regulatory
confidence high
sentiment positive
materiality 0.65
TriSalus receives FDA clearance for TriNav Advance liver embolization device
TriSalus Life Sciences, Inc.
- 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.
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