Preclinical Testing of a Novel Thin Film Nitinol Flow-Diversion Stent in a Rabbit Elastase Aneurysm Model.
OBJECTIVE
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/mm(2)) 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.


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.
From the Department of Neurointerventional Radiology (Y.D., D.D., D.F.K., D.S., R.K.), Mayo Clinic, Rochester, Minnesota ding.yonghong@mayo.edu.
Y
http://orcid.org/0000-0003-4329-3192
Y
Ding
From the Department of Neurointerventional Radiology (Y.D., D.D., D.F.K., D.S., R.K.), Mayo Clinic, Rochester, Minnesota.
D
http://orcid.org/0000-0003-4051-6450
D
Dai
From the Department of Neurointerventional Radiology (Y.D., D.D., D.F.K., D.S., R.K.), Mayo Clinic, Rochester, Minnesota.
D F
http://orcid.org/0000-0002-8495-0040
DF
Kallmes
From the Department of Neurointerventional Radiology (Y.D., D.D., D.F.K., D.S., R.K.), Mayo Clinic, Rochester, Minnesota.
D
http://orcid.org/0000-0002-9676-232X
D
Schroeder
NeuroSigma Inc. (C.P.K., V.G., A.D.J.), Los Angeles, California.
C P
http://orcid.org/0000-0002-0838-8164
CP
Kealey
NeuroSigma Inc. (C.P.K., V.G., A.D.J.), Los Angeles, California.
V
http://orcid.org/0000-0002-3422-3486
V
Gupta
NeuroSigma Inc. (C.P.K., V.G., A.D.J.), Los Angeles, California.
A D
http://orcid.org/0000-0002-2277-1813
AD
Johnson
From the Department of Neurointerventional Radiology (Y.D., D.D., D.F.K., D.S., R.K.), Mayo Clinic, Rochester, Minnesota.
R
http://orcid.org/0000-0002-6786-9953
R
Kadirvel
D000497:Alloys; D000818:Animals; D002533:Cerebral Angiography; D004195:Disease Models, Animal; D004621:Embolization, Therapeutic / Q000295:instrumentation* / Q000379:methods; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D010196:Pancreatic Elastase / Q000633:toxicity; D011817:Rabbits; D015607:Stents
D000497:Alloys; C013616:nitinol; D010196:Pancreatic Elastase