InspireMD reports 100% acute device success, zero adverse events in CGUARDIANS II TCAR trial

InspireMD, Inc.

Acute device success 100% (50/50 patients); no deaths, strokes, or MI at 30 days.
No stent thrombosis observed; complete stent patency in evaluable subjects.
PMA supplement under FDA review; potential approval H2 2026 for TCAR use.
CEO cites line-of-sight to full TCAR toolkit, addressing >35,000 annual US procedures.

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