Prospective Packing Density With Target Coils I

The Pro Pack Trial will evaluate the outcomes of subjects treated with Target Coils, in whom
the packing density is actively calculated prior to coil selection. Selecting the coil with
the best volumetric filling has been shown to increase overall packing density. Each coil
thereafter will be evaluated prior to placement to assess the resultant packing density. An
initial goal of 10% or greater packing density with the first coil will be used as a guide to
coil selection. A final packing density of greater than 25% should be attempted as feasible.
Currently, a maximum packing density is not defined. While theoretically a packing density
may approach 100%, in reality the spaces between the coil loops occupy a large percentage of
the coil mass, and packing densities rarely reach 50% or greater. As such, the final packing
density is left to the operator, and is based on ability to place coils safely by the
operator.

Potential subjects will be screened, consented, imaged, and evaluated in order to obtain 25
patients with complete 12-month follow-up. Baseline patient data will be collected at the
time of the procedure; follow-up information will be collected within 48 hours of the
procedure, and at approximately 12 months (±3 months) after the procedure. The anticipated
study duration is approximately 24 months: 12 month recruitment, 12 month primary endpoint
and closeout.

Enrollment in the study occurs after a signed Informed Consent form has been obtained, all
eligibility criteria have been met, aneurysm volume has been calculated, and the procedure to
place Target Coils with prospective density measurements has begun, i.e., at the time of
target procedural angiography. From the moment of placement of the first coil, the patient is
considered in the study whether they receive Target Coils or not, and will be followed up and
included in the final analysis. Patients enrolled in the trial will be followed for
approximately 12 months after the index embolization procedure. This will allow evaluation of
the primary and secondary study endpoints. Targeted enrollment is 25 patients with complete
12 month follow-up evaluations. Every effort will be made to follow the progress and monitor
the safety of patients who have been treated with Target® Coils.

Embolization utilizing Target® Coils may proceed at the time of diagnostic angiography for
eligible patients who have signed an Informed Consent form. The investigator must perform the
embolization procedure. Framing, filling, and finishing should be done with Target Coils. In
the event of aneurysms with wide necks or unfavorable anatomy, adjunctive therapy, Neuroform
Stent may be used to ensure the best clinical and angiographic results.

The site will enter ongoing, real time information into an electronic imaging database and
track outcomes during the follow-up angiographic evaluations. The degree of occlusion, by
coils and/or thrombus, will be measured post procedurally and at 12 +/- 3 months post
procedure by the Angiographic Core Laboratory using a 3 point categorical scale: complete,
residual neck/dog ear or residual aneurysm. Additionally, for the final angiogram, a same/
better / worse scale shall be applied.

Inclusion Criteria:

1. Patient is between 18 and 85 years of age (inclusive).

2. Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter
angiographic lumen, ruptured or unruptured, suitable for embolization with coils.

3. Target® Coils are considered a treatment option. Every attempt should be made to treat
with Target coils as possible to achieve optimal occlusion.

4. Target aneurysm can be adequately coiled at index procedure (NO staged coiling
procedures).

5. Target aneurysm morphology allows for adequate retention of coils within the
aneurysmal sac without occlusion of the parent artery, as determined by the treating
physician.

6. Patient or patient's legally authorized representative has provided written informed
consent.

7. Patient is willing and able to comply with protocol follow-up requirements.

Exclusion Criteria:

Candidates must be excluded from the study if ANY of the following criteria are met at the
time of screening:

1. Patient is <18 or >80 years old.

2. Target aneurysm is not saccular in nature (mycotic, fusiform, and dissecting).

3. Target aneurysm is >20 mm maximum luminal dimension, <4 mm maximum luminal dimension.

4. Target aneurysm has been previously treated by surgery or endovascular therapy.

5. Target aneurysm is in the physician's estimation unlikely to be successfully treated
by endovascular techniques.

6. Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.

7. Patient presents with Modified Rankin Score 4 or 5 at baseline.

8. Patient is concurrently enrolled in another investigational drug or device study
unless the sponsor grants permission.

9. Patient has known hypersensitivity to platinum, nickel, stainless steel or
structurally related compounds found in Target® Coils.

10. Patients who have had or could have a severe reaction to contrast agents that cannot
be adequately pre-medicated prior to the coiling procedure.

11. Patients who are unable to complete scheduled follow up assessments at the enrolling
center due to limited life expectancy (<12 months), comorbidities or geographical
considerations.

12. Planned use of adjunctive therapy stents except Neuroform is not allowed.

13. Patients with Moya-Moya disease, AVMs, arteriovenous fistula, intracranial tumors,
intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic
stenosis, tortuosity or other conditions preventing access to the target aneurysm.

15. Target aneurysm with significant thrombosis that may increase the likelihood of
recanalization at the discretion on the investigator.

16. Female patient has a positive pregnancy assessment at baseline.