- A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator's discretion. Lesion characteristic such as lesion length, percent stenosis, and/or calcification content may be used in study treatment decision. The non-target limb may be treated using currently available (non-investigational) methods >30 days post index procedure.