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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Contact your Territory Manager to learn more. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 3: Conditional 6 More. 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? Miscellaneous Implants . 2023 Boston Scientific Corporation or its affiliates. Coils, Filters, Stents, and Grafts More . 138 0 obj<>stream The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. Find products, medical specialty information, and education opportunities. Stent Placement Accuracy This policy covers Company Name: BOSTON SCIENTIFIC CORPORATION. Reproduced with Permission from the GMDN Agency. 0000194782 00000 n Replacement stents provided under the Program are not eligible for the Program. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The sale, distribution, and use of the device are restricted to prescription use in 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 510 (k) Number. Information for the use only in countries with applicable health authority product registrations. All trademarks are the property of their respective owners. 0000001584 00000 n First; Previous; . 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). 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 The patient should not be exposed to a magnetic field. Contraindications: the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Contact your Territory Manager for details of the Program. 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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 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. 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. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. All rights reserved. 0000012830 00000 n The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000003412 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. Tissue In-Growth Prevention Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Pancreatic Stent Advanix Pancreatic Stent - Device Characteristics Coils, Filters, Stents, and Grafts More. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . The Information is for use only in countries with applicable health authority product registrations. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0 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. 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 This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis. 0000006770 00000 n 0000002525 00000 n 3: Safe More. The NaviFlex RN Delivery System will be offered in 202.5cm working length. ** 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. Applicant Contact. 0000005372 00000 n 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. <]>> Below please find ordering information for WallFlex Biliary RX Stents. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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. Disposable devices intended to assist implantation may be included. Cochrane Database Systematic Review, 25 Jan. 2006. All images taken by Boston Scientific. Disposable devices intended to assist implantation may be included. 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 Corporation. Endoscopic Placement Radial Force Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 0000020391 00000 n 0000005940 00000 n Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Biliary Stent BOSTON SCIENTIFIC CORPORATION. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All trademarks are the property of their respective owners. Fluoroscopic Visualization 0000032476 00000 n GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000002030 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000002593 00000 n Advanix Duodenal Bend Preloaded RX Stent Systems Advanix Biliary Stent with NaviFlex RX Delivery System. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Are you a Medical Device Company? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. Boston Scientific Advanix biliary stents win FDA, CE mark . The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Information given here is checked thoroughly by "Implant-Register". Description. Claims under the Program are limited to a replacement stent. 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). 0000194654 00000 n 1. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. May be removed prior to MRI and replaced after the MRI exam. Post author By ; how much does 50 hours on netjets cost? 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. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. trailer ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. All rights reserved. 0000032705 00000 n 2023 Boston Scientific Corporation or its affiliates. 2022 Boston Scientific Corporation. All rights reserved. 4. Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Applicant. 043254. Find out who we are, explore careers at the company, and view our financial performance. 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. 1.5: Safe More. Make Offer. 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. Device Name: Biliary Stent with NaviflexTM RX Delivery System. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. and QEUH departments. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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). 0000003169 00000 n Contraindications: Please check availability with your local sales representative or customer service. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. - Boston Scientific Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . Other health care professionals should select their country in the top right corner of the website. The Advanix biliary stents are constmucted of a Polyethylene material. 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. 0000003127 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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

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