Kaitoh Atherectomy FIH

Inclusion Criteria:

• Age ≥18 years old

• Rutherford Classification: 3-5 in target limb; Rutherford Classification 3 subjectsmay be enrolled but will be capped to a limit of 20% of the total enrollment (nomore 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 atboth 30 days and 180 days (6 months)

• Able to comply with antiplatelet therapy as required

• Reference Vessel Diameter is ≥2.0 mm and ≤4.0 mm

• Target lesion length is ≤150 mm

• De novo or restenotic target lesion(s) (except for in-stent restenotic lesion) withstenosis ≥70%, by visual estimation, in a single limb in a single native vessel

• Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis isconsidered significant) as visually confirmed by angiography. Note: Successfulinflow artery treatment is allowed during the index procedure. Successful inflowartery treatment is defined as attainment of residual diameter stenosis ≤50% withoutmajor vascular complications (absence of flow limiting dissection, embolic event)

• Guidewire has successfully crossed the target lesion(s) within the true lumen

Exclusion Criteria:

• Females who are pregnant or lactating

• Pre-existing illness with life expectancy <1 year

• Known or suspected systemic infection

• Significant gastrointestinal bleeding or any coagulopathy that would preclude theuse of anti-platelet therapy

• Subjects with a diagnosis of osteomyelitis and are currently on IV antibiotictherapy

• Endovascular or surgical procedure performed on the target lesion within 3 months ofthe index procedure

• Subjects who in the opinion of the Investigator have underlying kidney disease andmay be at risk for contrast-induced acute kidney injury (AKI)

• Subjects who in the opinion of the Investigator have uncontrolled diabetes

• Allergic to iodine/radiopaque contrast that in the opinion of the Investigatorcannot be adequately pre-treated

• History of Coronary Artery Bypass Graft (CABG), unstable angina pectoris, ormyocardial infarction within 30 days and/or hemorrhagic stroke within 90 days

• Subjects scheduled to undergo a planned major amputation of the lower limb above theankle on the target limb

• Allergic to any of the components of the atherectomy device system

• Intraprocedural complications prior to use of the investigational device

• Subjects with a positive COVID-19 test within the last 60 days and/or issymptomatic, at the Investigator's discretion

• Subject with other medical, social or psychological problems that, in the opinion ofthe investigator, preclude them from receiving this treatment, and the proceduresand evaluations pre - and post-treatment

• Presence of flow-limiting stenosis (>50% diameter reduction) or occlusion of inflowvessels that was not successfully treated (<50% residual stenosis without flowlimiting dissection) before the study intervention/prior to the point of enrollment

• No obvious angiographic evidence of flow to the foot following inflow treatment

• Co-existing aneurysmal disease requiring treatment

• Presence of vessel dissection at the target lesion requiring stent placement

• Clinical/angiographic evidence of distal embolization or acute thrombus

• Severe calcification that is measured >10mm in length and circumferential

• Prior stent placement in the target lesion