A second-generation, endoluminal, flow-disrupting device for treatment of saccular aneurysms

David F Kallmes, Y. H. Ding, D. Dai, Ramanathan D Kadirvel, D. A. Lewis, H. J. Cloft

Research output: Contribution to journalArticle

141 Citations (Scopus)

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, nearcomplete, 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.

Original languageEnglish (US)
Pages (from-to)1153-1158
Number of pages6
JournalAmerican Journal of Neuroradiology
Volume30
Issue number6
DOIs
StatePublished - Jun 2009

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Aneurysm
Arteries
Equipment and Supplies
Animal Care Committees
Pancreatic Elastase
Abdominal Aorta
Embolism
Hyperplasia
Analysis of Variance
Pathologic Constriction
Neck
Animal Models
Rabbits

ASJC Scopus subject areas

  • Clinical Neurology
  • Radiology Nuclear Medicine and imaging

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A second-generation, endoluminal, flow-disrupting device for treatment of saccular aneurysms. / Kallmes, David F; Ding, Y. H.; Dai, D.; Kadirvel, Ramanathan D; Lewis, D. A.; Cloft, H. J.

In: American Journal of Neuroradiology, Vol. 30, No. 6, 06.2009, p. 1153-1158.

Research output: Contribution to journalArticle

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