Find out who we are, explore careers at the company, and view our financial performance. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 0000032476 00000 n %%EOF 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 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 Polymeric biliary stent, non-bioabsorbable. 0000002525 00000 n Testing of overlapped stents has not been conducted. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. 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*. 0000000016 00000 n Information given here is checked thoroughly by "Implant-Register". Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Instructions for use are found inside the product packaging. 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 Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Tissue In-Growth Prevention Coils, Filters, Stents, and Grafts More. Fluoroscopic Visualization 510 (k) Number. Documents Clinical Resource 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 Make Offer. 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 Biliary Stent BOSTON SCIENTIFIC CORPORATION. Please check availability with your local sales representative or customer service. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000003219 00000 n These stents may be used with short or long guidewires. Aequalis Humeral Plate and component parts Endoscopic Placement 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. Description. 0000022971 00000 n xref 0 Reproduced with Permission from the GMDN Agency. The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means 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. Find out who we are, explore careers at the company, and view our financial performance. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 0000194654 00000 n 2014 Copyright Boston Scientific Corporation. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. This program may not be available in all countries. 0000003307 00000 n Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Boston Scientific Corporation. 99 40 <]>> CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Replacement stents provided under the Program are not eligible for the Program. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 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 0000194722 00000 n The delivery system The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Reference Part Numbers are not the same in all countries/regions. ` X Device Name. 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). Device Name: Biliary Stent with NaviflexTM RX Delivery System. All device bench test results were acceptable. 0000008839 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. Radiopaque markers are not available on all stents. Are you a Medical Device Company? Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 138 0 obj<>stream Donelli, G, MD, et. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Find products, medical specialty information, and education opportunities. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 4. 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 material not intended for use in France. First; Previous; . Other health care professionals should select their country in the top right corner of the website. All rights reserved. MRI Information for Healthcare . 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. Coils, Filters, Stents, and Grafts More. 0000001584 00000 n FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. ** 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. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Radial force helps maintain stent patency and resist migration. Data claim does not apply to the 3Fr stent. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Stent Placement Accuracy All rights reserved. Migration Resistance The stent was . 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