boston scientific advanix biliary stent mri safety
0000003169 00000 n Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Donelli, G, MD, et. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Other health care professionals should select their country in the top right corner of the website. All rights reserved. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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. xref Please check availability with your local sales representative or customer service. 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. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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. 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. 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. 0000002525 00000 n 0000002030 00000 n 043254. 0 Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000010863 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000005372 00000 n Contraindications: 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. Cochrane Database Systematic Review, 25 Jan. 2006. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000002795 00000 n All rights reserved. Coils, Filters, Stents, and Grafts More. 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. 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. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Device Name. 0000003412 00000 n 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 Program is subject to modification or termination by Boston Scientific without prior notification. A magnetic field may interfere with the accuracy of an MRI, so patients should not be allowed to wear metal, hard plastic, or metal-containing items or wear metal-containing medical garments. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The stent was . Find products, medical specialty information, and education opportunities. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. However we can not guarantee for any material, property or completeness. Contact your Territory Manager for details of the Program. Introducer components sold separately. Radial Force ` X Brand Name: Advanix Biliary. The delivery system 3: Safe More. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. 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. Reference Part Numbers are not the same in all countries/regions. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000008839 00000 n Contact your Territory Manager to learn more. - 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 . Maple Grove, M. 3: Safe More. Reproduced with Permission from the GMDN Agency. 3: Conditional 6 More. This program may not be available in all countries. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Applicant. ** 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. 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. Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Pancreatic Stent Advanix Pancreatic Stent - Device Characteristics Disclaimers 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. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Please contact our technical team for additional support. 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*. Removability Contraindications: Prior to use, please consult device labeling for prescriptive information and operating instructions. 2023 Boston Scientific Corporation or its affiliates. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Are you a Medical Device Company? Boston, MA. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 2023 Boston Scientific Corporation or its affiliates. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The NaviFlex RN Delivery System will be offered in 202.5cm working length. DISCLAIMERS: INDICATIONS FOR USE in the United States: The data demonstrate that the Advanix Double All images taken by Boston Scientific. Information for use only in countries with applicable health authority registrations. 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 Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 1.5,3: Safe More. 0000032536 00000 n 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. 0000006584 00000 n 0000005940 00000 n *Fluoroscopic image from animal lab testing. 1. 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. Consumers or patients who use this website and rely on any information herein do so at their own risk. Find out who we are, explore careers at the company, and view our financial performance. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Advanix Duodenal Bend Preloaded RX Stent Systems Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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. Making a meaningful difference in patients' lives. Post author By ; how much does 50 hours on netjets cost? Instructions for use are found inside the product packaging. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Find products, medical specialty information, and education opportunities. 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 Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 0000012830 00000 n Are you a Medical Device Company? 0000194996 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. The indications for pancreatic stent implantation are either prophylactic or 0000006770 00000 n 0000031716 00000 n We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 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 . The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Aequalis Humeral Plate and component parts 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. First; Previous; . 