secwatch.observer — SEC 8-K summary
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Issuer:     TriSalus Life Sciences, Inc. (TLSI)
CIK:        0001826667
Form:       8-K
Filed at:   2026-09-22T20:14:43+00:00
Accession:  0001628280-26-063031
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

TriSalus receives FDA clearance for TriNav Advance liver embolization device
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1826667/000162828026063031/0001628280-26-063031-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1826667/000162828026063031/tlsi-20260922.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-063031

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer