Background The LUNA Aneurysm Embolization System (LUNA™ AES) is a self-expanding intra saccular flow disruption device that is placed inside the aneurysm cavity providing a mesh of metal across the neck of the aneurysms thereby isolating it from the parent artery blood flow. The purpose of this report is to characterize the safety and efficacy of the device for the treatment of intracranial aneurysms as part of the LUNA™ AES PMCF study.
Materials and methods Patient enrollment was initiated in June 2011 and terminated in November 2013. The study is ongoing (up to 36 months follow-up) and data presented includes 6 and 12-month follow-up data. The primary safety variables collected as part of the LUNA™ PMCF study are the occurrence and frequency of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), and unanticipated adverse device effects (UADE). An independent Core Laboratory evaluated angiographic assessment of aneurysm occlusion grade, parent vessel compromise, and occlusion durability. Occlusion grade and parent vessel compromise were assessed by DSA after the procedure as well as on the 6 and 12-month angiograms.
Results Patient enrolment was completed on November 19, 2013. 63 patients were enrolled at 9 European sites for treatment (63 individual patients). Among 63 patients, the mean age was 52.4 years (median 53 years). The majority of patients were female (84.1%). Most patients had an initial Modified Rankin Scale (mRS) of 0 (80%). Most aneurysms were unruptured (60/64, 93.8%) and the majority of aneurysms were Bifurcation or Terminal aneurysms (76.6%). All aneurysms were ≤10 mm (range 4–10 mm) in height with a mean width of 5.6 (range 3–9 mm) and neck size of 3.5 mm (range 2–6 mm). The majority of aneurysms were located in the anterior circulation (87.5%). A total of 35 AEs were reported in 21 patients. Additionally, there were 24 events classified as SAEs in 14 patients. No patient experienced a UADE. A total of 61 successful procedures were performed in 60 patients (One patient was re-enrolled and retreated for another aneurysm with LUNA™ AES). There were 3 patients that did not receive a LUNA™ AES implantation. One LUNA™ AES device was implanted in 60 patients and adjunctive devices were used in 6 cases including balloons (6 cases), coils (2 cases), and stents (2 cases). Post-procedure angiographic evaluation was available for 60 patients, 6-month data was reported in 59 patients, and 12-month data was reported for 57 patients. Combined complete and near-complete occlusion at 12-month follow-up was reported in 44 of 57 cases (77.2%). A summary of clinical and angiographic outcomes is provided in Table 1.
Conclusions The 12-month results demonstrate good safety profile and satisfactory angiographic follow-up. The 36-month clinical and angiographic follow-up is pending.
Disclosures M. Piotin: None. A. Biondi: None. N. Sourour: None. C. Mounayer: None. M. Söderman: None. T. Andersson: None. S. Mangiafico: None. M. Jaworski: None. R. Anxionnat: None. P. Goffette: None. R. Blanc: None.
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