The GORE® VIABIL® Biliary Endoprosthesis is a fully covered self-expanding metal stent intended for palliation of malignant strictures in the biliary tree. Unique anti-migration anchoring fin technology and highly conformable design aid in reducing the risk of reinterventions.1

This self-expanding biliary stent provides the control and ease of use physicians demand and the outcomes they count on to deliver palliative care to their high-risk patients, supported through proven results.

Improved treatment of biliary strictures

  • Accurate and secure placement: Non-foreshortening* stent design for optimal deployment positioning. 
  • Optimal conformability: Optimal balance of radial and axial force provides the right fit and flexibility to help minimize the risk of migration and sludge formation.2,3 
  • The delivery you need: One stent, two delivery methods: Endoscopic and percutaneous delivery. The GORE® VIABIL® Short Wire Biliary Endoprosthesis† is also available in a short wire delivery system for endoscopic placement.

The outcomes you demand 

Designed to reduce the risk of migration and premature obstruction, while sustaining long-term patency. 

  • Demonstrated low migration rates: Fully covered anchoring fins securely hold the device within the duct to minimize the risk of migration. A reported 0.1% - 1.7% migration rate range for GORE® VIABIL® Biliary Endoprosthesis outperforms BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rate range of 2.6% - 8.1%.4
  • Proven high patency: Helps provide a high standard of palliative care.5,6
    Reduces tissue ingrowth5,6 and promotes conformability, with a durable, non-porous FEP/ePTFE liner.

Learn about our Anti-Migration Assurance Program‡ for endoscopic delivery devices.

Endoscopic delivery: Contact your CONMED representative for support and product availability. Visit here for further support. 

Percutaneous delivery: Contact your Gore Sales Associate for support and product availability. Visit here for further support.

* If deployed as instructed, the endoprosthesis will not appreciably foreshorten.

† Note: GORE® VIABIL® Short Wire Biliary Endoprosthesis is not licensed in Canada in accordance with the Canadian Medical Device Regulation SOR/98-282.

‡ Anti-Migration Assurance Program specific to the U.S. only.

  1. Brown MA. Biliary Fully Covered Metal Stents: Systematic Review of the Clinical Literature.  Includes Attachment 1: Literature Appraisal for Viabil, Attachment 2: Literature Appraisal for Other Fully Covered Biliary Stents (FCBS), Attachment 3: Migration Rate Comparison. Flagstaff, AZ; 2019. [Work plan]. WP111272.
  2. Isayama H, Mukai T, Itoi T, et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointestinal Endoscopy 2012;76(1):84-92.
  3. Isayama H, Nakai Y, Toyokawa Y, et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointestinal Endoscopy 2009;70(1):37-44.
  4. Stevenson AT Jr, O'Neill F, Swarup VP; W. L. Gore & Associates. Fully covered self-expanding metal stents for endoscopic retrograde choangiopancreatography (ERCP) and percutaneous cholangiography (PTC) in the management of malignant biliary obstruction: a U. S. cost consequence analysis. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2022. [Poster]. 22566552-EN.
  5. Kitano M, Yamashita Y, Tanaka K, et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. American Journal of Gastroenterology 2013;108(11):1713-1722.
  6. Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Cardiovascular & Interventional Radiology 2010;33(1):97-106.

BOSTON SCIENTIFIC and WALLFLEX are trademarks of Boston Scientific Corporation.

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Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

FOR ENDOSCOPIC DELIVERY IN THE U.S.

INDICATIONS: (Non-Removable) The GORE® VIABIL® Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree.

CONTRAINDICATIONS: The GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. 

FOR GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS FOR ENDOSCOPIC DELIVERY IN THE U.S.

INDICATIONS: (Non-Removable) The GORE® VIABIL® Short Wire Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree.

CONTRAINDICATIONS: The GORE® VIABIL® Short Wire Biliary Endoprosthesis is contraindicated for. All CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. 

FOR PERCUTANEOUS DELIVERY IN THE U.S.

INDICATIONS: (Non-Removable) The GORE® VIABIL® Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree.

CONTRAINDICATIONS: The GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. 

FOR ENDOSCOPIC DELIVERY IN CANADA

INDICATIONS: (Non-Removable): The GORE® VIABIL® Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree. (Removable): The Removable GORE® VIABIL® Biliary Endoprosthesis is indicated for the treatment of benign and malignant biliary strictures and can be removed from such strictures for up to one year post implant.

CONTRAINDICATIONS: (Non-Removable): The GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. (Removable): The Removable GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter and removal when positioned within a previously placed bare metal stent. 

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