---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-063031"
form_type: "8-K"
ticker: "TLSI"
cik: "0001826667"
company_name: "TriSalus Life Sciences, Inc."
filed_at: "2026-09-22T20:14:43+00:00"
generated_at: "2026-09-22T20:16:16.529400+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# TriSalus receives FDA clearance for TriNav Advance liver embolization device

## Summary
- FDA 510(k) clearance for TriNav Advance PEDD device announced Sept 22, 2026; limited market release in coming weeks.
- TriNav Advance adds small-distal-vessel access via compatible microcatheter; two configurations: telescoping and high-flow.
- Expands TriSalus portfolio beyond liver embolization; supports broader range of embolization procedures.
- Company now has four FDA-cleared devices: TriNav, TriNav LV, Pancreatic Retrograde, and TriNav Advance.

## SEC filing metadata
- accession: 0001628280-26-063031
- form_type: 8-K
- ticker: TLSI
- cik: 0001826667
- company_name: TriSalus Life Sciences, Inc.
- filed_at: 2026-09-22T20:14:43+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1826667/000162828026063031/0001628280-26-063031-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1826667/000162828026063031/tlsi-20260922.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-063031
- JSON: https://secwatch.observer/filing/0001628280-26-063031.json
- Plain text: https://secwatch.observer/filing/0001628280-26-063031.txt

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