WallFlex® Biliary RX Stents

Treatment with Metal Stents

The Innovation

Provides greater flexibility than WALLSTENT® Endoprosthesis to aid placement in tortuous anatomies* Enhanced full-length radiopacity designed to aid in stent placement Radial force (similar to WALLSTENT® Endoprosthesis) designed to maintain patency and reduce risk of migration 3, 4

The Integrated Retrieval Loop

• Due to the integrated braided design of the fully and partially covered stents, when the retrieval loop is pulled using forceps, the entire length and diameter of the stent is designed to narrow (as shown in image below) to help facilitate repositioning and removal of the stent during the initial placement procedure.***

  Too see retreival loop sequence in action, click on image.

  Looped & Flared Ends

  Designed to reduce risk of tissue trauma and stent migration

  Closed Cell, Braided Construction & Permalume® Covering

  Designed to resist tissue ingrowth2,3,4

  
  
  The Delivery System

  RX Biliary System™ compatible, designed for physician control and locking of the guidewire Low profile 8.0 Fr (Uncovered) and 8.5 Fr (Partially Covered/Fully Covered) system and tapered tip 1:1 controlled deployment system Reconstrainable up to 80% of deployment to aid in repositioning** Yellow transition zone on catheter, 4 fluoroscopy markers and reconstrainment limit marker on handle are designed to aid in placement accuracy

  To see procedural footage of a fully covered distal duct placement, click here.
  
  

  The Options

  • Uncovered (UC), partially covered (PC) and fully covered (FC) stents available in multiple sizes
  • Short or long wire compatible
  
  
  

  The Science (Clinical Evidence)

  WallFlex Biliary RX Fully Covered & Partially Covered Stent Trials
  Clinical trials of the WallFlex Biliary FC Stent and the PC Stent have been completed. Final results from these trials will be published at a later date.
  
  To see preliminary results from these studies presented at the UEGW conference, please click here to see FC study and here for PC study.
  
  For more information on published clinical literature, click here.
  
  

   

  Warning: The safety and effectiveness of this device for use in the vascular system has not been established.

  * Flexibility varies by size of stent
  ** A stent cannot be reconstrained after the reconstrainment limit has been exceeded
  *** Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise.
  
  

  References

  ¹Kassis et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. GI Endoscopy 2003; 57: 178-182.
  ²Waschke K.A., Da Silviera E.,TouboutiY., Rahme E, Martel M, Barkun, A (Presenter). Poster MON-E-397, UEGW 2006.
  ³Moss A.; Morris E., MacMathuna P. Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Systematic Review; 25 Jan. 2006.
  ⁴Soderlund K., Linder S.Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointestinal Endoscopy; 2006; 63: 986-995.
  
  
  

   

  August 2009, MVG14790