Case Studies
WallFlex™ Biliary RX Stent In-service, by Thomas Kowalski, MD
Dr. Kowalski provides a step-by-step demonstration of set-up and deployment of a WallFlex Biliary RX Stent.
Physician Presentations
Ali Siddiqui, MD, Michel Kaheleh, MD, Prof. Marco Bruno, MD, Guido Costamagna, MD, and Jesus Carcia-Cano, MD discuss their experiences treating strictures due to chronic pancreatitis, including the effectiveness of fully covered biliary metal stents.
Biliary Metal Stent Bridge-to-Surgery, by V. Raman Muthusamy, MD
Dr. Muthusamy reviews pancreatic cancer staging, patient selection criteria and bridge-to-surgery case studies.
Endotherapy for Benign Biliary Strictures Secondary to Chronic Pancreatitis, by Paul Tarnasky, MD
Dr. Paul Tarnasky presents an overview of benign biliary strictures due to chronic pancreatitis as well as treatment options and clinical data.
Treatment of Benign Strictures in the Esophagus, by Christer Staël von Holstein, MD
In this presentation, Dr. Christer Staël von Holstein discusses various types of treatment for benign esophageal strictures, including dilation and stenting options.
Procedural Animations
See WallFlex™ Biliary Metal Stent Animation
This animation includes the steps for placement and deployment of a WallFlex Biliary RX Stent.
Procedural Animations
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System
This animation highlights the features of the Advanix Biliary Stent with NaviFlex™ RX Delivery System as well as the steps for placement and deployment.
See Device Tutorials for Advanix™ Pancreatic Stent
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Warning: The safety and effectiveness of biliary metal stents for use in the vascular system has not been established.
Results from case studies may vary. Results from case studies are not predictive of results in other case studies.
INDICATIONS FOR USE in the United States:
The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use inaccordance with 21 CFR §801.109
Contraindications:
• The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts.
• The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated.
Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. Testing of overlapped stents has not been conducted. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS
Case Studies