InspireMD Announces Late-Breaking Presentation of Early SIBERIA Clinical Trial Results to be Featured in an e-Course at EuroPCR

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.”