S.M.A.R.T.® Transhepatic Biliary Stent

When physicians think of nitinol stents, they think of Cordis. The Cordis S.M.A.R.T.® Stents are cut from a single piece of nitinol without rough or cutting edges.

Product Description

Trust the S.M.A.R.T.® Stent design.  

Super-elastic nitinol

  • Crush-recoverable.
  • Thermally self-expanding at body temperature.
  • Highly flexible before and after deployment.

Micromesh design

  • High radial resistive force*.
  • Superior strength.
  • Chronic outward force.
  • Minimal shortening.

Delivery system

  • Accurate placement and ease of use.
  • Treats range of lengths and diameters.
  • Atraumatic.
  • Available in 120mm and 150mm lengths.

* Data on file

Ordering Information

In the United States, email us your order at GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com or call us at 800.327.7714.

IFU

Please refer to the Instructions For Use for complete information, including indications, precautions, warnings, and potential adverse events.

Indications

The S.M.A.R.T.® Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Contraindications

  • Stent of a duct with total biliary occlusion which cannot be crossed by the delivery catheter
  • Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis
  • Patients with bleeding disorders
  • Severe ascites

Precautions

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

  • Store at ambient room conditions out of direct sunlight.
  • The device is provided STERILE and is intended for single use only. Do Not Resterilize the device and/or reuse the device. Do not autoclave.
  • Do not use beyond the “Use By” date.
  • Carefully inspect the sterile packaging and device prior to use. Do not use if it appears damaged.
  • If resistance is encountered at any time during the insertion procedure, do not force passage. Resistance may cause damage to the stent or lumen.
  • If resistance occurs during movement through the sheath, carefully withdraw the stent system.
  • Do not expose the delivery system to organic solvents.
  • If resistance is encountered at any time during the insertion procedure, do not force passage. Resistance may cause damage to the stent or lumen.
  • If resistance occurs during movement through the sheath, carefully withdraw the stent system.
  • If resistance is felt when initially retracting the outer deployment sheath, do not force deployment. Carefully withdraw the stent system without deploying the stent.
  • Persons allergic to nitinol (nickel titanium) may suffer an allergic reaction to this implant.
  • This product should only be used by physicians trained and experienced in diagnostic and interventional techniques.
  • Standard techniques for interventional procedures should be employed.
  • Do not use power injection systems with the delivery system.
  • Use in patients with a history of contrast sensitivity is not recommended unless the patient can be adequately premedicated.
  • The system is not designed for stent repositioning or recapturing.
  • Use caution when crossing a deployed stent with any adjunct device.

Potential Complications/Adverse Events

  • Potential hazards and side effects include, but are not limited to:
  • Infection secondary to contamination of the stent may lead to cholangitis, hemobilia, peritonitis, or abscess.

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