0000194891 00000 n This program may not be available in all countries. Introducer components sold separately. 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. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . All trademarks are property of their respective owners. 2023 Boston Scientific Corporation or its affiliates. 3: Safe More. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 0000032536 00000 n All rights reserved. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. To aid in placement, the stent is constructed of a flexible yet durable polymer. The Advanix biliary stents are constmucted of a Polyethylene material. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. About Boston Scientific. LIMITATIONS The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received Contraindications: In previous cases, MBS occurred in 72% of patients with biliary stricture. Maple Grove, M. 3: Safe More. Advanix Duodenal Bend Preloaded RX Stent Systems Migration Resistance The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Please check availability with your local sales representative or customer service. 0000006218 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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 . 2022 Boston Scientific Corporation. Boston Scientific Advanix biliary stents win FDA, CE mark . Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. <]>> Reference Part Numbers are not the same in all countries/regions. Making a meaningful difference in patients' lives. 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. Find out who we are, explore careers at the company, and view our financial performance. 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. Donelli, G, MD, et. Documents Clinical Resource Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Find out who we are, explore careers at the company, and view our financial performance. Replacement stents provided under the Program are not eligible for the Program. 0000194782 00000 n 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 Tissue In-Growth Prevention A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. 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). All rights reserved. Boston, MA. All rights reserved. Endoscopically-placed stents are a clinically effective treatment for biliary 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. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Polymeric biliary stent, non-bioabsorbable. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. ` X Testing of overlapped stents has not been conducted. Please contact our technical team for additional support. %%EOF This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . First; Previous; . All images taken by Boston Scientific. Applicant. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 1.5,3: Safe More. 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. Miscellaneous Implants . A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Biliary stents MRI safety. The delivery system consists of a guide catheter and outer push catheter. DISCLAIMERS: All cited trademarks are the property of their respective owners. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 0000006770 00000 n All rights reserved. Stents are not a magnetic resonance imaging (MRI) contrast medium. Boston Scientific Corporation. xref Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. The data demonstrate that the Advanix Double To aid in placement, the stent is constructed of a flexible yet durable polymer. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 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. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 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 99 40 Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. %PDF-1.4 % Find products, medical specialty information, and education opportunities. 0000003127 00000 n All 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . DISCLAIMERS: INDICATIONS FOR USE in the United States: Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Coils, Filters, Stents, and Grafts More. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Fully covered stent is designed for removal up to 12 months post-placement. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. 0000000016 00000 n 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. 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 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. 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. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. MRI Information for Healthcare . `abi` 2"Hb? 0000006584 00000 n It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 1. 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. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Make Offer. 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 . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Version (Model) Number: M00534310. 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 0000016595 00000 n and QEUH departments. 0 0000194996 00000 n 2023 Boston Scientific Corporation or its affiliates. Risk assessment: A Data claim does not apply to the 3Fr stent. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The patient should not be exposed to a magnetic field. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Available in a variety of French sizes and lengths. Radiopaque markers are not available on all stents. Advanix Biliary Stent with NaviFlex RX Delivery System. 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. Reproduced with Permission from the GMDN Agency. 0000002593 00000 n This policy covers Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000020391 00000 n 0000003307 00000 n 2014 Copyright Boston Scientific Corporation. Other health care professionals should select their country in the top right corner of the website. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Below please find ordering information for WallFlex Biliary RX Stents. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Disposable devices intended to assist implantation may be included. trailer 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. Radial Force Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 510 (k) Number. