Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

The BioMimics 3D stent is intended to improve luminal diameter in the treatment of
symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with
reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic
atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility
criteria may be considered for enrollment.

Inclusion Criteria:

- Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring
intervention to relieve de novo obstruction or occlusion of the native femoropopliteal
artery.

- PAD classified as Rutherford clinical category 2, 3 or 4.

- Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target
limb) or angiographic or DUS evidence of >/= 60%.

- Single or multiple stenotic or occlusive lesions within the native femoropopliteal
artery ("target lesions") that can be crossed with a guidewire and fully dilated.

- Single or multiple target lesions must be covered by a single stent or two overlapping
stents.

- Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep
femoral artery and at least 3 cm above the bottom of the femur.

- Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm.

- Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with
≥60% diameter stenosis by operator's visual estimate.

- Patent popliteal artery (no stenosis ≥50%) distal to the treated segment.

- At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle.

Exclusion Criteria:

- Iliac stent in target limb that has required re-intervention within 12 months prior to
index.

- Target vessel that has been treated with bypass surgery.

- PAD classified as Rutherford clinical category 0, 1, 5 or 6.

- Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count
less than 100,000/microliter or INR >1.8.

- Stroke diagnosis within 3 months prior to enrollment.

- History of unstable angina or myocardial infarction within 60 days prior to
enrollment.

- Thrombolysis within 72 hours prior to the index procedure.

- Acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL
or >220 umol/L), or on peritoneal or hemodialysis.

- Significant disease or obstruction (≥50%) of the inflow tract that has not been
successfully treated at the time of the index procedure (success measured as ≤30%
residual stenosis, without complication).

- No patent (≥50% stenosis) outflow vessel providing run-off to the ankle.

- Target lesion(s) requires percutaneous interventional treatment, beyond standard
balloon angioplasty alone, prior to placement of the study stent.