Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment

This is a prospective, single-arm, multi-center, international, open-label, non-randomized clinical study.

All enrolled subjects will undergo atherectomy procedure, during which the B-Laser™ catheter will be used to perform atherectomy in target lesion, followed by any other adjunctive therapy (balloon and/or stent etc.). The procedure will be done according to standard hospital procedure for atherectomy. The steps of the operation before and after the operating of the B-Laser™ device are routinely used practice and will be done according to local practice at each hospital. For the post-atherectomy stage, as an adjunctive therapy in the procedure, any approved device may be used (balloon and/or stent etc.).

Subjects will then be followed for 12 months after the procedure.

Inclusion criteria

• Subject is ≥ 18 years old.
• Subject is a candidate for endovascular intervention for peripheral artery disease in the lower extremities.
• Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
• Subject has infrainguinal target lesion(s) with any type of stenosis (naïve or recurrent) estimated to be ≥70% based on CT angiogram or other imaging modality.
• At least one patent tibial run-off vessel at baseline.
• Subject is capable and willing to comply with the scheduled follow up.
• Subject is able and willing to sign a written informed consent form (ICF).

Intraoperative inclusion criteria (by fluoroscopy angiogram):

• Reference vessel lumen diameter proximal to target lesion is ≥150% of the outer diameter of the B-Laser™ to be used.
• Target lesion has been crossed with a guidewire within the true lumen.
• Target lesion has a stenosis estimated to be ≥70%.

Exclusion criteria

• Target lesion is in a vessel graft or synthetic graft.
• Target lesion length >25 cm.
• Endovascular or surgical procedure 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.
• Intent to use other atherectomy device in the same procedure.
• Flow limiting dissection proximal to, distal to or in the target lesion.
• Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
• Evidence or history of aneurysm in the target vessel within the past 2 months.
• History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
• History of heparin-induced thrombocytopenia (HIT).
• Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis.
• Any thrombolytic therapy within 2 weeks of the index procedure.
• History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Serious illness that may affect subject compliance to protocol and at a minimum the 30-day follow-up.
• Participating in other clinical study that involves any kind of intervention, including pharmaceutical.
• Issue that in the judgment of the investigator, may affect the results of the study.
• Subject is pregnant or planning to become pregnant during the study period.

Intraoperative exclusion criteria (by fluoroscopy angiogram):

• Total occlusion of the Target lesion that cannot be crossed in the true lumen by 0.014" GW.
• Target lesion length >25 cm.
• Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-Laser™.
• Any clinical and/or angiographic complication attributed to the use of another device prior to the study procedure.
• Flow limiting dissection proximal, distal or in the target lesion.