Kaitoh Atherectomy FIH

Inclusion Criteria: Age ≥18 years old Rutherford Classification: 3-5 in target limb; a. Rutherford Classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (no more than two Rutherford Class 3 subjects may be enrolled into the study). Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months) Able to comply with antiplatelet therapy as required Exclusion Criteria: Females who are pregnant or lactating Pre-existing illness with life expectancy <1 year Known or suspected systemic infection Endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb Allergic to any of the components of the atherectomy device system Intraprocedural complications prior to use of the investigational device