SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry

Inclusion Criteria:

1. 18 to 80 years of age at the time of screening.

2. Unruptured aneurysm requiring endovascular treatment suitable for SEAL device andmeet the AHA guidelines for management of unruptured aneurysm.5 If there is evidenceof an additional aneurysm requiring treatment, the secondary aneurysm must also betreatable using a SEAL™ System Device, either during a single procedure orconsecutive procedures. No additional preplanned implanted devices are permissible except for as medicallyrequired for patient safety during the procedure.

3. Ruptured aneurysm

4. Ruptured aneurysms may be included according to the following criteria: Thesubject is neurologically stable with no seizure at the onset of the SAH, notrequiring EVD placement prior to inclusion.

5. Hunt and Hess scale of 3 or less at the time of treatment.

6. Modified Disability Scale (mRS) of ≤2 prior to presentation or aneurysmrupture.

7. Meet the AHA guidelines for management of ruptured aneurysm.6

8. The index intracranial aneurysm (IA) to be treated must include the followingfeatures:

9. Aneurysm features suitable for endovascular treatment with an intrasacculardevice per the treating interventionist.

10. Saccular morphology.

11. Located at a bifurcation, terminus, or sidewall in the anterior or posteriorcirculation.

12. 2.5 mm-20 mm in dome diameter.

13. Wide-neck aneurysm with neck size ≥ 4mm or Dome-to-Neck (DN) ratio < 2.

14. Aneurysm treatment does not require the preplanned use of any additional implanteddevices.

15. Subject is able to maintain compliance with all aspects of screening, evaluation,treatment, and post-procedure follow-up schedule.

16. Baseline pre-procedure mRS of 0-2 for unruptured aneurysm and 0-2 prior to the SAHfor the ruptured aneurysms.

17. Ability to obtain written informed consent from subject or legally authorizedrepresentative in SAH subjects prior to the initiation of any study procedures.

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 2.5 mm and larger than 20 mm in dome width.

3. Inability to access target aneurysm with microcatheter due to intracranialatherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angletake-off.

4. Patients with two 360 degrees loops in the carotid or vertebral arteries.

5. Presence of vascular disease or other vascular abnormality that could prohibitaccess to index aneurysm such carotid stenosis or diminished caliber of the targetartery.

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 ofischemic stroke symptoms such as transient ischemic attacks (TIAs), minor, or majorstrokes within the past 60 days. Other stroke risk factors such as intracranialstenosis or atrial fibrillation.

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.

10. Target index aneurysm that has been previously treated and contains devices,implants, or coils that could interfere with correct SEAL™ device placement.

11. 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.

12. Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy,or hemoglobinopathy.

13. 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.

14. Presence of an acute life-threatening illness requiring treatment.

15. Life expectancy of <1 year.

16. Subject has an uncontrolled co-morbid medical condition, that would adversely affectparticipation in the study.

17. Patient with chronic kidney disease (and not on dialysis) with creatinine > 2.0.

18. Subject is a prisoner or member of other vulnerable population.

19. Subject that is in the opinion of the treating interventionalist is not suitable forthe study.

• Sensitivity to nickel is not specifically excluded, Galaxy Therapeutics, Inc (GTI) performed ASTM F2129 testing recommended by the FDA in its 2015 and 2019guiding documents. GTI results from the testing indicated that SEALTM meets theacceptance criteria that there is a high probability that the margin of safetyagainst pitting (Eb-Er) is 200mV or higher, therefore, with high confidence, nofurther testing is required. The IFU contains the following precaution: "Forpatients with known hypersensitivity or allergic reaction to the implantcomponents such as titanium or to nickel, use of the SEALTM System may lead toallergic reaction and user should counsel the patient on the devicecomponents".