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InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke

MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States. The PMA approval is backed by best-in-class evidence from the Company’s C-GUARDIANS pivotal trial, first presented at the Leipzig Interventional Course (

articleInspiremd Inc.June 24, 20254/company/inspiremd-inc/news/inspiremd-announces-fda-approval-cguard-200500481
InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke

About this update from Inspiremd Inc.

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More updates from Inspiremd Inc.

InspireMD, Inc.Carotid Stentcarotid artery stenosisFDACarotid Stent SystemUnited Statesthe Companypivotal trialipsilateral strokeprimary endpointcarotid endarterectomy