title: Preliminary results of the luna aneurysm embolization system in a rabbit model: a new intrasaccular aneurysm occlusion device.
abstract: OBJECTIVE
  Recent advances in endovascular devices have been aimed at providing high density, mesh-like metallic materials across the aneurysm neck, in place of coil technology. Therefore our aim was to report the in vivo preclinical performance of a self-expanding intrasaccular embolization device.
  
  
  METHODS
  Elastase-induced aneurysms were created in 12 rabbits. Each aneurysm was embolized with a Luna AES. DSA was performed preimplantation; 5, 10, and 30 minutes postimplantation; and at 1 month in 12 rabbits and at 3 months in 8 rabbits. Early postimplantation intra-aneurysmal flow was graded as unchanged, moderately diminished, or completely absent. One- and 3-month DSAs were graded by using a 3-point scale (complete, near-complete, or incomplete occlusion). Aneurysms were harvested for gross and microscopic histologic evaluation at 1 month (n = 4) and at 3 months (n = 8). Tissues within the aneurysm dome and across the aneurysm neck were assessed by using HE staining.
  
  
  RESULTS
  Ten (83%) of 12 aneurysms demonstrated complete cessation of flow within 30 minutes of device implantation. At 1-month follow-up, 10 (83%) of 12 aneurysms were completely occluded. At 3 months, 7 of 8 (88%) aneurysms remained completely occluded. One-month gross examination in 4 rabbits demonstrated that membranous tissue completely covered the device in 3 subjects (75%). Microscopic examination showed that 3 aneurysms had loose connective tissue filling the aneurysm cavity. Three-month gross and microscopic examinations demonstrated membranous tissue completely covering the device, loose connective tissue filling the aneurysm cavity, and neointima formation crossing the aneurysm neck in 8 of 8 (100.0%) subjects.
  
  
  CONCLUSIONS
  The Luna AES achieved high rates of complete angiographic occlusion and showed promising histologic findings in the rabbit aneurysm model.
authors.affiliation: Department of Neurosurgery, Ulsan University Hospital, University of Ulsan College of Medicine, Republic of Korea.
authors.forename: S C
authors.initials: SC
authors.lastname: Kwon
authors.forename: Y H
authors.initials: YH
authors.lastname: Ding
authors.forename: D
authors.initials: D
authors.lastname: Dai
authors.forename: R
authors.initials: R
authors.lastname: Kadirvel
authors.forename: D A
authors.initials: DA
authors.lastname: Lewis
authors.forename: D F
authors.initials: DF
authors.lastname: Kallmes
mesh_terms: D000818:Animals; D004195:Disease Models, Animal; D004621:Embolization, Therapeutic / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D006801:Humans; D002532:Intracranial Aneurysm / Q000601:surgery*; D010865:Pilot Projects; D011817:Rabbits; D016896:Treatment Outcome