Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)

Inclusion Criteria: * Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4 * Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet the following criteria: * Severely calcified lesions with degree of stenosis ≥70% * Vessel diameter ≥3.0 mm and ≤6.0 mm * Total lesion length (or series of lesions) ≤150 mm Exclusion Criteria: * Target lesion/vessel with in-stent restenosis * History of major amputation in the target limb * Subject has a history of coagulopathy or hypercoagulable bleeding disorder * Subject with untreatable hemorrhagic disease or platelet count \<80,000mm3 or \>600,000mm3 as baseline assessment. * History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment * Unstable angina pectoris at the time of the enrollment * Septicemia at the time of enrollment * Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure * Presence of aneurysm in the target vessel * Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure * Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure