Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms

Inclusion Criteria: * Patient must be 18-75 years of age at the time of screening. * Patient must have a single ruptured or unruptured IA requiring treatment. * Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures. Exclusion Criteria: * Patient had an IA with characteristics unsuitable for endovascular treatment. * Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device. * Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device. * Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation. * Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy. * Patient was pregnant.