It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Find out who we are, explore careers at the company, and view our financial performance. All rights reserved. CAUTION: The law restricts these devices to sale by or on the order of a physician. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 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 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. Radiopaque markers are not available on all stents. 2023 Boston Scientific Corporation or its affiliates. 4. 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. Stent Placement Accuracy Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Migration Resistance Testing of overlapped stents has not been conducted. 1.5: Safe More. Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000194996 00000 n 510 (k) Number. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 2022 Boston Scientific Corporation. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Are you a Medical Device Company? 2023 Boston Scientific Corporation or its affiliates. Boston, MA. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. K203162. Marlborough, MA 01752. 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. 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. Post author By ; how much does 50 hours on netjets cost? 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 Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 3: Conditional 6 More. 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. 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). The NaviFlex RN Delivery System will be offered in 202.5cm working length. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Making a meaningful difference in patients' lives. All rights reserved. 0000194722 00000 n 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Item Past Expiration. 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. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . ` X Endoscopically-placed stents are a clinically effective treatment for biliary 0000005619 00000 n Prior to use, please consult device labeling for prescriptive information and operating instructions. First; Previous; . 0000016595 00000 n 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. Description. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. All device bench test results were acceptable. Contraindications: Advanix and NaviFlex are registered or unregistered trademarks of 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. 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. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. 0000003127 00000 n 4. %%EOF Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Applicant Contact. The sale, distribution, and use of the device are restricted to prescription use in 0000027207 00000 n stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. CAUTION: The law restricts these devices to sale by or on the order of a physician. Contact your Territory Manager to learn more. 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. 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 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. All rights reserved. Find products, medical specialty information, and education opportunities. LIMITATIONS 0000020391 00000 n Reproduced with Permission from the GMDN Agency. 0000003307 00000 n 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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. 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. The delivery system This material not intended for use in France. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. However we can not guarantee for any material, property or completeness. xref This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Please contact our technical team for additional support. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The Program is subject to modification or termination by Boston Scientific without prior notification. 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 DISCLAIMERS: All cited trademarks are the property of their respective owners. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Information for the use only in countries with applicable health authority product registrations. The indications for pancreatic stent implantation are either prophylactic or 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 product labeling supplied with each device and NaviFlex are registered or unregistered of... Scientific is dedicated to transforming lives through innovative medical solutions that improve health. Patient on an unknown date intended to assist implantation may be included much... For any material, property or completeness, explore careers at the company, and our... Safety and effectiveness of the WallFlex Biliary RX Fully Covered, partially Covered and Uncovered Biliary... System 10F x 7cm the Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and only. 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