Intra-tumoral pressure (ITP) significantly
impacts therapeutic delivery.3,4
Effective tumor penetration and saturation may not be achieved with standard approaches.1
Modulate intravascular pressure
to enable deeper perfusion.1
PEDD: A novel approach powered by SmartValve™ technology that works in sync with the heart6 to enhance delivery pressure beyond what the cardiovascular system can generate on its own,7 which may help to open collapsed vessels in the tumor and enable deeper perfusion.1,8
SmartValve: A one-way, intermittently occlusive valve that physiologically and atraumatically increases local vascular pressure at the target location7 to improve therapeutic delivery1 while sparing normal tissue.
TriNav is the latest infusion system with SmartValve technology for the PEDD approach.
Learn more about TriNav
The 5-year survival rate for HCC remains
poor at ~18% due to multiple factors.9
Difficult therapy delivery
Intra-tumoral pressure impacts the uptake of therapy in solid tumors.4,10
Limited therapy options
With systemic chemotherapy, it is difficult to achieve therapeutic levels within the tumor.11 Not only that, but concentrations of drug can accumulate in healthy tissue, which may lead to severe side effects and dose-limiting toxicity.11
Most patients are ineligible for curative treatments
Only 15% of patients are eligible for surgical resection or liver transplant.12
Slowing progression and improving tumor response can help more patients qualify for curative transplant.13
Patients with HCC or liver metastases can face dire outcomes. When transplant is an option, locoregional therapy (LRT) can help downstage ineligible patients to meet transplant criteria and bridge eligible patients through the waiting period,13 which is also recommended by clinical guidelines as an option.14
85% of HCC patients are ineligible for surgical resection or liver transplant.12
Liver transplantation for HCC provides a patient with the best chance at OS, with results of 60%-70% survival achieved at 5 years.15,16
Wait times for a liver transplant can range from <30 days to 5 years or more.17
Achieving complete response (CR) may extend overall survival (OS).18
Findings from a US multicenter HCC Transplant Consortium showed that patients who achieved CR to LRT had better 1-, 3-, and 5-year OS and recurrence rates post-transplant.18
Recurrence and Survival Outcomes at 1, 3, and 5 Years After Liver Transplantation18
Study Design
A database consisting of 20 transplant centers was retrospectively used to compare patients receiving pre-liver transplantation LRT with CR (n = 802) and without CR (n = 2637) from 2002 to 2013.18
Patients who achieved CR in fewer treatments also had superior OS.19
TriNav with SmartValve enables the Pressure-Enabled Drug Delivery (PEDD) approach.
PEDD with SmartValve has been shown in prospective and retrospective clinical studies and in multiple pre-clinical models to improve therapy uptake and tumor response.1,2,8,20,21
Review PEDD clinical data
News & Events
TriSalus Life Sciences®’ Surefire® Spark Infusion System (TriNav®) Receives CMS Approval for Transitional Pass-Through Payment Status
Let us tell you more.
Contact us to learn more about this improved technology for the proprietary PEDD approach.
Rx Only. For the safe and proper use of the TriNav device, refer to the Instructions for Use.
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.22
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).22
References
1. Titano JJ, Fischman AM, Cherian A, et al. End-hole Versus Microvalve Infusion Catheters in Patients Undergoing Drug-Eluting Microspheres-TACE for Solitary Hepatocellular Carcinoma Tumors: A Retrospective Analysis. Cardiovasc Intervent Radiol. 2019;42(4):560-568. 2. Pasciak AS, McElmurray JH, Bourgeois AC, Heidel RE, Bradley YC. The impact of an antireflux catheter on target volume particulate distribution in liver-directed embolotherapy: a pilot study. J Vasc Interv Radiol. 2015;26(5):660-669. 3. Sheth RA, Hesketh R, Kong DS, Wicky S, Oklu R. Barriers to drug delivery in interventional oncology. J Vasc Interv Radiol. 2013;24(8):1201-1207. 4. Heldin CH, Rubin K, Pietras K, Ostman A. High interstitial fluid pressure – an obstacle in cancer therapy. Nat Rev Cancer. 2004;4(10):806-813. 5. Stylianopoulos T, Martin JD, Chauhan VP, et al. Causes, consequences, and remedies for growth-induced solid stress in murine and human tumors. Proc Natl Acad Sci U S A. 2012;109(38):15101-15108. 6. Data on file (animal study video). TriSalus Life Sciences®, 2019. 7. Data on file (CEA 001 trial). TriSalus Life Sciences®, 2019. 8. Data on File. REP-0362. TriSalus Life Sciences®, 2021. 9. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 10. DuFort CC, DelGiorno KE, Hingorani SR. Mounting Pressure in the Microenvironment: Fluids, Solids, and Cells in Pancreatic Ductal Adenocarcinoma. Gastroenterology. 2016;150(7):1545-1557.e2. 11. Wolinsky JB, Colson YL, Grinstaff MW. Local drug delivery strategies for cancer treatment: gels, nanoparticles, polymeric films, rods, and wafers. J Control Release. 2012;159(1):14-26. 12. Crissien AM, Frenette C. Current management of hepatocellular carcinoma. Gastroenterol Hepatol (N Y). 2014;10(3):153-161. 13. Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019;380(15):1450-1462. 14. Heimbach JK, Kulik LM, Finn RS, et al. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018;67(1):358-380. 15. Galuppo R, McCall A, Gedaly R. The role of bridging therapy in hepatocellular carcinoma. Int J Hepatol. 2013;2013:419302. 16. Xing M, Kim HS. Independent prognostic factors for posttransplant survival in hepatocellular carcinoma patients undergoing liver transplantation. Cancer Med. 2017;6(1):26-35. 17. US Department of Health and Human Services. Organ Procurement and Transplantation Network. https://optn.transplant.hrsa.gov/data/view-data-reports/build-advanced/#. Accessed November 21, 2019. 18. DiNorcia J, Florman SS, Haydel B, et al. Pathologic Response to Pretransplant Locoregional Therapy is Predictive of Patient Outcome After Liver Transplantation for Hepatocellular Carcinoma: Analysis From the US Multicenter HCC Transplant Consortium. Ann Surg. 2020;271(4):616-624. 19. Kim BK, Kim SU, Kim KA, et al. Complete response at first chemoembolization is still the most robust predictor for favorable outcome in hepatocellular carcinoma. J Hepatol. 2015;62(6):1304-1310. 20. Katz et al. “HITM-SURE: Phase Ib CAR-T hepatic artery infusion trial for stage IV adenocarcinoma using Pressure-Enabled Drug Delivery technology.” SITC (2018) Poster Presentation. 21. Shankara Narayanan JS, Vicente DA, Ray P, et al. Pressure-enabled delivery of gemcitabine in an orthotopic pancreatic cancer mouse model. Surgery. 2020;168(3):448-456. 22. TriSalus™ TriNav® Infusion System, Instructions for Use.
