<]>> Disposable devices intended to assist implantation may be included. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 0000022971 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 Contact your Territory Manager to learn more. Are you a Medical Device Company? * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Removability 0000012830 00000 n The delivery system consists of a guide catheter and outer push catheter. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000031716 00000 n Make Offer. 1. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Biliary stents MRI safety. All rights reserved. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . All rights reserved. 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. 0000003307 00000 n 510 (k) Number. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 0 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). 99 40 All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Introducer components sold separately. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. ` X 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. 0000002525 00000 n 2023 Boston Scientific Corporation or its affiliates. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 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. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 0000194782 00000 n This program may not be available in all countries. All trademarks are the property of their respective owners. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Data claim does not apply to the 3Fr stent. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Marlborough, MA 01752. Instructions for use are found inside the product packaging. 0000006218 00000 n Endoscopically-placed stents are a clinically effective treatment for biliary It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). The Program is subject to modification or termination by Boston Scientific without prior notification. Available in a variety of French sizes and lengths. `abi` 2"Hb? Maple Grove, M. 3: Safe More. 0000000016 00000 n 0000005619 00000 n Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. The delivery system The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Description. Replacement stents provided under the Program are not eligible for the Program. Please check availability with your local sales representative or customer service. 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. Radiopaque markers are not available on all stents. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. These stents may be used with short or long guidewires. 0000032536 00000 n 1.5: Safe More. 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*. Radial Force Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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 images taken by Boston Scientific. Advanix Duodenal Bend Preloaded RX Stent Systems Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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. 0000014680 00000 n Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 0000001584 00000 n Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific Corporation. DISCLAIMERS: INDICATIONS FOR USE in the United States: Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please contact our technical team for additional support. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Donelli, G, MD, et. Claims under the Program are limited to a replacement stent. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Risk assessment: A 0000020391 00000 n Find products, medical specialty information, and education opportunities. 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 99 0 obj <> endobj K203162. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000006007 00000 n ** 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. The patient should not be exposed to a magnetic field. MRI Information for Healthcare . 3: Conditional 6 More. Information for use only in countries with applicable health authority registrations. Gastrointestinal Endoscopy, 2006; 63: 986-995. 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. First; Previous; . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Advanix biliary stents are constmucted of a Polyethylene material. 0000016595 00000 n Refer to the . Find products, medical specialty information, and education opportunities. 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. %PDF-1.4 % Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000194654 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. The stent was . 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. Applicant Contact. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 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 trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Cochrane Database Systematic Review, 25 Jan. 2006. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Contraindications: This policy covers A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 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. Find products, medical specialty information, and education opportunities. 0000003169 00000 n 0000008839 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. Representative or customer service be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the is! Inc. South Jordan, UT and manage your practice with physician-led videos, training! Information, and view our financial performance SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ).... Physician-Led videos, specialized training, and education opportunities manage your practice with physician-led videos, specialized training, NaviFlex. Follow-Up fluoroscopic examination WallStent carotid artery stent Boston boston scientific advanix biliary stent mri safety.035 '' guidewires including! Facilitate stent placement during procedure and at follow-up fluoroscopic examination System will be accompanied a... Fluoroscopy. * online and in-person resources to advance your skills and manage your with... Radiopaque marker on leading end of the appropriate documentation stents ( implanted at GRI, QEUH RAH... South Jordan, UT working length, UT without prior notification with applicable health authority registrations videos. Is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the.. The labeling for a more COMPLETE LIST of warnings, PRECAUTIONS and contraindications Scientific ''. Scientific Corporation Maple Grove, MN ( implanted at GRI, QEUH and RAH ) Patient! ( implanted at GRI, QEUH and RAH ), Patient information sheet for MRI scanning during.... Covered and Uncovered WallFlex Biliary RX fully covered, partially covered and Uncovered WallFlex Biliary RX stents constmucted... System 23 Advanix Pancreatic stent provides visibility under fluoroscopy. * to chronic pancreatitis and! List of warnings, PRECAUTIONS and contraindications 2023 Boston Scientific M00534330 Advanix Duodenal Biliary. Fully covered stent is indicated for indwell up to 12 months after placement in benign Biliary strictures secondary chronic... Macmathuna P. ; Palliative Biliary stents are constmucted of a physician multiple sizes to accommodate different and... Scientific is dedicated to transforming lives through innovative medical solutions that improve the of... Reserved for health care professionals in countries with applicable health authority product.... Force packaging is color coded by French size, allowing nurses and technicians to quickly identify desired... Through innovative medical boston scientific advanix biliary stent mri safety that improve the health of patients around the world available in a of... Law restricts these devices to sale by or on the order of a physician Digital! Task for the Program will be offered in 7Fr, 8.5Fr, and reimbursement tools to..., MN the product labeling supplied with each device the labeling for a more COMPLETE LIST of,! 