TriSalus Launches Enhanced TriNav FLX Infusion System for Improved Tumor Drug Delivery
Key Insights
TriSalus Life Sciences has launched the TriNav FLX Infusion System (search), featuring enhanced trackability with twice the length of flexible material at the distal end for easier navigation through tortuous vessels.
The new system demonstrates a 28% reduction in force during navigation compared to standard TriNav designs in benchtop models, particularly benefiting procedures requiring precise control in challenging peripheral vascular anatomy.
TriNav FLX is eligible for dual reimbursement coverage under HCPCS codes C8004 for simulation/mapping and C9797 for treatment procedures, allowing clinicians to use the system for both planning and delivery in radioembolization.
TriSalus Life Sciences has launched the TriNav FLX Infusion System (search), expanding its portfolio of pressure-enabled drug delivery devices designed to improve therapeutic outcomes for patients with solid tumors (search). The new system addresses key challenges in interventional oncology by enhancing navigation capabilities through complex vascular anatomy.
Enhanced Design Features
The TriNav FLX Infusion System (search) incorporates significant design improvements over existing TriNav products. The system features twice the length of more flexible material at the distal end, enabling easier navigation through tortuous vessels. This enhancement proves particularly valuable for procedures requiring precise control in challenging peripheral vascular anatomy.
In benchtop testing, the TriNav FLX demonstrated a 28% reduction in force during navigation compared to the standard TriNav design. This reduction in navigational force can translate to improved procedural efficiency and potentially reduced complications during complex interventional procedures.
Pressure-Enabled Drug Delivery Technology
The TriNav FLX maintains the same trusted Pressure-Enabled Drug Delivery (PEDD) benefits as existing products in the TriNav portfolio. This technology is designed to overcome high intratumoral pressure caused by tumor growth and collapsed vasculature, which typically restricts the delivery of oncology therapeutics to solid tumors (search).
Mary Szela, CEO of TriSalus Life Sciences, emphasized the system's comprehensive capabilities: "With TriNav FLX, we now offer a comprehensive suite of advanced technologies designed to support Interventional Radiologists in navigating a wide range of peripheral vessel sizes and complexities."
Reimbursement Coverage
The TriNav FLX system is eligible for reimbursement under two Healthcare Common Procedure Coding System (HCPCS) codes. Code C8004 covers simulation or mapping procedures, while code C9797 covers treatment procedures. This dual coverage structure allows clinicians to utilize TriNav FLX for both planning and delivery phases in radioembolization procedures, supporting greater precision and continuity of care.
Clinical Applications
The enhanced trackability of TriNav FLX expands treatment options for interventional radiologists working with patients who have solid tumors (search). The system's improved flexibility and reduced navigational force requirements make it particularly suitable for procedures involving complex peripheral vascular anatomy where precise catheter control is essential.
TriSalus is also exploring the integration of its delivery technology with nelitolimod, an investigational class C Toll-like receptor 9 (search) agonist immunotherapeutic, for liver and pancreatic cancer (search) indications. The company's platform aims to address both the physical barriers to drug delivery and the immunosuppressive properties of liver and pancreatic tumor immune cells.