A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of
older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths.
The most significant complication of AAA is an aneurysm sac rupture from which more than
15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to
85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm
repair (EVAR) and open surgical repair cases were performed in the year 2010 .

Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open
surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an
alternative treatment of AAA for most patients. It is less invasive than open repair and
carries lower rates of early mortality and morbidity . It has also extended treatment options
to patients who cannot undergo conventional surgical procedures due to a high operative risk.
As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the
aortic neck and access vessels.

The InCraft® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs
with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester
graft technology in an ultra-low profile delivery system, which assists the physician in
deploying the device in a controlled, consistent, and precise manner within the aortic neck
and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood
flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and
the potential for aneurysm sac rupture.

Inclusion Criteria:

- Subject must meet ALL of the following inclusion criteria to be enrolled in the study:

1. Male or Female age 20 years or older;

2. Proximal aortic neck is 17-31mm in diameter;

3. Supra-renal aorta, at 20mm above the anticipated landing location, is smaller
than the nominal diameter of the aortic bifurcate prosthesis to be used;

4. Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal
angulations ≤60°;

5. Subject has at least one of the following:

1. AAA size > 5.0 cm;

2. Increase of the AAA diameter of > 0.5 cm over the last 6 months;

6. Abdominal treatment length (lowest renal artery origin to the aortic bifurcation)
≥ 9.4cm;

7. Aortic bifurcation >18mm in diameter;

8. Iliac landing zone ≥15mm in length;

9. Iliac landing zone 7-22mm in diameter;

10. Minimum access vessel size of ≥ 5mm;

11. Minimum overall AAA treatment length (from lowest renal artery to distal landing
zone) of 128 mm;

12. Women of child bearing potential must be non-pregnant, non-lactating, and not
planning to become pregnant during the course of the trial; and have a negative
urine or serum pregnancy test within 7 days prior to index procedure;

13. Provide written informed consent and as applicable written HIPAA authorization
(For US sites only) prior to initiation of study procedures;

14. Willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

- Subjects will be excluded if ANY of the following exclusion criteria apply:

1. Vascular anatomy in which the placement of the stent-graft will cause occlusion
of both internal iliac arteries or necessitates surgical occlusion of both
internal iliac arteries;

2. Subject has one of the following:

1. Aneurysm sac rupture or leaking abdominal aortic aneurysm;

2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;

3. Clinically significant acute vascular injury due to trauma;

3. Significant aortic or iliac mural thrombus, plaque or calcification that would
compromise fixation and seal of the device;

4. A conical aortic neck defined as >3mm distal increase over a 10mm length in the
planned seal zone;

5. Thoracic aortic aneurysm ≥45mm;

6. Any aortic dissection;

7. Morbid obesity (BMI >40.0 kg.m2) or other clinical conditions that limit required
imaging studies or visualization of the aorta;

8. Renal insufficiency (Creatinine > 2.0mg/dL) or subject on renal dialysis;

9. Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene
terephthalate (PET), or polytetrafluoroethylene (PTFE);

10. Known contraindication to undergoing angiography or anticoagulation (e.g.
contrast allergies which cannot be treated);

11. Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);

12. Coagulopathy, bleeding disorder, or other hypercoagulable state;

13. Organ transplant recipient or subject requiring systemic immunosuppressant
therapy;

14. Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months
prior to the procedure;

15. Active infection or chronic systemic illness at the time of index procedure that
may interfere with the study objectives;

16. Major surgical procedure within 1 month prior to the index procedure or
pre-planned within 1 month afterwards;

17. Co-existing condition with a life expectancy of less than 2 years at time of
procedure;

18. Current or planned participation in any other investigational drug or medical
device clinical study that has not completed primary endpoint(s) evaluation;

19. Existing AAA surgical graft and/or a AAA stent-graft system;

20. Other medical, social, or psychological issues that in the opinion of the
investigator preclude the subjects from receiving this treatment, and the
procedures and evaluations pre- and posttreatment.