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The Derivo Embolization Device, a Second-Generation Flow Diverter for the Treatment of Intracranial Aneurysms, Evaluated in an Elastase-Induced Aneurysm Model

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Abstract

Purpose

In recent years, flow diverters have provided a promising alternative to treat complex intracranial aneurysms. In this study, we compare a second-generation flow-diverting device (Derivo Embolization Device) with its prototype flow diverter, in the treatment of elastase-induced aneurysms in New Zealand white rabbits.

Methods

The Derivo Embolization Device is a self-expanding stent consisting of 48 nitinol wires. The device was implanted across the necks of 17 elastase-induced aneurysms in New Zealand white rabbits. One additional device was implanted in the abdominal aorta of each animal covering the origin of lumbar arteries. Follow-up was performed after 3 months (n = 8) and 6 months (n = 9) under continuous double antiplatelet therapy. Statuses of angiographic and histological aneurysm occlusion as well as patency of branch arteries and neointimal growth were evaluated and compared with its prototype flow diverter.

Results

The Derivo Embolization Device provided advanced visibility and flexibility, which led to more accurate navigation and placement. Complete aneurysm occlusion rates were noted in 15 cases (88 %), respectively, compared with 5 cases (28 %) with the first-generation device (p = 0.001). Neointimal growth and diameter stenosis were significantly less with the Derivo Embolization Device and declining after 6 months follow-up in the abdominal aorta. Extreme device oversizing led to distal occlusion of the parent vessel in three cases. Covered branch arteries remained patent throughout the entire period of observation.

Conclusions

The Derivo Embolization Device provides excellent occlusion of elastase-induced aneurysms while preserving branch arteries.

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Abbreviations

FRED:

Flow Re-Direction Endoluminal Device

FD:

Flow Diverter

DSA:

Digital Subtraction Angiography

AA:

Abdominal Aorta

SA:

Subclavian Artery

BT:

Brachiocephalic Trunk

ICA:

Internal Carotid Artery

PED:

Pipeline Embolization Device

SFD:

SILK Flow Diverter

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Acknowledgments

This study was supported in part by a research grant of the BMWi (German Ministry of Economic Affairs and Energy, Grant number: KF2335801WL9).

We would like to thank the Head of the Department of Experimental Surgery, Prof. Menger, and his team for supporting this study.

Ethical Standards

We declare that our animal studies have been approved by the (ethics committee of the Saarland University) and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Publication

Parts of this study have been published as an oral poster presentation at the meeting of the German society of neuroradiology (DGNR) in Cologne, Germany in October 2013 and as an oral presentation at the 20th Symposium Neuroradiologicum Istanbul, Turkey in September 2014.

Conflict of Interest

This study was funded by Acandis GmbH, Pforzheim, Germany. Giorgio Franco Maria Cattaneo and Werner Mailänder, engineers at the company, served as proctors during this study.

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Authors and Affiliations

  1. Departments of Neuroradiology, Saarland University Hospital, Kirrbergerstraße1, 66424, Homburg/Saar, Germany

    D. Ley, R. Mühl-Benninghaus, U. Yilmaz, H. Körner, W. Reith & A. Simgen

  2. Acandis GmbH, Pforzheim, Germany

    G. F. M. Cattaneo & W. Mailänder

  3. Departments of Pathology, Saarland University Hospital, Homburg/Saar, Germany

    Y-J. Kim

  4. Departments of Cardiology, Saarland University Hospital, Homburg/Saar, Germany

    B. Scheller

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  1. D. Ley
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  2. R. Mühl-Benninghaus
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  4. H. Körner
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  5. G. F. M. Cattaneo
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  6. W. Mailänder
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  8. B. Scheller
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  9. W. Reith
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Correspondence to A. Simgen.

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Ley, D., Mühl-Benninghaus, R., Yilmaz, U. et al. The Derivo Embolization Device, a Second-Generation Flow Diverter for the Treatment of Intracranial Aneurysms, Evaluated in an Elastase-Induced Aneurysm Model. Clin Neuroradiol 27, 335–343 (2017). https://doi.org/10.1007/s00062-015-0493-9

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