Cordis PRECISE^® Transhepatic Biliary Stent

Essential Prescribing Information

Palliation of malignant neoplasms in the biliary tree

Use of this product outside of the biliary tree
Severe adverse events due to air embolism including, but not limited to coma, seizure, and stroke have been reported in connection with use of this product in the carotid arteries
Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis
Patients with bleeding disorders
Severe ascites

The safety and effectiveness of this device for use in the vascular system have not been established.

Persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.
Do not reuse.
Do not use with Ethiodol* or Lipiodol* contrast media.
Do not expose the delivery system to organic solvents (e.g. alcohol).
The stent is not designed for repositioning or recapturing.
Stenting across a major bile duct branch could lead to compromise future diagnostic or therapeutic procedures.
Any secondary expansion of the biliary stent should be performed with a device indicated for biliary stent placement.

Device intended for use by appropriate trained physicians
The delivery system is not designed for use with power injection systems
When catheters are in the body, they should be manipulated only under fluoroscopy
Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution

Potential complications associated with the use of transhepatic biliary endoprostheses may include, but are not limited to:

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

See package insert for full product information.

*The third-party trademarks used herein are trademarks of their respective owners.