Below please find ordering information for WallFlex Biliary RX Stents. AccessGUDID - WallFlex™ Biliary Transhepatic (08714729820512)- Stent System. Source: Boston Scientific Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Helping you deliver the best patient care possible. The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. AW0010-EN3. Model #: 7065 WallFlex® Biliary RX Uncovered Stent System - 10mm x 80mm. This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis. Featured stories and the latest news on what it takes to advance science for life. The hospital is responsible for reporting the replacement stent as a discount on the hospital’s cost report. The products on this website are available for sale in the United States. This non-randomized study was conducted at 13 centers in 11 countries across 5 continents, wherein 187 benign bile duct stricture patients were implanted with Boston Scientific's Fully Covered WallFlex Biliary RX Stent. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. 2 The WallFlex Biliary RX Fully Covered Stent was CE Marked in 2010 for an expanded indication to treat benign biliary strictures. Boston Scientific Corporation announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex(®) Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Featured stories and the latest news on what it takes to advance science for life, Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. Boston Scientific Wallflex Biliary Rx Fully Covered Stent System Rmv 8mm X 60mm M00570340 Endoscopic Placement The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. About Boston Scientific. The WallFlex® Biliary RX Fully Covered Stent was chosen due to ... Biliary RX Fully Covered Stent. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. One source. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Stent Placement Accuracy GMDN Preferred Term Name GMDN Definition; Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. According to the complainant, during the procedure, the stent failed to deploy. The WallFlex Stent is not approved in the United States for use in the treatment of benign biliary strictures. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System. Gastrointestinal Endoscopy, 2006; 63: 986-995. Available fcSEMS include WallFlex (Boston Scientific) (see Fig. The WallFlex Biliary RX Fully Covered Stent was CE Marked in 2010 for an expanded indication to treat benign biliary strictures. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Removability ... (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. GMDN Preferred Term Name GMDN Definition; Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. LIMITATIONS The WallFlex Biliary RX Uncovered Stent System is contraindicated for: • Placement in biliary strictures caused by benign tumors, as the longterm effects of the stent in the bile duct is unknown. $150.00. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume™ covering. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 1 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Duodenal Bend Preloaded. Boston Scientific Corporation has announced that the first patient has been enrolled in a clinical trial to evaluate its WallFlex biliary RX fully covered stent for the treatment of benign bile duct strictures. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex™ Stents. 7F x 9 cm. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume® covering. AccessGUDID - WallFlex™ Biliary Transhepatic (08714729820512)- Stent System. * Compatible with Boston Scientific .035" guidewires, including Dreamwire™ Guidewire. Boston Scientific has initiated the US and international launch of its WallFlex biliary transhepatic stent system, along with a percutaneous delivery system, designed for use by interventional radiologists in the palliative treatment of biliary strictures produced by malignant tumours. WallFlex Enteral Colonic Stent with Anchor Lock Delivery System Nitinol stent Boston Scientific Natick, MA Source: Boston Scientific, Inc. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Radial force helps maintain stent patency and resist migration. 23.2, C), Viabil stent (W.L. This program may not be available in all countries. BRIEF STATEMENT. Abstract. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. Description. AccessGUDID - WallFlex Biliary (08714729953173)- Stent System RMV. ©2021 Boston Scientific Corporation or its affiliates. Liver function test were also performed on (b)(6) 2016. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. accordance with 21 CFR §801.109 Boston Scientific. Migration Resistance 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. authored the largest study on the WallFlex Fully Covered Esophageal Stent, which was published in the December 2014 issue of Digestive and Liver Disease Journal. Covered WallFlex Biliary RX Stent Boston Scientific, www.bostonscientific.com. Contraindications: The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. Take action in addressing health inequities in your community. 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. Fully covered stent is designed for removal up to 12 months post-placement. Due to the altered anatomy, the plastic stent was unable to be removed. Closed cell construction and Permalume™ covered options designed to help resist tissue in-growth.1,2, Flexibility Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Boston Scientific Corp. (NYSE:BSX) enrolled the first patient in a clinical trial of its WallFlex biliary stent for the treatment of benign bile duct strictures. A patient with this device can be safely scanned under the following conditions: • Static magnetic field of 1.5 T and 3.0 T • Maximum spatial gradient magnetic field of 3,000 gauss/cm (30 T/m) WARNING: The safety and effectiveness of the WallFlex Biliary Stent for use in the vascular system has not been established. Fluoroscopic Visualization W. L. Gore & Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. These stents may be used with short or long guidewires. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Additionally, the duct tends to kink at the proximal edge of the stent, causing sludge formation or cholangitis .6 … Warning: The safety and effectiveness of these devices for use in the vascular system has not been established. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. MR imaging within these conditions may be performed immediately following the implantation of the stent. MRI Safety Information MR Conditional - Non-clinical testing has demonstrated that the WallFlex Biliary RX Stent(s) are MR Conditional. The WallFlex Stent is the most frequently implanted biliary metal stent worldwide. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. לעמוד המוצר אצל היצרן: Boston Scientific /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex® Biliary Transhepatic Stent System. Boston Scientific. GMDN Preferred Term Name GMDN Definition; Bare-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. This multicentre, prospective study plans to enroll 187 patients at … 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. Radial Force WallFlex ™ Esophageal Stents Fully and Partially Covered Self Expanding Metal Stents Place your trust in over 20 years of research and development. Note the acute angle of delivery in fluoro image #4. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. All rights reserved. Nexus Embolization Coil Nexus X-10-20-T10-TC Platinum-Iridium, Nitinol Micro Therapeutics, Inc. Irvine, CA • The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. Safety Topic / Subject Ultraflex Tracheobronchial Stent Boston Scientific, www.bostonscientific.com. The WallFlex Biliary Stents are CE Marked for use in the palliative treatment of biliary strictures produced by malignant neoplasms and for treatment of benign biliary strictures. 23.2, B) are available in pcSEMS variants. The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earth’s gravity. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Tissue In-Growth Prevention It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a stenosis in the common bile duct during a stenting procedure performed on (b)(6) 2020. • The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Lowest migration rates: 0-1.4% migration rate outperforming BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rates ranging from 0-13%. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. The sale, distribution, and use of the device are restricted to prescription use in Testing of overlapped stents has not been conducted. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Boston Scientific Corporation (NYSE: BSX) today announced the European availability of the WallFlex(R) Biliary RX Stent for the palliative treatment of malignant common bile duct strictures. For products available in other countries, please choose one of our other websites from the region selector at the top of the site or contact your local Cook Medical representative. 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