Safety and Performance Study of the Shockwave Lithoplasty System

Inclusion Criteria

• Subject is able and willing to comply with all assessments in the study.
• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• Age of subject is >18.
• Rutherford Clinical Category 2, 3, or 4.
• Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
• Moderate to severe calcification of target lesion(s) per pre-procedure CT scan. (Calcification must be: 1) ≥180 degrees circumferential at some point in the lesion and 2) extend ≥50 percent length of lesion or absolute length ≥20mm.)
• Estimated life expectancy >1 year.

Exclusion Criteria

• Rutherford Clinical Category 5 and 6.
• Subject has active infection in the target leg.
• Planned major amputation of the target leg (transmetatarsal or higher).
• In-stent restenosis within the target lesion(s).
• Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
• Chronic total occlusion of the target lesion(s).
• Target lesion(s) within native or synthetic vessel grafts.
• Chronic total occlusion of inflow vessel.
• Lesion in contralateral limb requiring intervention within the next 30 days.
• History of prior endovascular or surgical procedure on the index limb within the past 30 days.
• Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with plain old balloon angioplasty or stent and without complications before target lesion(s) treatment.
• Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) at the time of the enrollment / index procedure.
• Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or international normalized ratio >1.5.
• Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Subject has known allergy to urethane, nylon, or silicone.
• Myocardial infarction within 60 days prior to enrollment.
• History of stroke within 60 days prior to enrollment.
• History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
• History of thrombolytic therapy within two weeks of enrollment.
• Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
• Subject is pregnant or nursing.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.