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  • Treatment of experimental aneurysms with a GPX embolic agent prototype: preliminary angiographic and histological results

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New devices and techniques
Original research
Treatment of experimental aneurysms with a GPX embolic agent prototype: preliminary angiographic and histological results
  1. Frederik Fries1,
  2. Toshiki Tomori1,
  3. Walter J Schulz-Schaeffer2,
  4. Joshua Jones3,
  5. Umut Yilmaz1,
  6. Michael Kettner1,
  7. Andreas Simgen1,
  8. Wolfgang Reith1,
  9. Ruben Mühl-Benninghaus1
  1. 1 Department of Neuroradiology, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg, Saarland, Germany
  2. 2 Department of Neuropathology, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg, Saarland, Germany
  3. 3 Engeneering and Development, FLUIDX Medical Technology, Salt Lake City, Utah, USA
  1. Correspondence to Dr Ruben Mühl-Benninghaus, Department of Neuroradiology, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg 66424, Saarland, Germany; ruben.mbe{at}gmail.com

Abstract

Background Recently, liquid embolic agents have emerged for the endovascular treatment of cerebral aneurysms. Here we describe the in vivo performance of a novel liquid embolization agent (GPX Embolic Device).

Methods Elastase-induced aneurysms were embolized with a GPX prototype under balloon assistance. Digital subtraction angiography was performed pre-deployment and immediately after, and at 5, 10, and 30 min post-deployment in 10 rabbits and at 1 month in 8 rabbits. The early post-deployment intra-aneurysmal flow was graded as unchanged, moderately diminished, or completely absent. At 1 month the status of aneurysm occlusion was evaluated. Adhesion to catheter material and migration of GPX was assessed.

Results The mean aneurysm neck diameter, width, and height were 3.6±1.0 mm, 3.0±0.8 mm, and 7.4±1.4 mm, respectively. The mean dome-to-neck ratio was 0.9±0.2. Complete stagnation of intra-aneurysmal flow was observed in 9 of 10 aneurysms (90%) within 30 min of device deployment. One aneurysm showed moderately diminished intra-aneurysmal flow at 30 min. At 1 month, 8 aneurysms were completely occluded. There was no evidence of GPX adhesion to the catheter material. Histologically, a leukocyte and foreign body reaction to GPX was detectable 28 days after embolization.

Conclusions This is the first preclinical study reporting the performance of a protype version of the GPX Embolic Device in a wide-neck aneurysm model. GPX showed promising results by achieving and maintaining high rates of complete angiographic occlusion, but may induce an inflammatory reaction.

  • aneurysm
  • angiography
  • embolic
  • liquid embolic material
  • balloon

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/neurintsurg-2021-017308

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Contributors Study design: RM-B, FF, and WR. Data acquisition: FF, RM-B, TT, UY, AS, and MK. Literature research: FF and RM-B. Data analysis and interpretation: FF, RM-B, TT, UY, and WJS-S. Manuscript preparation: FF, RM-B and TT. Revision of manuscript for important intellectual content: UY, WR, and JJ. Approval of final version of the manuscript: all authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests JJ is an engineer at the company Fluidx Medical Technology (Salt Lake City, UT, USA) and served as a proctor during this study.

    • Provenance and peer review Not commissioned; externally peer reviewed.