---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-039640"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2024-10-07T23:59:59+00:00"
generated_at: "2026-05-30T19:09:30.264224+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA approves IDE for InspireMD's CGUARDIANS II pivotal study of CGuard Prime 80cm stent system

## Summary
- FDA approved IDE application for CGUARDIANS II pivotal study of CGuard Prime 80cm Carotid Stent System during TCAR procedures.
- Study intended to facilitate approval of CGuard Prime for TCAR indication; U.S. commercial sales after approval.
- Co-principal investigators: Patrick Geraghty, M.D. (Washington Univ.) and Patrick Muck, M.D. (Good Samaritan Hospital).
- Company also advancing development of next-generation TCAR neuroprotection system, SwitchGuard NPS.

## SEC filing metadata
- accession: 0001493152-24-039640
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2024-10-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315224039640/0001493152-24-039640-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315224039640/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-039640
- JSON: https://secwatch.observer/filing/0001493152-24-039640.json
- Plain text: https://secwatch.observer/filing/0001493152-24-039640.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.