Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms

The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.

Inclusion Criteria:

• Participant whose age ≥ 22 and ≤75 years
• Participant has single target aneurysm located in the internal carotid artery
• Participant sign and date an IRB/EC approved informed consent prior initiation of any study procedures

Exclusion Criteria:

• Participant who suffers from an intracranial hemorrhage in the last 30 days
• Participant who suffers from a subarachnoid hemorrhage in the last 60 days
• Participant with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and neck region
• Participant who is pregnant or breastfeeding
• Participant has an arteriovenous malformation (AVM) in the area of the target aneurysm