Product Information
Treatment - Metal stent placement is the most effective treatment of inoperable malignant common bile duct stricture.
1
Specifications
Platinum-cored Nitinol construction (Platinol™ Alloy)
- Designed to provide greater flexibility than WALLSTENT® RX Biliary Endoprosthesis to aid placement in tortuous anatomies*
- Allows for enhanced radiopacity compared to WALLSTENT RX Biliary Endoprosthesis to aid in stent placement
Looped and flared stent ends may reduce the risk of tissue trauma and stent migration
Closed cell construction is designed to resist tissue ingrowth3,4
Radial force (similar to WALLSTENT) is designed to maintain patency and resist migration3,4
RX Biliary System™Compatibility
- Allows for reconstrainability of stent up to approximately 80% of deployment to aid in repositioning**
- Designed for physician control and locking of the guidewire
Delivery System - Multiple markers (including 4 fluoroscopy markers, yellow transition zone on catheter and reconstrainment limit marker on handle) are designed to increase placement accuracy
Options
- Multiple stent sizes are available to accommodate different anatomical and clinical requirements
- The WallFlex Biliary RX Uncovered Stent System provides the option to use short or long guidewires
Device Illustration
Device Highlights
- Flared ends
- Closed cell construction
Magnetic Resonance (MR) Safe
The WallFlex Biliary RX Uncovered Stent will not present an additional hazard or risk to a patient in a 3 Tesla MRI environment or less with regard to translational attraction, torque and heating.
Magnetic Resonance (MR) Compatibility
Artifacts created by the presence of the WallFlex Biliary RX Uncovered Stent were shown as localized signal voices (i.e., signal loss) that were minimal in size relative to the size and shape of these implants. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of a WallFlex Biliary RX Uncovered Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of these metallic implants.
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
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.
2Rey JF et al.
Guidelines of the French Society of Digestive Endoscopy: Biliary Stenting. Endoscopy
2002; 34: 169-173.
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.
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