Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

Inclusion Criteria * Has a Rutherford Clinical Category Score of 1 - 6. * Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography. * Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot. * Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion. * Each discrete target lesion's length is ≤ 20 cm. * Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm. Exclusion Criteria * Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure. * Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. * Has had a previous peripheral bypass affecting the target limb. * Has end-stage renal disease defined as undergoing hemodialysis for kidney failure. * Has presence of severe calcification in target lesion(s). * Has in-stent restenosis of the target lesion. * Has an aneurysmal target vessel. * Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel. * Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment. * Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesi…