BioTech TLSI TriSalus Gets FDA Clearance For TriNav Advance For Liver Embolization; Overnight Stock Up 17% September 22, 2026 — 10:54 pm EDT Written by RTTNews.com for RTTNews linkedin facebook x email reddit (RTTNews) - TriSalus Life Sciences, Inc. (TLSI), an oncology-focused medical technology company, said the U.S. Food and Drug Administration has granted 510(k) clearance to TriNav Advance, expanding its Pressure-Enabled Drug Delivery, or PEDD portfolio for liver embolization procedures. Liver embolization is an international procedure used to deliver therapy to tumors by targeting their blood supply. TriNav Advance is designed to support drug delivery to small, distal vessels while maintaining the delivery and off-target protection associated with the company's PEDD technology. The device can be used with a compatible delivery microcatheter, allowing interventional radiologists to select the microcatheter based on the procedure and anatomy. It supports two configurations: a telescoping mode for selective delivery to smaller, distal vessels and a high-flow mode for infusion through a large lumen without an additional microcatheter. With the clearance, TriSalus said its PEDD portfolio now addresses a broader range of liver-directed therapy cases, while the device's indication also supports embolization procedures beyond the liver. The company plans to begin a limited market release of TriNav Advance in the coming weeks. Company Profile TriSalus currently has other FDA -cleared PEDD devices, including the TriNav Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors. The Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The company is also developing the investigational immunotherapeutic nelitolimod, a Toll-like receptor 9 agonist. TLSI closed Tuesday's trade at $4.93, down 1%. In the overnight market, shares are up 17.85% at $5.81. RTTNews Founded in the late 1990s by Andrew Mariathasan in New York, with the goal of covering Wall Street for a new generation of investors, RTTNews has expanded steadily over the years to become a trusted provider of content for a wide array of subjects across several platforms. RTT's Financial Newswire is relied upon by some of the world's largest financial institutions, including banks, brokerages, trading platforms and financial exchanges. More articles by this source facebook x website Tags BioTech Stocks Mentioned TLSI Latest Articles Data is currently not available