Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.

Population includes enrolled subjects who either experienced the defined event or were followed for at least 240 days.

Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.

Population includes subjects followed through discharge and had relevant procedural data.

Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.

Population includes subjects followed for at least 30 days and had relevant data.

Kaplan-Meier estimate of primary patency at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary patency at 9 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary assisted patency at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary assisted patency at 9 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of secondary patency at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of secondary patency at 9 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months

Population includes all subjects meeting eligibility.

Number of participants with change in Rutherford Category from pre-procedure at 30 days.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Population includes subjects followed for at least 23 days and had relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 9 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Population includes subjects followed for at least 240 days and relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Population includes subjects followed for at least 23 days and had relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.

Population includes subjects followed for at least 23 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.

Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.

Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.

Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.

Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.

Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.

Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.

Population includes subjects followed for at least 240 days and had relevant data.

Kaplan-Meier estimate of primary patency at 12 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary assisted patency at 12 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of secondary patency at 12 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months

Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months

Population includes all subjects meeting eligibility.

Number of participants with change in Rutherford Category from pre-procedure at 12 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Population includes subjects available at 12 Months with relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 24 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Population includes subjects available at 24 Months with relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 36 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Population includes subjects available at 36 Months with relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Population includes subjects available at 12 Months with relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Population includes subjects available at 24 Months with relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Population includes subjects available at 36 Months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.

Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.

Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.

Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.

Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.

Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.

Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.

Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.

Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.

Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.

Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.

Population includes subjects available at 24 months with relevant data.

Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome

Population includes subjects followed for at least 30 days.

Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome

Population includes subjects followed for at least 30 days.

Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome

Population includes subjects followed for at least 240 days.

Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome

Population includes subjects followed for at least 240 days.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.

Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.

Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.

Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.

Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.

Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.

Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.

Population includes subjects available at 36 months with relevant data.