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

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.