TriSalus Life Sciences receives FDA clearance for TriNav Advance device

TriSalus Life Sciences (Nasdaq: TLSI) announced it has received U.S. Food and Drug Administration 510(k) clearance for TriNav Advance, a new device added to its Pressure-Enabled Drug Delivery (PEDD) portfolio for liver embolization procedures.

According to the company's press release, TriNav Advance is designed to provide access to small, distal vessels via a compatible delivery microcatheter. The device can be used in two configurations: a telescoping mode, which pairs with a compatible microcatheter for selective delivery to smaller vessels, and a high-flow mode, which functions like the existing TriNav device for infusion through a large lumen.

The clearance expands TriSalus' existing PEDD device lineup, which includes the TriNav Infusion System, the TriNav Infusion System LV, and the Pancreatic Retrograde Venous Infusion System. The company stated that the new device's indication supports embolization procedures beyond the liver.

TriSalus plans to begin a limited market release of TriNav Advance over the coming weeks.

"TriNav Advance enhances our Pressure-Enabled Drug Delivery portfolio in support of the full range of liver embolization procedures," said Mary Szela, President and Chief Executive Officer of TriSalus.

Richard Marshall, M.D., Chief Medical Officer of TriSalus, said the clearance enables the company to expand into cases involving tortuous anatomies that were not previously fully addressable with existing devices.

You May Also Be Interested In

• US Seeks More Competition In Kidney Treatment Market - Axios
• Eloxx finalizes Phase 2 ADPKD trial design, names new CMO
• Tezspire hits key endpoints in Phase III eosinophilic esophagitis trial