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.
A clinical study (PANC-001) has been initiated to demonstrate the ability of the device to modulate pressure to introduce therapeutics directly to pancreatic tumors.
SIS Infusion Systems
The SIS Infusion System is the FDA cleared legacy technology for the PEDD approach. The SmartValve deployable tip enables delivery of therapeutic agents to selected sites in the peripheral vascular system, including solid tumors in the liver.2,8
In small, prospective and retrospective studies, PEDD with SmartValve delivered more therapy into the vasculature of liver tumors while decreasing exposure to normal tissue.8,9
*Titano et al: A small, retrospective, single-center study included 88 treatment-naive patients with solitary HCC tumors <6.5 cm who underwent treatment utilizing either SIS (n = 18) or standard EH microcatheters (n = 70). Twenty-three patients (5 SIS, 18 EH) received a liver transplant during the study, with 1 SIS and 6 EH patients excluded from the tumor necrosis analysis for receiving subsequent therapies prior to transplant. A pathologist performed a blinded review of the liver explant specimens to assess tumor necrosis and treatment distribution. Pathological analysis of explanted livers showed greater concentrations of microspheres within the tumor relative to the surrounding tissue in SIS explants (88.7 ± 10.6%) versus the EH explants (55.3 ± 32.7%) (p = 0.002).
†Pasciak et al: A small, prospective study including 9 patients with unresectable liver cancer who were enrolled for the treatment of HCC (n = 6), liver-dominant metastatic disease (n = 2), or intrahepatic cholangiocarcinoma (n = 1). Each patient was treated via SIS or standard EH microcatheter. Decreases in hepatic nontarget embolization were found in all patients when SIS was used (mean 42%; σ = 19%), representing a 24%–89% reduction. Increased tumor deposition was also noted in all patients (mean 68%; σ = 20%), representing a relative increase of 33%–90%. Both findings were statistically significant (P <0.05).
- 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.
- Design Validation testing in porcine model. The infusion system was deployed at various regions in the peripheral vasculature. An IBP pressure transducer coupled to a patient monitor was then attached to the device. Real-time distal pressure was monitored during infusion of contrast media and saline. TriSalus Life Sciences 2020.
- Titano, J.J., et al. Cardiovasc Intervent Radiol. 2019;42:560-568.
- Pasciak, A.S., et al. J Vasc Interv Radiol. 2015;26:660-669.