The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).

Inclusion Criteria14

• Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)/data protection authorization has been provided and signed by the subject or subject's LAR.
• Subject is 18-75 years of age at the time of consent.
• Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure.
• The target aneurysm must have the following characteristics:
• Saccular morphology
• Located at a bifurcation in the anterior or posterior circulation
• Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.
• Wide-necked, defined as neck size ≥ 4 mm and/or a dome-to-neck ratio of ≥ 1 and \< 2.
• If the target aneurysm was acutely ruptured, subject must be neurologically stable with Hunt and Hess Grade of I or II.
• Ruptured IA is defined as showing evidence of SAH attributed to the target aneurysm within the last 30-days (using computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP).)
• Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements (e.g., screening, evaluation, treatment, and the post-procedure follow-up schedule).
• Subject meets one or more risk factors for IA rupture, such as age, hypertension, cigarette smoking, use of sympathomimetic drugs, Japanese or Finnish ancestry, history of prior aneurysmal subarachnoid hemorrhage (aSAH), familial intracranial aneurysms or SAH, clinical or radiological mass effect, reduced quality of life due to fear of rupture, IA size, location, and morphology, documented growth of IA on serial imaging (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology.
• Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment
• If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment).