WallFlex™ Biliary PLUS
RX Fully Covered Stent System
The most flexible fully covered biliary metal stent currently available from Boston Scientific,* the WallFlex Biliary PLUS RX Fully Covered Stent System delivers an array of re-engineered features designed to help reduce the risk of migration. It features a decreased axial force* that’s intended to increase conformability1 while maintaining high radial force.2
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Overview
Why choose the WallFlex Biliary PLUS RX Stent System
AXIOS™ Stent-inspired
proximal anti-migration
bump
Designed to help reduce the risk of migration
Decreased axial force*
Engineered to help conform to ductal anatomy1
Enlarged distal flare diameter*
Designed to help aid against proximal migration into the bile duct
Designed with radial force intended for anti-migration and smooth bile flow2
High radial force5 is needed for anti-migration and luminal patency
Closed-cell construction
and Permalume™ covering
Designed to help resist tissue ingrowth3,4
Integrated retrieval loop
Designed for removal upon initial placement
See the unique features of WallFlex Biliary PLUS in action
Introducing the WallFlex Biliary PLUS RX Fully Covered Metal Stent, built on the legacy of WallFlex Biliary RX product lines, with redesigned anti-migration features* and reimagined axial*1 and radial forces.*2
WallFlex Biliary Portfolio
A proven biliary metal stent portfolio. PLUS so much more.
Choose the biliary metal stent that is right for the patient and their unique stricture with the comprehensive Boston Scientific portfolio. WallFlex Biliary RX Stents are intended to give you the predictable placement and patency you need as you strive to minimize unplanned patient interventions.
See the full WallFlex Biliary portfolio
With Boston Scientific’s comprehensive portfolio, clinicians are able to choose the biliary metal stent that’s appropriate for patient’s clinical presentation and anatomy. The addition of the WallFlex Biliary PLUS RX Stent System provides clinicians with an additional tool to meet individual patient needs.
WallFlex Biliary RX Stents
A comprehensive portfolio of biliary metal stents
Fully covered, partially covered and uncovered WallFlex Biliary RX stents are available in multiple sizes to accommodate different anatomical and clinical requirements.
WallFlex Biliary PLUS RX Fully Covered Stent System
Stent body re-engineered with anti-migration features including:
- A proximal bump inspired by the AXIOS™ Stent
- An enlarged distal flare* designed to help aid against stent migration
- Designed with balanced axial and radial forces to help conform to the ductal anatomy while addressing patency within the stricture1,2
WallFlex Biliary RX Fully Covered Stent System
Consists of a flexible delivery system preloaded with a self-expanding biliary metal stent. The stent is made from a metallic radiopaque material that is formed into a cylindrical mesh.
Indicated for:
- Malignant biliary neoplasm
- Bridge to surgery
WallFlex Biliary RX Fully Covered Stent System RMV
Consists of a flexible delivery system preloaded with a self-expanding biliary metal stent. The stent is made from a metallic radiopaque material that is formed into a cylindrical mesh.
- May eliminate the need for repeat procedures3
- May reduce the number of endoscopic retrograde cholangiopancreatography (ERCPs) per patient compared to treatment using multiple plastic stents3
Indicated for:
- Malignant biliary neoplasm
- Bridge to surgery
- Benign biliary strictures
WallFlex Biliary RX Partially Covered Stent System
The body portion of the stent has the advantages of fully covered stents with Permalume covering to help prevent tissue in‑growth, while flared uncovered ends are designed to help with tissue adherence and minimal6 migration.
