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 in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery, and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.
Warning: The safety and effectiveness of this device for use in vascular system has not been established.
Caution: U.S. Federal law restricts these devices to sale by or on the order of a physician.
*Compared to WallFlex Biliary RX Fully Covered Stents.
- 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.
- 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.