InspireMD says FDA reviews PMA supplement for CGuard Prime 80 cm stent in TCAR use

InspireMD

InspireMD

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  • InspireMD’s PMA supplement for its investigational CGuard Prime 80 cm stent for TCAR is under FDA review, with a potential approval in H2 2026.
  • Clearance would expand the addressable market to include TCAR, alongside the company’s existing carotid artery stenting focus.
  • CGUARDIANS II 30-day data showed 100% acute device success in 50 patients, with no deaths, strokes, or myocardial infarctions reported.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. InspireMD Inc. published the original content used to generate this news brief on June 11, 2026, and is solely responsible for the information contained therein.

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