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The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.

The WallFlex Biliary RX Fully Covered Stent System RMV consists of 2 components: the implantable fully covered self-expanding metallic biliary stent (FC-SEMBS) and the Rapid Exchange (RX) delivery device. The FC-SEMBS is made out of Nitinol monofilament wire with a radiopaque platinum core, braided in a tubular mesh configuration. The stent has proximal and distal flares at each end to aid in preventing migration. The proximal flare also contains the biliary stent retrieval loop. The biliary stent is covered with a Permalume™ silicone covering along its entire length except for 2 mm on the retrieval loop end. The RX delivery device is a coaxial tube design. The exterior tube is used to constrain the biliary stent before deployment and re-constrain the biliary stent, if biliary stent repositioning is necessary, after partial deployment. The exterior tube has a clear section so that the constrained stent is visible. A yellow transition zone on the inner tube of the delivery system is visible between the stent and the blue outer sheath. There are four radiopaque (RO) markers to aid in the deployment of the stent while using fluoroscopy. There are two RO markers on the inner tube of the delivery system identifying the ends of the constrained biliary stent. Between these RO markers is an additional RO marker that indicates at what point re-constrainment is no longer possible. The fourth RO marker at the leading end of the exterior tube indicates how far the biliary stent has been deployed. There is one visual marker on the interior tube between the handles to aid in the deployment of the biliary stent. The visual marker indicates the point at which re-constrainment is no longer possible. The interior tube has a single central lumen to accommodate a 0.035 inch (0.86 mm) guidewire.