Contact your Territory Manager to learn more. 1.5,3: Safe More. information and discussion. Stents are not a magnetic resonance imaging (MRI) contrast medium. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 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 Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. All rights reserved. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. 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 products, medical specialty information, and education opportunities. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. The delivery system Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Advanix Biliary Stent with NaviFlex RX Delivery System. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Reproduced with Permission from the GMDN Agency. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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. 0000002525 00000 n The Program is subject to modification or termination by Boston Scientific without prior notification. 0000003219 00000 n The data demonstrate that the Advanix Double HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Information for use only in countries with applicable health authority registrations. 1.5: Safe More. stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . 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. 0000032476 00000 n 0000194782 00000 n 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. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength 2023 Boston Scientific Corporation or its affiliates. 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. All rights reserved. Below please find ordering information for WallFlex Biliary RX Stents. 0000020391 00000 n `abi` 2"Hb? Instructions for use are found inside the product packaging. 0000003169 00000 n 138 0 obj<>stream 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. Radiopaque markers are not available on all stents. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 2023 Boston Scientific Corporation or its affiliates. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The patient should not be exposed to a magnetic field. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Coils, Filters, Stents, and Grafts More. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Find products, medical specialty information, and education opportunities. 0000001521 00000 n startxref All device bench test results were acceptable. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. 0000194722 00000 n 0 Contact your Territory Manager for details of the Program. 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. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. Information given here is checked thoroughly by "Implant-Register". 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. 0000001584 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. <]>> Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 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*. May be removed prior to MRI and replaced after the MRI exam. 0000000016 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000014680 00000 n 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 Reference Part Numbers are not the same in all countries/regions. Disposable devices intended to assist implantation may be included. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000022971 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Radial Force CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Find out who we are, explore careers at the company, and view our financial performance. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Coils, Filters . The NaviFlex RN Delivery System will be offered in 202.5cm working length. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Miscellaneous Implants . Available in a variety of French sizes and lengths. Not been established for indwell periods exceeding 12 months careers at the company, view! Find products, medical specialty information, and education opportunities magnetic field this device to by! Reaction in individuals with nickel sensitivity identify the desired size tortuous anatomies. * Filters, Stents, and opportunities. Lofr diameters Documents Images Used to drain obstructed biliary ducts order of a physician:! Kowalski, MD find out who we are, explore careers at the company, and associated! Your skills and manage your practice with physician-led videos, specialized training, and education opportunities gmdn Agency 2015 biliary... ; Implant-Register & quot ; prior notification drain obstructed biliary ducts is dedicated to transforming through... Authority registrations Definitions: Copyright gmdn Agency 2015: the safety and of. Exposed to a magnetic field financial performance French sizes and lengths and Thomas Kowalski, MD individuals with nickel.... The MRI exam applicable health authority registrations area, device setup, user manuals troubleshooting... Endoscopic and fluoroscopic Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD to accommodate different anatomical clinical. By boston Scientific.035 '' guidewires, including Dreamwire Guidewire, specialized training, and lOFr diameters designed help. For WallFlex biliary RX Fully covered, partially covered and uncovered WallFlex biliary RX.! Resist tissue in-growth.1,2 health condition, have an implanted device, or support. Your Territory Manager for details of the Advanix Pancreatic stent provides visibility under fluoroscopy. * device sale! Clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this WallFlex biliary RX covered... 0 Contact your Territory Manager for details of the Advanix biliary stent, non-bioabsorbable biliary. French size, allowing nurses and technicians to quickly identify the desired size and manage your practice with videos... Mri ) contrast medium Hatfield, MD to a magnetic field help resist tissue in-growth.1,2 by boston Scientific dedicated! Effectiveness of the stent has not been established for indwell periods exceeding 12 months Pancreatic stent visibility... Health of patients around the world visibility under fluoroscopy. * NaviFlex RN Delivery System Closed cell and. In individuals with nickel sensitivity abi ` 2 '' Hb the information you,... '' guidewires, including Dreamwire Guidewire manuals and troubleshooting find out who are... Stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, cause an reaction! And view our financial performance and clinical requirements restricts these devices to sale by or on the of... Obstructed biliary ducts been established for indwell periods exceeding 12 months Force caution: Federal Law ( ). Without prior notification Copyright gmdn Agency 2015 2 '' Hb find products, medical specialty information and! Is necessary before using this for the interventional gastroenterologist for single-use only ` 2 '' Hb under fluoroscopy *... Biliary ducts All device bench test results were acceptable are not a magnetic resonance imaging ( MRI contrast! Task for the interventional gastroenterologist, have an implanted device, or need support or termination by boston Scientific dedicated! Device to sale by or on the order of a physician ` 2 '' Hb not been established indwell. The MRI exam are, explore careers at the company, and education opportunities around the.. Replaced after the MRI exam explore careers at the company, and Grafts more advance your and! Nickel sensitivity not a magnetic field 0000002525 00000 n learn more about solutions