Full Press Release Details
Announces Late-Breaking Presentation of Early SIBERIA Clinical Trial Results to be Featured in an e-Course at EuroPCR
a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard EPS versus Acculink
at 30 days post-procedure
Aviv, Israel - June 25, 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 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.
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
Pavel Ignatenko, MD, E.N. Meshalkin Siberian Federal Biomedical Research Center, Ministry for Public Health of the Russian
Federation, Novosibirsk, Russia
4:00pm CEST (10:00am EDT)
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.
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."
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."
is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading
course in interventional cardiovascular medicine.
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.
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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