Value Analysis Committee Information

To be an effective device for the treatment of a biliary obstruction, precise placement, high patency, and low migration are needed. With its unique combination of features and benefits, GORE® VIABIL® Biliary Endoprosthesis is the only fully covered metal stent with anti-migration technology proven to reduce the risk of reintervention.

Fully covered self-expanding metal stents for endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous cholangiography (PTC) in the management of malignant biliary obstruction: A U.S. cost consequence analysis.


André T. Stevenson Jr., Ph.D. | Frank O’Neill, Ph.D. | Vimal Swarup, Ph.D. | W. L. Gore & Associates

Background

  • ERCP and PTC are commonly performed procedures in the management of malignant biliary obstruction.1
  • Randomized controlled trials have demonstrated that fully covered self-expandable metal stents (FCSEMS) provide lower rates of stent dysfunction compared to bare or partially covered self-expandable metal stents.
  • However, stent migration remains a challenging adverse event associated with FCSEMS, resulting in re-interventions and secondary complications.1

PICO table descriptions

Time frame and setting: Studies published from January 2000 through September 2021 in all countries.

 

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24 STUDIES

  • Met the inclusion criteria
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INTERVENTIONS/COMPARATORS

  • Include GORE® VIABIL® Short Wire Biliary Endoprosthesis, GORE® VIABIL® Biliary Endoprosthesis and  BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent
  • Exclude bare metal stent
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POPULATION

  • Malignant biliary obstruction
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OUTCOMES

  • Migration
  • Patency

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Value Analysis Overview

Anti-migration Assurance Program

The unique anti-migration technology aids in reducing the risk of reinterventions. The fully covered atraumatic anchoring fins securely hold the device within the duct.

  • Average migration rate: 0.9% (0.1% - 1.7%).2
  • GORE® VIABIL® Biliary Endoprosthesis is the only fully covered metal stent with anti-migration technology proven to reduce the risk of reintervention.
  • Replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation.

The extremely low migration rates of the GORE® VIABIL® Short Wire Biliary Endoprosthesis help me limit patients’ risks and keep their quality of life and satisfaction with their outcomes as high as I’m able, and I’m pleased to see that performance now backed by Gore’s cost-reducing Anti-Migration Assurance Program.

Todd Baron / MD, UNC Hospitals GI Medicine Clinic

Endoscopic delivery

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Percutaneous delivery

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  1. Medicine. 2021;100(3):e23938.

     

  2. Stevenson AT Jr, O'Neill F, Swarup VP; W. L. Gore & Associates. Fully covered self-expanding metal stents for endoscopic retrograde cholangiopancreatography (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.

 

 

22772509-EN