TriSalus Life Sciences receives FDA clearance for TriNav Advance device

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Go back to TriSalus Life Sciences receives FDA clearance for TriNav Advance device

TriSalus Life Sciences Receives FDA Clearance for TriNav® Advance, Strengthening Comprehensive Pressure-Enabled Drug Delivery™ (PEDD™) Portfolio for Liver Embolization

September 22, 2026 4:15 PM EDT

WESTMINSTER, Colo.--(BUSINESS WIRE)-- TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the Company), an oncology company integrating novel delivery technology with standard-of-care therapies and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TriNav® Advance, the newest addition to its Pressure-Enabled Drug Delivery (PEDD) portfolio.

TriNav® Advance expands TriSalus' portfolio of PEDD devices, adding access to small, distal vessels, via a compatible delivery microcatheter, while preserving PEDD's enhanced therapeutic delivery and off-target protection. Interventional... More