InspireMD submits PMA to FDA for CGuard Prime carotid stent; U.S. launch targeted H1 2025

InspireMD, Inc.

PMA submission on Sept 16, 2024, seeks FDA marketing approval for CGuard Prime carotid stent system.
Application based on C-GUARDIANS pivotal trial showing 1.95% primary endpoint major adverse event rate through 12 months.
Trial enrolled 316 patients across 24 U.S. and European sites; lowest event rate reported for any carotid stent pivotal trial.
U.S. commercial launch anticipated in first half of 2025, subject to FDA approval.
CEO Marvin Slosman cites best-in-class clinical outcomes and building U.S. commercial infrastructure.

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