title: Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device.
abstract: BACKGROUND
  The low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling.
  
  
  OBJECTIVE
  To present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms.
  
  
  METHODS
  31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. 'Probable benefit' was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints.
  
  
  RESULTS
  Average aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up.
  
  
  CONCLUSIONS
  The LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up.
  
  
  BACKGROUND
  NCT01541254.
authors.affiliation: Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA.
authors.forename: David
authors.initials: D
authors.lastname: Fiorella
authors.affiliation: Methodist Hospital, Memphis, Tennessee, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Arthur
authors.affiliation: Albany Medical Center, Albany, New York, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Boulos
authors.affiliation: Methodist Houston, Houston, Texas, USA.
authors.forename: Orlando
authors.initials: O
authors.lastname: Diaz
authors.affiliation: Department of Neurological Surgery, Thomas Jefferson Hospital, Philadelphia, Pennsylvania, USA.
authors.forename: Pascal
authors.initials: P
authors.lastname: Jabbour
authors.affiliation: Department of Neuroradiology, University of Texas Southwestern, Dallas, Texas, USA.
authors.forename: Lee
authors.initials: L
authors.lastname: Pride
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Aquilla S
authors.initials: AS
authors.lastname: Turk
authors.affiliation: Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA.
authors.forename: Henry H
authors.initials: HH
authors.lastname: Woo
authors.affiliation: Washington University, St. Louis, Missouri, USA.
authors.forename: Colin
authors.initials: C
authors.lastname: Derdeyn
authors.affiliation: Department of Neuroradiology, Wessex Neurological Centre, Southampton, UK.
authors.forename: John
authors.initials: J
authors.lastname: Millar
authors.affiliation: St Georges Hospital Medical School, London, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Clifton
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002533:Cerebral Angiography; D057176:Compassionate Use Trials; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010984:Platinum; D011446:Prospective Studies; D015607:Stents; D055815:Young Adult
chemical_list: D010984:Platinum
keywords: Aneurysm; Device; Stent