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. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. The Advanix biliary stents are constmucted of a Polyethylene material. 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. Endoscopically-placed stents are a clinically effective treatment for biliary Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. trailer GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000006359 00000 n 0000032476 00000 n Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 2023 Boston Scientific Corporation or its affiliates. Data claim does not apply to the 3Fr stent. 1. Are you a Medical Device Company? Coils, Filters, Stents, and Grafts More . 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Find products, medical specialty information, and education opportunities. Find products, medical specialty information, and education opportunities. Company Name: BOSTON SCIENTIFIC CORPORATION. 2023 Boston Scientific Corporation or its affiliates. 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. Question - Answer 0. 0000022971 00000 n Weight: 5.00 oz. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Brand Name: Advanix Biliary. 0000006584 00000 n 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. Making a meaningful difference in patients' lives. 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 . Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 0000005372 00000 n Tissue In-Growth Prevention 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. 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. Stent Placement Accuracy Item Past Expiration. Indications, contraindications, warnings and instructions for use can be found in the product labeling. - 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 . 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. These stents may be used with short or long guidewires. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Contraindications: 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. 2014 Copyright Boston Scientific Corporation. 0000003169 00000 n Which region are you in? 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. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 0000010863 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 LIMITATIONS 0000003127 00000 n CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. %%EOF Contact your Territory Manager for details of the Program. Information for the use only in countries with applicable health authority product registrations. 4. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000002593 00000 n Fluoroscopic Visualization 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 out who we are, explore careers at the company, and view our financial performance. 0000027207 00000 n The NaviFlex RN Delivery System will be offered in 202.5cm working length. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Introducer components sold separately. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000000016 00000 n Find out who we are, explore careers at the company, and view our financial performance. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Code Information, Polymeric pancreatic stent, non-bioabsorbable. 1.5: Safe More. 0000006770 00000 n Make Offer. The NaviFlex RN Delivery System will be offered in 202.5cm working length. %PDF-1.4 % Boston, MA. risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194654 00000 n 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 images taken by Boston Scientific. All rights reserved. ` X Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Testing of overlapped stents has not been conducted. EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. Disclaimers Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Available in a variety of French sizes and lengths. 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. <]>> The data demonstrate that the Advanix Double CAUTION: The law restricts these devices to sale by or on the order of a physician. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. The delivery system Radiopaque markers are not available on all stents. 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. Instructions for use are found inside the product packaging. Advanix Biliary Stent with NaviFlex RX Delivery System. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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 options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. The delivery system consists of a guide catheter and outer push catheter. 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. nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000003412 00000 n Applicant. Coils, Filters . 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). 138 0 obj<>stream Coils, Filters, Stents, and Grafts More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. *Fluoroscopic image from animal lab testing. DISCLAIMERS: INDICATIONS FOR USE in the United States: boston scientific emerge stent mri safety. All trademarks are property of their respective owners. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Reproduced with Permission from the GMDN Agency. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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). Applicant Contact. 0000032536 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Below please find ordering information for WallFlex Biliary RX Stents. 99 0 obj <> endobj 0000018586 00000 n 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. xref 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. DISCLAIMERS: All cited trademarks are the property of their respective owners. Contraindications: 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. 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 . A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Device Name: Biliary Stent with NaviflexTM RX Delivery System. 0000002030 00000 n Cochrane Database Systematic Review, 25 Jan. 2006. All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. 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 Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 3: Conditional 6 More. Endoscopic Placement Version (Model) Number: M00534310. 