5
ENGLISH
ZILVER 635® BILIARY STENT
EXPANDABLE METAL BILIARY STENT SYSTEM
CAUTION: U.S. federal law restricts this device to sale by or on the order of a
physician (or properly licensed practitioner).
WARNING: The safety and effectiveness of this device for use in the vascular system
has not been established.
DEVICE DESCRIPTION
Zilver 635® Biliary Self-Expanding Stent
The Zilver Biliary stent is a self-expanding, open-ended cylinder of nitinol (Fig. 1). The
design of the stent resists radial compression and easily conforms to bends in the bile
duct anatomy without collapsing. There are radiopaque markers on each end of the
stent to assist in fluoroscopic visualization of the stent position. It can be used in the
Biliary tree from the intrahepatic ducts through the papilla. The device is recommended
for use in the adult population.
Delivery System
The stent is compressed into a flexible delivery system (Fig. 1). There is a radiopaque
marker at the distal end of the delivery system to aid in deployment of the stent under
fluoroscopic guidance. The delivery system accepts a .035 inch wire guide.
INTENDED USE
This device is used in palliation of malignant neoplasms in the biliary tree.
CONTRAINDICATIONS
• Contraindications include those specific to ERCP and any procedure to be performed
in conjunction with stent placement.
• Additional contraindications include, but are not limited to:
• Inability to pass the wire guide or stent delivery system through the obstructed
area
• Very small intrahepatic ducts
• Biliary duct strictures of benign etiology
• Biliary obstruction preventing cholangiography
• Concurrent perforated bile duct
• Concurrent bile duct stones
• Patients for whom endoscopic procedures are contraindicated
• Patients with coagulopathy
• Any use other than that specifically outlined in the Intended Use section of this
booklet
