Boston Scientific Logo
HEALTH CARE PROFESSIONALS
Prescriptive Information

Advanix™ Biliary Stent with NaviFlex™ RX Delivery System

Refer to the device directions for use for complete instructions on device use.


Intended Use/Indications for Use

The Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile duct, for splinting of a bile duct during healing, or for providing bile duct patentcy in a stricture or past a stone.

Contraindications

None known.

Adverse Events

Potential complications associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) may include but may not be limited to:

Precautions


Perscriptive Information

Indications for Use

The device is indicated for the palliative treatment of Colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Contraindications

Contraindications associated with the use of the WallFlex™ Colonic Stent System with Anchor Lock Delivery System include:

Warnings


Precautions


MR Conditional

Non-clinical testing has demonstrated that the WallFlex™ Colonic Stent System with Anchor Lock Delivery System is MR Conditional. A patient with this device may undergo MRI immediately under the following conditions: In non-clinical testing, the WallFlex Colonic Stent System with Anchor Lock Delivery System produced a temperature rise of less than or equal to 0.6°C at a maximum whole body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 Tesla Excite®, G3.0-052B, General Electric Medical Systems, Milwaukee, WI; active-shielded, horizontal field MR scanner. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the WallFlex Colonic Stent System with Anchor Lock Delivery System.

Adverse Events

Complications associated with the use of the WallFlex Colonic Stent System with Anchor Lock Delivery System may include:
Procedural Complications Post Stent Placement Complications

Prescriptive Information

Refer to the Directions for Use for complete instructions for use.

Indications
The WallFlex Esophageal Partially Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Contraindications
The WallFlex Esophageal Partially Covered Stent System is contraindicated for:



Warnings
The WallFlex Esophageal Stent System should be used with caution and only after careful consideration in patients with:


Potential Adverse Effects
The potential adverse effects associated with esophageal stent placement may include: Possible Post Stent Complications

Instructions in the Event of Damage
Warning: Visually inspect the system for any signs of damage. Do not use if the system has any visible signs of damage. Failure to observe this warning may result in patient injury.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Additional Resources & Info
Latest SpyGlass® System News
Latest SpyGlass® System News
Check out what's new with the SpyGlass Direct Visualization System.
Learn More »
Proven Excellence
Proven Excellence
Learn why CRE™ Balloon Dilators have been the market leader for GI balloon dilations for over 10 years.
Learn More »
Investigator-Sponsored Research Studies
Investigator-Sponsored Research Studies
The Investigator-Sponsored Research (ISR) Program facilitates the support of researchers by funding studies that are of interest to Boston Scientific and the medical community.
Learn more about the ISR Program »