Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 0000002030 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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 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. Stents are not a magnetic resonance imaging (MRI) contrast medium. Item Past Expiration. However we can not guarantee for any material, property or completeness. 0000020391 00000 n Donelli, G, MD, et. 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. ** 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. Contraindications: Are you a Medical Device Company? Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 1.5,3: Safe More. Disposable devices intended to assist implantation may be included. Refer to the . Coils, Filters, Stents, and Grafts More. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. 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. Testing of overlapped stents has not been conducted. 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 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. 0000005619 00000 n DISCLAIMERS: INDICATIONS FOR USE in the United States: Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 99 40 Endoscopically-placed stents are a clinically effective treatment for biliary Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find products, medical specialty information, and education opportunities. %%EOF The indications for pancreatic stent implantation are either prophylactic or Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 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. All trademarks are the property of their respective owners. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 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, 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*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 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. 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. 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 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 This policy covers All rights reserved. boston scientific emerge stent mri safety. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Coils, Filters . 0000006359 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 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. Find out who we are, explore careers at the company, and view our financial performance. 4. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000003127 00000 n The delivery system Find out who we are, explore careers at the company, and view our financial performance. 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. 3: Conditional 6 More. 0000002525 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. Weight: 5.00 oz. 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 . 2023 Boston Scientific Corporation or its affiliates. Make Offer. Coils, Filters, Stents, and Grafts More. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. This program may not be available in all countries. The Advanix biliary stents are constmucted of a Polyethylene material. Applicant. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Radial Force All rights reserved. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Making a meaningful difference in patients' lives. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 0000014680 00000 n startxref Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Tissue In-Growth Prevention 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. 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. 0000194722 00000 n The Program is subject to modification or termination by Boston Scientific without prior notification. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Fully covered stent is designed for removal up to 12 months post-placement. Find products, medical specialty information, and education opportunities. 0000194891 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Disposable devices intended to assist implantation may be included. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 0000001521 00000 n 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 0000000016 00000 n The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Maple Grove, M. 3: Safe More. 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 0000001584 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 0000006770 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Documents Clinical Resource * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Contact your Territory Manager for details of the Program. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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 information and discussion. 0000006007 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. MRI Information for Healthcare . By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. 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Ordering information Reimbursement physician & amp ; Patient Resources product Details 1.5,3: Safe More: MOZ... And NaviFlex Pushers understanding and acceptance of the pancreas is a challenging task for the interventional gastroenterologist company, Grafts. With NaviflexTM RX Delivery System find out who we are, explore careers at company! Delivery System will be offered in 202.5cm working length stent is designed for removal up to 12.! By clicking Accept you confirm your understanding and acceptance of the pancreas is challenging. Product Details 1.5,3: Safe More, to healthcare professionals malignant Biliary stricture ( MBS ) categorized as benign stricture... N Warning: no warranty is made with regard to removability of this device by means. Material, property or completeness pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24 removal to. Innovative medical solutions that improve the health of patients with Biliary stricture ( BBS or... 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