FDA 510(k) clears TriNav Advance with dual configurations for liver embolization

FDA 510(k) clearance granted to TriSalus’ TriNav Advance, a pressure-enabled drug delivery device for liver embolization, offering telescoping and high-flow configurations to reach distal vessels and limit surrounding tissue exposure.

• The telescoping configuration positions the SmartValve proximally via a microcatheter to access smaller distal vessels.
• The high-flow configuration allows larger-lumen infusion without an additional microcatheter, similar to standard TriNav devices.
• Clearance expands the portfolio into tortuous anatomies previously beyond the reach of the company’s existing technology.

Automated summary

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