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InspireMD Announces Publication of 12-Month Results of CGuard™ EPS SIBERIA Trial in Journals of the American College of Cardiology: Cardiovascular Interventions
TEL AVIV, Israel, Nov. 03, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the
About this update from Inspiremd Inc.
[{"type":"text","content":"TEL AVIV, Israel, Nov. 03, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced that results from the investigator-initiated SIBERIA randomized clinical trial of CGuard EPS, that evaluated the peri-procedural and 30-day silent brain infarcts associated with the use of its MicroNet™ covered stent (CGuard) versus a conventional “workhorse” open-cell Acculink™ nitinol stent were published this week. The principal investigator study was published in Journals of the American College of Cardiology (JACC) and is titled Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization. The main findings of the study included: CGuard MicroNet-covered carotid stent, in relation to a first-generation stent: reduced 4.5-fold the magnitude of peri-procedural silent brain infarcts volume; andabolished post-procedural silent infarcts, that were on-going with the first-generation stent. This data constitutes level 1 evidence in favor of a CGuard MicroNet-covered stent in demonstrating reduction of cerebral infarcts in neuroprotective CAS versus Acculink. This randomized control study evaluated 30-day silent brain infarcts associated with the use of the Acculink conventional open-cell nitinol stent vs the CGuard MicroNet-covered stent. The MicroNet-covered stent significantly reduced peri-procedural cerebral embolism, showing an average of 57% reduction in lesion per patient (171 mm3 vs 73 mm3 (P = 0.017)) and a 4.5 fold reduction in total volume of peri-procedural lesions (701 mm3 vs 157 mm3 (P = 0.007)) when compared to Acculink. Additionally, postprocedural (48 hours to 30 day) cerebral was abolished by the MicroNet covered stent, while it was ongoing with the conventional, first-generation carotid stent. “We are very pleased with the results of the SIBERIA trial and the subsequent publication, as the first randomized, controlled clinical trial to directly compare CGuard EPS head-to-head against a widely used conventional stent,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The study highlights our growing body of real-world clinical evidence as well as scientific evidence showing the superiority of the CGuard device in prev...