Read about the latest hot topics, news, and innovations in endoscopy. BOSTON SCIENTIFIC CORP. K030107: 03/21/2003 10mm x 40mm uncovered wallflex billiary rx stent system, model m00570890: BOSTON SCIENTIFIC CORP. K081733: 10/27/2008 advanix biliary stent with naviflex rx delivery system: BOSTON SCIENTIFIC CORP. K101314: 07/23/2010 advanix double pigtail biliary stent: BOSTON SCIENTIFIC CORP. K101786 Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. For Sale BOSTON SCIENTIFIC M00570340 BOSTON SCIENTIFIC 7036 WallFlex Biliary RX Fully Covered Stent System RMV, 8mm x 60mm (X) Asking Price : $200.00 USD ; Condition : New; Est. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The name and coordinator of the study were not provided. All cited trademarks are the property of their respective owners. Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Closed cell construction and Permalume™ Coating options designed to resist tissue in-growth, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol™ Wire construction provides flexibility to aid placement in tortuous anatomies, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information. All rights reserved. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011 article 34. This Website is protected by the laws on copyright and by the relevant international conventions. ©2021 Boston Scientific Corporation or its affiliates. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume® covering. The Sentinol system expands Boston Scientific's family of high-performance self-expanding biliary stents, which includes the WALLSTENT® Endoprosthesis and the Symphony® Biliary Stent. When the item is … When the item is expired must … It was reported to boston scientific corporation that an advanix preloaded biliary stent was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure in the common bile duct performed on (b)(6) 2012. Boston Scientific (BSC) gastrointestinal stents have been studied in Over 500 publications. CAUTION: The law restricts these devices to sale by or on the order of a physician. The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. PROCEDURAL EXCELLENCE SUPPORTED BY CLINICAL EVIDENCE. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced an expansion to its DYNALINK(tm) .035 Biliary Self-Expanding Stent System family. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. These stents … Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. BOSTON SCIENTIFIC 7036 WallFlex Biliary RX Fully Covered Stent System RMV, 10mm x 40mm (X) All items listed are on inventory. Biliary stents such as metal stents, plastic stents, and biodegradable stents that are specialized for diseases or patient conditions represent some … According to the complainant, the indication for the stent placement was treatment for a benign stenosis at the cystic bifurcation of the common bile duct (cbd). ™Biliary RX Stent Fully, Partially and Uncovered Self-Expanding Metal Stents The WallFlex Biliary RX Stent technology is built on science and innovation to expand options for the treatment of biliary … * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. All trademarks are the property of their respective owners. Below please find ordering information for WallFlex Biliary RX Stents. It was reported to boston scientific corporation a wallflex biliary rx covered stent was to be implanted to treat a stenosis in the bile duct during a stenting procedure performed on (b)(6) 2020. It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. DISCLAIMERS: 1 Press Release - August 9, 2011, Boston Scientific's WallFlex™ Biliary RX Stent Receives Canadian Approval for Expanded Indication Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. NATICK, Mass., March 22, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex ® Biliary Transhepatic Stent System. For the WallFlex Biliary RX Partially Covered and Fully Covered Stents, the following complications have been reported in the literature for biliary prostheses or have been observed in the Boston Scientific clinical trial of this device. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Natick, MA (August 9, 2011) – Boston Scientific Corporation’s (NYSE: BSX) WallFlex® Biliary RX Fully Covered Stent has received Health Canada approval for the treatment of benign biliary strictures, which supplements its current indication for management of malignant biliary … 1 Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. The WallFlex Biliary RX Stent is 510(k) cleared for the treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. BOSTON SCIENTIFIC 3231 Advanix Biliary Double Pigtail Biliary Stent, 10F x 15cm (X) All items listed are on inventory. The stent was removed from the patient partially deployed on the delivery system. Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. All rights reserved. The Epic Biliary Stent was developed for physicians who prefer a laser cut stent. Biliary RX Metal Stent Placement of a Fully Covered WallFlex Biliary RX Stent ... on the use of Boston Scientific Corporation’s products, please refer to the Instructions for Use included with Boston Scientific’s product packages. NATICK, Mass., May 15, 2013 /PRNewswire/ -- The first patient has been enrolled in a clinical investigation evaluating the use of the Boston Scientific Corporation (NYSE: BSX) WallFlex® Biliary RX Stent, a self-expanding metal stent (SEMS), as a bridge to surgery compared with the absence of drainage prior to surgery.
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