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. 0000003219 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 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 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. Are you a Medical Device Company? Disposable devices intended to assist implantation may be included. 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. Migration Resistance Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Find products, medical specialty information, and education opportunities. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Coils, Filters, Stents, and Grafts More . 0000002593 00000 n 0000003412 00000 n 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. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. xb``c``ig`e`bd@ A6v[*/`` j[rc Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Below please find ordering information for WallFlex Biliary RX Stents. 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 Aequalis Humeral Plate and component parts A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 043254. Available in a variety of French sizes and lengths. Applicant Contact. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Making a meaningful difference in patients' lives. However we can not guarantee for any material, property or completeness. 0000194996 00000 n 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 0000031716 00000 n 99 0 obj <> endobj Fully covered stent is designed for removal up to 12 months post-placement. 0000012830 00000 n Cochrane Database Systematic Review, 25 Jan. 2006. 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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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 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. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? information and discussion. boston scientific emerge stent mri safety. All rights reserved. Information for the use only in countries with applicable health authority product registrations. GMDN Names and Definitions: Copyright GMDN Agency 2015. First; Previous; . CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. All rights reserved. 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*. 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. 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. Consumers or patients who use this website and rely on any information herein do so at their own risk. Contraindications: Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000022971 00000 n Boston Scientific Advanix biliary stents win FDA, CE mark . Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. Marlborough, MA 01752. 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. and QEUH departments. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. trailer Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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). 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. All device bench test results were acceptable. Find out who we are, explore careers at the company, and view our financial performance. Please check availability with your local sales representative or customer service. 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. Stent Placement Accuracy Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. accordance with 21 CFR 801.109 Endoscopic Placement 1.5: Safe More. ` X Please contact our technical team for additional support. 2023 Boston Scientific Corporation or its affiliates. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All images taken by Boston Scientific. 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. 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. 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. 0000000016 00000 n 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. All trademarks are property of their respective owners. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Make Offer. %%EOF This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000014680 00000 n Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 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. 2023 Boston Scientific Corporation or its affiliates. All rights reserved. Information given here is checked thoroughly by "Implant-Register". startxref * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Contraindications: 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. 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. 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Patients who use this website and rely on any information herein do so at their own.!