Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

Inclusion Criteria:

1. 20 to 80 years of age at the time of screening
2. Evidence of a single unruptured aneurysm requiring treatment. If there is evidence ofan additional aneurysm requiring treatment, the secondary aneurysm must also betreatable using a SEAL™ System Device, either during a single procedure or consecutiveprocedures. In these instances, no additional implanted devices are permissible except for asmedically required for patient safety.
3. Ruptured aneurysms may be included according the following criteria: The subjectis neurologically stable with a Hunt and Hess scale of 3 or less at the time oftreatment
4. Modified Disability Scale (mRS) of ≤2 prior to presentation or rupture
5. The index intracranial aneurysm (IA) to be treated must include the followingfeatures:
6. Aneurysm features suitable for endovascular treatment with an intrasacculardevice per the treating interventionist.
7. Saccular morphology
8. Located at a bifurcation, terminus, or sidewall in the anterior or posteriorcirculation
9. 3mm-25mm in dome diameter
10. Narrow or wide-neck aneurysm with neck size ≥ 4mm or Dome-to-Neck (DN) ratio < 2
11. Aneurysm treatment does not require the preplanned use of any additional implanteddevices
12. Subject is able to maintain compliance with all aspects of screening, evaluation,treatment, and post-procedure follow-up schedule
13. Baseline mRS of 0-1 for unruptured cases
14. Ability to obtain written informed consent from subject prior to the initiation of anystudy procedures
15. Subject has been approved for inclusion by Galaxy Therapeutics INC. clinical affairsteam.

Exclusion Criteria:

1. Aneurysm features unsuitable for endovascular treatment with an intrasaccular devicesuch as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
2. Aneurysms smaller than 3mm and larger than 25mm in dome diameter.
3. Inability to access target aneurysm with microcatheter due to intracranialatherosclerosis, vessel tortuosity or poor aneurysm angle take-off.
4. Presence of vascular disease or other vascular abnormality that could prohibit accessto index aneurysm such carotid stenosis or diminished caliber of the target artery.
5. Proximal vessel tortuosity or morphology that could prohibit access to target aneurysm
6. Clinical, angiographic, or CT evidence of CNS arterial vasculitis, moyamoya disease,intracranial tumor (except small meningioma), or any other intracranial vascularmalformations
7. Patients with high risk for recurrent ischemic stroke due to previous history ofintracranial ischemic stroke symptoms such as transient ischemic attacks (TIAs),minor, or major strokes within the past 60 days
8. Patients with hemodynamic or medical compromise due to medical comorbidities such assevere unstable congestive heart failure (ejection fraction <30%) or severe COPDrequiring home oxygen.
9. Modified Rankin Scale (mRS) score of ≤ 2 prior to presentation or acute rupture (asapplicable)
10. SAH from non-index aneurysm or any other intracranial hemorrhage within the past 60days
11. Target aneurysm has been previously treated and contains devices, implants, or coilsthat could interfere with correct SEAL™ device placement.
12. Subject is pregnant or a lactating female (For females of child-bearing potential, apositive pregnancy test within 7 days of the day of procedure or refusal to use amedically accepted method of birth control for the duration of the study.
13. Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, orhemoglobinopathy
14. Hypersensitivity that cannot be medically controlled to any component of the SEAL™System, procedural materials, or medications commonly used during the procedure
15. Currently enrolled in another investigational study or post-market study that couldaffect the safety and efficacy of aneurysm treatment or interfere with the studyfollow- up schedule
16. Presence of an acute life-threatening illness requiring treatment
17. Life-expectancy of < 5 years
18. Subject has an uncontrolled co-morbid medical condition, including mental healthissues, that would adversely affect participation in the study
19. Subject is a prisoner or member of other vulnerable population