TurboHawk™ Japan Trial in Patients With PAD

Determination of Safety and Effectiveness of the TurboHawk and the SpiderFX for the Treatment of Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries in Japan

The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.

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