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WallFlex™

Biliary RX Stents

The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent cleared in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.

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Product Details

In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis.

WallFlex Biliary RX Stent

Removability
The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis.

Migration Resistance
Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration.

Tissue In-Growth Prevention
Closed cell construction and Permalume™ covered options designed to help resist tissue in-growth.1,2

Flexibility
Platinol™ Wire construction provides flexibility to help aid placement in tortuous anatomies.*

Radial Force
Radial force helps maintain stent patency and resist migration.

Stent Satisfaction Program Stent Satisfaction Program

RX Biliary Delivery System

Stent Placement Accuracy
The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control.

Endoscopic Placement
Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2

Fluoroscopic Visualization
The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization.

Stent Patency Satisfaction Program

Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex™ Stents. Contact your Territory Manager to learn more.

Program Details

Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014.

Replacement stents provided under the Program are not eligible for the Program. Claims under the Program are limited to a replacement stent. Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. The hospital is responsible for reporting the replacement stent as a discount on the hospital’s cost report.

The Program is subject to modification or termination by Boston Scientific without prior notification. This program may not be available in all countries. Contact your Territory Manager for details of the Program.

* Flexibility varies by size of stent

** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise.
Indications, contraindications, warnings and instructions for use can be found in the product labeling.
*** A stent cannot be reconstrained after the reconstrainment line has been exceeded
**** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD  

 

Ordering Information

WallFlex Biliary RX Stents

Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Below please find ordering information for WallFlex Biliary RX Stents. These stents may be used with short or long guidewires.

WallFlex Biliary RX Fully Covered Stent System* WallFlex Biliary RX Fully Covered Stent System*

WallFlex Biliary RX Fully Covered Stent System* RMV

Order Number Diameter (mm) Length (mm) Covered Length (mm) (PC Only) Catheter Diameter (Fr/mm) Guidewire Diameter (in/mm) Working Length (cm) Packaging
M00570340 8 60 8.5F / 2.83 .035 / .89 194 Each
M00570350 8 80 8.5F / 2.83 .035 / .89 194 Each
M00570360 10 40 8.5F / 2.83 .035 / .89 194 Each
M00570370 10 60 8.5F / 2.83 .035 / .89 194 Each
M00570380 10 80 8.5F / 2.83 .035 / .89 194 Each

* Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering.

Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use.

View Fully Covered Stent Ordering Information WallFlex Biliary RX Partially Covered Stent System* WallFlex Biliary RX Partially Covered Stent System*

WallFlex Biliary RX Partially Covered Stent System*

Order Number Diameter (mm) Length (mm) Covered Length (mm) (PC Only) Catheter Diameter (Fr/mm) Guidewire Diameter (in/mm) Working Length (cm) Packaging
M00570700 8 60 48 8.5 / 2.83 .035 / .89 194 Each
M00570710 8 80 68 8.5 / 2.83 .035 / .89 194 Each
M00570720 10 40 28 8.5 / 2.83 .035 / .89 194 Each
M00570730 10 60 48 8.5 / 2.83 .035 / .89 194 Each
M00570740 10 80 68 8.5 / 2.83 .035 / .89 194 Each

* Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume® covering.

Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use.

View Partially Covered Stent Ordering Information WallFlex Biliary RX UnCovered Stent System* WallFlex Biliary RX UnCovered Stent System*

WallFlex Biliary RX Uncovered Stent System*
Order Number Diameter (mm) Length (mm) Covered Length (mm) (PC Only) Catheter Diameter (Fr/mm) Guidewire Diameter (in/mm) Working Length (cm) Packaging
M00570600 8 40 8.0 / 2.67 .035 / .89 194 Each
M00570610 8 60 8.0 / 2.67 .035 / .89 194 Each
M00570620 8 80 8.0 / 2.67 .035 / .89 194 Each
M00570630 8 100 8.0 / 2.67 .035 / .89 194 Each
M00570890 10 40 8.0 / 2.67 .035 / .89 194 Each
M00570640 10 60 8.0 / 2.67 .035 / .89 194 Each
M00570650 10 80 8.0 / 2.67 .035 / .89 194 Each
M00570660 10 100 8.0 / 2.67 .035 / .89 194 Each

* Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. 

Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use.

View Uncovered Stent Ordering Information

Case Studies

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Treating Benign Biliary Strictures Due to Chronic Pancreatitis Case Studies


 


 

Reimbursement

 
REFERENCES
  1. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Systematic Review, 25 Jan. 2006.
  2. Soderlund 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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