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
Patients Treated
With PEDD
0
Data on file (TriNav U.S. Sales). TriSalus Life Sciences, 2020.

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 influence 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
Effective tumor penetration and saturation may not be achieved with standard end-hole (EH) microcatheters or balloon procedures.1,15

PEDD™ with SmartValve™ has demonstrated in small retrospective studies 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 normal tissue18§
  • Significantly increased objective response and tumor necrosis, even in larger tumors1
  • Clinically demonstrated CR in fewer treatments1,16
In a small retrospective study:
Clinical data demonstrated improved on-target distribution, objective response rates, and tumor necrosis rates for PEDD™ vs EH microcatheters1*
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.
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.
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 small retrospective 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
Device
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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Or call us at: +1.8‍88.321.5212
Increase Perfusion. Empower Response.1

Study Designs

  • *
    Titano et al Study Design1: A retrospective, single-center study included 88 treatment-naive patients with solitary HCC tumors <6.5 cm who underwent treatment utilizing either the Surefire® Infusion System (SIS) with SmartValve™ technology (n=18) or standard end-hole (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).
  • Kim et al Study Design16: This retrospective, single-center study included 22 patients with 39 HCC lesions who received treatment via SIS with SmartValve™ technology. Information was taken from the electronic medical record system for patients who underwent treatment with SIS for HCC between January 2015 and June 2016. Response rates from treatment were measured using the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Evaluation of adverse events was categorized per Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
  • O’Hara et al Study Design17: Six patients received transarterial hepatic arteriography before selective internal radiation therapy (SIRT). Cone beam computed tomography (CT) was done at 1 and 5 minutes after 10 mL infusion of contrast media using a standard EH microcatheter via hand injection and later using SIS with SmartValve™ technology via power injection. Regions of interest were selected in the tumor and the ratio of intensity between the SIS and EH microcatheter was calculated. An equivalence test was done with 95% confidence to find out the significance of the enhancement differences between the two infusion systems.
  • §
    van den Hoven et al Study Design18: This study included 3 case reports of radioembolization in which SIS with SmartValve™ technology was used in patients with unresectable liver tumors. The microcatheter (internal diameter 0.027 in, vessel size range 4-6 mm) had a funnel-shaped expandable tip that expanded during reverse flow to minimize reflux of radioactive microspheres while also allowing for antegrade flow. The first patient was a 63-year-old man with an unresectable, multifocal HCC. The second patient was a 77-year-old man with a sigmoid carcinoma and synchronous liver metastases. The third patient was a 66-year-old man with liver metastases from an esophageal carcinoma. In all patients, intra-arterial administration of yttrium-90 (90Y) microspheres was performed exclusively with SIS, without coil embolization of extrahepatic vessels.
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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