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