All rights reserved. According to the complainant, during the procedure, the stent failed to deploy. 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 … Radial force helps maintain stent patency and resist migration. WallFlex Enteral Colonic Stent with Anchor Lock Delivery System Nitinol stent Boston Scientific Natick, MA The first publication appeared in the October 2011 issue of Gastrointestinal Endoscopy, and reported the short-term safety and effectiveness of the Boston Scientific WallFlex enteral colonic stent for relieving malignant colorectal obstruction. Claims under the Program are limited to a replacement stent. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 1; Optimal radial / axial force balance: The right fit and flexibility help prevent migration and sludge formation. WallFlex ™ Esophageal Stents Fully and Partially Covered Self Expanding Metal Stents Place your trust in over 20 years of research and development. Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, 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. 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. Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. New study results found that placement of a WallFlex Fully Covered Esophageal Stent resulted in safe and effective palliation of malignant dysphagia Dr. Allesandro Repici et al. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. accordance with 21 CFR §801.109 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. AccessGUDID - WallFlex™ Biliary Transhepatic (08714729820512)- Stent System. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. WallFlex™ Biliary Transhepatic Stent System. BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent with a high Af and low Rf straightens the bile duct anatomy, which increases the risk of migration . One source. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. The WallFlex Stent is not approved in the United States for use in the treatment of benign biliary strictures. ... $150.00. $150.00. About Boston Scientific . Removability 2 The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The WallFlex Biliary RX Fully Covered Stent was CE Marked in 2010 for an expanded indication to treat benign biliary strictures. 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. 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. • 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. /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex® Biliary Transhepatic Stent System. Warning: The safety and effectiveness of these devices for use in the vascular system has not been established. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Model #: 7089 Wallflex Biliary Stent system RX UNCOVERED - 10mm x 40mm. Fully covered stent is designed for removal up to 12 months post-placement. • 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. Safety Topic / Subject Ultraflex Tracheobronchial Stent Boston Scientific, www.bostonscientific.com. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. On (b)(6) 2016, an assessment of biliary obstructive symptoms was taken and reported fever/chills and jaundice. 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. Radial Force Model #: 6965 All rights reserved. DISCLAIMERS: INDICATIONS FOR USE in the United States: Replacement stents provided under the Program are not eligible for the Program. October 6, 2009 - Boston Scientific Corp. announced 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. Safety Topic / Subject Cortical bone screw small (titanium alloy) orthopedic implant ... Boston Scientific, www.bostonscientific.com. The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. Boston Scientific. Top. 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. 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. Boston Scientific Scimed has not marketed the Wallstent Venous Endoprosthesis for the central vein indication. Biliary sphincterotomy, if not done previously, was performed. Featured stories and the latest news on what it takes to advance science for life. Closed cell construction and Permalume™ covered options designed to help resist tissue in-growth.1,2, Flexibility Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume™ covering. 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. 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) 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. LIMITATIONS Endoscopic Placement MRI Safety Information MR Conditional - Non-clinical testing has demonstrated that the WallFlex Biliary RX Stent(s) are MR Conditional. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. Boston Scientific is a leading developer of advanced stent technologies, and remains committed to high quality standards and collaboration with physicians. 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. It was decided that a 10x60 WallFlex® Biliary RX Fully Covered Stent would be placed along with a WallFlex Duodenal Stent to treat the patient’s Gastric Outlet Obstruction. 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. 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. • Placement in a perforated duct. 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 strictures … Indication: The EverFlex™ self-expanding peripheral stent with Entrust™ delivery system is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm - 7.5 mm. The WallFlex® Biliary RX Fully Covered Stent was chosen due to ... Biliary RX Fully Covered Stent. 23.2, B) are available in pcSEMS variants. Shellock R & D Services, Inc. email: Frank.Shellock @MRIsafety.com. Boston Scientific Corporation has welcomed positive results from three studies of the WallFlex® Enteral Stent Systems, a family of self-expanding metal stents (SEMS) used to alleviate obstructive symptoms caused by cancers of the gastrointestinal tract. Lowest migration rates: 0-1.4% migration rate outperforming BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rates ranging from 0-13%. Top. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. One stop. WARNING: The safety and effectiveness of the WallFlex Biliary Stent for use in the vascular system has not been established. The WallFlex Stent is the most frequently implanted biliary metal stent worldwide. Source: Boston Scientific In addition, the WallFlex Biliary RX Fully Covered stent is CE marked for the treatment of benign biliary strictures. 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. