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 January 1, 2020.12
This supplemental payment is intended to “facilitate access for [Medicare] beneficiaries to the advantages of new and innovative devices”13. The TriNav Infusion System met the required criteria to receive transitional pass-through status, including the demonstration of substantial clinical improvement, with the CMS saying it believes there is no existing pass-through payment category for this device because its SmartValve technology offers a unique mechanism for therapy delivery to selected sites in the peripheral vascular system, including solid tumors in the liver.12
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*Study design: A retrospective, single-center study included 88 treatment-naive patients with solitary HCC tumors <6.5 cm who underwent treatment utilizing either PEDD™ (n = 18) or standard end-hole (EH) microcatheters (n = 70). Explant liver assessment of pathological response after first treatment: PEDD n=4; EH n=12.
About the TriNav™ Infusion System
The TriNav Infusion System is a 0.021-inch lumen microcatheter with SmartValve™ self-expanding tip. SmartValve supports pressure generation, which enables delivery of therapeutic agents to select sites in the peripheral vascular system, including solid tumors in the liver.2,3,8,14
The TriNav SmartValve has demonstrated the potential to overcome intratumoral pressure in solid tumors to improve distribution and penetration of therapy during arterial embolization procedures per clinical studies performed to date. 2,3,14
Intended Use: The TriNav Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.15
Contraindications: TriNav is not intended for use in the vasculature of the central nervous system (including the neurovasculature) or central circulatory system (including the coronary vasculature).15
About TriSalusTM Life Sciences
TriSalusTM Life Sciences is dedicated to improving patient outcomes in pancreatic and other highly intractable solid tumors. TriSalus Infusion Systems have the potential to deliver diagnostic, therapeutic agents, and immuno-stimulants directly into tumor vasculature powered by its proprietary Pressure-Enabled Drug DeliveryTM (PEDD™) approach with SmartValve™ technology to improve the distribution and penetration of therapy in solid tumors. This innovative approach has the potential to allow for the administration of multiple mechanisms that can work together to overcome inherent immune suppression within the solid tumor microenvironment.
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