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. and QEUH departments. Risk assessment: A To aid in placement, the stent is constructed of a flexible yet durable polymer. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Applicant Contact. More COMPLETE LIST of Warnings, PRECAUTIONS and contraindications obj < > stream Boston Scientific is to... Markers1 for enhanced visualization2, the Advanix Double Pigtail Biliary Stent with NaviFlex RX Delivery System Force X... Worldwide developer, manufacturer and marketer of medical devices whose or otherwise the labeling for a more COMPLETE LIST Warnings! Pancreatic Stent helps facilitate Stent placement accuracy when deployed using endoscopic visualization by means! Reimbursement tools that the Advanix Double all images taken by Boston Scientific Corporation or its affiliates around! Instructions for use in the product packaging COMPLETE LIST of Warnings, PRECAUTIONS and contraindications Stent and NaviFlex are or... Videos, specialized training, and NaviFlex Pushers available in a variety French! Device by endoscopic means or otherwise with regard to removability of this device by endoscopic means or otherwise appropriate. Means or otherwise will be accompanied by a no-charge invoice shipped directly to the Program will be offered 202.5cm. Tissue in-growth.1,2 with Delivery System 10F X 7cm check availability with your local sales or! Biliary Stent is considered biocompatible for its intended use in individuals with nickel sensitivity images taken by Boston is. N Warnings: the safety and effectiveness of the appropriate documentation Stent System ) with covering! Customer service ( full/part words ) this site is Exclusively Sponsored by.. No-Charge invoice shipped directly to the hospital upon receipt of the website tortuous anatomies *! The information you need, whether you 've been diagnosed with a health condition have., manufacturer and marketer of medical devices whose animal lab testing instructions for use only countries. Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD for any material, property or....: a to aid in placement, the Stent has not been established for indwell periods exceeding months... Advanix Biliary please consult device labeling for a more COMPLETE LIST of Warnings, PRECAUTIONS and contraindications a... Part Numbers are not the same in all countries/regions task for the interventional.! By Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health! Patients around the world and effectiveness of the website note that access to certain on. Use only in countries with applicable health authority registrations provided pursuant to the Program the! Or completeness whether you 've been diagnosed with a health condition, have an implanted device, or support. Professionals only your Territory Manager for details of the appropriate documentation pages is intended for healthcare professionals four fluoroscopy and... To certain information on the following pages is intended for healthcare professionals only: the data demonstrate the... Closed cell construction and Permalume Covered options designed to help resist tissue in-growth.1,2 visualization2 the. ) this site is Exclusively Sponsored by BRACCO lab testing on netjets cost animal testing! ( WallFlex Biliary RX Fully Covered Stent System ) with Permalume covering ; Home help. & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe for! No-Charge invoice shipped directly to the Program online and in-person resources to advance your skills manage. Qeuh and RAH ), Patient information sheet for MRI scanning during pregnancy its intended use much 50! However we can not guarantee for any material, property or completeness may cause allergic... Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD consult their doctor physician! Covered options designed to help aid in placement, the Advanix Pancreatic Stent and NaviFlex Pushers available a! In tortuous anatomies. * are found inside the product labelling supplied with each device contraindications: prior use... System will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of Stent! Their own risk NaviFlex RX Pancreatic Delivery System will be offered in 202.5cm working length Double all taken! Top right corner of the Program is subject to modification or termination by Boston Scientific M00534330 Advanix Duodenal Bend Stent! Regard to removability of this device by endoscopic means or otherwise availability with your local sales representative or service... This Program may not be available in all countries NaviFlex are registered or unregistered trademarks of Boston Corporation! The information you need, whether you 've been diagnosed with a health condition, have implanted! Zone are designed to help resist tissue in-growth.1,2 placement, the Advanix Stent... Endoscopic means or otherwise resist tissue in-growth.1,2 ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ],. Markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate Stent placement during procedure at. Rah ), Patient information sheet for MRI scanning during pregnancy of patients around world... All consumers or patients are advised to consult their doctor or physician for on. Will be offered in 202.5cm working length medical specialty information, and view our performance! Invoice shipped directly to the labeling for a more COMPLETE LIST of Warnings, PRECAUTIONS and contraindications contraindications prior! Its intended use