Trial Outcomes & Findings for Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD (NCT NCT03157531)

Unavailable data for 4 participants out of the 97.

Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported: * As assessed quantitatively by the core laboratory. * This endpoint will be met if the mean reduction in residual diameter stenosis is greater than 20%. * A greater reduction means better results.

1. Unplanned target limb amputation above the ankle 2. Clinically Driven Target Lesion Revascularization (CDTLR) 3. Cardiovascular related deaths * As adjudicated by the Clinical Event Committee (CEC). * This endpoint will be met if the freedom from MAE rate is greater than 85%.

1. Perforation 2. Dissection 3. Distal embolization or in situ thrombus 4. Pseudoaneurysm * As adjudicated by the Clinical Event Committee (CEC). \[1\] Note: Clinically Significant AEs are defined as adverse events that REQUIRE any intervention,treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect.

1. Perforation 2. Dissection 3. Distal embolization or in situ thrombus 4. Pseudoaneurysm * As adjudicated by the Clinical Event Committee (CEC). \[1\] Note: non-Clinically Significant AEs are defined as adverse events that DO NOT REQUIRE any intervention, treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect.

Number of Lesions with residual stenosis by angiography of ≤ 30% post-procedure including any adjunctive therapy, with no flow limiting dissection. \* As assessed quantitatively by the core laboratory.

1. Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa. 2. Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa.

c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs \& feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.

Defined as \< 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is \< 2.5. \* As assessed quantitatively by the core laboratory.

1. Unplanned target limb amputation above the ankle 2. Clinically Driven Target Lesion Revascularization (CDTLR) 3. Cardiovascular related deaths * As adjudicated by the Clinical Event Committee (CEC).

1. Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa. 2. Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa.

c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs \& feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.

Defined as \< 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is \< 2.5. \* As assessed quantitatively by the core laboratory. This is not a study pre-specified endpoint.