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

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 all of the following criteria: * Calcified lesions with degree of stenosis ≥70% or occlusions * Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course * Vessel diameter ≥3.0 mm and ≤6.0 mm * Total lesion length (or series of lesions) ≤150mm * Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate * Patent infrapopliteal and popliteal artery Exclusion Criteria: * Target lesion/vessel with in-stent restenosis * Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to the procedure * Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure * Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure * Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure * 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. * Concomitant renal failure with a serum creatinine \>2.0 mg/dL * Receiving dialysis or immunosuppressant therapy * 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