WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Inclusion Criteria:

• Age 18 or older

• Willing and able to comply with the study procedures and provide written informedconsent to participate in the study

• Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)

• Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed bycholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange ofprior plastic stent(s) for management of benign stricture

Exclusion Criteria: General:

• Placement of the stent in strictures that cannot be dilated enough to pass thedelivery system

• Placement of the stent in a perforated duct

• Placement of the stent in very small intrahepatic ducts

• Patients for whom endoscopic techniques are contraindicated

• Biliary stricture of malignant etiology

• Biliary stricture of benign etiology other than chronic pancreatitis or livertransplant anastomosis or other abdominal surgery

• Stricture within 2 cm of duct bifurcation

• Symptomatic duodenal stenosis (with gastric stasis)

• Prior biliary self-expanding metal stent

• Suspected stricture ischemia based on imaging of hepatic artery occlusion orendoscopic evidence of biliary cast syndrome

• Known bile duct fistula

• Known sensitivity to any components of the stent or delivery system

• Participation in another investigational study within 90 days prior to consent orduring the study Additional Specific to Chronic Pancreatitis Patients:

• Developing obstructive biliary symptoms associated with an attack of acutepancreatitis Additional Specific to Post-Abdominal Surgery Patients:

• History of hepatectomy

• History of liver transplant Additional Specific to Liver Transplant Patients:

• Live donor transplantation