---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-051453"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2026-11-12T21:45:54+00:00"
generated_at: "2026-11-12T21:47:07.551549+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# InspireMD wins FDA approval for CGuard Prime TCAR stent, doubling US addressable market

## Summary
- FDA approved the PMA supplement for the CGuard Prime TransCarotid Stent System (80 cm delivery) for TCAR procedures used with an embolic protection system specified in labeling.
- Approval adds access to more than 35,000 annual US TCAR procedures, doubling CGuard Prime's TAM; TCAR plus CAS total ~75,000 US carotid stenting procedures yearly per company estimates.
- CGUARDIANS II pivotal trial: 50 patients across 11 US sites; 100% acute device success with zero death, stroke, MI or stent thrombosis at 30 days.
- Commercial entry can proceed independently of the investigational SwitchGuard NPS, which is still enrolling in the CGUARDIANS III pivotal trial.
- CEO Marvin Slosman called it a 'strong near-term growth driver' and said InspireMD is the first company with both CAS and TCAR delivery options.

## SEC filing metadata
- accession: 0001493152-26-051453
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2026-11-12T21:45:54+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315226051453/0001493152-26-051453-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315226051453/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-051453
- JSON: https://secwatch.observer/filing/0001493152-26-051453.json
- Plain text: https://secwatch.observer/filing/0001493152-26-051453.txt

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