BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO
™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be
conducted at a maximum of 35 investigational sites ("sites") in the United States, and Europe
and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy
(170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred
forty (340) consecutive subjects in a non-randomized fashion. It is assumed that
approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all
treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and
36-months post-index procedure.

Inclusion Criteria:

1. The subject provides written informed consent using an Informed Consent Form approved
by Ethics Committee/ Institutional Review Board for the site.

2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.

3. The subject is a male or non-pregnant female ≥ 18 years old with an expected lifespan
sufficient to allow for completion of all study procedures.

4. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral
"venous segments".

5. The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral
venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS
pain score of ≥ 2).

6. The subject is able and willing to comply with any required medication regimen.

7. The reference vessel diameters are between 7mm and 19 mm.

Exclusion Criteria:

1. Subject is unable or unwilling to provide written informed consent, or is unable or
unwilling to conform to the study protocol follow-up procedures and visits.

2. Subject is or plans to become pregnant during the study.

3. Subject has contralateral disease of the common femoral vein, external iliac vein,
common iliac vein, or any combination thereof and does not meet the venous outflow
obstruction requirement or has a malignant obstruction.

4. The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.

5. The subject has a venous obstruction that extends into the inferior vena cava (IVC) or
below the level of the lesser trochanter.

6. The subject has a known uncorrectable bleeding diathesis or active coagulopathy.

7. The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to
antiplatelet, anticoagulant or thrombolytic medications medications required per the
protocol

8. The subject has a known allergy or sensitivity to contrast media, which cannot be
adequately pre-medicated.

9. The subject has any planned surgical interventions within 30 days prior to, or within
30 days after the planned study procedure.

10. The subject has a lesion or occlusion which cannot be traversed with a guidewire.

11. The subject has had prior stenting in the target vessel.

12. The subject has iliofemoral venous segments unsuitable for treatment with available
sizes of study devices.

13. The subject has another medical condition, which may cause him/her to be non-compliant
with the protocol, confound the data interpretation, or is associated with a life
expectancy insufficient to allow completion of study procedures and follow ups.

14. The subject is currently participating in an investigational drug, biologic, or
another device study.

15. The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.