TriSalus Life Sciences Shares Rise 15.6% After FDA Clearance for TriNav Advance

TriSalus Life Sciences (NASDAQ:TLSI) shares rose 15.6% in pre-market trading after the company announced that the U.S. Food and Drug Administration had granted 510(k) clearance for its TriNav Advance device.

Shares reached $5.70 in pre-market trading following the announcement, which was released on the evening of September 22, 2026.

TriNav Advance expands the company’s Pressure-Enabled Drug Delivery portfolio and is designed for use in liver embolization procedures.

TriNav Advance Targets Smaller Distal Vessels

According to TriSalus, the new device is designed to enable drug delivery to smaller, distal vessels through a compatible microcatheter.

TriNav Advance can be used in two configurations. Its telescoping mode is designed for selective delivery into smaller, more distal vessels, while its high-flow mode enables infusion through a larger lumen without requiring an additional microcatheter.

Chief Executive Officer Mary Szela said the clearance “enhances our Pressure-Enabled Drug Delivery portfolio in support of the full range of liver embolization procedures.”

Chief Medical Officer Richard Marshall said the device could extend the company’s approach “particularly in cases involving tortuous anatomies.”

Limited Market Release Planned

TriSalus plans a limited market release of TriNav Advance in the coming weeks.

The company develops medical devices for interventional oncology, including technologies intended to support the delivery of therapies during liver-directed procedures.

Broader U.S. equity indices showed limited movement at the time referenced in the source, with the S&P 500 and Dow Jones each up approximately 0.1% and the Nasdaq broadly unchanged.

TriSalus has also previously raised its full-year 2026 revenue guidance above earlier consensus expectations.

TriSalus Life Sciences stock price