Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

Inclusion Criteria: * Age 19 to 80 years * Subject or legal representative is willing and able to give informed consent * Subject has a single targeted intracranial aneurysm * Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up Exclusion Criteria: * Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia * Known history of life threatening allergy to contrast dye * Known allergy to nickel, chromium cobalt, tungsten or platinum * Subject has documented resistance to clopidogrel/Plavix * Major surgery within previous 30 days or planned in the next 120 days after enrollment date * Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date * Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date * Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device * Any previous coiling where it would interfere with the placement and proper apposition of the device * Platelet count less than 100,000 cells/mm3 or known platelet dysfunction * More than one intracranial aneurysm (IA) that requires treatment within 12 months * Asymptomatic extradural aneurysms requiring treatment * Contraindication to CT scan or MRI * Severe neurological deficit that renders the subject incapable of living independently * Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days) * Evidence of active infection at the time of treatment * Dementia or psychiatric problem that prevents the patient from completing required follow up * Co-morbid conditions that may limit survival to less than 24 months * Serum creatinine greater or equal to 2.5 mg/dL * Female subjects who are pregnant or planning to become pregnant within the study period * Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis * Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm * Other known serious concurrent medical conditions * History of intracranial vasospasm not responsive to medical therapy * Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region * Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions * Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date * Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm * Inability to understand the study or a history of non-compliance with medical advice * Current use of illicit substance * Enrollment in another trial involving an investigational product * Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)