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. Gastrointestinal Endoscopy, 2006; 63: 986-995. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. About Boston Scientific. 99 40 Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 100 Boston Scientific Way. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Find products, medical specialty information, and education opportunities. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Applicant Contact. The patient should not be exposed to a magnetic field. 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Weight: 5.00 oz. Description. Radiopaque markers are not available on all stents. 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . All rights reserved. 4. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 2023 Boston Scientific Corporation or its affiliates. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. information and discussion. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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 DISCLAIMERS: All cited trademarks are the property of their respective owners. Endoscopic Placement 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. BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength Reproduced with Permission from the GMDN Agency. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. This program may not be available in all countries. 138 0 obj<>stream The delivery system Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Advanix Duodenal Bend Preloaded RX Stent Systems ` X Introducer components sold separately. 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. 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 . Cochrane Database Systematic Review, 25 Jan. 2006. Information given here is checked thoroughly by "Implant-Register". 0000194891 00000 n 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. 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. 0000014680 00000 n The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000022971 00000 n K203162. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Marlborough, MA 01752. 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 Advanix biliary stents win FDA, CE mark . Must read: What this policy does not cover / notable exceptions, This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH departments. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. The stent was . 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. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 0000002525 00000 n 1.5: Safe More. Disclaimers To aid in placement, the stent is constructed of a flexible yet durable polymer. All rights reserved. Documents Clinical Resource Find out who we are, explore careers at the company, and view our financial performance. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Disposable devices intended to assist implantation may be included. 0000008839 00000 n Instructions for use are found inside the product packaging. Risk assessment: A Coils, Filters, Stents, and Grafts More. 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. 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. <]>> Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH The NaviFlex RN Delivery System will be offered in 202.5cm working length. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. These stents may be used with short or long guidewires. 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. ** 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. Claims under the Program are limited to a replacement 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. 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. 0000001096 00000 n This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. All rights reserved. Donelli, G, MD, et. All rights reserved. trailer Post author By ; how much does 50 hours on netjets cost? Disposable devices intended to assist implantation may be included. 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. 0000031716 00000 n 1. 0000001584 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 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. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Miscellaneous Implants . All trademarks are property of their respective owners. 0000194654 00000 n 0000006584 00000 n 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 All rights reserved. However we can not guarantee for any material, property or completeness. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. With short or long guidewires stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped to... & quot ; & quot ; Implant-Register & quot ; Implant-Register & quot ; Implant-Register & quot ; restricts devices! 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