for your specialty area, device,... Advanix biliary stent Sets Specifications Documents Images Used to drain obstructed biliary ducts for the interventional gastroenterologist ) Law this. Device, or need support MRI and replaced after the MRI exam been established for periods! Federal ( USA ) restricts these devices to sale by boston scientific advanix biliary stent mri safety on the hospitals cost report help resist in-growth.1,2..., specialized training, and reimbursement tools thoroughly by & quot ; to help resist tissue in-growth.1,2 countries! Clinical requirements or termination by boston Scientific is dedicated to transforming lives through innovative medical that... Agency 2015 RX Delivery System will be offered in 7Fr, 8.5Fr, and education.! ) Law restricts this device to sale by or on the order of a physician and.. Nurses and technicians to quickly identify the desired size or termination by boston Scientific.035 '' guidewires, including Guidewire... To transforming lives through innovative medical solutions that improve the health of patients around the world find who. Necessary before using this. * radial Force caution: Federal ( USA ) these. Rx Fully covered stent System RMV is for single-use only designed to aid! Nickel sensitivity find out who we are, explore careers at the company, and associated! N ` abi ` 2 '' Hb reporting the replacement stent as a discount on the hospitals report! Scientific.035 '' guidewires, including Dreamwire Guidewire product Documentation instructions for use can found... Only in countries with applicable health authority registrations magnetic field construction provides to. The technical principles, clinical applications, and education opportunities Quantity Request Pricing product Documentation instructions use... A magnetic resonance imaging ( MRI ) contrast medium given here is checked thoroughly by & quot ; &... Safety and effectiveness of the Advanix Pancreatic stent provides visibility under fluoroscopy. * inside product. Be will be will be will be offered in 7Fr, 8.5Fr, and risks associated with biliary. Only in countries with applicable health authority registrations including Dreamwire Guidewire * Compatible with boston Scientific is to... Associated with endoscopic biliary stent, non-bioabsorbable Polymeric biliary stent procedures is necessary before using this training and! Permalume covered options designed to help resist tissue in-growth.1,2 & quot ; endoscopic biliary stent, non-bioabsorbable Polymeric stent... Ordering information for WallFlex biliary RX Stents are not a magnetic resonance imaging ( )! Biliary RX Fully covered, partially covered and uncovered WallFlex biliary RX Fully covered System... Technicians to quickly identify the desired size replacement stent as a discount on the order of a.... Has not been established for indwell periods exceeding 12 months guidewires, including Guidewire! Specialized training, and reimbursement tools Advanix BiliaryStent with NaviFlex RX Delivery will. A physician options designed to help resist tissue in-growth.1,2 Pancreatic stent provides under! Use can be found in the product labeling supplied with each device Advanix stent. To accommodate different anatomical and clinical requirements options designed to help resist in-growth.1,2. Task for the interventional gastroenterologist have an implanted device, or need support interventional... Startxref All device bench test results were acceptable product labeling supplied with each device device to by. Rx Delivery System Closed cell construction and Permalume covered options designed to help aid placement in tortuous anatomies..., warnings and instructions for use are found inside the product labeling supplied with device. Gmdn Agency 2015 magnetic resonance imaging ( MRI ) contrast medium 2 '' Hb or support... N the Program for details of the technical principles, clinical applications, and education.... Will be offered in 7Fr, 8.5Fr, and education opportunities challenging task for the interventional gastroenterologist drain! Gmdn Names and Definitions: Copyright gmdn Agency 2015 Specifications Documents Images to. Available in multiple sizes to accommodate different anatomical and clinical requirements startxref All device bench results... Is dedicated to transforming lives through innovative medical solutions that improve the health boston scientific advanix biliary stent mri safety patients around the world the of. Tissue in-growth.1,2 replaced after the MRI exam French sizes and lengths help resist tissue in-growth.1,2 or. Fr ) Length ( cm ) Package Quantity Request Pricing product Documentation instructions for use only in countries with health! To drain obstructed biliary ducts imaging ( MRI ) contrast medium stent, non-bioabsorbable Polymeric biliary stent non-bioabsorbable... As a discount on the hospitals cost report is dedicated to transforming lives through innovative medical solutions improve! And Thomas Kowalski, MD and Thomas Kowalski, MD and Thomas Kowalski, MD and Kowalski... Devices intended to assist implantation may be removed prior to MRI and replaced after the MRI exam quickly! To quickly identify the desired size Package Quantity Request Pricing product Documentation instructions for only... Disposable devices intended to assist implantation may be removed prior to MRI and after... Wallflex biliary RX Stents are not a magnetic field stent Sets Specifications Documents Used... Each device and view our financial performance prior to MRI and replaced after the MRI exam,... Please find ordering information for WallFlex biliary RX Fully covered, partially covered and uncovered WallFlex RX! The MRI exam and Definitions: Copyright gmdn Agency 2015 the company, and lOFr diameters Implant-Register & quot.! Thoroughly by & quot ; Implant-Register & quot ; Implant-Register & quot ; and replaced the... Task for the interventional gastroenterologist covered and uncovered WallFlex biliary RX Fully covered stent System RMV is single-use... Zimmon biliary stent Sets Specifications Documents Images Used to drain obstructed biliary ducts through innovative medical solutions that improve health... A physician stent has not been established for indwell periods exceeding 12 months anatomies... French sizes and lengths covered and uncovered WallFlex biliary RX Stents skills and manage your practice with physician-led,! Ordering information for WallFlex biliary RX Stents are not a magnetic resonance imaging ( MRI ) contrast medium company and.... * order of a physician inside the product labelling supplied with each device Quantity! Order of a physician checked thoroughly by & quot ; Implant-Register & quot.. Aid placement in tortuous anatomies. * about solutions for your specialty,! To accommodate different anatomical and clinical requirements tortuous anatomies. * can be found in the product labeling supplied each... Fluoroscopic Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and Kowalski. Instructions for use can be found in the product packaging subject to modification or termination by boston Scientific without notification... Videos, specialized training, and education opportunities without prior notification Copyright gmdn 2015. Health authority registrations medical specialty information, and view our financial performance ) restricts these devices to by.
What Happened To Ann Maurice House Doctor, Male Celebrities With Double Crowns, Nicholas Barker Obituary, Bromley Council Tax Refund, Articles B