@article{7fb188a7519a40d0b26a525300491a48,
title = "Preclinical testing of a novel thin film nitinol flow-diversion stent in a rabbit elastase aneurysm model",
abstract = "Background and Purpose: Thin film nitinol can be processed to produce a thin microporous sheet with a low percentage of metal coverage (<20%) and high pore attenuation (∼70 pores/mm2) for flow diversion. We present in vivo results from the treatment of experimental rabbit aneurysms by using a thin film nitinol-based flow-diversion device. MATERIALS AND METHODS: Nineteen aneurysms in the rabbit elastase aneurysm model were treated with a single thin film nitinol flow diverter. Devices were also placed over 17 lumbar arteries to model perianeurysmal branch arteries of the intracranial circulation. Angiography was performed at 2 weeks (n = 7), 1 month (n = 8), and 3 months (n = 4) immediately before sacrifice. Aneurysm occlusion was graded on a 3-point scale (grade I, complete occlusion; grade II, near-complete occlusion; grade III, incomplete occlusion). Toluidine blue staining was used for histologic evaluation. En face CD31 immunofluorescent staining was performed to quantify neck endothelialization. RESULTS: Markedly reduced intra-aneurysmal flow was observed on angiography immediately after device placement in all aneurysms. Grade I or II occlusion was noted in 4 (57%) aneurysms at 2-week, in 6 (75%) aneurysms at 4-week, and in 3 (75%) aneurysms at 12-week follow-up. All 17 lumbar arteries were patent. CD31 staining showed that 75% ± 16% of the aneurysm neck region was endothelialized. Histopathology demonstrated incorporation of the thin film nitinol flow diverter into the vessel wall and no evidence of excessive neointimal hyperplasia. CONCLUSIONS: In this rabbit model, the thin film nitinol flow diverter achieved high rates of aneurysm occlusion and promoted tissue in-growth and aneurysm neck healing, even early after implantation.",
author = "Y. Ding and D. Dai and Kallmes, {D. F.} and D. Schroeder and Kealey, {C. P.} and V. Gupta and Johnson, {A. D.} and R. Kadirvel",
note = "Funding Information: This work was supported by NeuroSigma Inc. and a National Institutes of Health Grant (R41 NS074576). This work was partially supported by a National Institutes of Health Small Business Technology Transfer (STTR) grant (1R41NS074576). David F. Kallmes—RELATED: Grant: NeuroSigma, * Comments: National Institutes of Health Small Business Innovation Research (SBIR) grant subcontract; UNRELATED: Board Membership: GE Healthcare (cost-effectiveness board); Consultancy: ev3/Covidien/Medtronic, Comments: planning and implementing clinical trials; Grants/Grants Pending: MicroVention, * Sequent, * SurModics, * Codman, * ev3/Covidien/Medtronic, * Comments: preclinical and clinical research; Royalties: University of Virginia Patent Foundation (Spine Fusion); Travel/Accommodations/ Meeting Expenses Unrelated to Activities Listed: ev3/Covidien/Medtronic, * Comments: travel to the FDA panel meeting. Colin P. Kealey—RELATED: The work was partially funded by a STTR grant from the National Institutes of Health (1R41NS074576)*; UNRELATED: Employment: NeuroSigma (full-time employee); Patents (planned, pending or issued): I am a coinventor on patents related to this technology that are owned and/or licensed by NeuroSigma*; Stock/Stock Options: I have stock options in NeuroSigma. Vikas Gupta—RELATED: Grant: National Institutes of Health *; Consulting Fee or Honorarium: NeuroSigma, Comments: Work during May 2014 to March 2015 was performed as an independent consultant. Since April 2015, the work has been performed as full-time employee; Support for Travel to Meetings for the Study or Other Purposes: NeuroSigma; UNRELATED: Consultancy: NeuroSigma; Employment: NeuroSigma; Stock/Stock Options: NeuroSigma; Travel/Accommodations/Meeting Expenses Unrelated to Activities Listed: Neuro- Sigma. Alfred David Johnson—RELATED: Grant: National Institutes of Health (1R41NS074576)*; Support for Travel to Meetings for the Study or Other Purposes: Travel expenses were paid for experiments at the Mayo Clinic by NeuroSigma; UNRELATED: Other: salary from TiNi Alloy Company for work unrelated to the submitted work. Ramanathan Kadirvel—RELATED: Grant: National Institutes of Health (NS076491).* *Money paid to the institution.",
year = "2016",
month = mar,
doi = "10.3174/ajnr.A4568",
language = "English (US)",
volume = "37",
pages = "497--501",
journal = "American Journal of Neuroradiology",
issn = "0195-6108",
publisher = "American Society of Neuroradiology",
number = "3",
}