Article Text
Abstract
Purpose The LUNA is a self-expanding ovoid device that serves as an intra saccular flow diverter as well as a scaffold for endothelization across the neck. The objective of this prospective clinical study (9 European centers) aiming to include a total of 63 patients was to evaluate the ability of the AES to occlude intracranial aneurysms while maintaining patency of the parent artery.
Methods Immediate post-implantation occlusion grade, near-complete, or incomplete, and parent vessel compromise were evaluated. Patients underwent neurological testing with the NIHSS at baseline and time of discharge. Follow-up included clinical assessment at one, 3, 6, 9 and 12 months, and angiographic follow-up at 6 and 12 months.
Results In 5 cases, the LUNA AES placement was carried out with balloon microcatheter assistance. In 2 cases, the LUNA AES placement was carried out with a stent (Table 1). Clinical and angiographic immediate results and at follow up are summarised in Table 2. Adverse events are summarised in Table 3.
Conclusion Preliminary results demonstrate good safety profile. Angiographic follow up are promising. The clinical and angiographic follow-up will be extended to 36 months.
Disclosures M. Piotin: 2; C; Covidien, Stryker, Balt, MicroVention, Reverse Medical, Neuravi, Penumbra. A. Biondi: None. N. Sourour: 2; C; Covidien, Penumbra. R. Blanc: 2; C; Covidien, Stryker, Balt, MicroVention, Reverse Medical, Neuravi, Penumbra.