Response Graphic

TriNav™ Infusion System

Introducing improved technology for the proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach

The same benefits of PEDD™ with SmartValve™ technology in an enhanced design.

  • Trackable: Featuring a new, single-body design, TriNav™ is engineered for improved selectivity2
  • Compatible: TriNav™ can be used with 0.035-inch and 0.038-inch standard angiographic catheters3
  • Simple: Standard preparation and operation that integrates easily into existing workflows

Hepatocellular carcinoma (HCC) is a complex disease that’s difficult to treat and often has poor patient outcomes4-7

Graphic showing reasons why hepatocellular carcinoma is difficult to treat
Graphic showing reasons why hepatocellular carcinoma is difficult to treat
Graphic showing reasons why hepatocellular carcinoma is difficult to treat
Graphic showing reasons why hepatocellular carcinoma is difficult to treat
Graphic showing reasons why hepatocellular carcinoma is difficult to treat
Surgical resection and liver transplantation are among the only curative options5
Eligibility and wait times for liver transplantation are an obstacle for many HCC patients.5,8
Graphic showing that 85% of HCC patients are ineligible for a liver transplant.
 
Graphic showing that wait times for a liver transplant can range from <30 days to 5 years or more.
Locoregional therapy (LRT) can help downstage ineligible patients to meet transplant criteria and bridge eligible patients through the waiting period4

LRT plays a critical role in controlling HCC until transplantation and may also predict post-transplant outcomes4,10

Patients who achieved complete response (CR) to LRT had better 1-, 3-, and 5-year overall survival (OS) and recurrence rates post-transplant according to findings from a US Multicenter HCC Transplant Consortium.10
recurrence and survival outcomes at 1, 3, and 5 years after liver transplantation10
Chart showing patients who had a complete response to pre-transplant LRT had better overall survival and recurrence rates at 1, 3, and 5 years post-transplant compared to those who did not.
Chart showing patients who had a complete response to pre-transplant LRT had better overall survival and recurrence rates at 1, 3, and 5 years post-transplant compared to those who did not.
In a different study, patients who achieved CR in fewer treatments also had superior OS.11

Infusion barriers

Achieving better response in fewer treatments depends in part on overcoming the challenges of the tumor microenvironment (TME)12,13

  • Abnormal vascularity: HCC tumors have a network of leaky, low-integrity blood vessels that can interfere with drug delivery to cancer cells13
  • Interstitial fluid pressure: Fluid from leaky blood vessels seeps into the interstitial space with no way out, contributing to highly pressurized tumor tissue13
  • Solid stress: Compresses already compromised blood and lymph vessels, limiting drug delivery within the tumor mass12
Illustration showing abnormal blood vessels, solid stress, hypoxia, and necrosis in a liver tumor.
Current LRT approaches may be limited in their ability to address infusion barriers4,14
Tumor penetration and saturation may not be achieved with standard end-hole (EH) microcatheters or balloon procedures.1,15

PEDD™ with SmartValve™ has demonstrated the potential to achieve the response patients need to move toward transplantation1,16

The first LRT solution of its kind, used in procedures worldwide

PEDD™ with SmartValve™ leverages the body’s own natural blood flow to safely increase infusion pressure and overcome interstitial fluid pressure and solid stress in the TME.1,17

  • Shown to improve therapy delivery, uptake, and response1
  • Reflux protection may help reduce the risk of nontarget delivery to help protect healthy tissue18
  • Significantly increased objective response and tumor necrosis, even in larger tumors1
  • Clinically demonstrated CR in fewer treatments1,16
In a study:
PEDD™ with SmartValve™ delivered a significantly higher concentration of therapy in tumor vs EH microcatheters1
% Beads in tumor vs surrounding tissue as measured by explant analysis
Chart showing 88.7% more therapy delivered into the tumor with the proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach vs 55.3% with end-hole microcatheters.
PEDD™ significantly improved objective response1
objective response
Graphic showing 100% objective response with PEDD™ vs 76.5% with end-hole microcatheters.
Clinically demonstrated CR in fewer treatments1
Complete response at 1 month
Graphic showing 66.6% complete response with PEDD™ vs 50.0% with end-hole microcatheters.
Significantly higher percentage of tumor necrosis was shown with PEDD™1
% tumor necrosis after only 1 TACE treatment
Chart showing 88.8% (±2.5%) tumor necrosis after 1 TACE treatment with PEDD™ vs 33.8% (±41.1%) with end-hole microcatheters.
TACE = transarterial chemoembolization
The percentage of tumor necrosis remained significantly higher after all treatments1*
% tumor necrosis after all treatments
Chart showing 89.0% (±2.2%) tumor necrosis after all TACE treatments with PEDD™ vs 56.1% (±44.5%) with end-hole microcatheters.
in another study:
9 out of 10 patients were successfully downstaged after their first treatment16
Graphic showing that 9 out of 10 patients with HCC were successfully downstaged using pressure-enabled drug delivery (PEDD™) with SmartValve™
  • The majority of patients were successfully downstaged: 92% had their disease successfully downstaged to be within transplant criteria after their initial treatment with PEDD™
  • PEDD™ with SmartValve™ demonstrated CR in one treatment: 32% of patients and 54% of lesions had CR after one treatment
Compatible with all 0.035-inch and 0.038-inch standard angiographic catheters
Table showing specifications for TriNav™ with pressure-enabled drug delivery (PEDD™) with SmartValve™ technology Photo of TriNav™ SmartValve™ and specifications
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.3

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).3

The TriNav™ Infusion System with SmartValve™ supports hope for a curative transplant

Contact us to learn more about this improved technology for the proprietary PEDD™ approach
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Our team is here to support you. Place a domestic or international order, connect with your local TriSalus™ Life Sciences sales representative, or learn more about our products.
Or call us at: +1.8‍88.321.5212
Increase Perfusion. Empower Response.1
References
  1. Titano JJ, et al. Cardiovasc Intervent Radiol. 2019;42:560-568.
  2. Data on file (510K). TriSalus™ Life Sciences, 2019.
  3. TriSalus™ TriNav™ Infusion System, Instructions for Use.
  4. Villanueva A. N Engl J Med. 2019;380:1450-1462.
  5. Crissien AM, Frenette C. Gastroenterol Hepatol. 2014;10(3):153-161.
  6. Eggert T, Greten TF. Pharmacol Ther. 2017;173:47-57.
  7. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019.
  8. 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.
  9. Heimbach J, et al. Hepatol. 2018;67(1):358-380.
  10. DiNorcia J, et al. Ann Surg. 2019 Mar 5. DOI: 10.1097/SLA.0000000000003253.
  11. Kim BK, et al. J Hepatol. 2015;62(6):1304-1310.
  12. Jain RK. Sci Am. 2014;310:46-53.
  13. Sheth RA, et al. J Vasc Interv Radiol. 2013;24:1201-1207.
  14. Guan YS, et al. ISRN Gastroenterol. Epub 2012 Aug 26. DOI: 10.5402/2012/480650.
  15. Data on file. TriSalus™ Life Sciences, 2019.
  16. Kim AY, et al. PLoS One. 2017;12(9):e0183861.
  17. O’Hara R. Poster presented at: European Conference on Interventional Oncology (ECIO); April 22-25, 2018; Vienna, Austria.
  18. van den Hoven AF, et al. Cardiovasc Intervent Radiol. 2014;37:523-528.
  19. Data on file (REP-0324). TriSalus™ Life Sciences, 2019.
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