title: Preliminary in vivo evaluation of a novel intrasaccular cerebral aneurysm occlusion device.
abstract: OBJECTIVE
  Current endovascular technology does not offer a perfect solution for all cerebral aneurysms. Our group has built two versions of a novel aneurysm intrasaccular occlusion device (AIOD) to address the drawbacks associated with current occlusion devices. The objective of the present study was to perform pilot proof of concept in vivo testing of this new AIOD in swine and canines.
  
  
  METHODS
  Two configurations of the AIOD, termed 'coil-in-shell' and 'gel-in-shell', were implanted in surgically created sidewall aneurysms (n=4) in swine for acute occlusion studies, as well as sidewall (n=8) and bifurcation aneurysms (n=3) in canines to assess long term occlusion efficacy. Occlusion at all time points (immediate, 6 weeks, and 12 weeks) was evaluated by angiography. Neointimal healing at 12 weeks post-implantation in canines was examined histologically.
  
  
  RESULTS
  Angiographic analysis showed that both the coil-in-shell and gel-in-shell devices achieved complete aneurysm occlusion immediately following device delivery in sidewall aneurysms in swine. In longer term canine studies, initial occlusion ranged from 71.3% to 100%, which was stable with no recurrence in any of the sidewall aneurysms at 6 or 12 weeks. Histological analysis at 12 weeks showed mature fibromuscular tissue at the neck of all aneurysms and no significant inflammatory response.
  
  
  CONCLUSIONS
  The AIOD tested in this study showed promise in terms of acute and chronic occlusion of aneurysms. Our findings suggest that these devices have the potential to promote robust tissue healing at the aneurysm neck, which may minimize aneurysm recurrence. Although proof of principle has been shown, further work is needed to deliver this device through an endovascular route.
authors.affiliation: Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.
authors.forename: Roham
authors.initials: R
authors.lastname: Moftakhar
authors.affiliation: Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Fangmin
authors.initials: F
authors.lastname: Xu
authors.affiliation: Department of Radiology, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Beverly
authors.initials: B
authors.lastname: Aagaard-Kienitz
authors.affiliation: Department of Radiology, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Consigny
authors.affiliation: Department of Radiology, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Julie R
authors.initials: JR
authors.lastname: Grinde
authors.affiliation: Department of Engineering Physics, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Hart
authors.affiliation: Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Claire E
authors.initials: CE
authors.lastname: Flanagan
authors.affiliation: Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA Department of Engineering Physics, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Wendy C
authors.initials: WC
authors.lastname: Crone
authors.affiliation: Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.
authors.forename: Kristyn S
authors.initials: KS
authors.lastname: Masters
mesh_terms: D000818:Animals; D002533:Cerebral Angiography; D004285:Dogs; D004621:Embolization, Therapeutic / Q000592:standards* / Q000639:trends; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging* / Q000628:therapy*; D013552:Swine
keywords: Aneurysm; Bioactive; Device; Liquid Embolic Material