Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

The registry is a prospective, multicenter, single arm post-market real-world registry in the
U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the
Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be
followed for up to three year's post-index procedure.

Inclusion Criteria:

1. The subject provides written informed consent using an Informed Consent Form (ICF)
that is reviewed and approved by the Institutional Review Board (IRB) for the site.

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

3. The subject is ≥ 21 years old.

4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB
Catheter according to IFU.

Exclusion Criteria:

1. The subject is unable or unwilling to provide informed consent.

2. The subject is unable or unwilling to comply with the patient registry protocol
follow-up procedures and visits.

3. The subject has another medical condition or is currently participating in an
investigational drug or an investigational device study that, which, in the opinion of
the Investigator, may cause him/her to be non-compliant with the protocol, confounds
the data interpretation, or is associated with a life expectancy insufficient to allow
for the completion of patient registry procedures and follow-up.