O-004 Final Results of the US Humanitarian Device Exemption Study of the Low-profile Visualised Intraluminal Support (LVIS) Device

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Abstract

Introduction

The Low-profile Visualised Intraluminal Support (LVIS) Device is a novel, braided, intracranial microstent designed for stent-assisted coiling. We present the results of a single-arm, prospective, multicenter trial of the LVIS for the 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 6 US centers (IDE G110014). Clinical follow was conducted at 30d 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 lab adjudicated angiographic results. An independent clinical events committee adjudicated clinical endpoints.

Results

Average aneurysm size was 7.2 mm (STD 3.8) and average neck width was 4.6 mm (STD 3.1). 68% of patients had a dome: neck ratio >2. LVIS placement was technically successful in 29 of 31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months when compared to baseline. 26 of 28 (92.9%) treated aneurysms with 6 month angiographic follow-up demonstrated >90% angiographic occlusion. Of these, 21 (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.

Disclosures

D. Fiorella: 1; C; Microvention/Terumo, Sequent Medical, NIH, Siemens Medical Imaging. 2; C; JNJ/Codman, ev3/Covidien. 4; C; Vascular Simulations, CVSL. C. Derdeyn: 1; C; Terumo/Microvention. A. Turk: None. A. Boulos: None. O. Diaz: None. G. Pride: None. P. Jabbour: None. H. Woo: None.

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