Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.

One subject expired on day 22 post-index procedure due to pneumonia (total N = 173, as per Participant Flow). The event was unrelated to study device but possibly related to procedure as adjudicated by the Clinical Events Committee (CEC).

The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness.

Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length.

Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).

Target Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel.

• Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.

Target lesions >160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.

Primary Effectiveness (Device Success) of Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.

Target lesions >160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.

Freedom from Fracture (FFF) at 12- and 24-months post-index procedure.

The results presented in this analysis include active patients that had available x-ray images appropriate for analysis by the core-lab at follow-up time (12 and 24 months). Therefore n=166 instead of N=173.

Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of < 2.0, <2.5, and < 3.0.

Eighteen (18) patients were enrolled with lesions >160mm, therefore N=18. However, 15 patients had available data for analysis at 12, 24 and 36 months, therefore n=15.

Freedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure.

Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure.

(n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section

Acute technical success is defined as successful deployment of the stent to the intended location.

Acute lesion success is defined as attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data.

N=175 (lesions) differs from the baseline characteristics module that mentions 187 treated lesions due to availability of angiographic image that show less than, or equal to 30% residual stenosis post-dilatation, as evaluated by the independent core-lab at time of analysis.

Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel).

One patient died at day 22, therefore, in this analysis N=172 instead of N=173.

Sustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure.

Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects.

The number of participants for each time period represents the evaluable subjects for this specific outcome measure.

Sustained clinical success is defined as sustained cumulative improvement from baseline value of ≥ 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects.

(n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section

Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR < 2.5.

The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (24 and 36 months). Therefore n=161 instead of N=173.

Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 3.0.

The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=161 instead of N=173.

Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 2.5, and PSR < 3.0.

The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=160 instead of N=173.

The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure.

(n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.