Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

The registry is a prospective, multi-center, single-arm, real-world study to assess the
clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic
lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal
arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated
subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index
procedure.

Inclusion Criteria:

1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to
collection of study data or performance of study procedures.

2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an
expected lifespan sufficient to allow for completion of all study procedures.

3. Subject must be willing to comply with the protocol requirements, including the
follow-up procedures.

4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can
be treated with the UltraScore™ Focused Force PTA balloon according to the
Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or
infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may
be treated for this study.

5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with
at least one vessel run-off.

6. The target lesion must be able to be crossed using a guidewire (use of chronic total
occlusion (CTO) or atherectomy is allowed).

Exclusion Criteria:

1. Subjects that are to receive one or more stents as adjunctive therapy at the target
lesion (bail out stenting is allowed).

2. The subject has a single target lesion that involves both ATK and BTK arteries.

3. The subject has a target lesion in a previously placed stent or stent graft (in-stent
restenosis).

4. The subject has a lesion, which in the opinion of the Investigator, would preclude
safe use of the UltraScore™ Focused Force PTA balloon.

5. The subject has a flow limiting dissection at the target lesion prior to use of the
UltraScore™ Focused Force PTA balloon.

6. The subject has acute limb ischemia.

7. The subject has been assessed Rutherford category 6.

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

9. The subject has another medical condition or is currently participating in an
investigational drug or another device study that, in the opinion of the Investigator,
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 for the
completion of study procedures and follow-up.