Events Details
TriSalus Receives FDA Clearance for TriNav Advance for Liver Embolisation
Wednesday, September 23, 2026
TriSalus Life Sciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for TriNav Advance, a new device within its Pressure-Enabled Drug Delivery (PEDD) portfolio for liver-directed embolisation procedures.
TriNav Advance is designed to support drug delivery to smaller and more distal blood vessels. The device can be used with a compatible delivery microcatheter, allowing interventional radiologists to select a microcatheter based on the procedure and vessel anatomy.
The device is intended to extend the use of PEDD technology across a broader range of liver-directed therapies and embolisation procedures. TriSalus plans to begin a limited market release of TriNav Advance in the coming weeks.
TriNav Advance can be used in two configurations based on vessel anatomy and treatment requirements.
Telescoping configuration: The device is used with a compatible microcatheter, with the TriNav Advance SmartValve positioned near the delivery site. This configuration is intended to support selective drug delivery to smaller and more distal vessels.
High-flow configuration: The device can be used without an additional microcatheter, allowing infusion through its larger lumen in a configuration similar to the standard TriNav device.
The FDA clearance expands TriSalus' PEDD device portfolio and provides an additional option for procedures involving complex or tortuous vascular anatomy. The company expects the device to support a wider range of liver embolisation procedures.
Source: trisaluslifesci.com
