Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD

Exclusion Criteria

• •1. Target lesion is in a vessel graft or synthetic graft.
• •2. Target lesion length \<1cm and \>15 cm (in ISR cases could be \>25cm).
• •3. Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure.
• •4. Intent to use other atherectomy device in the same procedure.
• •5. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
• •6. Evidence or history of aneurysm in the target vessel within the past 2 months.
• •7. History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
• •8. History of heparin-induced thrombocytopenia (HIT) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
• •9. Subjects requiring dialysis.
• •10. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• •11. Serious illness that may affect subject compliance to protocol and 30-day follow-up.
• •12. Participating in another clinical study
• •13. Subject is pregnant or planning to become pregnant during the study period.
• •14. Life expectancy \< 12 months
• •15. Any planned amputation above the ankle.
• •1. Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
• •2. Target lesion length \<1cm and \>15 cm (in ISR cases \>25cm).
• •3. Reference vessel lumen diameter proximal to target lesion is \<150% of the outer diameter of the B-LaserTM.
• •4. Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.
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