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

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 radiation therapy 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 103 cells/mm3 or known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents or thrombolytic drugs.
• •6. Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
• •7. Subject with known hypersensitivity to any component of the treatment device that cannot 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 or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, 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 unwilling to prevent pregnancy during their participation in the study.
• •14. Subject has a serious or life-threatening comorbidity that could confound study results and/or prevent completion of 5-year followup.
• •15. Subject is enrolled in another device or drug study in which participation could confound study results.
• •16. Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach.