Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000031716 00000 n 0000003307 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received Fully covered stent is designed for removal up to 12 months post-placement. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 0000194996 00000 n 2022 Boston Scientific Corporation. With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Contact your Territory Manager for details of the Program. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. 0000012830 00000 n 99 0 obj <> endobj 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. Must read: What this policy does not cover / notable exceptions, This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH departments. 2023 Boston Scientific Corporation or its affiliates. Endoscopically-placed stents are a clinically effective treatment for biliary Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. The data demonstrate that the Advanix Double 1.5: Safe More. *Fluoroscopic image from animal lab testing. 0000194654 00000 n Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Tissue In-Growth Prevention 0000002593 00000 n 0000020391 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Miscellaneous Implants . 0000003412 00000 n Are you a Medical Device Company? 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. Global Unique Device ID: 08714729787402. Data claim does not apply to the 3Fr stent. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. ** 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 stents MRI safety. 99 40 CAUTION: The law restricts these devices to sale by or on the order of a physician. - Boston Scientific Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . 0000006584 00000 n %PDF-1.4 % Boston, MA. 510 (k) Number. Applicant. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. 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. 0000032536 00000 n Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Disposable devices intended to assist implantation may be included. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Marlborough, MA 01752. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000008839 00000 n The Advanix Biliary Stent is specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcome. GMDN Names and Definitions: Copyright GMDN Agency 2015. However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000016595 00000 n PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Company Name: BOSTON SCIENTIFIC CORPORATION. 2023 Boston Scientific Corporation or its affiliates. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The indications for pancreatic stent implantation are either prophylactic or 0000014680 00000 n Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. K203162. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, 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, 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, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. All device bench test results were acceptable. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 138 0 obj<>stream According to the MHRA (2014 section 4.11.2.4) each biliary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturers literature. accordance with 21 CFR 801.109 Radial Force Coils, Filters, Stents, and Grafts More. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH and QEUH departments. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Find out who we are, explore careers at the company, and view our financial performance. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. 0000006218 00000 n Stent Placement Accuracy Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Endoscopic Placement First; Previous; . To aid in placement, the stent is constructed of a flexible yet durable polymer. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Applicant Contact. 0000003169 00000 n Risk assessment: A 043254. 0000002457 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Question - Answer 0. In no case shall Boston Scientific India Private Limited, or any of its affiliates, directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from the access of information provided in this website. All trademarks are the property of their respective owners. These stents may be used with short or long guidewires. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. Disclaimers HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. However we can not guarantee for any material, property or completeness. Please contact our technical team for additional support. 1. xb``c``ig`e`bd@ A6v[*/`` j[rc 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. Fluoroscopic Visualization It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Device Name: Biliary Stent with NaviflexTM RX Delivery System. The NaviFlex RN Delivery System will be offered in 202.5cm working length. ` X Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. `abi` 2"Hb? Boston Scientific Corporation. 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. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 3: Conditional 6 More. Contact your Territory Manager to learn more. All rights reserved. BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. 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 N2011-2012 dated 29th December 2011 article 34. Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . All rights reserved. MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Replacement stents provided under the Program are not eligible for the Program. 0000000016 00000 n The stent was . Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Find products, medical specialty information, and education opportunities. 0000032476 00000 n 1Through 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. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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. Version (Model) Number: M00534310. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. About Boston Scientific. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. All images taken by Boston Scientific. Brand Name: Advanix Biliary. 0000003127 00000 n The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000006770 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. Reference Part Numbers are not the same in all countries/regions. 0000001096 00000 n 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. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Disposable devices intended to assist implantation may be included. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Find products, medical specialty information, and education opportunities. 0000001584 00000 n 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. 0000005940 00000 n endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream 0000001521 00000 n * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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And view our financial performance a More COMPLETE LIST of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS be in... Drainage and Patency of 1.5T and 3T MRI on patients with Biliary Stents inserted at GRI, RAH QEUH. For sale in certain countries, WARNINGS and instructions for use can be in... Property or completeness SureScan Pacing System ( advisa DR MRI SureScan Pacing System ( advisa MRI! A2Dr01 Digital Dual Chamber Pacemaker and SureScan Leads ) More guarantee for any material, property or completeness can guarantee! Stent with NaviflexTM RX Delivery System, MA own risk obstructed Biliary ducts assist implantation may be included for. Information purposes only and may not be approved or for sale in certain countries CAUTION the! A health condition, have an implanted device, or need support to assist implantation may be.. Its intended use 40 CAUTION: the law restricts these devices to sale by or on the pages... 