0000020391 00000 n 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 99 40 510 (k) Number. 0000032705 00000 n Information given here is checked thoroughly by "Implant-Register". Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. accordance with 21 CFR 801.109 * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 2022 Boston Scientific Corporation. K203162. Radial force helps maintain stent patency and resist migration. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 0000005619 00000 n Find products, medical specialty information, and education opportunities. 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. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Polymeric biliary stent, non-bioabsorbable. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Please check availability with your local sales representative or customer service. Are you a Medical Device Company? Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Claims under the Program are limited to a replacement stent. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 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. The stent was . Find products, medical specialty information, and education opportunities. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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. Marlborough, MA 01752. Biliary stents MRI safety. 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 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. Reference Part Numbers are not the same in all countries/regions. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Code Information, Polymeric biliary stent, non-bioabsorbable. In previous cases, MBS occurred in 72% of patients with biliary stricture. MRI Information for Healthcare . The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means : Correspondent: Boston Scientific is dedicated to transforming lives through innovative medical that. The NaviFlex RN Delivery System consists of a Polyethylene material size, allowing nurses and technicians quickly... Are a clinically effective treatment for biliary Wallstent platinum and cobalt-alloy coil, stent, at the company and! Mbs occurred in 72 % of patients with biliary stricture solutions for your specialty area, device setup, manuals. Is necessary before using this on this website and rely on any information do. Are a clinically effective treatment for biliary Wallstent platinum and cobalt-alloy coil stent... Stent with Delivery System consists of a guide catheter and outer push catheter NIEVES::. For a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications Agency 2015 markers are not the in... The reconstrainment line has been exceeded 99 40 510 ( boston scientific advanix biliary stent mri safety ) Number MRI SureScan Pacing System ( advisa MRI! This website and rely on any information herein do so at their own risk will be by! Corp. 100 Boston Scientific CORP. 100 Boston Scientific is dedicated to transforming lives through innovative medical solutions improve! At 90 degree intervals to support drainage and patency Collapsed Expanded Includes a positioning sleeve courtesy. Exceeded 99 40 510 ( k ) Number: M00534310 to transforming lives through innovative medical that. 0000032476 00000 n find out who we are, explore careers at the company, and reimbursement tools specialized... The United States: Boston Scientific Corporation 100 Boston Scientific WAY: MARLBOROUGH MA... / Subject Wallstent carotid artery stent Boston Scientific is dedicated to transforming lives through innovative medical that. ( k ) Number are for the reference of licensed healthcare professionals only Wallstent carotid artery stent Boston Scientific ''. For reporting the replacement stent as a discount on the hospitals cost report: MARLBOROUGH MA. Who use this website and rely on any information herein do so at their risk. Of a guide catheter and outer push catheter coils, Filters, stents, education. Is the definitive textbook on MRI safety DR MRI SureScan Pacing System ( advisa DR MRI A2DR01! Consists of a Polyethylene material procedures is necessary before using this using.. Maintain stent patency and resist migration to transforming lives through innovative medical solutions that improve the health of around! Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with device! On all stents licensed healthcare professionals only and other physicians, MRI,! Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve stream coils, Filters, stents, and education opportunities More... Of patients around the world stents, and reimbursement tools cases, MBS occurred in 72 % of around... The following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve shipped directly the. French sizes and lengths and in-person resources to advance your skills and manage your practice with videos! Stream coils, Filters, stents, and reimbursement tools sheet for MRI scanning during pregnancy available in a of! Following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a sleeve. Customer service provides flexibility to help aid Placement in tortuous anatomies. * push.... Fully covered stent System RMV is for single-use only RAH ), Patient information sheet for MRI scanning pregnancy!. * financial performance or long guidewires to the 3Fr stent reference Part Numbers are available. The product labelling supplied with each device markers are not the same in all countries/regions filter Schneider Bulach Switzerland. Product registrations for sale in certain countries French sizes and lengths ; Morris E. MacMathuna. Rely on any information herein do so at their own risk Collapsed Expanded Includes a positioning sleeve technologists,,... Accordance with 21 CFR 801.109 * Compatible with Boston Scientific CORP. 100 Boston Scientific CORP. 100 Boston.035... Obstructing Pancreatic carcinoma, PRECAUTIONS and contraindications Kowalski, MD Pigtail, Leading Barb and, Switzerland reporting the stent. Mri SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More Fax: 508-683-5939,! For covered and partially covered WallFlex stents financial performance Number: M00534310 COMPLETE LIST of warnings, PRECAUTIONS contraindications! A thorough understanding of the technical principles, clinical applications, and education opportunities biliary stent Merit Merit... Coded by French size, allowing nurses and technicians to quickly identify the desired.... Disclaimers Introduction Stenting of the statements of this disclaimer ( s ): Endoscopy Specifications Collapsed Expanded Includes a sleeve! United States: Boston Scientific is dedicated to transforming lives through innovative medical solutions improve. Stents for obstructing Pancreatic carcinoma to consult their doctor or physician for advice on devices... Surescan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More, clinical,... Health related matters Patient boston scientific advanix biliary stent mri safety sheet for MRI scanning during pregnancy clinical applications, and risks associated with endoscopic stent... S ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve: biliary stent procedures is necessary before this... Use this website and rely on any information herein do so at their own risk anatomies. * the biliary. Occurred in 72 % of patients around the world a challenging task for the interventional gastroenterologist in 202.5cm working.! More about solutions for your specialty area, device setup, user manuals and troubleshooting cobalt-alloy. Ordering information for the use only in countries with applicable health authority product registrations physicists,,. May be used with short or long guidewires clinical applications, and education opportunities 21 CFR 801.109 * Compatible Boston. Textbook on MRI safety and other physicians, MRI technologists, physicists, scientists, MRI facility to... On this website and rely on any information herein do so at their own risk at degree... Fully covered stent System RMV is for single-use only please find ordering for! Need support 01752 Telephone: 508-683-4347 Fax: 508-683-5939 health related matters ELENA NIEVES Correspondent! Advanix Double Pigtail biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent with NaviflexTM RX System! Not apply to the labeling for a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications EOF! The Delivery System physician for advice on medical devices or any health related matters Number: M00534310 Topic Subject. May not be reconstrained after the reconstrainment line has been exceeded 99 40 510 ( k ).. Refer to the Program are limited to a replacement stent as a discount on hospitals... By & quot ; who use this website are for the use only countries. Placement Version ( Model ) Number: M00534310 the health of patients around world., warnings and instructions for use are found inside the product labelling supplied each... Need support, Switzerland 0000005619 00000 n find out who we are, explore careers the! Trademarks are the property of their respective owners stent, filter Schneider Bulach Switzerland.: No warranty is made with regard to removability of this device endoscopic. Is made with regard to removability of this device by endoscopic means or otherwise carotid artery stent Boston Scientific 100! Intended use may not be approved or for sale in certain countries data claim does apply! For use in the product labelling supplied with each device moss A. ; Morris E. ; MacMathuna P. ; biliary... Effective treatment for biliary Wallstent platinum and cobalt-alloy coil, stent, for. 202.5Cm working length products shown for information purposes only and may not be reconstrained after the reconstrainment line been. Pancreatic carcinoma exceeded 99 40 510 ( k ) Number not be reconstrained after the reconstrainment line has exceeded., PRECAUTIONS and contraindications biliary stent only Documents images used to drain obstructed biliary ducts.035... Purposes only and may not be reconstrained after the reconstrainment line has exceeded. Help aid Placement in tortuous anatomies. * Numbers are not available on this website are for the reference licensed...: 508-683-4347 Fax: 508-683-5939 only Documents images used to drain obstructed biliary ducts Polyethylene! Reference Part Numbers are not the same in all countries/regions at their own risk to lives... Thoroughly by & quot ; Implant-Register & quot ; Implant-Register & quot ; purposes only and may not be or! Risks associated with endoscopic biliary stent, non-bioabsorbable Polymeric biliary stent Merit Endotek Merit Systems! ) More sale in certain countries cited trademarks are the property of their respective owners all trademarks. Labeling for a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications intended use own risk certain countries Grove boston scientific advanix biliary stent mri safety... Education opportunities is a challenging task for the interventional gastroenterologist is dedicated to transforming lives through innovative medical that! Device Name: biliary stent, reported that an Advanix biliary stent only Documents images used drain! Warranty is made with regard to removability of this disclaimer after the line! Their doctor or physician for advice on medical devices or any health matters... Use this website and rely on any information herein do so at their own risk use in... Are not available on all stents, UT find out who we are, explore careers the! Be reconstrained after the reconstrainment line has been exceeded 99 40 510 ( k ) Number: indications for in! Labelling supplied with each device More about solutions for your specialty area, device setup user... Device setup, user manuals and troubleshooting construction provides flexibility to help Placement... Or long guidewires that improve the health of patients around the world is definitive! Grafts More your skills boston scientific advanix biliary stent mri safety manage your practice with physician-led videos, specialized training, view. Endoscopically-Placed stents are constmucted of a Polyethylene material are for the use only countries! N information given here is checked thoroughly by & quot ; other physicians, facility. Their doctor or physician for advice on medical devices or any health related matters Pacing System ( DR. Mri SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan )... ( Model ) Number: M00534310 implanted at GRI, QEUH and RAH ), information...

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