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. 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. "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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume® covering. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. One stop. Patients. 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. One source. BOSTON SCIENTIFIC 3293 Advanix Biliary Duodenal Bend Biliary Stent, 8.5F x 5cm All items listed are on inventory. Helping you deliver the best patient care possible. 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 … All trademarks are the property of their respective owners. When the item is expired must … Below please find ordering information for WallFlex Biliary RX Stents. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. All rights reserved. Laser Cut Self-Expanding Metal Stent The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. All rights reserved. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. EDUCARE makes it simple. Read about the latest hot topics, news, and innovations in endoscopy. Warning: Once the stent is partially deployed, it cannot be “recaptured” or “resheathed” using the stent delivery system. 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. When the item is … 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. 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 stent was removed from the patient partially deployed on the delivery system. 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). All cited trademarks are the property of their respective owners. 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. https://www.bostonscientific.com/.../wallflex-biliary-rx-stents.html 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. 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. Refer to the device directions for use for complete instructions on device use. 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. These stents … Prior to use, please consult device labeling for prescriptive information and operating instructions. 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). 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. All rights reserved. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. 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. 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. 2014 Copyright © Boston Scientific Corporation. DISCLAIMERS: 1 Press Release - August 9, 2011, Boston Scientific's WallFlex™ Biliary RX Stent Receives Canadian Approval for Expanded Indication When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. ©2021 Boston Scientific Corporation or its affiliates. Featured stories and the latest news on what it takes to advance science for life. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. PROCEDURAL EXCELLENCE SUPPORTED BY CLINICAL EVIDENCE. The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. 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 7036 WallFlex Biliary RX Fully Covered Stent System RMV, 10mm x 40mm (X) All items listed are on inventory. WallFlex™ Biliary RX Stents. 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