InspireMD got FDA approval for its CGuard Prime Stent, opening up over 35,000 new procedures each year in the U.S.

Nov 12, 2026, 4:50 PM ETTrialRead the original at SEC EDGAR

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The approval lets doctors use CGuard Prime in TCAR, opening access to over 35,000 U.S. procedures each year. Use requires a specified protection system, and the supporting study included 50 patients.

NSPR · InspireMD, Inc.

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This gives InspireMD a way to reach doctors who perform a different type of carotid procedure. In the 50-person study, every device was successful, and no deaths, strokes, heart attacks, or stent clots were reported within 30 days. Doctors must use the stent with a specified embolic-protection system. InspireMD’s own SwitchGuard system is still being studied and is not available for sale in the U.S., but an existing FDA-cleared system can be used.

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