The BRILLIANT Study

This trial is designed as a prospective, multi-center, randomized clinical trial to evaluate
the safety and effectiveness of the Bright Tip Fiber as compared to standard bare laser
fiber for the treatment of varicose veins associated with reflux within the GSV.

Subjects can be pre-screened utilizing standard of care data (including documented evidence
of reflux within the GSV) for the specified inclusion/exclusion criteria to ensure that they
are eligible for treatment in the investigation. If the subject appears to qualify for the
investigation, the subject will then be asked to give his/her written informed consent and
be enrolled in the investigation.

Upon study enrollment, the subject will be randomized to receive the Bright Tip fiber and/or
a standard bare fiber for use during endovenous laser therapy in the following manner:

- If the subject has one limb to be treated, he/she will be randomized to receive either
the Bright Tip fiber or the standard bare fiber.

- If the subject has two limbs to be treated, he/she will be randomized to receive the
Bright Tip fiber in one leg and the bare fiber in the other leg.

After enrollment, the subject will undergo endovenous laser therapy, followed by a limited
duplex ultrasound of the GSV segment treated if vein diameter or other required data has not
been obtained. A physical assessment of the treated limb(s) and an assessment for
complications will also be obtained.

All subjects will be required to complete follow-up visits at 1 week, 1 month and 6 months
post-procedure for a clinical assessment of the treated segment(s). Assessment of the
primary and secondary endpoints will take place at these time points. A telephone follow-up
will be conducted at 12 months post procedure in order to supplement the data gathered at
six months. Adverse events assessment will be made at each follow-up time point.

From baseline to the final study exam, data pertaining to the investigational objectives
will be recorded on the appropriate case report forms at the predetermined study intervals.

Assignment of bruising will be completed by a single blinded rater.

Inclusion Criteria:

1. Subject is 18 years of age or older

2. Subjects with primary varicose veins resultant of GSV reflux documented on duplex
ultrasound

3. Subjects that will be undergoing endovenous laser ablation treatment of varicose
veins

4. Subjects treatment includes the Greater Saphenous Vein

5. If bilateral, subject is willing and able to undergo treatment of both legs within
two weeks.

6. Subjects who are willing and able to comply with the requirements of the study
protocol

7. Subjects who have provided written informed consent

Exclusion Criteria:

1. Subjects with severe peripheral vascular disease (PVD) as evidenced by an
ankle-brachial index of < 0.5 (If the subject has evidence of PVD then an ABI should
be collected. However, if the subject has no signs of PVD then there will be no need
to collect an ABI.)

2. Subjects who are unable to ambulate at baseline

3. Subjects with thrombosis in the vein segment(s) to be treated

4. Subjects that have had prior vein treatment including stripping and ligation,
radiofrequency ablation, laser ablation, sclerotherapy.

5. Subjects who are known or suspected to be pregnant or lactating

6. Subjects that are concurrently participating in an investigational study that may
confound the treatment or outcomes of the present study

7. Subjects with an active or systemic infection

8. Anatomic variants- duplication of the GSV, presence of incompetent accessory GSV