Boston Scientific Receives Expanded Indication in the U.S. for the WallFlex™ Biliary RX Fully Covered Stent System RMV
In this article, physicians provide feedback on treatment options for benign biliary strictures secondary to chronic pancreatitis based on their experience, and share highlights from data presented at Digestive Diesease Week® 2016.
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 in accordance 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
