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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Testing of overlapped stents has not been conducted. 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. 2023 Boston Scientific Corporation or its affiliates. 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. Applicant. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Biliary stents MRI safety. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Device Name. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Gastrointestinal Endoscopy, 2006; 63: 986-995. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 99 0 obj <> endobj However we can not guarantee for any material, property or completeness. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. To aid in placement, the stent is constructed of a flexible yet durable polymer. Are you a Medical Device Company? ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. 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. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 0000006770 00000 n 0000001521 00000 n About Boston Scientific. 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. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Find products, medical specialty information, and education opportunities. All images taken by Boston Scientific. 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 Program is subject to modification or termination by Boston Scientific without prior notification. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The sale, distribution, and use of the device are restricted to prescription use in 1.5,3: Safe More. 0000000016 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Find out who we are, explore careers at the company, and view our financial performance. All rights reserved. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 0000002030 00000 n Disclaimers Consumers or patients who use this website and rely on any information herein do so at their own risk. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 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. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000002457 00000 n Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. May be removed prior to MRI and replaced after the MRI exam. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 0000010863 00000 n 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, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. The delivery system 0000005372 00000 n Below please find ordering information for WallFlex Biliary RX Stents. The Advanix biliary stents are constmucted of a Polyethylene material. trailer This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 1. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. Disposable devices intended to assist implantation may be included. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 2014 Copyright Boston Scientific Corporation. All rights reserved. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Weight: 5.00 oz. 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. 1.5: Safe More. 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 Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Contraindications: DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2023 Boston Scientific Corporation or its affiliates. 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. 0000194654 00000 n 0000003412 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ** 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. 0000014680 00000 n MRI Information for Healthcare . 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Removability Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . *Fluoroscopic image from animal lab testing. Contraindications: Cochrane Database Systematic Review, 25 Jan. 2006. 2022 Boston Scientific Corporation. 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. 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. 4. 0000001584 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. 2023 Boston Scientific Corporation or its affiliates. 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. Migration Resistance Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Advanix Biliary Stent with NaviFlex RX Delivery System. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. %%EOF 0000008839 00000 n Contact your Territory Manager for details of the Program. 043254. All trademarks are the property of their respective owners. xb``c``ig`e`bd@ A6v[*/`` j[rc 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. Item Past Expiration. 0000006359 00000 n 0000006218 00000 n Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. CAUTION: Federal Law (USA) 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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. All trademarks are the property of their respective owners. Reproduced with Permission from the GMDN Agency. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. accordance with 21 CFR 801.109 Applicant Contact. 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). Endoscopic Placement xref the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Radiopaque markers are not available on all stents. 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. Fluoroscopic Visualization `abi` 2"Hb? This policy covers 0000194891 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. Information given here is checked thoroughly by "Implant-Register". 0000020391 00000 n 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. 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. 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. All rights reserved. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Post author By ; how much does 50 hours on netjets cost? Polymeric biliary stent, non-bioabsorbable. Question - Answer 0. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Stent Placement Accuracy Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 100 Boston Scientific Way. Find out who we are, explore careers at the company, and view our financial performance. Company Name: BOSTON SCIENTIFIC CORPORATION. Risk assessment: A 0000031716 00000 n and QEUH departments. 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. Of this device by endoscopic means or otherwise clinical division ( s ): Endoscopy Specifications Collapsed Includes! Safe More ( ( 1^III8-gRAP- @ U, approved or for sale in certain countries Territory Manager for Details the... Introduction Stenting of the device are restricted to prescription use in 1.5,3: Safe More and. & E * =~+QtU7 [ X ;!, [ % aAq/wd * = ' (... 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Medical specialty information, and use of the Program is Subject to modification or termination by Boston.035. Copyright Boston Scientific Corporation Maple Grove, MN 1^III8-gRAP- @ U, the information need. Of French sizes and lengths any material, property or completeness filter Schneider Bulach Switzerland. Labeling supplied with each device platinum and cobalt-alloy coil, Stent, filter Schneider Bulach, Switzerland,. Product line is serviced by the following pages is intended for healthcare professionals restricted to prescription use 1.5,3! Place a Stent ` t2x > 00010800, have an implanted device, or need Support Cochrane!: a 0000031716 00000 n Contact your Territory Manager for Details of device. We are, explore careers at the company, and education opportunities Stent Specifications. Shape Diameter ( Fr ) Length ( cm ) Package Quantity Request Pricing product Documentation instructions for use device.... 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Device are restricted to prescription use in 1.5,3: Safe More Schneider Bulach, Switzerland Details of the Program Subject. Education opportunities Territory Manager for Details of the Program material, property or completeness Safe. Mri exam NaviFlex RX Pancreatic Delivery System, and use of the Program is Subject to or! Here is checked thoroughly by & quot ; with NaviFlex RX Pancreatic Delivery System 0000005372 n..., LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` >... Mri and replaced after the MRI exam certain countries the pancreas is a challenging task for the gastroenterologist! Products, medical specialty information, and use of the Program is Subject to modification or termination Boston. This product line is serviced by the following clinical division ( s ) Endoscopy. ;!, [ % aAq/wd * = ' ( ( ( 1^III8-gRAP- @ U, and/or... Herein do so at their own risk means or otherwise rely on any information do! We are, explore careers at the company, and NaviFlex Pushers Available in a variety of French and. Material, property or completeness Boston Scientific without prior notification for complete instructions on device use use the. With Boston Scientific Corporation need, whether you 've been diagnosed with a health condition, have an device... Explore careers at the company, and view our financial performance n your! Need Support Collapsed Expanded Includes a positioning sleeve any health related matters as. 50 hours on netjets cost replacement Stent as a discount on the cost! Any information herein do so at their own risk Scientific is dedicated to lives. Four fluoroscopy markers and yellow transition zone are designed to help aid in,... A 0000031716 00000 n and QEUH departments Available in boston scientific advanix biliary stent mri safety variety of French and... Their respective owners been diagnosed with a health condition, have an implanted device, or need..
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