TriSalus Life Sciences’ TriNav Advance Cleared by FDA for Liver Embolization

September 29, 2026—TriSalus Life Sciences, Inc. announced it has received FDA 510(k) clearance for the company’s TriNav Advance, which expands the company’s portfolio of pressure-enabled drug delivery (PEDD) devices.

With this addition, TriSalus offers a complete portfolio addressing liver-directed therapy cases; its indication supports a broader range of embolization procedures beyond the liver, noted the press release.

According to the company, TriNav Advance provides access to small, distal vessels via a compatible delivery microcatheter, while preserving the PEDD portfolio’s enhanced therapeutic delivery and off-target protection. The TriNav Advance can be paired with a compatible microcatheter of an interventionalist’s choice, giving flexibility across a broader range of procedures and anatomies.

TriSalus stated that TriNav Advance can be used in two configurations to match vessel anatomy and treatment goals:

1. Telescoping, which is used with a compatible microcatheter, with the TriNav Advance SmartValve positioned proximal to the delivery site—enabling selective delivery to smaller, distal vessels while maintaining the benefits of PEDD.
2. High flow, which is used like a standard TriNav device, without an additional microcatheter, for easy infusion through a large lumen.

The company advised it intends to initiate a limited market release of the device in the coming weeks.