POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling

Exclusion Criteria

• •1. Rutherford Category 0, 1, 5, and 6.
• •2. Subject has active infection in the target leg requiring antibiotic therapy.
• •3. Planned major amputation of the target leg (transmetatarsal or higher).
• •4. In-stent restenosis within the target lesion(s).
• •5. Significant target vessel tortuosity (bends \>30 degrees over the arc length of the balloon) or other parameters prohibiting access to the target lesion.
• •6. Chronic total occlusion of the target lesion(s) \> 40mm.
• •7. Target lesion(s) within native or synthetic vessel grafts.
• •8. Chronic total occlusion of inflow vessel.
• •9. Lesion in contralateral limb requiring intervention within the next 30 days.
• •10. Subject has had any major (e.g., cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure.
• •11. Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with percutaneous transluminal angioplasty (PTA) or percutaneous stent.
• •12. Deep heel ulcers or any evidence of osteomyelitis.
• •13. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) at the time of the enrollment / index procedure.
• •14. Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet counts \<100,000/microliter, or international normalized ratio \>1.5.
• •15. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• •16. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• •17. Subject has known allergy to urethane, nylon, or silicone.
• •18. Myocardial infarction within 60 days prior to enrollment.
• •19. History of stroke within 60 days prior to enrollment.
• •20. Subjects that are non-ambulatory and confined to bed.
• •21. Subject has life expectancy \<12 months.
• •22. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
• •23. History of thrombolytic therapy within 2 weeks of enrollment.
• •24. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 µmol/L or is on dialysis).
• •25. Women who are pregnant, breast-feeding, or intend to become pregnant
• •26. Subject is participating in another investigational drug, biological, or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints of this study, or subject is planning to participate in such studies prior to the completion of this study.
• •27. Subject has any other condition that, at the discretion of the Investigator, would preclude them completing the study protocol.