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StocksMediumUpdated•Originally published 23 September 2026•Updated 23 September 2026•
1 min read

TriSalus Wins FDA 510(k) Clearance for TriNav Advance

Key Facts

1TriNav Advance received FDA 510(k) clearance, and TriSalus filed the announcement in a Form 8-K on September 22, 2026.
2The device reaches small, distal vessels through a compatible microcatheter and operates in 2 configurations.
3TLSI closed at $4.93 on September 22, 2026, within a $4.82-$5.15 range.

TriSalus Life Sciences said its TriNav Advance device received U.S. Food and Drug Administration clearance through the 510(k) pathway, adding it to the company’s Pressure-Enabled Drug Delivery, or PEDD, portfolio. The company filed the announcement in a Form 8-K with the U.S. Securities and Exchange Commission on September 22, 2026.

TriNav Advance reaches small, distal vessels through a compatible microcatheter and operates in 2 configurations: a telescoping mode for selective delivery to smaller vessels and a high-flow mode without an additional microcatheter. TriSalus said the indication supports a broader range of embolization procedures, including procedures beyond the liver.

TriSalus plans a limited market release in the coming weeks. A 510(k) clearance removes a regulatory barrier to marketing by establishing substantial equivalence to a legally marketed device, but it does not establish demand; the financial impact will depend on launch execution, physician adoption and utilization.

TLSI closed at $4.93 on September 22, 2026, after trading between $4.82 and $5.15 during the session. Launch timing, adoption data and subsequent sales disclosures will provide clearer evidence of whether the device contributes to revenue growth.