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

The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject

Time frame: Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy)

Population: Generally angiographic outcomes are evaluated per lesions (53) and not per participants (50). Yet, this specific endpoint is analyzed for 52 lesions (instead of 53), since the data for this timepoint in one participant with one lesion was missing for evaluation of this specific endpoint.

1. Need for emergency surgical revascularization of the target limb 2. Unplanned target limb amputation above the ankle 3. Clinically driven Target Lesion Revascularization (TLR) 4. Cardiovascular related deaths

Time frame: 30 days post procedure

(\*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.) 1. Clinically Significant Perforations requiring intervention 2. Clinically Significant Dissections requiring intervention 3. Clinically Significant Embolus requiring intervention 4. Clinically Pseudo-aneurysm requiring intervention

Time frame: Perioperative (until discharge), an average of 6 days

Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline. ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa.

Time frame: baseline and 30 days, 6 months and 12 months post procedure

Population: The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points

Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa.

Time frame: baseline and 30 days, 6 months and 12 months post procedure

Population: The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points.~Answers to all questions in the Walking Impairment Questionnaire (WIQ) must be provided to obtain a valid result, incomplete questionnaires were not considered.

Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline. Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate a better outcome: 0= Asymptomatic; 1= Mild claudication; 2= Moderate claudication; 3= Severe claudication; 4= Rest pain; 5= Ischemic ulceration not exceeding ulcer of the digits of the foot; 6= Severe ischemic ulcers or frank gangrene. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa.

Time frame: baseline and 30 days, 6 months and 12 months post procedure

Population: The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points

The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of \<30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable

Time frame: Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)

Population: This endpoint is analyzed for lesions (53) and not for participants (50)

(\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Clinically Significant Dissections requiring intervention 2. Clinically Significant Embolus requiring intervention 3. Clinically Pseudo-aneurysm requiring intervention

Time frame: 30 days post procedure

(\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator 2. Flow limiting dissection

Time frame: Perioperative (until discharge), an average of 6 days

EX-PAD-01 study secondary efficacy endpoint of the post adjunctive therapy residual diameter stenosis, was set per protocol with a threshold at \<30%, however, in many other atherectomy studies, this threshold is set at ≤30%, Therefore results with this threshold are presented as well

Time frame: Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)

Population: This endpoint is analyzed for lesions (53) and not for participants (50)