MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study

Inclusion Criteria:

Subjects for this study must meet ALL the following criteria:

1. Subject has single target aneurysm in the internal carotid artery from petroussegment to the terminus of the internal carotid artery.

2. The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the targetintracranial aneurysm.

3. Negative pregnancy test (serum or urine) in a female subject who has had menses inthe last 18 months.

4. Subject commits to return to the investigational site for the 30- day, 6-month, 12-month, 2-year, 3-year, and 5-year follow-up evaluations.

5. The subject or his/her authorized representative must sign the IRB-approved writteninformed consent form prior to the start of any study procedures.

6. The subject has a modified Rankin Scale (mRS) ≤ 2.

7. The subject has a wide-necked ( ≥4mm or dome-to-neck ratio <2) saccular or fusiformaneurysm.

Exclusion Criteria:

Subjects shall be excluded from the study if ANY of the following conditions exist:

1. Subject who suffers from a subarachnoid hemorrhage in the last 60 days.

2. Subject who suffers from intracranial hemorrhage in the last 30 days.

3. Subject who presents with an intracranial mass or currently undergoing radiationtherapy for carcinoma of the head or neck region.

4. Subject with symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.

5. Subject with an irreversible bleeding disorder, a platelet count < 100 x 103cells/mm3 or known platelet dysfunction or a contraindication to or inability totolerate anticoagulants/antiplatelet agents or thrombolytic drugs.

6. Subject with history of major bleeding disorder (based on coagulation profile andplatelet count) and/or subject presents with signs of active bleeding.

7. Subject with known hypersensitivity to any component of the treatment device thatcannot be medically controlled.

8. Subject with documented contrast allergy, or other condition that prohibits imaging.

9. Evidence of active bacterial infection at the time of treatment.

10. Presence of any of the following unequivocal cardiac sources of embolism: chronic orparoxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis,intracardiac clot or vegetation, myocardial infarction within 3 months, dilatedcardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.

11. Subject with a pre-existing stent in place at the target aneurysm.

12. Subject who is unable to complete the required follow-ups.

13. Subject who is pregnant, breastfeeding, or of childbearing potential and unwillingto prevent pregnancy during their participation in the study.

14. Subject has a serious or life-threatening comorbidity that could confound studyresults and/or prevent completion of 5-year followup.

15. Subject is enrolled in another device or drug study in which participation couldconfound study results.

16. Subject has absent femoral pulses or other condition preventing femoral access, oris planned to be treated using a radial access approach.