Results indicate that 12 months after carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against postprocedural neurologic events
Tel Aviv, Israel — June 10, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease treatment, announced today that 12-month PARADIGM trial results have been published in the EuroIntervention journal. The paper, entitled, “Routine MicroNET™ covered embolic prevention stent system use for consecutive symptomatic and increased stroke-risk asymptomatic carotid stenosis revascularization: Twelve-month outcomes from the PARADIGM study,” details the results of 101 unselected consecutive real-life patients treated with the CGuard™ MicroNET covered stent for carotid stenosis and the 12-month prevention of postprocedural neurologic events.
101 unselected consecutive patients for carotid revascularization were enrolled in the PARADIGM trial. At 30 days, only one adverse event occurred (a minor transient stroke with no other strokes, myocardial infarctions, or deaths. Furthermore, these study results show that no strokes occurred between 30 days and twelve months.
“PARADIGM evaluates CGuard™ in unselected consecutive patients for carotid revascularization, with higher clinical standards, and constitutes a reference for future carotid stenting studies,” said Marvin Slosman, Chief Executive Officer of InspireMD. “This is substantiated by a new paper in EuroIntervention, a prestigious medical journal covering the latest advancements in vascular intervention. The risk of peri-procedural or post-procedural stroke in the treatment of carotid stenotic lesions has long been a significant obstacle to more widespread adoption of less invasive stenting as an alternative to surgery for carotid revascularization. We believe these new data demonstrate the sustained safety of our unique CGuard™ EPS system incorporating proprietary MicroNet™ technology. Data such as these are integral to our ongoing efforts to make CGuard™ the eventual standard of care because of the many clinical benefits of CGuard™.
“Our present work indicates that an effective MicroNET™-covered stent protection against post-procedural neurologic events extends at least mid-term in the absence of any procedure- or device-related issues,” stated Dr. Piotr Musialek, co-author of the paper and lead investigator of the PARADIGM study.
EuroIntervention is an international peer-reviewed journal whose aim is to create a community of high-quality research and education in the field of percutaneous cardiovascular interventions. EuroIntervention is the official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for the treatment of carotid artery disease by providing outstanding acute results and durable stroke-free long-term outcomes.
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 symbols NSPR.WS and NSPR.WSB.
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