PT  - JOURNAL ARTICLE
AU  - Kallmes, D.F.
AU  - Ding, Y.H.
AU  - Dai, D.
AU  - Kadirvel, R.
AU  - Lewis, D.A.
AU  - Cloft, H.J.
TI  - A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms
AID  - 10.3174/ajnr.A1530
DP  - 2009 Jun 01
TA  - American Journal of Neuroradiology
PG  - 1153--1158
VI  - 30
IP  - 6
4099  - http://www.ajnr.org/content/30/6/1153.short
4100  - http://www.ajnr.org/content/30/6/1153.full
SO  - Am. J. Neuroradiol.2009 Jun 01; 30
AB  - 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.