Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

Inclusion Criteria: * Patient is ≥18 years of age * Patient is Rutherford category 2-4 * De novo lesion in the SFA or popliteal artery with a diameter stenosis ≥50% * Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of \<99% * Target lesion stenosis has a length of ≤100 mm based on visual assessment * Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment * Angiographic evidence of distal runoff defined as minimum one (1) patent tibial artery with a straight flow to the foot * Patient is willing and able to provide written informed consent prior to any study specific procedure * Patient is willing and able to comply with specified follow-up evaluations at the specified times Exclusion Criteria: * Any prior intervention in the intended target lesion including 10 mm proximal or distal from the intended treatment area * Evidence of thrombus in the target vessel * Prior ipsilateral or contralateral lower limb arterial bypass * Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure * Target lesion is severely calcified * Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated). * Any planned surgery within 30 days of the study procedure. * Renal failure (serum creatinine \> 2.0 mg/dL) * Female with childbearing potential without a negative pregnancy test * Patient has had an organ transplant * Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study * In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study