All rights reserved. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- - 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 . information and discussion. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 0000005619 00000 n Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Advanix Duodenal Bend Preloaded RX Stent Systems Endoscopically-placed stents are a clinically effective treatment for biliary 1.5,3: Safe More. 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. K203162. Donelli, G, MD, et. Are you a Medical Device Company? These stents may be used with short or long guidewires. All rights reserved. The indications for pancreatic stent implantation are either prophylactic or Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. May be removed prior to MRI and replaced after the MRI exam. 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. 0000020391 00000 n Advanix Biliary Stent with NaviFlex RX Delivery System. Other health care professionals should select their country in the top right corner of the website. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 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. 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. xref 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. Weight: 5.00 oz. 0000001521 00000 n *Fluoroscopic image from animal lab testing. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Maple Grove, M. 3: Safe More. 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). 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 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. All device bench test results were acceptable. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Information for use only in countries with applicable health authority registrations. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 3: Safe More. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use All trademarks are property of their respective owners. 100 Boston Scientific Way. Which region are you in? Post author By ; how much does 50 hours on netjets cost? 0000010863 00000 n 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. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 0000006584 00000 n 0000022971 00000 n Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Reproduced with Permission from the GMDN Agency. Brand Name: Advanix Biliary. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The Information is for use only in countries with applicable health authority product registrations. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 138 0 obj<>stream Biliary stents MRI safety. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Brand Name: Advanix Biliary Version or Model: M00534320 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787419 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Find out who we are, explore careers at the company, and view our financial performance. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. 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. 0000003169 00000 n The patient should not be exposed to a magnetic field. 0000006359 00000 n However we can not guarantee for any material, property or completeness. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Question - Answer 0. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 0000005940 00000 n The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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. Risk assessment: A Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 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). When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. ` X Coils, Filters . 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 043254. Please check availability with your local sales representative or customer service. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Data claim does not apply to the 3Fr stent. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000000016 00000 n Contact your Territory Manager for details of the Program. Coils, Filters, Stents, and Grafts More. Device Name. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 0000006007 00000 n %%EOF United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Miscellaneous Implants . 0000194654 00000 n Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 2023 Boston Scientific Corporation or its affiliates. Gastrointestinal Endoscopy, 2006; 63: 986-995. Radiopaque markers are not available on all stents. Radial Force Disposable devices intended to assist implantation may be included. 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. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Disposable devices intended to assist implantation may be included. `abi` 2"Hb? and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 0000002457 00000 n A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 2023 Boston Scientific Corporation or its affiliates. Contraindications: 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). All rights reserved. Description. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 0000003127 00000 n 0000194782 00000 n Global Unique Device ID: 08714729787402. 0000003307 00000 n The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000003412 00000 n Coils, Filters, Stents, and Grafts More. Tissue In-Growth Prevention Testing of overlapped stents has not been conducted. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. { a Ct, O-PJ ` t2x > 00010800 by ; how much 50... 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