- High patency rates with a low migration rate6
- Demonstrated migration rate as low as 0%6
Indicated for:
- Malignant biliary neoplasm
- Bridge to surgery
WallFlex Biliary RX Uncovered Stent System
A well-trusted tool for biliary malignancy treatment. Uncovered stent with no Permalume covering, this stent is used when patency is needed and there needs to be as little a chance of migration as possible
Indicated for:
- Malignant biliary neoplasm
- Bridge to surgery
| WallFlex Biliary PLUS RX Fully Covered Stent System |
WallFlex Biliary RX Fully Covered Stent System |
WallFlex Biliary RX Fully Covered Stent System RMV |
WallFlex Biliary RX Partially Covered Stent System |
WallFlex Biliary RX Uncovered Stent System |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8 | 10 | 8 | 10 | 6 | 8 | 10 | 8 | 10 | 8,10 | ||
| Lengths (mm) | 60, 80, 100 | 40, 60, 80, 100 | 60, 80, 100, 120 | 40, 60, 80, 100, 120 | 40, 60, 80 | 60, 80, 100, 120 | 40, 60, 80, 100, 120 | 60, 80, 100, 120 | 40, 60, 80, 100, 120 | 40, 60, 80, 100, 120 | |
| Malignant biliary neoplasm | ✔ | ✔ | ✔ | ✔ | ✔ | ||||||
| Bridge to surgery | ✔ | ✔ | ✔ | ✔ | ✔ | ||||||
| Benign biliary strictures secondary to chronic pancreatitis, with indwell up to 12 months | ✔ | ||||||||||
Ordering information
Product codes
| Material (UPN)/Catalog / REF # | Product description | Stent diameter X length | Box Qty |
|---|---|---|---|
| M00547500 | WallFlex Biliary PLUS RX Fully Covered Stent System | 8mm x 60mm | 1 |
| M00547510 | WallFlex Biliary PLUS RX Fully Covered Stent System | 8mm x 80mm | 1 |
| M00547520 | WallFlex Biliary PLUS RX Fully Covered Stent System | 8mm x 100mm | 1 |
| M00547530 | WallFlex Biliary PLUS RX Fully Covered Stent System | 10mm x 40mm | 1 |
| M00547540 | WallFlex Biliary PLUS RX Fully Covered Stent System | 10mm x 60mm | 1 |
| M00547550 | WallFlex Biliary PLUS RX Fully Covered Stent System | 10mm x 80mm | 1 |
| M00547560 | WallFlex Biliary PLUS RX Fully Covered Stent System | 10mm x 100mm | 1 |
*Compared to WallFlex Biliary RXFully Covered Stents.
Indications for use:
WallFlex Biliary RX Stent System, WallFlex Biliary PLUS RX Stent System: indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
WallFlex Biliary RX Stent System RMV: indicated for use palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for treatment of benign biliary strictures.
Warning: The safety and effectiveness of this device for use in vascular system has not been established.
Sources:
1. The conformability of the WallFlex Biliary PLUS RX Fully Covered Stent System was assessed through axial force measurements in DV bench tests conducted by Boston Scientific, demonstrating that its axial force is lower than that of other self-expandable metal stents, as referenced in the literature by Isayama H, Nakai Y, Hamada T, Yamamoto N, Koike K. Development of an ideal self-expandable metallic stent design. Gastrointestinal Intervention. 2015 ;4 :46–49. Data on file. Bench testing is not indicative of clinical performance.
2. The radial force of the WallFlex Biliary PLUS RX Fully Covered Stent System was assessed through radial force measurements in DV bench tests conducted by Boston Scientific, demonstrating that its radial force exceeds the threshold set by other self-expandable metal stents, as defined in the literature by Isayama H, Nakai Y, Hamada T, Yamamoto N, Koike K. Development of an ideal self-expandable metallic stent design. Gastrointestinal Intervention. 2015 ;4 :46–49. Data on file. Bench testing is not indicative of clinical performance.
3. Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc. 2006;63(7):986-995.
4. Moss AC, Morris E, Mac Mathuna P. Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Syst Rev. 2006;(1):CD004200. Published 2006 Jan 25.
5. Isayama H, Nakai Y, Hamada T, Yamamoto N, Koike K. Development of an ideal self-expandable metallic stent design. Gastrointestinal Intervention. 2015 ;4 :46–49.
6. Yokota Y, Fukasawa M, Takano S, et al. Partially covered metal stents have longer patency than uncovered and fully covered metal stents in the management of distal malignant biliary obstruction: A retrospective study. BMC Gastroenterol. 2017;17:105.
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