Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon

PREVEIL will enroll patients presenting with angiographic evidence of significant stenosis in
the femoral or popliteal arteries. All enrolled subjects will be treated with the SurVeil
DCB.

Inclusion Criteria:

Subjects must meet all of the following criteria to participate in the trial:

- Subject is ≥ 18 years.

- Subject has lifestyle-limiting claudication or rest pain with Rutherford
classification 2, 3 or 4.

- Subject has provided written informed consent.

- Subject is willing to comply with study follow-up requirements.

- A de novo target lesion in the femoral or popliteal arteries.

- Target lesion must have angiographic evidence of ≥ 50% stenosis by operator visual
estimate.

- Target lesion must be ≤ 90 mm in length (one long lesion or multiple serial lesions)
by operator visual estimate. Note: Multiple serial lesions are allowed provided that
they can be treated as a single lesion with one balloon.

- Target vessel must have an reference vessel diameter (RVD) of 4 mm to 6 mm by operator
visual estimate.

- After pre-dilatation, the target lesion is ≤ 70% residual stenosis, absence of a flow
limiting dissection and treatable with a single balloon.

- A patent inflow artery free from significant stenosis (≥ 50% stenosis) as confirmed by
angiography.

- At least one patent native outflow artery to the ankle or foot, free from significant
stenosis (≥ 50% stenosis) as confirmed by angiography.

Exclusion Criteria:

Subjects will be excluded from the trial if any of the following criteria are met:

- Subject has acute limb ischemia.

- Subject has Rutherford classification of 0, 1, 5 or 6.

- Subject previously underwent any lower extremity percutaneous transluminal angioplasty
(PTA) using a DCB within 3 months.

- Subject has had prior vascular intervention within 2 weeks before the planned study
index procedure or subject has planned vascular intervention within 30 days after the
study index procedure.

- Subject is pregnant and/or breast-feeding or intends to become pregnant during the
time of the study OR subject is a male intending to father children within 60 days of
index procedure.

- Life expectancy less than 2 years.

- Subject has a known allergy to contrast medium that cannot be adequately
pre-medicated.

- Subject is allergic to ALL antiplatelet treatments.

- Subject has impaired renal function (i.e. serum creatinine level ≥ 2.5 mg/dl).

- Subject is dialysis dependent.

- Subject is receiving immunosuppressant therapy.

- Subject has known or suspected active infection at the time of the index procedure.

- Subject has platelet count < 100,000/mm3 or > 700,000/mm3.

- Subject has white blood cell (WBC) count < 3,000/mm3.

- Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3
months prior to the index procedure.

- Subject is diagnosed with coagulopathy that precludes treatment with systemic
anticoagulation and/or dual antiplatelet therapy (DAPT).

- Subject is unable to tolerate blood transfusions because of religious beliefs or other
reasons.

- Subject is unwilling or unable to comply with procedures specified in the protocol or
has difficulty or inability to return for follow-up visits as specified by the
protocol.

- Subject is known to be incarcerated, mentally incompetent and/or an alcohol or drug
abuser.

- Subject is participating in another investigational drug or medical device study that
has not completed primary endpoint(s) evaluation or that clinically interferes with
the endpoints from this study, or subject is planning to participate in such studies
prior to the completion of this study.

- Subject has had major surgical or interventional procedures unrelated to this study
within 30 days prior to this study or has planned surgical or interventional
procedures within 30 days of entry into this study.

- Previous intervention at the lesion site including previous stenting within 3 cm of
the target lesion or previous bypass surgery of the target lesion.

- Previous treatment of the target vessel with thrombolysis or surgery.

- Severe concentric calcification of the target lesion.

- Target lesion involves an aneurysm or is adjacent to an aneurysm.

- Target lesion requires treatment with alternative therapy such as stenting, laser,
atherectomy, cryoplasty, brachytherapy or re-entry devices.

- Significant vessel tortuosity or other parameters prohibiting access to the target
lesion.

- Presence of thrombus in the target vessel.

- Iliac inflow disease requiring treatment , unless the iliac artery disease is
successfully treated first during the index procedure. Success is defined as ≤ 30%
residual diameter stenosis without death or major complications.

- Absence of at least one patent native outflow artery.

- Presence of an aortic, iliac or femoral artificial graft.

- Failure to cross the target lesion with a guide wire. Successful crossing of the
target lesion occurs when the tip of the guide wire is distal to the target lesion
without the occurrence of flow-limiting dissection or perforation.

- Failure to successfully pre-dilate the target lesion. Successful pre-dilatation is
defined as residual stenosis ≤ 70% with no flow-limiting dissection.