InspireMD Company Overview
Positive CGuard TM Clinical Experience
CARENET Clinical Trial (2014)
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30 Patient Safety and Efficacy clinical trial
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InspireMD
Zero major adverse cardiac or cerebral events (MACCE) at 30 days (Comparative data 5.72%*)
50% fewer new ischemic lesions with lesion volume being 10x times smaller compared to
historical non-mesh carotid artery stenting data
All new ischemic lesions fully resolved at 30 days except one
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3.6% MACCE rate at 6 months (Comparative data 8.09%**)
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Zero strokes or stroke related deaths at 12 months
PARADIGM 101 Clinical Trial (2015, 2016, and 2018)
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101 patient trial evaluating CGuard EPS in unselected,
consecutive carotid patients (all-comers)
99.1% device success
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0% MACCE (Death/stroke/MI) @ 48 hr
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0% MACCE @ 30 day
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Zero strokes or stroke related deaths at 12 months
"CGuard can safely be used
on more than 90% of all-
comer patients that have
carotid artery stenosis."
P. Musialek, MD
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No device-related adverse events and no procedure-related events at 24 months*
Sustained stroke prevention at 24 months
* Trials included in analysis: ARCHER pooled, ARMOUR, BEACH, CABERNET, CREATE, EMPIRE, EPIC, MAVERIC
1+2, MAVERIC International, PRIAMUS, SAPPHIRE, SECURITY, PROFI, ICSS
** Values extrapolated from event curves
***
Musialek, ICCA 2018
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