DENVER--(BUSINESS WIRE)--TriSalusTM Life Sciences (“TriSalus”), a company committed to transforming outcomes for patients with solid tumors, today announced the launch of its TriNav™ Infusion System (“TriNav”). Powered by its proprietary Pressure-Enabled Drug DeliveryTM (PEDD™) approach with SmartValveTM technology, TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumors, including hepatocellular carcinoma (HCC) and liver metastases.2,3

The TriNav System can provide interventional radiologists intravascular tumor access with improved trackability, compatibility with standard angiographic catheters and workflow comparable to standard interventions.4

The tumor microenvironment creates pressure barriers that limit flow into solid tumors.5,6 PEDD with SmartValve creates a high-pressure gradient that improves delivery and penetration of therapy into tumors.7,8 The porous expandable SmartValve is designed to allow antegrade flow and leverages blood flow to carry the dose deep into the solid tumor.1,7 SmartValve enables therapy delivery to the intended target while minimizing non-target delivery that has been shown to damage healthy tissue.2,9
In a clinical study, PEDD with SmartValve demonstrated the ability to overcome tumor infusion barriers and significantly improve response rates in HCC.2 Outcomes from a retrospective, single-center study of patients with solitary HCC tumors who underwent treatment utilizing either PEDD or standard end-hole microcatheters, showed 100% Objective Response (OR) with PEDD versus 76.5% with standard end-hole microcatheters (p=0.019).2* Additionally, after first treatment, Pathological Response (PR) as shown by tumor necrosis percentage was significantly greater with PEDD (88.8%) vs. standard end-hole microcatheters (33.8%), (p=0.026).2* Improving response rates could potentially help more patients meet transplant criteria, lead to successful downstaging, bridging, and post-transplant survival.10

“Tumor-directed delivery of therapeutics is an exciting opportunity to help improve outcomes across a wider range of procedures by overcoming intratumoral pressure that can prevent drugs from adequately penetrating the tumor,” said Mary Szela, President and CEO of TriSalus. “The new TriNav Infusion System utilizes SmartValve™, a first-in-kind, proprietary technology that has been shown to modulate pressure and flow with the goal for improved therapeutic delivery and deeper penetration into the tumor while helping to protect healthy tissue.”1-3,7,8

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