GORE® VIABIL® Biliary Endoprosthesis

Proven to Minimize the Risk of Reintervention1

GORE® VIABIL® Biliary Endoprosthesis is the only non-foreshortening fully covered metal stent in the market. This means the implant will not appreciably foreshorten when deployed.* In addition, the GORE® VIABIL® Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique. Physicians can trust that the length and position of the stent will be the same pre-deployment and post-deployment.

gore viabil comparison to boston scientific wallflex

Patency, or the ability for a stent to remain open and unoccluded, is a crucial characteristic of any Self-Expanding Metal Stent (SEMS). Based on clinical publications, the GORE® VIABIL® Biliary Endoprosthesis maintains higher primary patency than the leading competitor at 3, 6 and 12 months post-deployment, when implanted to manage malignant biliary strictures.5,6 The moderate radial force, low axial force and durable, nonporous ePTFE/FEP liner of GORE® VIABIL® Biliary Endoprosthesis are designed to enhance patency.

graph comparing gore viabil to wallflex

The GORE® VIABIL® Biliary Endoprosthesis offers the optimal balance of low Axial force (Af) and moderate Radial force (Rf), allowing natural conformance of the stent to the bile duct anatomy while maintaining industry-leading primary patency rates. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy.

Low Axial Force: GORE®VIABIL® Biliary Endoprosthesis features the preferred combination of low Af and moderate Rf to minimize risk of migration, conforming naturally to the bile duct anatomy.

High Axial Force: SEMS with high Af do not conform well to curved biliary anatomy.  This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3

chart showing how gore viabil can bend

25X Reduction in Migration Rates

Malignant biliary stricture migration rate comparison1
(Reported data is aggregated from 47 studies reported between 2002 and 2018)

Significantly Lower Migration Rates than the Market Leaders1


Based on a number of clinical publications, GORE® VIABIL® Biliary Endoprosthesis demonstrates substantially lower migration rates than the competition. Proprietary built-in anti-migration fins gently stabilize the device within the common bile duct, resisting the anatomical forces that could push the device out of place.

 

*Not available in all markets.

Header Illustration: Keith Kasnot, MA, CMI, FAMI
If deployed as instructed, the endoprosthesis will not appreciably foreshorten. Data on File.
** p<0.00000001, when compared to GORE® VIABIL® Biliary Endoprosthesis migration rates. 
W. L. Gore & Associates, Inc; Biliary Fully Covered Metal Stents Systematic Review of the Clinical Literature. Flagstaff, AZ; 2019. [Work plan]. WP111272.
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. 
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. 
W. L. Gore & Associates, Inc; Radial Force and Bend Stiffness Characterization of Biliary Stents. Flagstaff, AZ; 2012. [Work plan]. WP103837. 
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. 
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. Am J Gastroenterol. 2013 Nov;108(11):1713-22.