
Sep 25, 2026
FDA Clears TriNav Advance for Expanded Liver Embolization Access
The FDA has granted 510(k) clearance to TriSalus Life Sciences for its TriNav Advance device, designed to enhance tumor penetration during liver embolization procedures. This catheter-based system extends the company's Pressure-Enabled Drug Delivery (PEDD) technology to smaller hepatic vessels, utilizing a SmartValve mechanism to improve drug and microsphere delivery to tumors while minimizing exposure to healthy tissue. Preclinical studies have supported the effectiveness of PEDD in increasing therapeutic concentration within tumors.
Company relevance
100.00%
Company sentiment
Bullish
Overall sentiment
Bullish

Sep 23, 2026
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 receiving 510(k) clearance from the FDA for its TriNav Advance device. This new device is designed to enhance pressure-enabled drug delivery in liver embolization procedures, particularly for smaller, distal vessels. TriSalus plans a limited market release in the coming weeks and previously raised its full-year 2026 revenue guidance.
Company relevance
100.00%
Company sentiment
Bullish
Overall sentiment
Bullish