PEDD increased the T/N by a median of 24%, and the TD by a median of 23% vs. a traditional microcatheter.
PEDD Evidence
TriNav’s PEDD approach significantly increases the T:N* ratio. Increased T:N ratio is associated with improved patient outcomes.
PEDD Improved Tumor Targeting in Liver Radioembolization with Resin Microspheres.2
PEDD significantly increased both T:N Ratio and Tumor Dose compared to a traditional microcatheter (TMC).
24%
increase to T:N via PEDD
23%
increase to tumor dose via PEDD
Study Design
A retrospective analysis of 61 patients with liver cancer (190 lesions). All patients underwent an MAA planning procedure delivered via a standard EH catheter. Resin Y90 was delivered via either an EH catheter (control group) or via PEDD, followed by PET/CT imaging. Each patient’s post–Y90 PET/CT was co-registered to their post-MAA SPECT/CT to compare the tumor to normal liver ratio and tumor dose.
PEDD Significantly Increased Tumor Penetration and Improved Response When Used to Deliver DEM-TACE to Treat HCC.1
PEDD delivered a significantly higher concentration of therapy in the tumor compared to a traditional microcatheter (TMC).
33%
increase to on-target
therapy delivery
via PEDD
55%
increase to
pathological response
via PEDD
23%
increase to
objective response
via PEDD
Study Design
A retrospective, single-center study included 88 treatment-naive patients with solitary HCC tumors <6.5 cm who under when treatment utilizing either PEDD (n=18) or standard EH microcatheters (n=70).
Board-certified radiologists conducted blinded review of follow-up imaging according to mRECIST. Following liver explant (n=23), a board-certified pathologist performed a blinded review of the liver specimens to assess tumor necrosis and therapeutic distribution.
DEB-TACE performed using PEDD was associated with improved tumor response, higher percentage tumor necrosis at explant, and improved on-target distribution.
PEDD Significantly Improved Tumor Targeting Compared to a Traditional Microcatheter.3
In a variety of tumor types, PEDD significantly increased tumor deposition and significantly decreased non-target embolization compared to a traditional microcatheter (TMC).
Mean
58%
decrease in non-target embolization via PEDD
Mean
68%
increase in tumor targeting via PEDD
Study Design
A prospective study included 9 patients who were referred for Y90 radioembolization treatment of their liver tumors. Prior to treatment delivered via PEDD, each patient received two same-day sequential lobar infusions of macroaggregated albumin (MAA) via traditional microcatheter and PEDD. Every infusion was performed from the same location, and post-MAA SPECT imaging was obtained. Differences in MAA distribution within the tumors and non-target sites were evaluated.
PEDD was shown to increase targeting while reducing non-target embolization across a variety of tumor types.
PEDD was shown to increase targeting while reducing non-target embolization across a variety of tumor types.
The TriNav Infusion System Significantly Increased Tumor Penetration of Glass Microspheres in Both Lobar and Selective Deliveries.5
In a porcine liver tumor model, TriNav with PEDD was shown to significantly improve glass microspheres (GM) uptake in liver tumors compared to a traditional microcatheter (TMC) in both lobar and selective infusions (n=17 each).
117%
increase in total tumor penetration via PEDD
39%
increase in total tumor penetration via PEDD
Lobar infusions via TriNav had statistically equivalent tumor penetration to selective delivery via TMC
Study Design
Transgenic pigs (Oncopigs) had tumors induced which measured 1-3 cm. Fluorescently labeled GMs were delivered via hepatic arterial infusion using a TheraSphere™ Administration Set to simulate TARE-Y90 therapy delivery. The study compared delivery via a TriNav to a TMC in both lobar and selective delivery positions. Livers were collected immediately after dosing, and a specialized imaging tool was used to detect GM fluorescent signal in and around tumors. A blinded quantitative analysis of signal intensity was performed.
Intra-arterial Pressure-Enabled Drug Delivery™ Significantly Increases Penetration of Glass Microspheres in a Porcine Liver Tumor Model
A Multi-Center Registry Study of the Safety, Feasibility, and Outcomes of PEDD in DEB-TACE for Patients with HCC.6
Across 10 enrolling centers and a range of HCC tumor sizes, PEDD demonstrated a 6-month objective response rate (ORR) of 82.2% and a complete response rate (CRR) of 64.3%), with no toxicities above grade.
Study Design
Multi-center registry study in which 114 HCC lesions in 72 patients were treated with DEB-TACE delivered via the Pressure-Enabled Drug Delivery method from 2014 to 2017. All available 1, 3 and 6-month follow up imaging (CT and/or MRI) was analyzed and efficacy was assessed by treatment response via mRECIST criteria. Safety was assessed according to CTCAE v4.0.
* Tumor to normal
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. d’Abadie P, Walrand S, Goffette P, et al. Antireflux catheter improves tumor targeting in liver radioembolization with resin microspheres. Diagn Interv Radiol. 2021;27(6):768-773.
3. 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.
4. Cook K, Gupta D, Liu Y, et al. Real-world evidence of pressure-enabled drug delivery for trans-arterial chemoembolization and radioembolization among patients with hepatocellular carcinoma and liver metastases. Curr Med Res Opin. 2024;40(4):591-598.
5. Jaroch DB, Liu Y, Kim AY, Katz SC, Cox BF, Hullinger TG, Intra-arterial Pressure Enabled Drug Delivery Significantly Increases Penetration of Glass Microspheres in a Porcine Liver Tumor Model, Journal of Vascular and Interventional Radiology (2024), doi: https://doi.org/10.1016/ j.jvir.2024.06.030.
6. Kapoor, B. et al. 3:18 PM Abstract No. 133 Surefire Infusion System (SIS) hepatocellular carcinoma registry study interim results: a multicenter study of the safety, feasibility, and outcomes of the SIS expandable-tip microcatheter in DEB-TACE. J. Vasc. Interv. Radiol. 29, S60 (2018).
7. TriSalusTM TriNav®Infusion System Instructions for Use.
8. TriSalusTM TriNav®LV Infusion System Instructions for Use.