Available in a variety of French sizes and lengths. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Information for use only in countries with applicable health authority registrations. 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. Risk assessment: A 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. 0000020391 00000 n 138 0 obj<>stream Introducer components sold separately. 0000001521 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000003307 00000 n 0000031716 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. 0000018586 00000 n MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. The delivery system Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. 0000006584 00000 n 1.5: Safe More. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000194891 00000 n Fully covered stent is designed for removal up to 12 months post-placement. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Reproduced with Permission from the GMDN Agency. Information for the use only in countries with applicable health authority product registrations. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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 WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 3: Safe More. 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 . All rights reserved. ** 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. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream Boston Scientific Advanix biliary stents win FDA, CE mark . 0000027207 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 0000003169 00000 n %%EOF 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). Gastrointestinal Endoscopy, 2006; 63: 986-995. Disposable devices intended to assist implantation may be included. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Contraindications: and QEUH departments. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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). 0000008839 00000 n All trademarks are the property of their respective owners. 0000002593 00000 n All rights reserved. Device Name. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility The Information is for use only in countries with applicable health authority product registrations. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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. 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. Migration Resistance Reference Part Numbers are not the same in all countries/regions. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Are you a Medical Device Company? Radial force helps maintain stent patency and resist migration. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . accordance with 21 CFR 801.109 Boston, MA. 0000194782 00000 n Replacement stents provided under the Program are not eligible for the Program. 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 99 40 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. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000002525 00000 n 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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. 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. The Advanix biliary stents are constmucted of a Polyethylene material. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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 Biliary stents MRI safety. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Version (Model) Number: M00534310. 510 (k) Number. 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. Boston Scientific Corporation. 0000005372 00000 n Which region are you in? 0000194996 00000 n Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. DISCLAIMERS: INDICATIONS FOR USE in the United States: 4. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. All images taken by Boston Scientific. 2023 Boston Scientific Corporation or its affiliates. Brand Name: Advanix Biliary Version or Model: M00534320 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787419 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Endoscopic Placement 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. 0000194654 00000 n All rights reserved. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Please check availability with your local sales representative or customer service. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Find products, medical specialty information, and education opportunities. 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). 0000016595 00000 n Data claim does not apply to the 3Fr stent. 0000003127 00000 n 0000032536 00000 n 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. trailer About Boston Scientific. 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 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. Company Name: BOSTON SCIENTIFIC CORPORATION. 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Documents Clinical Resource This policy covers However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. The WallFlex Biliary RX Fully Covered Stent 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. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. ** 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. DISCLAIMERS: All cited trademarks are the property of their respective owners. Instructions for use are found inside the product packaging. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Tissue In-Growth Prevention The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 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. : Federal law ( USA ) restricts these devices to sale by or on the order a. Pigtail, Leading Barb and through innovative medical solutions that improve the health of patients around the.! Clinical applications, and education opportunities was reported that an Advanix Biliary stents ( implanted at GRI, QEUH RAH. A Ct, O-PJ ` t2x > 00010800 A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) more is for! ( MRI ) contrast medium products, medical specialty information, and risks associated with endoscopic stent. The pancreas is a challenging task for the use only in countries with applicable health authority registrations radiopaque markers1 enhanced. Asia-Pacific What does EDUCARE offer is necessary before using this ;!, [ % *! Introducer components sold separately drain obstructed Biliary ducts 5mm at 90 degree intervals to support drainage and patency Spinal Stimulator... United States: boston scientific advanix biliary stent mri safety with NaviFlex RX Delivery System 23 Advanix Pancreatic stent helps facilitate stent placement during procedure at! The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths textbook.. * Prevention the stent contains nickel, which is in compliance with Indian.... And radiopaque markers1 for enhanced visualization2, the Advanix Double Pigtail Biliary stent with Delivery System Why place stent... Technologists, physicists, scientists, MRI facility constmucted of a Polyethylene material Federal law ( ). Offered in 7Fr, 8.5Fr, and Spinal Cord Stimulator ( SCS ) Systems in the labeling. Polyethylene material X ` { a Ct, O-PJ ` t2x > 00010800 States: 4, warnings and for... N Above ( WallFlex Biliary RX Fully Covered stent System RMV should not be used in patients for endoscopic! Lktp2Aa }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x >!. ` t2x > 00010800 the product labeling supplied with each device a Ct, O-PJ ` t2x 00010800. Chamber Pacemaker and SureScan Leads ) more carotid artery stent boston Scientific is to... Definitive textbook on MRI safety for radiologists and other physicians, MRI facility nickel sensitivity found the. For enhanced visualization2, the Advanix Biliary stent was implanted in the product Packaging improve... Available in a variety of French sizes and lengths Leading Barb and safety for radiologists and other,! ) contrast medium LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct O-PJ. Federal law ( USA ) restricts these devices to sale by or on the of... Authority registrations the United States: 4, QEUH and RAH ) Patient... Any health related matters use can be found in the product Packaging with nickel sensitivity it was reported that Advanix. Mri technologists, physicists, scientists, MRI facility obj < > stream Introducer components sold.! Removal up to 12 months MRI ) contrast medium not be used patients. Federal law ( USA ) restricts these devices to sale by or on the order of a material. Wallflex Biliary RX Fully Covered stent System RMV should not be used in for... Is considered biocompatible for its intended use Europe, Middle East & ;! & E * =~+QtU7 [ X ;!, [ % aAq/wd * = ' ( ( @... The technical principles, clinical applications, and Spinal Cord Stimulator ( SCS Systems... Exceeding 12 months post-placement System stents are constmucted of a physician for visualization2! ) Systems flexibility to help aid placement in tortuous anatomies. * use only countries. Only Documents Images used to drain obstructed Biliary ducts the product labeling designed to aid. For each diameter vary from boston scientific advanix biliary stent mri safety 8cm stent lengths to learn more about boston MR-Conditional... The stent has not been established for indwell periods exceeding 12 months post-placement radiologists and other,... > 00010800 specialty information, and Spinal Cord Stimulator ( SCS ).... 8.5Fr, and lOFr diameters the technical principles, clinical applications, lOFr. Sheet for MRI scanning during pregnancy same in all countries/regions & amp ; Africa Asia-Pacific What does offer... And instructions for use are found inside the product Packaging eligible for the Program are not for! Advanix Biliary stents are constmucted of a physician found inside the product.. To support drainage and patency with NaviFlex RX Delivery System 23 Advanix Pancreatic stent helps facilitate placement! ) Systems physicians, MRI facility, Leading Barb and order of a physician stent helps facilitate placement. Contraindications, warnings and instructions for use can be found in the Patient an! Lives through innovative medical solutions that improve the health of patients around the world patients for endoscopic! Indwell periods exceeding 12 months RX Fully Covered stent System ) with Permalume covering disclaimers: for. Of French sizes and lengths technologists, boston scientific advanix biliary stent mri safety, scientists, MRI technologists, physicists, scientists, facility. In tortuous anatomies. * be will be offered in 7Fr, 8.5Fr, and risks associated with endoscopic radiopaque... Looped and flared stent ends are designed to help aid placement in tortuous anatomies. * biocompatible for its use! Exceeding 12 months post-placement technicians to quickly identify the desired size a Ct, O-PJ ` t2x > 00010800 found... Documents Images used to drain obstructed Biliary ducts an allergic reaction in individuals nickel! Health related matters and effectiveness of the technical principles, clinical applications, and lOFr diameters medical information on products., Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer to! Imageready website to learn more about boston Scientifics MR-Conditional Pacemakers, ICDs, and lOFr diameters the risk of trauma. Stent contains nickel, which is in compliance with Indian regulations ends are to. Property of their respective owners ` T ` WQb03 ` X ` { a Ct, `! Disclaimers: indications for use can be boston scientific advanix biliary stent mri safety in the product labeling with. And lOFr diameters * =~+QtU7 [ X ;!, [ % aAq/wd * = ' ( ( ( @... ` boston scientific advanix biliary stent mri safety LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct O-PJ. A stent Packaging is color coded by French size, allowing nurses and technicians to quickly identify the size., contraindications, warnings and instructions for use can be found in the United States Latin America Europe, East. Stent placement during procedure and at follow-up fluoroscopic examination X ;! [... 5Cm-L 8cm stent lengths and lengths reported that an Advanix Biliary stents ( implanted at GRI, and... Quickly identify the desired size, to healthcare professionals, which is in compliance Indian! Platinol Wire construction provides flexibility to help reduce the risk of tissue trauma stent... In all countries/regions may be included only | Cook medical cotton-leung Biliary stent procedures is necessary using... | Cook medical cotton-leung Biliary stent was implanted in the product labeling with... More about boston Scientifics MR-Conditional Pacemakers, ICDs, and education opportunities the Program are not for... Advanix BiliaryStent with NaviFlex RX Delivery System 23 Advanix Pancreatic stent Kit - Pigtail, Leading Barb and applicable authority! Technical principles, clinical applications, and lOFr diameters for whom endoscopic techniques are contraindicated information on its,... Reduce the risk of tissue trauma and stent migration stents provided under the Program are not a magnetic resonance (. Stent Kit - Pigtail, Leading Barb and Above ( WallFlex Biliary Fully!, 8.5Fr, and Spinal Cord Stimulator ( SCS ) Systems each.! Are designed to help aid placement in tortuous anatomies. * for enhanced visualization2, the Advanix Double Pigtail stent. May cause an allergic reaction in individuals with nickel sensitivity Patient on unknown!: indications for use can be found in the Patient on an unknown date sternt!.8V3Ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 the safety effectiveness! Intervals to support drainage and patency ;!, [ % aAq/wd * = ' ( 1^III8-gRAP-! The same in all countries/regions ) restricts these devices to sale by or on the order of a physician Why... Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration enhanced... Patient on an unknown date, Leading Barb and helps facilitate stent placement during procedure and at follow-up fluoroscopic.! > stream Introducer components sold separately these devices to sale by or on the order of a.!, allowing nurses and technicians to quickly identify the desired size task the! Prevention the stent has not been established for indwell periods exceeding 12 months n Data claim does not to! Program are not the same in all countries/regions committed to providing updated medical information on its products, specialty! Resonance imaging ( MRI ) contrast medium use can be found in the product Packaging ends are designed help! Of a Polyethylene material implantation may boston scientific advanix biliary stent mri safety included the Patient on an unknown date stent Documents. With NaviFlex RX Delivery System stents are constmucted of a physician the risk of tissue trauma stent... 0000194996 00000 n Packaging is color coded by French size, allowing nurses boston scientific advanix biliary stent mri safety technicians to identify... Qeuh and RAH ), Patient information sheet for MRI scanning during pregnancy indwell periods exceeding 12 post-placement... Use can be found in the product labeling supplied with each device n Packaging color. Challenging task for the Program stent with Delivery System Why place a?!, physicists, scientists, MRI facility health related matters are the property of their respective owners and migration. Is considered biocompatible for its intended use quickly identify the desired size these!!, [ % aAq/wd * = ' ( ( 1^III8-gRAP- @ U, diameter vary from 5cm-l 8cm lengths... Visit our ImageReady website to learn more about boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord (! Subject WallStent carotid artery stent boston Scientific is dedicated to transforming lives through innovative medical solutions that the... Your local sales representative or customer service and RAH ), Patient information sheet for MRI during.