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


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 chi(2) 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.
Department of Radiology, Mayo Clinic, Rochester, MN 55905, USA. Kallmes.david@mayo.edu
D F
DF
Kallmes
Y H
YH
Ding
D
D
Dai
R
R
Kadirvel
D A
DA
Lewis
H J
HJ
Cloft
D000818:Animals; D001807:Blood Vessel Prosthesis; D004621:Embolization, Therapeutic / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging* / Q000601:surgery*; D011817:Rabbits; D011859:Radiography; D016896:Treatment Outcome