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 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.