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FDA grants 510(k) clearance for TriSalus' TriNav Advance device, expanding PEDD portfolio
TLSITriSalus Life Sciences, Inc.
TriSalus Life Sciences, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its TriNav Advance device on September 22, 2026. This approval expands the company's Pressure-Enabled Drug Delivery (PEDD) portfolio by enabling access to small, distal vessels via compatible microcatheters while preserving enhanced therapeutic delivery and off-target protection. The device supports two configurations: telescoping for selective delivery to smaller vessels and high-flow for easy infusion through large lumens. TriSalus intends to initiate a limited market release of the TriNav Advance over the coming weeks. This regulatory milestone strengthens the company's comprehensive portfolio for liver embolization and broader embolization procedures beyond the liver, potentially catalyzing further physician adoption. TriSalus Life Sciences is an oncology-focused medical technology company that integrates novel drug delivery devices with standard-of-care therapies and investigational immunotherapeutics to treat solid tumors.