SuperNOVA Clinical Stenting Trial

Atherosclerosis is a systemic disease that has become increasingly recognized in the
expanding elderly population as a significant cause of morbidity and mortality.
Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms
ranging from intermittent claudication to ischemic rest pain and critical ischemia with
major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully
treat with endovascular therapy because the disease is often diffuse and located in an area
of the body subject to significant mobility stresses such as extension, contraction,
compression, elongation, flexion and torsion.

The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global
study. Approximately 50 centers located in the United States, Europe, Canada and/or
Australia are expected to participate in recruiting patients needing treatment of lesions in
their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a
minimum of 296 stented segments are treated with the Innova Stent System.

Inclusion Criteria:

1. Subjects age 18 and older

2. Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

3. Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the
native superficial femoral artery or proximal popliteal artery:

1. Degree of stenosis >/=70% by visual angiographic assessment

2. Vessel diameter >/= 4 and
3. Total lesion length (or series of lesions) >/=30mm and lesions may be treated, provided that the tandem lesion segment can be covered
with only one stent)

4. If lesion is restenotic, PTA treatment must be >3 months prior to stent
placement

5. Target lesion located at least three centimeters above the inferior edge of the
femur

4. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with
at least one of three vessels patent (<50% stenosis) to the ankle or foot

5. Subject (or Legal Guardian) is willing and able to provide consent before any
study-specific tests or procedures are performed and agrees to attend all required
follow-up visits

Exclusion Criteria:

1. Previous stent placement in the target vessel

2. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat
atherosclerotic disease

3. Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the
target SFA/PPA in the past 3 months

4. Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the
index procedure

5. History of major amputation in the same limb as the target lesion

6. Life expectancy less than 12 months due to other medical co-morbid condition(s) that
could limit the subject's ability to participate in the clinical study, limit the
subject's compliance with the follow-up requirements, or impact the scientific
integrity of the clinical study

7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of
the investigator, cannot be adequately pre-medicated.

8. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications

9. Platelet count <150,000 mm3 or >600,000 mm3

10. Concomitant renal failure with a serum creatinine >2.0 mg/dL

11. Receiving dialysis or immunosuppressant therapy

12. Pregnancy

13. Current participation in another investigational drug or device clinical study

14. Known allergy to Nitinol

15. Septicemia at the time of the index procedure

16. Presence of other hemodynamically significant outflow lesions requiring intervention
within 30 days of the index procedure

17. Target lesion is within or near an aneurysm

18. Acute ischemia and/or acute thrombosis of the SFA/PPA

19. Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic
therapy

20. Perforated vessel as evidenced by extravasation of contrast media

21. Heavily calcified lesions