Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Inclusion Criteria: * Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis * Subject is ≥18 years of age * Subject is able to comply with study protocol and follow-up requirements * Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form Exclusion Criteria: * Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region) * Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent * The subject has malignant biliary disease * Subject has known pregnancy * Participated in protocol involving investigational drug or device within 90 days prior to entry into this study