The Jetstream (JET) Post-market Registry

- To observe the treatment effects of the Jetstream NAVITUS System in long, occluded,
diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common
femoral, superficial femoral, or popliteal arteries.

- To assess and quantify vessel patency 1 year post atherectomy treatment.

Inclusion Criteria:

- Patient is ≥ 18 years of age.

- The target de novo or restenotic PTA lesion(s) is/are located in the common femoral,
superficial femoral or popliteal arteries.

- The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.

- Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.

- Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
before the patient is considered as entered into the study.

- Patient is an acceptable candidate for percutaneous intervention using the Jetstream
NAVITUS System in accordance with its labeled indications and instructions for use.

- Lesion length ≥ 4cm.

- Patient has a Rutherford category score of 1-3.

- Patient has signed approved informed consent.

- Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion Criteria:

- Patient has an uncontrollable allergy to nitinol, stainless steel or other stent
materials or to contrast agent.

- Patient is unable to take appropriate anti-platelet therapy.

- Patient has no patent distal runoff vessels.

- Patient has critical limb ischemia (i.e., Rutherford class 4-6)

- Limited vascular access that precludes safe advancement of the Jetstream NAVITUS
System to the target lesion(s).

- Interventional treatment is intended for in-stent restenosis.

- Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or
tortuosity at the treatment segment.

- Patient has a history of coagulopathy or hypercoagulable bleeding disorder.

- Patient is receiving hemodialysis or has significantly impaired renal function
(creatinine is > 2.5 mg/dl) at the time of treatment.

- Patient has evidence of intracranial or gastrointestinal bleeding within the past 3
months.

- Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal
organ within the past 14 days.

- Patient has had surgical or endovascular procedure in the same vascular territory
within 30 days prior to the index procedure.

- Patient has any planned surgical intervention or endovascular procedure within 30
days after the index procedure.

- Use of another debulking device during the index procedure prior to the Jetstream
NAVITUS System will exclude the patient.