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Research ArticleINTERVENTIONAL

A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms

D.F. Kallmes, Y.H. Ding, D. Dai, R. Kadirvel, D.A. Lewis and H.J. Cloft
American Journal of Neuroradiology June 2009, 30 (6) 1153-1158; DOI: https://doi.org/10.3174/ajnr.A1530
D.F. Kallmes
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Y.H. Ding
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D. Dai
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R. Kadirvel
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D.A. Lewis
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H.J. Cloft
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Abstract

BACKGROUND AND PURPOSE: We report a preclinical study of a second-generation endoluminal device (Pipeline Embolization Device [PED-2] for aneurysmal occlusion and compare the PED-2 with its first-generation predecessor (PED-1).

MATERIALS AND METHODS: Our Institutional Animal Care and Use Committee approved all studies. The PED-2 is a braided endoluminal, flow-diverting device and was implanted across the necks of 18 elastase-induced aneurysms in New Zealand white rabbits and followed for 1 month (n = 6), 3 months (n = 6), and 6 months (n = 6). A second PED-2 was implanted in the abdominal aorta to cover the origins of the lumbar arteries. Angiographic occlusion rates were documented as complete, near-complete, and incomplete. Parent artery percent diameter stenosis was calculated. Results were compared with a previous publication focused on the PED-1, with use of the same model. We compared ordinal outcomes using Fisher Exact or χ2 tests. We compared continuous data using analysis of variance.

RESULTS: Occlusion rates (complete and incomplete) for the PED-2 were noted in 17 cases (94%) and 1 (6%), respectively, compared with 9 cases of complete (53%) and 8 (47%) of incomplete occlusion with the PED-1 (P = .0072). No incidents of branch artery occlusion or distal emboli in vessels downstream of the parent artery were observed with the PED-2. Parent artery neointimal hyperplasia was minimal in most cases and was significantly less than in the PED-1.

CONCLUSIONS: The PED-2 is a biocompatible and hemocompatible device that occludes saccular aneurysms while preserving the parent artery and small-branch vessels in our animal model.

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American Journal of Neuroradiology: 30 (6)
American Journal of Neuroradiology
Vol. 30, Issue 6
June 2009
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A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms
D.F. Kallmes, Y.H. Ding, D. Dai, R. Kadirvel, D.A. Lewis, H.J. Cloft
American Journal of Neuroradiology Jun 2009, 30 (6) 1153-1158; DOI: 10.3174/ajnr.A1530

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A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms
D.F. Kallmes, Y.H. Ding, D. Dai, R. Kadirvel, D.A. Lewis, H.J. Cloft
American Journal of Neuroradiology Jun 2009, 30 (6) 1153-1158; DOI: 10.3174/ajnr.A1530
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