Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

General Inclusion Criteria (≤30 Days from Clinical Trial Treatment): * 18 years of age or older * Subject has signed the approved KAIZEN study Informed Consent Form prior to any study-related procedures * Chronic, symptomatic lower limb ischemia * Clinical indication for percutaneous transluminal angioplasty intervention in the native SFA and/or POP artery General Exclusion Criteria (≤30 Days from Clinical Trial Treatment): * Female who is pregnant and/or breastfeeding * Currently participating in another investigational clinical study * Unwilling to follow the Investigator's instructions or follow-up requirements * Any non-diagnostic peripheral vascular intervention that was unsuccessful or had complications within 30 days before clinical trial treatment * Any non-diagnostic coronary intervention within 30 days before clinical trial treatment * Any planned non-diagnostic vascular intervention(s) within 30 days after clinical trial treatment * Any planned procedures or other medical conditions which, in the Investigator's opinion, may interfere with the study result and/or subject's optimal participation in the study * Prior major amputation within one year of the clinical trial treatment procedure * Planned major amputation * Life expectancy of ≤6 months * History of coagulopathy or hypercoagulable bleeding disorder * History of Myocardial Infarction (MI), or stroke/cerebrovascular accident within 6-months prior to the clinical trial treatment * Unstable angina pectoris *…