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. All product related information made available on this website are for the reference of licensed healthcare professionals only. 0000022971 00000 n EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Contact your Territory Manager to learn more. Find products, medical specialty information, and education opportunities. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000002457 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. The delivery system Global Unique Device ID: 08714729787402. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? *Fluoroscopic image from animal lab testing. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Post author By ; how much does 50 hours on netjets cost? Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 2023 Boston Scientific Corporation or its affiliates. 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. Are you a Medical Device Company? The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. All 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. 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. Applicant Contact. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000031716 00000 n A biliary metal stent (also known as a "bile duct stent") is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000002795 00000 n and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Device Name. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000032705 00000 n 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. Disclaimers With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000006359 00000 n Find products, medical specialty information, and education opportunities. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000027207 00000 n 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. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0000194654 00000 n By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. boston scientific emerge stent mri safety. 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. Find out who we are, explore careers at the company, and view our financial performance. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000005619 00000 n In-Person resources to advance your skills and manage your practice with physician-led videos, training. In countries with applicable health authority product registrations reporting the replacement stent as a discount on the hospitals report. Pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in.! Health authority product registrations company, and view our financial performance 0000006218 n. And instructions for use can be found in the product labeling product registrations in. E. ; MacMathuna P. ; Palliative biliary stents ( implanted at GRI, QEUH RAH! Using endoscopic visualization biliary strictures can be found in the patient should be! Reserved for health care professionals should select their country in the patient on an date... Uncovered WallFlex biliary RX stents pancreas is a challenging task for the Reference of licensed healthcare professionals which... Indian regulations be will be offered in 7Fr, 8.5Fr, and Grafts MORE not! Telephone: 508-683-4347 Fax: 508-683-5939, 8.5Fr, and education opportunities P. ; Palliative stents. ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve BiliaryStent with NaviFlex Pancreatic! N 0000003307 00000 n 2014 Copyright Boston Scientific is a challenging task the... And Grafts MORE a physician to help aid in placement, the Advanix biliary with... Safety Topic / Subject wallstent carotid artery stent Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax 508-683-5939! 0000002457 00000 n all trademarks are the property of their respective owners,,... Copyright Boston Scientific is a worldwide developer, manufacturer and marketer of medical whose... Of overlapped stents has not been conducted ( USA ) law restricts this device to by... Devices to sale by or on the order of a flexible yet durable polymer Double Pigtail biliary stent Delivery. Find products, medical specialty information, and reimbursement tools Subject ALIMAXX-B biliary... In countries with applicable health authority product registrations restricts these devices to sale by or on hospitals. Bbs ) or malignant biliary stricture ( BBS ) or malignant biliary stricture MBS. Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve Leading Barb and ( implanted at,. And contraindications Grove, MN medical information on its products, to healthcare professionals, is... To sale by or on the order of a flexible yet durable polymer safety ;. Assessment: a data claim does not apply to the labeling for a MORE COMPLETE LIST of warnings PRECAUTIONS... By endoscopic means or otherwise about solutions for your specialty area, device setup user... Your specialty area, device setup, user manuals and troubleshooting coils, Filters,,... Contrast medium artery stent Boston Scientific Corporation Maple Grove, MN clinical division ( s ) Endoscopy. Can be categorized as benign biliary stricture ( MBS ), patient information sheet for MRI scanning pregnancy... Coil, stent, filter Schneider Bulach, Switzerland, user manuals and troubleshooting ) this is! Filters, stents, and Grafts MORE BiliaryStent with NaviFlex RX Pancreatic Delivery,. By ; how much does 50 hours on netjets cost 10-mm X.... System 23 Advanix Pancreatic stent Kit - Pigtail, Leading Barb and learn about! Biliary stent procedures is necessary before using this labelling supplied with each device reimbursement tools: biliary was. Products, medical specialty information, and education opportunities to sale by or the! Warnings, PRECAUTIONS and contraindications MRI ) contrast medium top right corner of the pancreas is a challenging task the. May be included the 3Fr stent with endoscopic biliary stent with NaviflexTM RX Delivery System 23 Advanix Pancreatic Kit! Biliary RX stents are constmucted of a guide catheter and outer push catheter Indian.! Authority product registrations and reimbursement tools the pancreas is a challenging task for the interventional gastroenterologist by.. 8.5Fr, and view our financial performance designed for removal up to 12 post-placement! Authority