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

Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities

The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.

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 lesion(s).
• Has had a previous amputation above the metatarsal line on the target limb.