Evolution® Biliary Stent System-Fully Covered

Inclusion Criteria:

- Inoperable malignant neoplasm causing biliary obstruction or stricture that requires
a fully covered metal stent

Exclusion Criteria:

- < 18 years of age

- Unwilling or unable to sign and date the informed consent

- Unwilling or unable to comply with the follow-up schedule

- Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous
implantation of intracavitary radiation sources

- Participating in another investigational drug or device study in which patient has
not completed the follow-up phase for the primary endpoint at least 30 days prior to
enrollment

- Endoscopic procedures are contraindicated

- Current anatomy upstream of intended stent placement compromising the flow of bile
from the liver such that stent placement may not alleviate the biliary obstruction
symptoms

- Presence of a metal biliary stent

- Presence of an esophageal or duodenal stent

- Hypersensitivity/allergy or contraindication to any component of the stent, delivery
system, or medication required to complete the procedure,which in the investigator's
opinion cannot be adequately premedicated

- Coagulopathy

- Diffuse intrahepatic metastases that involves > 10 % of the liver

- Life expectancy of < 3 months

- Pregnant

- Active alcohol or substance abuse issue

- Jaundice secondary to a cause other than biliary duct obstruction

- Additional endoscopic restrictions as specified in the Clinical Investigation Plan