Featured stories and the latest news on what it takes to advance science for life. According to the complainant, during the procedure, the stent was unable to deploy inside the patient. Guidant Expands Biliary Stent System Line Additional Stent Lengths and Diameters Give Physicians Broader Treatment Options Indianapolis, Ind. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. The Epic Biliary Stent was developed for physicians who prefer a laser cut stent. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. A biliary metal stent (also known as a “bile duct stent”) is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. Warning: Once the stent is partially deployed, it cannot be “recaptured” or “resheathed” using the stent delivery system. When the item is expired must … 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. 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. WallFlex™ Biliary RX Fully Covered Stent System RMV .....15 WallFlex Biliary RX Partially Covered Stent System .....15 WallFlex Biliary RX Uncovered Stent System .....15 ™WALLSTENT RX Biliary Endoprosthesis Stent System.....17 WALLSTENT Endoscopic Biliary Endoprosthesis Stents.....18 Biliary Plastic Stents Warning: The safety and effectiveness of this device for use in the vascular system have not been established. Boston Scientific (BSC) gastrointestinal stents have been studied in Over 500 publications. 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 … Read about the latest hot topics, news, and innovations in endoscopy. 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. It was reported to boston scientific corporation that a wallflex fc biliary stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2012. 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. When the item is expired must … The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. Take action in addressing health inequities in your community. BOSTON SCIENTIFIC 3293 Advanix Biliary Duodenal Bend Biliary Stent, 8.5F x 5cm All items listed are on inventory. Implanted Devices; Coronary Stents; Cardiac Resynchronization Therapy (CRT) Devices CAUTION: The law restricts these devices to sale by or on the order of a physician. 2014 Copyright © Boston Scientific Corporation. Established soft knitted, flexible stent available in proximal release which can aid in stent placement in proximal strictures of the esophagus WallFlex TM Esophageal Stent (partially covered) Seeks to deliver luminal patency through flexibility and control designed to traverse tight strictures. This Website is protected by the laws on copyright and by the relevant international conventions. Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. Advanix Biliary Stent 7Fr center bend, double pig tail, and duodenal bend. Biliary stents such as metal stents, plastic stents, and biodegradable stents that are specialized for diseases or patient conditions represent some … 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. 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. Wallflex Transhepatic Biliary Stent System Animation The most frequently implanted biliary metal stent throughout the U.S., Canada and Europe – is available with a transhepatic delivery system designed specifically to meet the needs of IRs. All trademarks are the property of their respective owners. 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. Other health care professionals should select their country in the top right corner of the  website. Two decades of metal stent development and demonstrated safety and effectiveness from multiple studies have helped make WallFlex Biliary Stents the most frequently implanted biliary metal stent throughout the U.S., Canada, and Europe.1. It is strictly forbidden to make copies, whether partial or total and on whichever media without prior approval. https://www.bostonscientific.com/.../wallflex-biliary-rx-stents.html 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 Boston Scientific Advancing science for lifew YOUR TRUST FOR OVER 20 YEARS, developer of advanced stent technologies and remains committed to high quality standards and collaboration with physicians. All rights reserved. The stent was removed from the patient partially deployed on the delivery system. 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. ©2021 Boston Scientific Corporation or its affiliates. All rights reserved. The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was to be implanted to treat a benign and malignant strictures in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date. DISCLAIMERS: 1 Press Release - August 9, 2011, Boston Scientific's WallFlex™ Biliary RX Stent Receives Canadian Approval for Expanded Indication These stents … 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. These stents may be used with short or long guidewires. WallFlex Biliary RX Stents Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. WallFlex™ Biliary RX Stents. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. Event Description It was reported to boston scientific corporation that a wallflex biliary fc removable stent was attempted to be implanted during a ercp (endoscopic retrograde cholangiopancreatography) procedure. When the item is … ©2021 Boston Scientific Corporation or its affiliates. Boston Scientific Completes Enrollment in Benign Stricture Study of WallFlex® Biliary RX Stent NATICK, Mass., Oct. 18, 2011 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) has completed enrollment in a clinical trial to evaluate its WallFlex® Biliary RX Fully Covered Stent for the treatment of benign bile duct strictures (narrowing or blockages). The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Patients. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. 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. EDUCARE makes it simple. Below please find ordering information for WallFlex Biliary RX Stents. BOSTON SCIENTIFIC 3231 Advanix Biliary Double Pigtail Biliary Stent, 10F x 15cm (X) All items listed are on inventory. Thumb wheel deployment with auditory indicators and tactile feedback for ease of placement and control, or the optional pull grip, Tantalum radiopaque markers at proximal and distal end of stent, 220 cm long-wire delivery system to aid in enteroscopy-assisted ERCP, 6, 8, 10mm diameters, up to 100mm in length, Cardiac Resynchronization Therapy (CRT) Devices, Transcatheter Aortic Valve Replacement (TAVR), Medical Device ID Cards - Pacemaker, ICD, & CRT devices, Remote Patient Monitoring and Diagnostic Monitoring, Guide for Patients with a Biliary Metal Stent, Stent Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings: Epic Biliary Endoscopic Stent System, ADVANTICS™ Innovative Healthcare Solutions. 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. ™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 … 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. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. "Guidant''s DYNALINK Biliary Self-Expanding Stent System provides physicians with a self-expanding stent that is deliverable and can be accurately and predictably placed at the site of the occlusion," said Don Schwarten, M.D., vice president and chief medical officer for Guidant''s Cardiac & Vascular Surgery Group. BOSTON SCIENTIFIC 7036 WallFlex Biliary RX Fully Covered Stent System RMV, 10mm x 40mm (X) All items listed are on inventory. 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). The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume® covering. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Information for the use only in countries with applicable health authority product registrations. Prior to use, please consult device labeling for prescriptive information and operating instructions. It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. All rights reserved. One stop. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Laser Cut Self-Expanding Metal Stent The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. Refer to the device directions for use for complete instructions on device use. Below please find ordering information for WallFlex Biliary RX Stents. Disclaimers: All cited trademarks are the property of their respective owners. One source. 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. It was reported to boston scientific corporation that two wallstent biliary endoprostheses were implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6), 2010 as part of a post market study. 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. The name and coordinator of the study were not provided. 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