Deep expertise in product development and commercialization of innovative drug delivery infusion systems enables us to efficiently address an unmet need to deliver therapeutics directly to liver metastases and pancreatic solid tumors.
TriNav™ Infusion System
The TriNav Infusion System is FDA cleared advanced technology for the proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach. It offers the same benefits of PEDD with new, self-expanding SmartValve™ technology.
- Trackability has been enhanced with a single catheter body design1,2
- Compatibility with standard angiographic guide catheters1,2
- Workflow is simple and similar to a standard end-hole catheter1,2
TriNav is approved for Medicare Transitional Pass-Through Payment.3
Pancreatic Infusion System
The Pancreatic Retrograde Venous Infusion™ (PRVI™) transhepatic approach is intended to provide direct venous access to vessels draining pancreatic tumors and enable targeted delivery of therapeutics into the tumor vasculature.
- The venous network is not compromised by the extensive collateralization that makes the arterial route challenging for targeted delivery.4,5,6
- Transhepatic access provides a less tortuous path to target vasculature.6
The TriSalus Pancreatic Infusion System with SmartValve technology is an FDA cleared device for delivery of therapeutics to the peripheral vasculature. This includes delivering therapy via the PRVI approach into unresectable pancreatic tumors.
- Data on file (510K). TriSalus™ Life Sciences, 2019.
- TriSalus™ TriNav™ Infusion System, Instructions for Use.
- US Department of Health and Human Services, Centers for Medicare & Medicaid Services. Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems, 84 Fed. Reg. 61142, 61273 (Nov. 12, 2019).
- Homma, H., et al. Cancer. 2000;89:303-313.
- Rosemurgy, A.S., et al. Pancreat Cancer. 2017;3:58-65.
- Piras, C., et al. Acta Cirurgica Brasileira. 2010;25:105-110.