InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. ...
InspireMD submitted a PMA application to the FDA for its CGuard Prime carotid stent system, based on positive C-GUARDIANS trial results. The trial showed a 1.95% major adverse event rate, the lowest for any carotid stent trial. U.S. commercial launch is anticipated in H1 2025, if approved.
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InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. ...
InspireMD submitted a PMA application to the FDA for its CGuard Prime carotid stent system, based on positive C-GUARDIANS trial results. The trial showed a 1.95% major adverse event rate, the lowest for any carotid stent trial. U.S. commercial launch is anticipated in H1 2025, if approved.