EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. %%EOF
Information given here is checked thoroughly by "Implant-Register". With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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. The patient should not be exposed to a magnetic field. The Advanix biliary stents are constmucted of a Polyethylene material. Applicant Contact. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 0000002525 00000 n
Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. This policy covers 0000002795 00000 n
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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 0000020391 00000 n
Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 0000001521 00000 n
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Disposable devices intended to assist implantation may be included. Radiopaque markers are not available on all stents. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 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 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 . startxref
Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. ** 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. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 3: Safe More. Coils, Filters . 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. 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. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. However we can not guarantee for any material, property or completeness. 0000014680 00000 n
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Disclaimers 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 HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. 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 Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Testing of overlapped stents has not been conducted. 2023 Boston Scientific Corporation or its affiliates. All rights reserved. Brand Name: Advanix Biliary. Are you a Medical Device Company? al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Available in a variety of French sizes and lengths. 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. Advanix Duodenal Bend Preloaded RX Stent Systems Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 510 (k) Number. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 0000005940 00000 n
Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. The sale, distribution, and use of the device are restricted to prescription use in 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Prior to use, please consult device labeling for prescriptive information and operating instructions. K203162. 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 options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. May be removed prior to MRI and replaced after the MRI exam. 0000194654 00000 n
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100 Boston Scientific Way. xb``c``ig`e`bd@ A6v[*/`` j[rc * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. All rights reserved. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 0000000016 00000 n
A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . boston scientific emerge stent mri safety. Endoscopic Placement * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 2023 Boston Scientific Corporation or its affiliates. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. MRI Information for Healthcare . About Boston Scientific. 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Maple Grove, M. 3: Safe More. 0000002593 00000 n
Disposable devices intended to assist implantation may be included. The NaviFlex RN Delivery System will be offered in 202.5cm working length. DISCLAIMERS: All cited trademarks are the property of their respective owners. All trademarks are the property of their respective owners. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Endoscopically-placed stents are a clinically effective treatment for biliary The delivery system Introducer components sold separately. 043254. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. All trademarks are property of their respective owners. To aid in placement, the stent is constructed of a flexible yet durable polymer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 3: Conditional 6 More. 0000008839 00000 n
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By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. The Information is for use only in countries with applicable health authority product registrations. 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. trailer
Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Coils, Filters, Stents, and Grafts More . Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Make Offer. 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. Miscellaneous Implants . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Claims under the Program are limited to a replacement stent. Version (Model) Number: M00534310. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. Instructions for use are found inside the product packaging. Information for the use only in countries with applicable health authority product registrations. 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. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Post author By ; how much does 50 hours on netjets cost? 0000003127 00000 n
Device Name. Are you a Medical Device Company? 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. 1.5,3: Safe More. 0000012830 00000 n
Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Removability 0000003169 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. Other health care professionals should select their country in the top right corner of the website. Polymeric biliary stent, non-bioabsorbable. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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 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. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. First; Previous; . Biliary stents MRI safety. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0
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Find products, medical specialty information, and education opportunities. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. These stents may be used with short or long guidewires. Boston Scientific Advanix biliary stents win FDA, CE mark . Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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 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. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. <]>>
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. 0000010863 00000 n
2023 Boston Scientific Corporation or its affiliates. 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. All product related information made available on this website are for the reference of licensed healthcare professionals only. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Contact your Territory Manager to learn more. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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. Coils, Filters, Stents, and Grafts More. endstream
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information and discussion. Coils, Filters, Stents, and Grafts More. 4. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000194782 00000 n
Migration Resistance 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. Risk assessment: A The stent was . All trademarks are the property of their respective owners. DISCLAIMERS: INDICATIONS FOR USE in the United States: Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. ` X
A biliary metal stent (also known as a "bile duct stent") is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. Find products, medical specialty information, and education opportunities. 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. LIMITATIONS accordance with 21 CFR 801.109 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 4. 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). 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*. Weight: 5.00 oz. 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 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 committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Please contact our technical team for additional support. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000003307 00000 n
Donelli, G, MD, et. Company Name: BOSTON SCIENTIFIC CORPORATION. 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. All device bench test results were acceptable. All images taken by Boston Scientific. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 0000006007 00000 n
Consumers or patients who use this website and rely on any information herein do so at their own risk. 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). Fully covered stent is designed for removal up to 12 months post-placement. This material not intended for use in France. CAUTION: The law restricts these devices to sale by or on the order of a physician. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 1. 0000005372 00000 n
2014 Copyright Boston Scientific Corporation. Fluoroscopic Visualization 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. Cochrane Database Systematic Review, 25 Jan. 2006. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. Global Unique Device ID: 08714729787402. Marlborough, MA 01752. Replacement stents provided under the Program are not eligible for the Program. 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
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