Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.Any thrombolytic therapy within 2 weeks of the index procedure.Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis.History of heparin-induced thrombocytopenia (HIT).History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.Evidence or history of aneurysm in the target vessel within the past 2 months.Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.Flow limiting dissection proximal to, distal to or in the target lesion.Intent to use other atherectomy device in the same procedure.Endovascular or surgical procedure performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure.Target lesion is in a vessel graft or synthetic graft.Target lesion has a stenosis estimated to be ≥70%.Target lesion has been crossed with a guidewire within the true lumen.Reference vessel lumen diameter proximal to target lesion is ≥150% of the outer diameter of the B-Laser™ to be used.Intraoperative inclusion criteria (by fluoroscopy angiogram): Subject is able and willing to sign a written informed consent form (ICF).Subject is capable and willing to comply with the scheduled follow up.At least one patent tibial run-off vessel at baseline.Subject has infrainguinal target lesion(s) with any type of stenosis (naïve or recurrent) estimated to be ≥70% based on CT angiogram or other imaging modality.Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.Subject is a candidate for endovascular intervention for peripheral artery disease in the lower extremities.Why Should I Register and Submit Results?.
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