Evaluation of the Pantheris Atherectomy System

Inclusion Criteria: * Age ≥ 18 years old; * Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs; * Subject is willing and able to give informed consent; * Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5; * Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation; * Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device; * Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length); * Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months; * At least one patent tibial run-off vessel at baseline. Inclusion Criteria for the 24-month follow up: * Completed the 6-month follow-up visit * Re-consented prior to the 24-month follow-up visit Exclusion Criteria: * Subject is pregnant or breast feeding; * Rutherford Class 0 to 1 (asymptomatic and mild claudication); * Rutherford Class 6 (critical limb ischemia); * Moderate to severe calcification of the target lesion; * Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment; * In-stent restenosis within the target lesion; * Target lesion with any type of stent or graft; * Target lesion in the iliac artery; * Target lesion stenosis \<70%; * Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion; * Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure; * Planned endovascular or surgical procedure 30 days after the index procedure; * Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure; * Subjects with active systemic infections whether they are being currently treated or not; * Subjects on chronic hemodialysis or creatinine level \>2.0mg/dL; * Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months; * Evidence or history of aneurysmal target vessel within the past 2 months; * History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days; * Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated; * Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated; * History of heparin-induced thrombocytopenia (HIT); * Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) \>1.5; * Any thrombolytic therapy within 2 weeks of the index procedure; * Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject; * Subjects or their legal guardians who have not or will not sign the Informed Consent; * Subjects who are unwilling or unable to comply with the follow-up study requirements; * Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.