WESTMINSTER, Colo. — September 22, 2026
TriSalus Life Sciences, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for TriNav® Advance, the newest addition to the company’s Pressure-Enabled Drug Delivery™ (PEDD™) portfolio. The device is designed to expand access to small, distal vessels through a compatible delivery microcatheter while maintaining the pressure-enabled delivery approach used across TriSalus’ existing platform. The company said the clearance broadens its portfolio for liver-directed therapy and supports a wider range of embolization procedures.
TriNav Advance Enables Distal Vessel Drug Delivery
TriNav Advance can be configured for telescoping or high-flow use, allowing clinicians to adapt the system to vessel anatomy and treatment requirements. In the telescoping configuration, the device is used with a compatible microcatheter and positions the TriNav Advance SmartValve proximal to the delivery site, enabling selective access to smaller and more distal vessels. In the high-flow configuration, TriNav Advance can be used without an additional microcatheter for infusion through a larger lumen. TriSalus said the two configurations are intended to provide physicians with greater procedural flexibility.
FDA Clearance Expands TriSalus PEDD Portfolio
TriNav Advance expands TriSalus’ portfolio of PEDD devices across liver-directed therapy and embolization procedures. The company currently offers FDA-cleared devices including the TriNav Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors, as well as the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. TriSalus said the new device is particularly intended to extend PEDD capabilities into procedures involving smaller vessels and more challenging anatomies. The company plans to begin a limited market release of TriNav Advance in the coming weeks.
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TriSalus Advances Pressure-Enabled Oncology Delivery
The PEDD platform is designed to modulate pressure and flow during regional drug delivery, with the goal of increasing therapeutic delivery to tumors while limiting undesired exposure to normal tissue. TriSalus is developing the technology for solid-tumor applications and is also advancing nelitolimod, an investigational Toll-like receptor 9 agonist, in combination with its delivery platform. The company has completed three Phase 1 clinical trials of nelitolimod and plans to explore development partnerships. The TriNav Advance clearance represents a device-platform expansion and does not itself establish improved clinical outcomes for patients.
Source :TriSalus Life Sciences, press release