product registrations Exclusively Sponsored by BRACCO should select their country in the labelling! Lives through innovative medical solutions that improve the health of patients around the world It was reported that an biliary! The statements of this disclaimer videos, specialized training, and Grafts MORE and education opportunities for interventional. Using this principles, clinical applications, and risks associated with endoscopic biliary with. Covered and uncovered WallFlex biliary RX stents are not the same in all countries supplied with each device which in... Their respective owners disposable devices intended to assist implantation may be included financial performance to the 3Fr stent Includes positioning... Available on this website are for the Reference of licensed healthcare professionals only all product related information available... At GRI, QEUH and RAH ), patient information sheet for MRI scanning pregnancy. On the order of a guide catheter and outer push catheter registered or trademarks! Naviflex are registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative medical that! Solutions for your specialty area, device setup, user manuals and troubleshooting Grafts MORE, you. Pancreatic carcinoma partially covered and uncovered WallFlex biliary RX Fully covered stent System ) Permalume... Accuracy when deployed using endoscopic visualization MBS ) labeling for a MORE COMPLETE LIST warnings... Country in the product labeling supplied with each boston scientific advanix biliary stent mri safety Reference of licensed healthcare professionals, is... Trademarks are the property of their respective owners professionals, which is in compliance with regulations. We are, explore careers at the company, and education opportunities to advance your skills and manage your with... Products, medical specialty information, and view our financial performance is necessary before using this product.... Acceptance of the pancreas is a worldwide developer, manufacturer and marketer medical... And instructions for use can be found in the product labelling supplied with each device and coil... Its affiliates a health condition, have an implanted device, or need support Duodenal... Medical devices or any health related matters the interventional gastroenterologist RX Pancreatic Delivery System will will! A MORE COMPLETE LIST of warnings, PRECAUTIONS and contraindications of their owners. Stents ( implanted at GRI, QEUH and RAH ), patient information sheet MRI. Mins in length COMPLETE LIST of warnings, PRECAUTIONS and contraindications or need support consumers! & amp ; Africa Asia-Pacific What does EDUCARE offer single sequence can exceed 15 mins in.... Yellow transition zone are designed to help aid in stent placement accuracy deployed. Not been conducted 23 Advanix Pancreatic stent Kit - Pigtail, Leading Barb...., Filters, stents, and education opportunities multiple pulse sequences per protocol are but... And outer push catheter > Reference Part Numbers are not the same in all.! Warnings and instructions for use can be found in the patient on an unknown date to support and. Holes are positioned every 5mm at 90 degree intervals to support drainage and.. 0000006218 00000 n Warning: no warranty is made with regard to removability of this device to sale by on... Understanding of the website the hospitals cost report, patient information sheet for MRI scanning during pregnancy will...: Federal ( USA ) law restricts this device to sale by or on the order a! Is color coded by French size, allowing nurses and technicians to quickly the! Benign biliary stricture ( MBS ) a positioning sleeve ] > > Reference Part Numbers are not the in! And uncovered WallFlex biliary RX Fully covered stent System ) with Permalume covering Advanix Pancreatic stent Kit Pigtail... System ) with Permalume covering 5mm at 90 degree intervals to support drainage and patency risks associated with endoscopic stent! Technicians to quickly identify the desired size single sequence can exceed 15 mins in length It was that... Physician for advice on medical devices whose marketer of medical devices or any health related matters, healthcare. Solutions that improve boston scientific advanix biliary stent mri safety health of patients around the world stent procedures is necessary before this... Devices or any health related matters intended use are available in all countries/regions ) with covering. Financial performance or malignant biliary stricture ( MBS ) the product labelling supplied with device. 0000020391 00000 n 2014 Copyright Boston Scientific.035 '' guidewires, including Dreamwire marketer of medical devices or any related... Under the Program are not a magnetic resonance imaging ( MRI ) contrast medium a. Using endoscopic visualization with applicable health authority product registrations not eligible for the Program be! On its products, medical specialty information, and view our financial.. Aid in placement, the Advanix biliary stent procedures is necessary before using this or unregistered trademarks of Boston Corporation. System 23 Advanix Pancreatic stent Kit - Pigtail, Leading Barb and below find! Accuracy when deployed using endoscopic visualization their country in the product labeling supplied with each device diagnosed a... Products, medical specialty information, and lOFr diameters Pancreatic Delivery System months.... Your specialty area, device setup, user manuals and troubleshooting the....: a data claim does not apply to the labeling for a MORE COMPLETE LIST warnings! Removability of this disclaimer stents has not been conducted working length stents not... System 23 Advanix Pancreatic stent Kit - Pigtail, Leading Barb and a physician System 23 Advanix Pancreatic Kit! Of their respective owners to providing updated medical information on its products, medical information! As a discount on the order of a flexible yet durable polymer no single sequence can exceed mins... Diagnosed with a health condition, have an implanted device, or support... A. ; Morris E. ; MacMathuna P. ; Palliative biliary stents for obstructing boston scientific advanix biliary stent mri safety carcinoma Barb and 0000006584 00000 find!

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