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FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

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TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via TriSalus Life Sciences

FDA cleared TriSalus Life Sciences' TriNav Advance on September 23. It joins the TriNav Infusion System, the TriNav Infusion System LV and the Pancreatic Retrograde Venous Infusion System in the company's Pressure-Enabled Drug Delivery line.

The device runs two ways. In telescoping mode it takes a compatible delivery microcatheter to reach small distal vessels in tortuous anatomy. In high-flow mode it infuses through its own large lumen. The clearance covers liver embolization and a broader set of embolization procedures.

CEO Mary Szela said a limited market release starts in the coming weeks. TriSalus trades on Nasdaq as TLSI and is based in Westminster, Colorado. Adding configurations to an already cleared platform is the least expensive way to widen a label, which is what makes the first predicate worth getting right.

Questions & Answers

What did FDA clear for TriSalus Life Sciences in September 2026?

FDA cleared TriSalus Life Sciences' TriNav Advance on September 23, 2026 for liver embolization and a broader range of embolization procedures.

How is TriNav Advance different from the original TriNav Infusion System?

TriNav Advance adds two operating configurations. In telescoping mode it accepts a compatible delivery microcatheter to reach small distal vessels in tortuous anatomy, and in high-flow mode it infuses through its own large lumen.

When will TriSalus launch TriNav Advance?

TriSalus CEO Mary Szela said the company intends a limited market release of TriNav Advance in the weeks following the September 23, 2026 clearance.

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