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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. 1Department of Neuroradiology, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg, Saarland, Germany
  2. 2Department of Neuropathology, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg, Saarland, Germany
  3. 3Engeneering 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.

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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.