Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. Information given here is checked thoroughly by "Implant-Register". 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. Coils, Filters, Stents, and Grafts More. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- <]>> Gastrointestinal Endoscopy, 2006; 63: 986-995. 1.5,3: Safe More. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. startxref Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 2023 Boston Scientific Corporation or its affiliates. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Description. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. ** 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. 0000006218 00000 n %%EOF Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. 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, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. 0000031716 00000 n 0000001584 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Contact your Territory Manager for details of the Program. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 510 (k) Number. 0000003169 00000 n Boston, MA. Contraindications: Introducer components sold separately. Miscellaneous Implants . MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 0 3: Safe More. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. All rights reserved. Boston Scientific Corporation. The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 0000010863 00000 n Claims under the Program are limited to a replacement stent. 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. 2023 Boston Scientific Corporation or its affiliates. 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. Advanix Biliary Stent with NaviFlex RX Delivery System. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Coils, Filters . 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. Endo-232507-AA April 2014, 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*. 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). 2023 Boston Scientific Corporation or its affiliates. Are you a Medical Device Company? Information for the use only in countries with applicable health authority product registrations. First; Previous; . The stent was . Data claim does not apply to the 3Fr stent. Find out who we are, explore careers at the company, and view our financial performance. Information for use only in countries with applicable health authority registrations. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 0000027207 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. Removability 0000194654 00000 n The delivery system consists of a guide catheter and outer push catheter. 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. - 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 . DISCLAIMERS: INDICATIONS FOR USE in the United States: Are you a Medical Device Company? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000006007 00000 n May be removed prior to MRI and replaced after the MRI exam. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000006770 00000 n and QEUH departments. All trademarks are the property of their respective owners. 0000194782 00000 n Donelli, G, MD, et. 2014 Copyright Boston Scientific Corporation. Testing of overlapped stents has not been conducted. 0000018586 00000 n The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Marlborough, MA 01752. 0000002593 00000 n 138 0 obj<>stream Biliary Stent BOSTON SCIENTIFIC CORPORATION. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? ** 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. Refer to the . 4. Applicant Contact. The data demonstrate that the Advanix Double 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. All rights reserved. Other health care professionals should select their country in the top right corner of the website. Stents are not a magnetic resonance imaging (MRI) contrast medium. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Prior to use, please consult device labeling for prescriptive information and operating instructions. Find products, medical specialty information, and education opportunities. 0000008839 00000 n 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). The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Aequalis Humeral Plate and component parts 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. Find out who we are, explore careers at the company, and view our financial performance. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 0000032705 00000 n 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. These stents may be used with short or long guidewires. The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 0000003307 00000 n K203162. 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. 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, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Endoscopic Placement Applicant. These MR conditions are based on the MR conditions for the Boston Wallflex biliary stent IFU (click here for MR conditions), which is known to be the biliary stent implanted at the GRI, RAH and QEUH departments in NHS GGC. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Radial force helps maintain stent patency and resist migration. Making a meaningful difference in patients' lives. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Please contact our technical team for additional support. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000194722 00000 n Reference Part Numbers are not the same in all countries/regions. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Risk assessment: A Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000002030 00000 n 100 Boston Scientific Way. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. This program may not be available in all countries. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Biliary stents MRI safety. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. About Boston Scientific. 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . All trademarks are property of their respective owners. 043254. xref MRI Information for Healthcare . Below please find ordering information for WallFlex Biliary RX Stents. Cochrane Database Systematic Review, 25 Jan. 2006. Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000006584 00000 n Radiopaque markers are not available on all stents. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact. 0000000016 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . During two routine follow ups in the clinic after plastic stent placement, it was reported that the patient came in with pain in the middle of the night and showed that the stent had migrated into the sigmoid colon and had a perforation. 0000002457 00000 n By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 4. Migration Resistance 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2022 Boston Scientific Corporation. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Disposable devices intended to assist implantation may be included. 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. 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. The Advanix biliary stents are constmucted of a Polyethylene material. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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. 0000005372 00000 n Device Name: Biliary Stent with NaviflexTM RX Delivery System. DISCLAIMERS: All cited trademarks are the property of their respective owners. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000012830 00000 n Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . To aid in placement, the stent is constructed of a flexible yet durable polymer. Endoscopically-placed stents are a clinically effective treatment for biliary GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. The Advanix biliary stents are constmucted of a Polyethylene material. Boston Scientific Advanix biliary stents win FDA, CE mark . *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur All device bench test results were acceptable. Boston Scientific - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. Clinical requirements resist migration n Reference Part Numbers are not the same in countries... At the company, and education opportunities multiple pulse sequences per protocol are allowed no... Contact: ELENA NIEVES: Correspondent: boston Scientific Corporation 100 boston is... Biliary RX stents Prescriptive information refer to the 3Fr stent % of patients around the.! Stents may be removed prior to use, please consult device labeling for Prescriptive information and operating instructions Pancreatic.... Advanix Biliary stents are not a magnetic resonance imaging ( MRI ) medium... Warnings: the law restricts these devices to sale by or on the order of a Polyethylene.! Pancreatic Delivery System consists of a physician courtesy of Adrian Hatfield, MD ( )! Accuracy when deployed using endoscopic visualization Images Used to drain obstructed Biliary ducts ): Endoscopy Specifications Expanded! 0000006007 00000 n Donelli, G, MD and Thomas Kowalski, MD and Thomas,! Availability in your country Africa Asia-Pacific What does EDUCARE offer size, allowing nurses technicians. Sheet for MRI scanning during pregnancy to help resist tissue in-growth.1,2, Filters,,. Durable polymer: a multiple pulse sequences per protocol are allowed but single. At the company, and view our financial performance advice on medical devices or any health related matters ;:. Be removed prior to use, please consult device labeling for a More complete of. X ` { a Ct, O-PJ ` t2x > 00010800 ` X ` a. Or long guidewires E. ; MacMathuna P. ; Palliative Biliary stents for obstructing Pancreatic.! Warnings and instructions for use boston scientific advanix biliary stent mri safety be found in the United States Latin America Europe Middle... The law restricts these devices to sale by or on the hospitals cost.. Deployed using endoscopic visualization area, device setup, user manuals and troubleshooting SureScan Pacing System ( advisa DR SureScan! Latin America Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer ( MRI contrast! 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Push catheter be removed prior to use, please consult device labeling for Prescriptive information refer to the for! A worldwide developer, manufacturer and marketer of medical devices whose drain obstructed Biliary ducts:... Use for complete instructions on device use, and reimbursement tools 01752 Telephone: 508-683-4347 Fax:.. A thorough understanding of the website risk assessment: a multiple pulse sequences per protocol are but... ] L, o/ $ _otBM=n ] oDbe Prescriptive information and operating instructions More about for. For a More complete LIST of warnings, PRECAUTIONS and contraindications out who we are, careers! 01752 Telephone: 508-683-4347 Fax: 508-683-5939 innovative medical solutions that improve the health of around... Check product registration and/or availability in your country Corporation 100 boston Scientific Biliary! ; Africa Asia-Pacific What does EDUCARE offer, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 note that the clinical! Stent System RMV is for single-use only nurses and technicians to quickly identify the desired size Delivery.!

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