US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

Inclusion Criteria:

1. Patient is 18-75 years of age at the time of screening.

2. Patient has a single ruptured or unruptured IA requiring treatment. If the patienthas an additional IA requiring treatment, the additional IA must not requiretreatment within 60 days of the index procedure.

3. The target IA must have the following characteristics:

• Saccular morphology

• Located at a bifurcation in the anterior or posterior circulation

• Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameterbetween 2 and 10.5 mm

• Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2

4. Patient may be treated with Contour without the use of additional implanted devices.

5. Patient is able to comply with all aspects of the screening, evaluation, treatment,and the post-procedure follow-up schedule.

6. Patient or legally authorized representative has signed and dated an institutionalreview board (IRB)/Ethics Committee (EC)-approved written informed consent prior toinitiation of any study procedures. FOR PATIENTS WITH UNRUPTURED ANEURYSM

7. Patient meets the criteria outlined in the "Guidelines for the Management ofPatients With Unruptured Intracranial Aneurysms" as published by the AHA/ASA FORPATIENTS WITH RUPTURED ANEURYSM

8. Patient meets the criteria outlined in the "Guidelines for the Management ofAneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals Fromthe American Heart Association/American Stroke Association" as published by theAHA/ASA.

9. Patient must be neurologically stable with Hunt & Hess Score of I, II or III.

Exclusion Criteria:

1. Anatomy or physiology considered unsuitable for endovascular treatment with theContour device by the implanting physician and/or the Patient Selection Committee

2. Target IA contains other devices/implants (e.g., coils) that could interfere withthe correct placement of the Contour device

3. Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or anycomponent of the treatment device.

4. Contraindication to anticoagulants or anti-platelet medications

5. Stenosis of the target IA's parent vessel is >50%

6. Anticoagulation medications (e.g., warfarin) that cannot be discontinued

7. Acute / chronic renal failure (unless on dialysis) and/or creatinine > 2.00 mg/dl or > 182 μmol/L

8. Vascular disease or other vascular anomaly that precluded the necessary access tothe aneurysm for use of the study device.

9. Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranialtumor (except small meningioma) or any other intracranial vascular malformations onpresentation.

10. Conditions placing them at high risk for ischemic stroke or had exhibited ischemicsymptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolutionwithin the prior 60-days.

11. Any circulatory, neurovascular, cardiovascular, or neurologic conditions that canresult in unstable neurological symptoms (e.g., multiple sclerosis, establishedseizure disorder).

12. modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (asapplicable).

13. SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days.

14. Physical, neurologic or psychiatric conditions which precluded his/her ability tocomply with all aspects of the screening, evaluation, treatment, and thepost-procedure follow-up schedule.

15. Pregnant, breastfeeding or planning pregnancy in the next 2 years

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

17. Life expectancy of less than 2 years due to an illness or condition other than theindex intracranial aneurysm.