TriSalus Life Sciences has launched its TriNav infusion system (TriNav). Powered by its proprietary pressure-enabled drug delivery (PEDD) approach with SmartValve technology, according to a press release, TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumours, including hepatocellular carcinoma and liver metastases.

The press release states that the TriNav system can provide interventional radiologists intravascular tumour access with improved trackability, compatibility with standard angiographic catheters and workflow comparable to standard interventions. The tumour microenvironment creates pressure barriers that limit flow into solid tumours. PEDD with SmartValve is designed to create a high-pressure gradient that improves delivery and penetration of therapy into tumours. The porous expandable SmartValve aims to allow antegrade flow and leverages blood flow to carry the dose deep into the solid tumour. SmartValve enables therapy delivery to the intended target while minimising non-target delivery that has been shown to damage healthy tissue.

In a clinical study, PEDD with SmartValve demonstrated the ability to overcome tumour infusion barriers and significantly improve response rates in hepatocellular carcinoma. Outcomes from a retrospective, single-centre study of patients with solitary hepatocellular carcinoma tumours who underwent treatment using either PEDD or standard end-hole microcatheters, showed 100% objective response with PEDD vs. 76.5% with standard end-hole microcatheters (p=0.019). Additionally, after first treatment, pathological response as shown by tumour necrosis percentage was significantly greater with PEDD (88.8%) vs. standard end-hole microcatheters (33.8%), (p=0.026). Improving response rates could potentially help more patients meet transplant criteria, lead to successful downstaging, bridging, and post-transplant survival.

Mary Szela, president and CEO of TriSalus, states: “Tumour-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 tumour. The new TriNav Infusion System uses 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 tumour while helping to protect healthy tissue.”

Acknowledging its unique technology for therapeutic delivery, the Centers for Medicare and Medicaid Services (CMS) granted TriNav transitional pass-through payment as part of the 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS-1717-FC), effective 1 January 2020.