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

The only delivery system offering two deployment mechanisms for both rapid delivery and true placement accuracy.

Product Description

Cordis S.M.A.R.T.® CONTROL® Transhepatic Biliary Stent, the only delivery system offering two deployment mechanisms for both rapid delivery and true placement accuracy.

  • Deployment Lever – Slide down for rapid deployment.
  • Tuning Dial – Advance for more controlled deployment.

S.M.A.R.T.® CONTROL® Stent Delivery System (SDS) for Accurate Placement

  • Offers one-handed operation for stent delivery.
  • Uses perpendicular applied force to reduce unintentional stent movement.
  • Allows user to adjust stent position prior to vessel wall apposition.
  • Maintains tactile feel via fine adjustment and controlled deployment.
     

Redesigned 6F SDS for Enhanced Delivery

  • Unique TRUMARK® Technology innercoil throughout the length of the catheter reduces delivery system compression and movement during deployment.
  • More flexible tapered tip enhances crossability.
  • 6F sheath compatible delivery system improves trackability.
     

S.M.A.R.T.® CONTROL® Stent Attributes Enhance Placement Accuracy and Confidence

  • MicroMarker® Technology aids in visualization at any angle. The Cordis Marker Securement System of laser-cutting a solid tube of Nitinol and coning the markers ensures marker security on the S.M.A.R.T.® CONTROL® Stent.
  • The S.M.A.R.T.® CONTROL® Stent’s 1mm flare provides immediate wall apposition to prevent stent migration and increases crossability for post dilatation.
  • The unique segmented design and offset bridges allow the S.M.A.R.T.® CONTROL® Stent to achieve continuous wall apposition, even in tortuous anatomy.
  • Less than 6% shortening (from proximal end only) ensures predictable and accurate placement.

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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