In a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure
TEL AVIV, Israel, June 25, 2020 (GLOBE NEWSWIRE) -- 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 early results from the investigator-initiated SIBERIA randomized clinical trial of CGuard™ EPS are being featured as a late-breaking presentation in an EuroPCR e-Course, which is being held June 25-27, 2020. The 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.
Title: The SIBERIA trial for carotid artery stenosis: A randomized controlled trial of conventional versus Micronet™-covered stent use in percutaneous neuroprotected carotid artery revascularization: Peri-procedural and 30-day diffusion-weighted magnetic resonance imaging and clinical outcomes
Presenter: Pavel Ignatenko, MD, E.N. Meshalkin Siberian Federal Biomedical Research Center, Ministry for Public Health of the Russian Federation, Novosibirsk, Russia
Date: June 25, 2020
Time: 4:00pm CEST (10:00am EDT)
The SIBERIA trial evaluated one hundred patients who qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either CGuard or Acculink™. Primary endpoints were incidence and volume of new cerebral embolic post-procedural lesions (24-48 hours) as determined by diffusion weighted magnetic resonance imaging (DW-MRI). Principal secondary endpoints included incidence of periprocedural or postprocedural stroke, myocardial infarction and death at 30 days.
Post Procedure (24-48 hours), the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions (157 mm3 vs. 700 mm3), a statistically significant improvement (p=0.007)
At 30 days, DW-MRI showed zero new cerebral lessons in the CGuard™ arm versus six in the Acculink™ arm (p=0.03)
At 30 days, there were zero strokes, myocardia infarctions or deaths in the CGuard arm and three events the Acculink™ arm (two strokes and one myocardial infarction)
Dr. Ignatenko stated, “CGuard™ Micronet™-covered stent use in consecutive unselected patients subjected to neuroprotected carotid artery stenting was associated with a greater than three-fold reduction in the procedure-generated mean cerebral lesion volume, and with zero post-procedural cerebral embolisms observed.”
“The SIBERIA trial is the first randomized, controlled clinical trial to directly compare CGuard™ EPS head-to-head against a widely used conventional stent, and needless to say, we are very pleased with the results,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The data from this important study provide critical validation and adds to the growing body of evidence as we work to make CGuard™ EPS the standard of care not only in carotid stenting, but also as a safe and less-invasive alternative to carotid endarectomy, which accounts for more than 75% of carotid artery revascularization procedures. We are grateful to Prof. Karpenko, Dr. Ignatenko, their colleagues and the patients who made this trial possible.”
EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading course in interventional cardiovascular medicine.
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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