Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

The percentage of subjects with the following, post-procedure: 1. ≤50% residual stenosis post OAD + POBA \[Angiographic Core Lab assessed\] and, 2. No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].

Time frame: At the end of the procedure

Population: The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol.

Acute procedural success is defined as both acute technical success and absence of death, stroke, myocardial infarction (MI), acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery within 72 hours of the clinical trial treatment \[CEC adjudicated\].

Time frame: 72 hours after index procedure

Population: The FAS population included all subjects enrolled into the trial regardless of treatment with the OAD or deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.

Acute technical success defined per the Peripheral Academic Research Consortium (PARC) definition of achievement of a final residual stenosis \<30% for stented and \<50% for non-stented subjects by angiography at the end of the procedure \[Angiographic Core Lab assessed\] without severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].

Time frame: At the end of the procedure

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of enrolled 67 subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.

The Ankle-Brachial Index (ABI) is a simple, non-invasive test used to assess peripheral artery disease (PAD). It compares the blood pressure measured at the ankle with the blood pressure measured at the arm (brachial artery).

Time frame: Baseline (within 30 days of the clinical treatment), and Post Procedure (after the clinical trial treatment prior to discharge: post procedure ABI was collected on average 1.1 days post clinical trial treatment)

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.

The percentage changes in diameter stenosis of the target lesion at each stage of the procedure: Baseline, Post OAD, Post POBA and Post DCB \[Angiographic Core Lab assessed\].

Time frame: Baseline, Post OAD, Post POBA

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects

Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.

Time frame: Baseline, 30 days and 6 months

Population: Analysis population includes all enrolled ITT (intent to treat) subjects who have been treated with the OAD regardless of deviations from the protocol.

Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.

Time frame: Baseline, 30 days and 6 months

Population: The mITT analysis set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol.

DCB Device Success defined as the ability to achieve successful delivery and deployment of all DCB to the target lesion as described per the Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device.

Time frame: Within 3 minutes of insertion of DCB

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.

Major Adverse Event (MAE) rate at 30 days and 6 months (CEC adjudicated) was defined as: 1. All-cause death through 30 days or 2. Major amputation of the target limb or 3. Clinically-driven TLR

Time frame: 30 days and 6 months

Population: The FAS population included all subjects enrolled into the trial regardless of treatment with the OAD or deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.

Rate of severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\]

Time frame: At the end of the procedure

Population: The FAS population included all subjects enrolled into the trial regardless of treatment with the OAD or deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects

Target Vessel Patency is a binary composite endpoint comprised of: * CEC adjudicated absence of clinically driven repeat procedure performed for ≥50% stenosis confirmed by angiography within all or part of the target lesion after documentation of recurrent clinical symptoms of PAD following clinical trial treatment procedure (i.e. clinically-driven TLR) occurring at any time-point on, or prior to the 6-month visit date and, * a Duplex Ultrasound Core Lab assessed PSVR value of ≤2.4 (or equivalent by visual assessment if the lesion is non-patent and the PSVR cannot be numerically calculated). The vessel is considered patent if both criteria are met at the time of assessment.

Time frame: Up to 6 months

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.