Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.

Time frame: One Year

The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.

Time frame: One year

Population: Kaplan-Meier estimate of the freedom from loss of primary patency in lesions (N=743 lesions)

Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.

Time frame: 1 year

Population: Lesions in patients with claudication at baseline

Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.

Time frame: One Year

Population: All claudicants.

Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9 was calculated.

Time frame: 1 Year

Population: All patients with compressible arteries and a baseline ABI \< 0.9.

Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.

Time frame: Immediately following use of the SilverHawk device

Population: Lesions with core angiographic laboratory measurements of residual stenosis

Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.

Time frame: 1 Year

Population: All patients with RCC data at baseline and 1 year

WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.

Time frame: Baseline and 1 Year

Population: All subjects treated for claudication RCC 1-3 with completed WIQ forms

Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.

Time frame: 3 months

Population: Patients with wounds at baseline who had wound assessment scores at baseline and at 3 months.

Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).

Time frame: 30 Days

Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).

Time frame: One Year

The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment

Time frame: One Year

Population: All patients with CLI.

Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.

Time frame: Immediately following use of the SilverHawk and adjunctive devices

Population: All lesions with angiographic core lab assessment of residual stenosis at the end of the procedure were included

Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.

Time frame: One Year

Population: All claudicants.