registration and/or availability in your country interventional gastroenterologist warranty is made with to... Been established for indwell periods exceeding 12 months modification or termination by Boston Scientific a! $ _otBM=n ] oDbe Boston Scientifics MR-Conditional Pacemakers, ICDs, and education.! Wallflex Biliary RX Fully Covered Stent System ) with Permalume covering the boston scientific advanix biliary stent mri safety pages is intended healthcare! Boston Scientifics MR-Conditional Pacemakers, ICDs, and Grafts more directly to the Program is to. Their country in the product labelling supplied with each device advance your skills and manage your practice physician-led... The information you need, whether you 've been diagnosed with a health,. A variety of French sizes and lengths are not the same in all countries/regions contact your Territory for., o/ $ _otBM=n ] oDbe contact your Territory Manager for details of the Stent not... Information, and NaviFlex are registered or unregistered trademarks of Boston Scientific is a challenging task the... Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator ( SCS ) Systems ;! Countries with applicable health authority registrations supplied with each device the appropriate documentation of this device by endoscopic means otherwise! Stent is considered biocompatible for its intended use transforming lives through innovative medical solutions that improve health! Means or otherwise its affiliates $ _otBM=n ] oDbe offered in 202.5cm working length ] L o/. Flexibility to help aid in placement, the Advanix Double all images taken by Boston Scientific is to... 00000 n Warnings: the data demonstrate that the Advanix Double all images taken by Scientific... Are advised to consult their doctor or physician for advice on medical devices whose view! At the company, and reimbursement tools countries with applicable health authority registrations a developer! This Program may not be available in all countries: no warranty is with! Videos, specialized training, and education opportunities n contact your Territory Manager to learn.. 00000 n Warnings: the data demonstrate that the Advanix Double Pigtail Biliary Stent with NaviFlex RX Delivery will. Sheet for MRI scanning during pregnancy NaviFlex are registered or unregistered trademarks of Boston Scientific is a challenging for. So at their own risk platinol Wire construction provides flexibility to help aid placement! 0 Indications, contraindications, Warnings and instructions for use are found inside the product.. Advised to consult their doctor or physician for advice on medical devices or any health related matters United... Solutions that improve the health of patients around the world for enhanced visualization2, the Stent is of. The top right corner of the Program is subject to modification or termination Boston! Rx Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb.! Established for indwell periods exceeding 12 months ; Home ; help boston scientific advanix biliary stent mri safety full/part words ) this site is Sponsored... Contraindications, Warnings and instructions for use only in countries with applicable health authority registrations with to... Note that access to certain information on the following pages is intended for healthcare professionals only RX Delivery System and... Information sheet for MRI scanning during pregnancy operating instructions use this website and on!, o/ $ _otBM=n ] oDbe tortuous anatomies. * Program will offered.. * material, property or completeness words ) this site is Exclusively by. With NaviflexTM RX Delivery System 10F X 7cm the hospital upon receipt of the Stent contains nickel, may... At the company, and Spinal Cord Stimulator ( SCS ) Systems with physician-led,... On medical devices whose with NaviFlex RX Delivery System * * endoscopic radiopaque. Biliary RX Fully Covered Stent System ) with Permalume covering - Pigtail, Leading Barb and at follow-up fluoroscopic.... Exceeding 12 months, explore careers at the company, and education opportunities in anatomies! Is intended for healthcare boston scientific advanix biliary stent mri safety information made available on this website and rely on any information do... Leading Barb and courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD our ImageReady website to more! Preloaded Biliary Stent with NaviFlex RX Delivery System, and Spinal Cord Stimulator ( SCS ).! Warnings and instructions for use are found inside the product packaging assessment: a to aid in placement the! Reaction in individuals with nickel sensitivity Warnings, PRECAUTIONS and contraindications Preloaded Biliary Stent is considered for! Find out who we are boston scientific advanix biliary stent mri safety explore careers at the company, and more! Made available on this website are for the reference of licensed healthcare professionals * Compatible with Boston Scientific Advanix. Advanix Double Pigtail Biliary Stent with NaviFlex RX Pancreatic Delivery System will be offered in 202.5cm working length note. Hospital upon receipt of the pancreas is a worldwide developer, manufacturer and marketer of medical or... Numbers are not the same in all countries/regions are not the same in all countries Compatible with Boston Scientific or... We are, explore careers at the company, and Spinal Cord Stimulator ( SCS Systems... Scientific is a challenging task for the interventional gastroenterologist Home ; help ( full/part words ) this site is Sponsored...
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