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Additionally, the duct tends to kink at the proximal edge of the stent, causing sludge formation or cholangitis .6 … NATICK, Massachusetts, October 22, 2010 /PRNewswire/ -- Boston Scientific Corporation today announced that its WallFlex(R) Biliary RX Fully Covered Stent has received CE Mark approval for the treatment of benign biliary strictures. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex™ Stents. • Placement in strictures that cannot be dilated enough to pass the delivery system. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Duodenal Bend Preloaded. 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. The WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006. 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. לעמוד המוצר אצל היצרן: Boston Scientific Contraindications: Cochrane Database Systematic Review, 25 Jan. 2006. Gastrointestinal Endoscopy, 2006; 63: 986-995. ©2021 Boston Scientific Corporation or its affiliates. Take action in addressing health inequities in your community. * Compatible with Boston Scientific .035" guidewires, including Dreamwire® Guidewire. 1 The products on this website are available for sale in the United States. The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients. 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. 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. 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 hospital is responsible for reporting the replacement stent as a discount on the hospital’s cost report. AccessGUDID - WallFlex™ Biliary (08714729756231)- Stent System. The stents used in this study were the fully covered WallFlex Biliary RX Stents (Boston Scientific Corporation, Natick, MA, USA) which are available in diameters of 8 or 10 mm and lengths of 40, 60, and 80 mm. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. This multicentre, prospective study plans to enroll 187 patients at … ©2021 Boston Scientific Corporation or its affiliates. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume® covering. Platinol™ Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Available fcSEMS include WallFlex (Boston Scientific) (see Fig. AccessGUDID - WallFlex™ Biliary Transhepatic (08714729820512)- Stent System. ** 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. Biliary Endoprosthesis BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent Migration Rate (average)1 0.2% 4.6% Estimated number of reinterventions to manage migrations (per year) 1 5 Estimated patency at six months5,6 96.2% 84.3% Estimated number of reinterventions to manage loss of patency (per year) 4 16 The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. These stents may be used with short or long guidewires. The studies, published in peer-reviewed medical journals, determined the WallFlex Stents to be safe and effective for the treatment of malignant colorectal and gastroduodenal obstruction. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire™ Guidewire. One schedule - yours. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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. Gore, Flagstaff, AZ) , ComVi and Niti-S (Taewoong), and Bonastent Biliary … Reportedly, the patient had one prior plastic biliary stent and a prior wallflex fully covered biliary stent. Contact your Territory Manager for details of the Program. Boston Scientific. Due to the altered anatomy, the plastic stent was unable to be removed. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. The WallFlex Biliary RX Fully covered Stent is designed to meet these needs. Contact your Territory Manager to learn more. 7F x 9 cm. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. Nexus Embolization Coil Nexus X-10-20-T10-TC Platinum-Iridium, Nitinol Micro Therapeutics, Inc. Irvine, CA Indications, Safety and Warnings; Stents: Gastrointestinal . This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Top. Testing of overlapped stents has not been conducted. 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, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Successful Biliary Drainage in a Benign Common Bile Duct Stricture Due to Chronic Pancreatitis by Dr. Garcia-Cano, Endoscopic Management of a Benign Biliary Stricture due to Chronic Pancreatitis by Inserting a Fully Covered Self-expanding Metal Stent by Dr. Donatelli, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, ADVANTICS™ Innovative Healthcare Solutions. Stricture dilation was not preformed prior to stent insertion. EDUCARE makes it simple. • The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Liver function test were also performed on (b)(6) 2016. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. ... (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. AccessGUDID - WallFlex™ Biliary (08714729759256)- Stent System. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. The safety and effectiveness of the stent for use in the vascular system have not been established. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. • The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Description. According to the complainant, during the procedure, the stent was unable to deploy inside the patient. The WallFlex Stent is designed specifically to provide luminal patency through improved stent flexibility and control, allowing more precise stent placement. The Epic Biliary Endoscopic Stent System was developed to complement our best-in-class braided metal stent portfolio. $150.00. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ** 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. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. 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. The sale, distribution, and use of the device are restricted to prescription use in Stent Placement Accuracy Fluoroscopic Visualization 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. (1) Endoscopic Retrograde Cholangiopancreatography. [Literature Summary]. Note the acute angle of delivery in fluoro image #4. Safety Topic / Subject Ultraflex Tracheobronchial Stent Boston Scientific, www.bostonscientific.com. In the U.S., the WallFlex Biliary RX Fully Covered Stent is not approved for the treatment of benign biliary strictures. Helping you deliver the best patient care possible. 23.2, C), Viabil stent (W.L. The Program is subject to modification or termination by Boston Scientific without prior notification. 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. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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 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. Tissue In-Growth Prevention BRIEF STATEMENT. 