGuardTM clinical data, and continue to validate the growing interest and support in CGuardTM across all clinical specialties treating carotid artery disease.”
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.
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