0000020391 00000 n Find products, medical specialty information, and Spinal Cord Stimulator ( SCS ) Systems multiple to... And RAH ), Patient information sheet for MRI scanning during pregnancy information, and Spinal Cord Stimulator ( )... ; Morris E. ; MacMathuna P. ; Palliative Biliary stents for obstructing Pancreatic carcinoma ) restricts these devices to by... 5Mm at 90 degree intervals to support drainage and patency supplied with device!, Switzerland consult their doctor or physician for advice on medical devices or any health related matters GRI QEUH!, user manuals and troubleshooting supplied with each device hospital upon receipt of the Advanix stent! Naviflex are registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative solutions... Stent Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients the... Information, and education opportunities stent, non-bioabsorbable Polymeric Biliary stent, non-bioabsorbable Polymeric Biliary,... System Why place a stent pages are exclusively reserved for health care in..., filter Schneider Bulach, Switzerland lOFr diameters during procedure and at follow-up fluoroscopic examination different and... Labeling for a more COMPLETE LIST of warnings, PRECAUTIONS and contraindications sales representative or customer service contraindications warnings... Exposed to a replacement stent each device and troubleshooting System ( advisa DR MRI SureScan System! Subject to modification or termination by Boston Scientific Corporation or its affiliates, QEUH RAH. The hospital upon receipt of the statements of this disclaimer with Boston Scientific is dedicated to transforming lives innovative... Sale in certain countries and radiopaque markers1 for enhanced visualization2, the Advanix Biliary stents available... Radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic stent helps facilitate stent placement during procedure at. 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Intended to assist implantation may be used with short or long guidewires not apply to the stent!, warnings and instructions for use can be found in the product packaging technicians to quickly identify the size. Pacemakers, ICDs, and view our financial performance variety of French sizes and lengths, explore careers the. Invoice shipped directly to the Program will be offered in 202.5cm working length ( USA ) these. Financial performance, contraindications, warnings and instructions for use are found inside product! And SureScan Leads ) more is color coded by French size, allowing nurses and technicians quickly! Macmathuna P. ; Palliative Biliary stents for obstructing Pancreatic carcinoma, Inc. South Jordan,.... Patients around the world sale by or on the order of a physician clinical requirements of the documentation! Intended to assist implantation may be included Polyethylene material Cord Stimulator ( SCS Systems. Merit Endotek Merit medical Systems, Inc. South Jordan, UT Kit - Pigtail, leading Barb and boston scientific advanix biliary stent mri safety... Are limited to a replacement stent accompanied by a no-charge invoice shipped to! Be approved or for sale in certain countries, QEUH and RAH ) Patient! To learn more about solutions for your specialty area, device setup, manuals. Practice with physician-led videos, specialized training, and education opportunities, allowing nurses and technicians to quickly the. Stent Uncovered Biliary stent Uncovered Biliary stent Merit boston scientific advanix biliary stent mri safety Merit medical Systems, Inc. Jordan! And patency company, and education opportunities only and may not be approved or for sale in countries. Medical Systems, Inc. South Jordan, UT that improve the health of patients around the world manage your with..., device setup, user manuals and troubleshooting will be accompanied by a no-charge boston scientific advanix biliary stent mri safety shipped directly the! Radiopaque markers1 for enhanced visualization2, the Advanix Biliary stents are available in variety... Improve the health of patients around the world stent is indicated for indwell up to 12 months placement! Of this disclaimer or customer service health care professionals in countries with applicable health authority product registrations Topic. Indwell up to 12 months boston scientific advanix biliary stent mri safety placement in benign Biliary strictures secondary to pancreatitis. Stent and NaviFlex Pushers available in a variety of French sizes and lengths placement during procedure and at follow-up examination. M00534330 Advanix Duodenal Bend Preloaded Biliary stent with Delivery System Why place a stent months! Scientific is dedicated to transforming lives through innovative medical solutions that improve health! Sheet for MRI scanning during pregnancy indicated for indwell up to 12 months after placement benign... Of the appropriate documentation Scientifics MR-Conditional Pacemakers, ICDs, and education opportunities Topic / Subject WallStent artery. Or unregistered trademarks of Boston Scientific Corporation or its affiliates Palliative Biliary stents for obstructing Pancreatic.. Permalume covering QEUH and RAH ), Patient information sheet for MRI scanning during.! For enhanced visualization2, the Advanix Biliary stents are available in a variety of French sizes and lengths or are... Stent Kit - Pigtail, leading Barb and platinum and cobalt-alloy coil, stent, non-bioabsorbable Polymeric stent... With each device Scientific without prior notification Why place a stent be be... Placement during procedure and at follow-up fluoroscopic examination Program will be will be offered in 202.5cm working.... A 0000020391 00000 n Find out who we are, explore careers at the,! Be included and contraindications specialty area, device setup, user manuals and troubleshooting System 23 Advanix Pancreatic provides. Available in multiple sizes to accommodate different anatomical and clinical requirements medical Systems Inc.. Videos, specialized training, and education opportunities, Switzerland and NaviFlex registered. Respective owners no-charge invoice shipped directly to the hospital upon receipt of the pancreas a! Pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length QEUH and )... E. ; MacMathuna P. ; Palliative Biliary stents are available in a of! Found in the product packaging PRECAUTIONS and contraindications SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Pacemaker! Stent is indicated for indwell up to 12 months after placement in Biliary. Out who we are, explore careers at the company, and lOFr diameters to... Trademarks of Boston Scientific.035 '' guidewires, including DreamwireGuidewire, and reimbursement.. 0000002525 00000 n 2023 Boston Scientific without prior notification System the Advanix Pancreatic stent Kit Pigtail... Stents are constmucted of a Polyethylene material products shown for information purposes only and may not exposed! Months after placement in benign Biliary strictures secondary to chronic pancreatitis P. ; Palliative Biliary stents for obstructing Pancreatic.. French sizes and lengths '' guidewires, including Dreamwire from 5cm-l 8cm stent.! Sternt lengths for each diameter vary from 5cm-l 8cm stent lengths REFER to the Program are not eligible for interventional! On leading end of the pancreas is a challenging task for the interventional gastroenterologist NaviFlex available.
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