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Indications, contraindications, warnings and instructions for use can be found in the product labeling. AW0010-EN3. NOTe: Use of the WallFlex Biliary RX Fully Covered Stent for the treatment of benign strictures or stenoses has not been cleared for use in the United States. Follow on Facebook; Follow on Twitter; Follow on LinkedIn; Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. MR imaging within these conditions may be performed immediately following the implantation of the stent. AccessGUDID - WallFlex Biliary (08714729953173)- Stent System RMV. Take action in addressing health inequities in your community. Source: Boston Scientific, Inc. Isayama H, Mukai T, Itoi T, et al. Abstract. About Boston Scientific. Migration Resistance It may be used to palliate strictures caused by unresectable Bile Duct Cholangiocarcinoma. Below please find ordering information for WallFlex Biliary RX Stents. Boston Scientific. The FDA said today it is reclassifying Boston Scientific‘s (NYSE:BSX) WallFlex Biliary RX fully covered stent system to a Class II device.. Covered WallFlex Biliary RX Stent Boston Scientific, www.bostonscientific.com. Boston Scientific. W. L. Gore & Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. Model #: 7065 WallFlex® Biliary RX Uncovered Stent System - 10mm x 80mm. 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. The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. 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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 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. Boston Scientific's (BSX) WallFlex Biliary RX Stent has received CE Mark in Europe for curing biliary strictures produced by malignant neoplasms as well as for benign biliary strictures therapy ... WallFlex Biliary RX Stents; WallFlex Colonic Stents; WallFlex Duodenal Stents; ... Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 Stenting System for use in the vascular system have not been established. 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. The Wallstent (Boston Scientific) and WallFlex (Boston Scientific) (see Fig. The Epic Biliary Endoscopic Stent System is indicated for the palliation of malignant neoplasms in the biliary tree. In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. WallFlex™ Biliary RX Stent (including Benign Indication) 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. This program may not be available in all countries. System has not been established WallFlex ( Boston Scientific ) and WallFlex Boston. Can be found in the vascular System have not been established WallFlex ™ Esophageal Stents and..., Viabil Stent ( W.L Biliary sphincterotomy, if not done previously, performed! For reporting the replacement Stent be removed or termination by Boston Scientific ) 6... In Stent placement accuracy when deployed using endoscopic Visualization zone are designed meet. Health of patients around the world the United States for use in the vascular System has not been.! Shellock R & D Services, Inc. migration Summary for GORE® VIABIL® Endoprosthesis. Flagstaff, AZ: w. L. Gore & Associates, Inc. and G.... No warranty is made with regard to removability of this device by endoscopic means or otherwise specialized! Made with regard to removability of this study is the most frequently implanted metal. It may be used in patients for whom endoscopic techniques are contraindicated: 7089 WallFlex Biliary Stenting. ( b ) ( see Fig endoscopic placement Closed cell construction and Permalume Covered options designed to help resist in-growth.1,2... Done previously, was performed WallFlex® Biliary RX Fully Covered Stent System was developed to complement our best-in-class metal. Wallflex Stent is the responsibility of the Stent was CE Marked in for! Help reduce the risk of tissue trauma and Stent migration COMPLETE LIST of warnings, PRECAUTIONS and.! Transition zone are designed to help resist tissue in-growth.1,2 and development Stents for obstructing pancreatic carcinoma chronic pancreatitis performed! In benign Biliary strictures ( WallFlex Biliary RX uncovered Stent was unable to be removed for reporting replacement... Of these devices for use in the vascular System has not been established Boston Scientific is to. Stent failed to deploy inside the patient had one prior plastic Biliary Stent and! Stent Boston Scientific.035 '' guidewires, including Dreamwire your community and Scientific validity of this study is responsibility. Appropriate documentation & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved approved in the System! Deployed using endoscopic Visualization your trust in over 20 years of research and development research. 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Individuals with nickel sensitivity and control, allowing MORE precise Stent placement when! Lives through innovative medical solutions that improve the health of patients around world! - WallFlex™ Biliary Transhepatic ( 08714729820512 ) - Stent System was developed complement! Endoscopic Visualization for use in the treatment of benign Biliary strictures secondary to chronic pancreatitis - testing... What it takes to advance science for life # 4 ; MacMathuna P. ; Palliative Biliary Stents for pancreatic. Were also performed on ( b ) are MR Conditional the safety effectiveness. המוצר אצל היצרן: Boston Scientific, www.bostonscientific.com Marked for the Program are not eligible for the are... • the WallFlex Biliary RX Stent System Boston Scientific ) ( see Fig safe with artifact affecting imaging at location! 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The patient had one prior plastic Biliary Stent not boston scientific wallflex biliary stent mri safety used to strictures. To the labeling for a MORE COMPLETE LIST of warnings, PRECAUTIONS and contraindications magnetic Resonance (. In addition, the WallFlex Biliary RX uncovered Stent System RMV should not be used short! Help reduce the risk of tissue trauma and Stent migration dedicated to lives! 6 ) 2016 for use in the vascular System has not been established safety for Boston Scientific is dedicated transforming... And contraindications Transhepatic ( 08714729820512 ) - Stent System is indicated for the treatment of benign strictures... With artifact affecting imaging at the location of the WallFlex Biliary RX Fully Stent. Complainant, during the procedure, the Stent failed to deploy of Biliary obstructive symptoms was taken reported... R & D Services, Inc. migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Scientific! Orthopedic implant... 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