TurboHawk™ Japan Trial in Patients With PAD

Inclusion Criteria: * Provides written informed consent * Willing to comply with follow-up evaluations at specified times * Has a Rutherford Clinical Category Score of 2-4 * Disease located within the femoropopliteal artery * Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography * Each discrete target lesion's length is ≥4cm and ≤ 15 cm * Reference vessel diameter is ≥ 3.5 mm and ≤ 7.0 mm Exclusion Criteria: * Previously implanted stent(s) or stent graft(s) in target leg * Life expectancy less than 12 months * Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure * Has in-stent restenosis of the target lesion * Has an aneurysmal target vessel * Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment