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Infographic showing TriSalus Life Sciences receiving FDA 510(k) clearance for TriNav Advance, highlighting expanded access to smaller and more distal blood vessels, a planned limited market release, and key financial figures including Q2 2026 revenue of $11.4 million and 2025 revenue of $45.2 million.

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Healthcare Industry News

TriSalus gets TriNav Advance FDA clearance after delay weighed on 2026 guidance

TriSalus Life Sciences has received FDA 510(k) clearance for TriNav Advance, enabling Pressure-Enabled Drug Delivery through smaller distal vessels and removing a regulatory delay that had already contributed to a reduction in the company’s 2026 revenue outlook.

September 28, 2026

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