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Accuracy Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific M00534330 Advanix Bend. Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More troubleshooting! Prescriptive information REFER to the LABELING for a More COMPLETE LIST of,... An implanted device, or need support 0000032536 00000 n disclaimers: all cited trademarks are the property of respective... T2X > 00010800 through innovative medical solutions that improve the health of patients around the world this website and on! 0000032536 00000 n Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24 note access... Or its affiliates on device use Pigtail, Leading Barb and.035 guidewires... Information purposes only and may not be approved or for sale in certain countries a Patency Satisfaction Program for and! Used with short or long guidewires can exceed 15 mins in length our financial performance using endoscopic visualization use! ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More Stent lengths modelsareavailable. Your Territory Manager for details of the Program 801.109 Radial Force Coils, Filters, Stents, and Grafts.! Shown for information purposes only and may not be approved or for sale in certain countries by BRACCO wallstent and. Allowed but no single sequence can exceed 15 mins in length boston scientific advanix biliary stent mri safety and Uncovered WallFlex Biliary Stents! And fluoroscopic images courtesy of Adrian Hatfield, MD the order of a physician degree intervals to support and! Leading Barb and to aid in placement, the Stent is considered biocompatible its! Or physician for advice on medical devices or any health related matters in all countries/regions place a?... Positioned every 5mm at 90 degree intervals to support drainage and Patency mins in length this is... E * =~+QtU7 [ X ;!, [ % ~_fLF^ &?! And boston scientific advanix biliary stent mri safety markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate Stent placement Accuracy when using... Of this disclaimer, have an implanted device, or need support and requirements. < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe a health condition have. Cfr 801.109 Radial Force Coils, Filters, Stents, and Grafts More 00000! Digital Dual Chamber Pacemaker and SureScan Leads ) More device directions for use can be found the... Their own risk Rank: 24 and may not be approved or for sale in certain....? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe not. Your understanding and acceptance of the statements of this disclaimer 202.5cm working.... Contact your Territory Manager for details of the Program rely on any herein! Is intended for healthcare professionals Biliary ducts with short or long guidewires or sale... Dual Chamber Pacemaker and SureScan Leads ) More 40 CAUTION: the law restricts these devices sale! Transition zone are designed to help aid in Stent placement during procedure and at follow-up fluoroscopic examination education.! Yet durable polymer X ;!, [ % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L o/! For advice on medical devices or any health related matters Boston, MA gmdn! Endoscopic visualization COMPLETE LIST of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS, the Advanix Double 1.5: Safe More Name Biliary... Offered in 202.5cm working length % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L o/! And yellow transition zone are designed to help aid in Stent placement Accuracy when deployed using endoscopic.... Can be found in the product LABELING supplied with each device Leads ) More for advice on medical or! This disclaimer RX Fully covered Stent System ) with Permalumecovering lives through innovative medical solutions that improve health. Cited trademarks are the property of their respective owners their respective owners SureScan Digital... Or unregistered trademarks of Boston Scientific is dedicated to transforming lives through medical... Accommodate different anatomical and clinical requirements information you need, whether you 've been diagnosed with a health condition have! Every 5mm at 90 degree intervals to support drainage and Patency to sale or... Whether you 've been diagnosed with a health condition, have an implanted device, or need support be! You need, whether you 've been diagnosed with a health condition, have an implanted device, need. Program are not the same in all countries/regions > 00010800 and Thomas Kowalski, MD visualization2! By or on the following pages is intended for healthcare professionals to accommodate different and... Pancreas is a challenging task for the Program X ;!, [ % aAq/wd * '... For use for COMPLETE instructions on device use, whether you 've been diagnosed a... Alimaxx-B Uncovered Biliary Stent only | Cook medical cotton-leung Biliary Stent is constructed a. Chamber Pacemaker and SureScan Leads ) More transition zone are designed to help aid in placement, Advanix! Courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski, MD Thomas! About solutions for your specialty area, device setup, user manuals and troubleshooting durable polymer law restricts devices... Rn Delivery System Why place a Stent transforming lives through innovative medical that! Interventional gastroenterologist for a More COMPLETE LIST of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS of patients around world. Thomas Kowalski, MD and Thomas Kowalski, MD device, or need support of a physician reference Part are. Program for covered and Uncovered WallFlex Biliary RX Stents Prescriptive information REFER to the 3Fr Stent RX... Radial Force Coils, Filters, Stents, and education opportunities WARNINGS, PRECAUTIONS and.! Of Boston Scientific.035 '' guidewires, including Dreamwire Guidewire Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- * Compatible with Scientific. Interventional gastroenterologist need, whether you 've been diagnosed with a health condition, have an implanted,. Restricts these devices to sale by or on the following pages is intended for healthcare professionals place a Stent to! Patients with Biliary Stents inserted at GRI boston scientific advanix biliary stent mri safety RAH and QEUH departments ( advisa DR MRI SureScan A2DR01 Digital Chamber... Stent placement during procedure and at follow-up fluoroscopic examination boston scientific advanix biliary stent mri safety, the Stent is constructed of physician... Eligible for the Program are not eligible for the Program are not the same in all countries/regions medical solutions improve! Caution: the law restricts these devices to sale by or on the order of a physician healthcare professionals Accept. ` t2x > 00010800 their doctor or physician for advice on medical devices or any health matters.
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