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Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device
  1. David Fiorella1,
  2. Adam Arthur2,
  3. Alan Boulos3,
  4. Orlando Diaz4,
  5. Pascal Jabbour5,
  6. Lee Pride6,
  7. Aquilla S Turk7,
  8. Henry H Woo1,
  9. Colin Derdeyn8,
  10. John Millar9,
  11. Andrew Clifton10
  1. 1Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA
  2. 2Methodist Hospital, Memphis, Tennessee, USA
  3. 3Albany Medical Center, Albany, New York, USA
  4. 4Methodist Houston, Houston, Texas, USA
  5. 5Department of Neurological Surgery, Thomas Jefferson Hospital, Philadelphia, Pennsylvania, USA
  6. 6Department of Neuroradiology, University of Texas Southwestern, Dallas, Texas, USA
  7. 7Medical University of South Carolina, Charleston, South Carolina, USA
  8. 8Washington University, St. Louis, Missouri, USA
  9. 9Department of Neuroradiology, Wessex Neurological Centre, Southampton, UK
  10. 10St Georges Hospital Medical School, London, UK
  1. Correspondence to Dr David Fiorella, Department of Neurological Surgery, Stony Brook University Medical Center, Cerebrovascular Center, Health Sciences Center T-12 080, Stony Brook, NY 11794-8122, USA; david.fiorella{at}sbumed.org

Abstract

Introduction 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.

Trial registration number NCT01541254.

  • Aneurysm
  • Device
  • Stent

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