FDA Clears TriSalus TriNav Advance for Liver Embolization

TriSalus Life Sciences has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TriNav Advance, a new device designed to expand pressure-enabled drug delivery options for liver embolization procedures.

The clearance, announced on September 22, 2026, adds TriNav Advance to TriSalus’ portfolio of Pressure-Enabled Drug Delivery (PEDD) devices. The company said the new device is designed to help physicians deliver treatments to smaller and more distant blood vessels during liver-directed procedures.

TriNav Advance can be used with a compatible delivery microcatheter, allowing interventional radiologists to reach small distal vessels that may be difficult to access with standard devices. The system is designed to give physicians more flexibility when working with different vessel anatomies and treatment needs.

The device has two configurations. The telescoping configuration is used with a compatible microcatheter and is designed for selective delivery to smaller vessels. The high-flow configuration can be used without an additional microcatheter, allowing infusion through a larger lumen.

TriSalus said the addition of TriNav Advance expands its PEDD portfolio for liver-directed therapy and supports a broader range of embolization procedures. The company plans to begin a limited market release of the device in the coming weeks.

PEDD is designed to control pressure and blood flow during drug delivery. According to TriSalus, the approach is intended to deliver more therapy to tumors while reducing unwanted exposure to surrounding healthy tissue. The company currently has other FDA-cleared devices using the technology for liver and pancreatic tumor treatment.

“TriNav Advance enhances our Pressure-Enabled Drug Delivery portfolio in support of the full range of liver embolization procedures,” said Mary Szela, president and CEO of TriSalus Life Sciences.

Richard Marshall, chief medical officer of TriSalus, said the clearance could help the company address procedures involving more difficult vessel anatomy.

The FDA clearance marks another step in TriSalus’ efforts to expand its medical technology platform for interventional oncology. The company is also developing nelitolimod, an investigational immunotherapy being studied for solid tumors.