SeCure Endovenous Laser Treatment Study

This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will
be summarized and submitted to the FDA in a premarket notification once all treated subjects
have completed the 3 month visit. Longer term followup is being performed for publication
purposes.

Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none
of the exclusion criteria will be eligible for this study.

INCLUSION CRITERIA

Patients are required to fulfill all the following criteria to be included in the study:

1. Is ≥ 18 years of age

2. IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after
manual release of manual compression

3. IPV(s) to be treated have a diameter of ≥ 3.5 mm (measured at the level of the fascia)
located superior to foot and distal ankle

4. Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6)
attributable to the IPV to be treated

5. Has palpable pedal pulses in the study limb

6. Any pathologic superficial saphenous veins have been previously eliminated and were
done so at least more than 30 days prior to the study procedure

7. Is able to ambulate

8. Is able to comprehend and have signed the Informed Consent Form (ICF) to participate
in the study

9. Is willing and able to comply with the Clinical Investigation Plan and follow-up
schedule

EXCLUSION CRITERIA

Patients will be excluded from participation in the study if they meet any of the
following:

1. Has venous insufficiency secondary to venous obstruction proximal to the intended
treatment site

2. Has thrombus in the vein segment to be treated

3. Has known peripheral arterial disease

4. Has a BMI calculation (BMI = W / H2 ) ≥40kg/m2

5. Is undergoing active anticoagulant therapy for Deep VeinThrombosis or other conditions
(e.g., warfarin, Q10 inhibitors or low molecular weight heparin) or has a history of
Deep Vein Thrombosis within the last 6 months or hypercoagulable state.

6. Has had prior venous procedures in the study limb within the last 30 days (including
but not limited to, thrombolysis / thrombectomy / stenting / ablation / phlebectomy /
sclerotherapy)

7. Has undergone or is expected to undergo any major surgery within 30 days prior to or
within 90 days following the study procedure

8. Has a condition, judged by the treating physician, that may jeopardize the patient's
well-being and/or confound the results or the soundness of the study

9. Is pregnant or lactating at the time of the study procedure or is intending on
becoming pregnant within 90 days following the study procedure

10. Is participating in another clinical study that is contraindicative to the treatment
or outcomes of this investigation