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November 7, 2016
Early Experience Reported for the MicroVention LVIS Jr Stent to Treat Wide-Necked Intracranial Aneurysms
November 8, 2016—A report of the multicenter experience with use of the Low-profile Visualized Intraluminal Support Junior (LVIS Jr) stent (MicroVention, Inc., a wholly owned subsidiary of Tokyo-based Terumo Corporation) was published online by Jonathan A. Greenberg, MD, et al in the Journal of the NeuroInterventional Surgery (JNIS). The LVIS Jr device is approved under a humanitarian device exemption (HDE) from the US Food and Drug Administration (FDA) for the treatment of wide-necked intracranial aneurysms.
The investigators concluded that LVIS Jr is a technically feasible, safe, and effective treatment for wide-necked intracranial aneurysms. They advised that these early results are promising but will need to be corroborated with longer-term follow-up.
In the study, the neurointerventional databases of the participating institutions were retrospectively reviewed for aneurysms treated with LVIS Jr from the time of the FDA’s HDE approval in July 2014 to February 2016. All patients in the study period were included. Clinical presentation, aneurysm location, aneurysm size, vessel size, procedural complications, as well as clinical and imaging follow-up were included in the analysis.
As summarized in JNIS, 85 patients (54 women and 31 men) met the inclusion criteria for the study. Sixty-eight (80%) of the aneurysms were unruptured, and the remainder were ruptured. The most common location of the treated aneurysms was the anterior communicating artery (36%), middle cerebral artery bifurcation (22%), and basilar terminus (15%). The mean aneurysm size was 6.1 mm, and the mean minimum parent vessel size was 2.3 mm.
The investigators reported that the LVIS Jr device was successfully deployed in all but one case (99%). Initial angiographic results demonstrated Roy-Raymond class 1–2 occlusions in 61 of 84 patients (73%). At 6 months, 85% of the patients seen at follow-up had Roy-Raymond class 1–2 aneurysm occlusions. No procedure-related deaths occurred. Two cases of procedure-related complications were seen (intraprocedural rupture and delayed rupture at day 2), which led to permanent neurologic morbidity. Both of these cases were in patients with ruptured aneurysms, noted the investigators in JNIS.
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