Evaluation of WIRION™ EPS in Lower Extremities Arteries

Inclusion Criteria

• Subject is at least 18 years of age
• Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
• Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
• Rutherford classification 2-4
• Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
• Planned atherectomy of the native femoropopliteal arteries
• Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
• An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
• A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria

• Any planned surgical or endovascular intervention within 30 days before or after the index procedure
• A lesion deemed not accessible by the WIRION™ EPS
• Inability to take aspirin or ADP receptor antagonists
• History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
• Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
• Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
• Life expectancy less than 12 months
• Known severe renal insufficiency (eGFR <30 ml/min/1.72m2).
• ≤1-vessel tibial run-off status