Prospective Multicenter GPX® Embolic Device
Clinical Trial Summary
INTRODUCTION

The use of liquid embolic devices in peripheral applications
continues to expand significantly, but device preparation canbe burdensome and embolic delivery can be complicated anduncontrolled. The GPX Embolic Device is a novel, simple toprepare, easy to deliver, aqueous-based embolic agent thatsolidifies in situ through ionic bonds.
A prospective, multicenter, feasibility clinical trial wasconducted examining the use of the GPX Embolic Devicefor distal applications within the peripheral vasculature. The
primary objective of this study was to evaluate safety andearly indicators of performance for the GPX Embolic Device.

MATERIALS & METHODS

Enrollment consisted of 17 patients with diverse distalembolization needs, including renal angiomyolipoma,
primary and secondary renal cell carcinoma, portal veins,
pelvic sarcoma, and polycystic kidney embolizations (Referto Table 1 for study demographics). No significant changes
in embolization procedure or delivery microcatheter wererequired for embolization using the study device. The
microcatheter used for study device delivery was chosen byeach investigator based on preferences and/or anatomical
determinants. Pre-and post-embolization angiograms werecompleted to confirm complete occlusion of the targetregion.
TABLE 1: STUDY DEMOGRAPHICS
SEX

MALE

FEMALE

8 (47%)
9 (53%)AGE

MEAN/MEDIAN
RANGE

54.3/58
22-85• Primary Endpoints:- Technical success (complete occlusion of target region
at time of procedure).
- Incidence of Device-Related Serious Adverse Events(SAEs).
- Follow-up was performed at 30 days, with imaging
included if dictated by standard of care.

• For each case, operators were asked to score several
dimensions of their experience with the GPX Embolic
Device including acceptability of preparation, delivery,and visibility.

Scan this link to view trial
results as published in theJournal of Vascular andInterventional Radiology.

RESULTS• In all cases (100%), technical success was achieved withtarget regions fully occluded at the first angiogram (taken
immediately after delivery).
• Excellent distal penetration into vessel beds was observedin all cases.
• 15/17 patients (88.2%) were free from device related SAEs.
- Both patients with SAEs were undergoing treatment forosseous renal cell carcinomas metastasis, which is often
a significantly painful procedure.
- Adverse event rate was comparable to other feasibility
trials in the space.
• Each patient completed a 30-day follow-up evaluation, andsites remained fully occluded in each case where imaging
was available (6/17 patients (35.3%) had follow-up imaging
with all sites deemed occluded (100%) and a mean of 30.2
days post-procedure).
• GPX Embolic Device scored very highly across all usability
dimensions, averaging “Very Acceptable” for key aspects
including Ease of Preparation, Delivery, and Visibility,with no responses lower than “Acceptable” for any of thedimensions studied (Graph 1).
GRAPH 1: KEY INVESTIGATOR USABILITY QUESTIONNAIRE RESULTS
EASE OF PREPARATIONEASE OF DELIVERY
EASE OF VISIBILITY

1VERY
UNACCEPTABLE

23NEUTRAL

45VERYACCEPTABLE

CONCLUSIONS• While limited by sample size, the study indicates that
the GPX Embolic Device may provide safe and effectiveembolization for arterial or venous applications where distal
penetration is desired.
• 100% technical success with no instances of recanalization
or migration observed.
• Adverse event rate was comparable to other feasibility trials
in the space.
• Investigators gave GPX Embolic Device high scores forsimple preparation, radiographic visibility, and favorable
control during delivery.

Continued on following page.

ILLUSTRATIVE CASES

Below are cases from the trial that highlight the utility, distal penetration, and durable nature of the GPX Embolic Device across arange of applications.

RENAL ANGIOMYOLIPOMA EMBOLIZATION

Figure 1A-D: Embolization of Renal Angiomyolipoma (AML) Demonstrating Targeted Delivery and Post-Treatment Tumor Shrinkage. (A) Preembolization angiogram of AML treatment area. (B) Post-embolization DSA showing complete occlusion of target area with study material. (C) CT imageof targeted region 5 days post-treatment. (D) CT image of targeted region 6 months post-treatment showing shrinkage of the AML. Note: The results inFigure 1D fall outside of the trial period.

PELVIC SARCOMA EMBOLIZATIONFigure 2A-C: Distal Penetration in Embolization of Pelvic Sarcoma. (A) Pre-embolization angiogram of treatment area. (B) Post-embolization angiogram
showing study material in target area. (C) Post-embolization DSA showing complete occlusion of target area with study material.

PORTAL VEIN EMBOLIZATION

3A

3B

3C

3D

Figure 3A-D: Distal Penetration of Study Device in Portal Vein Embolization. (A) Pre-embolization angiogram of treatment area. (B) Post-embolization
DSA showing complete occlusion of target area with study material (target area denoted with red arrows). (C) Explanted tissue at 57 days postembolization procedure showing vessels filled with embolic study material. (D) H&E pathology showing tissue response to embolization with the studymaterial.
The GPX Embolic Device is under development anddoes not have marketing clearance or approval in
any market at this time. For investigation use only.

F LUI DX ME D I CA L .COM

GPX is the registered trademark of Fluidx MedicalTechnology, Inc. © 2023. All rights reserved. 00040
Rev A (12/23)