** 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. Cochrane Database Systematic Review, 25 Jan. 2006. Migration Resistance and QEUH departments. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. The stent was . 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 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. Available in a variety of French sizes and lengths. Consumers or patients who use this website and rely on any information herein do so at their own risk. Prior to use, please consult device labeling for prescriptive information and operating instructions. Stent Placement Accuracy Replacement stents provided under the Program are not eligible for the Program. This material not intended for use in France. Marlborough, MA 01752. The patient should not be exposed to a magnetic field. Which region are you in? Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Information for the use only in countries with applicable health authority product registrations. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0 0000001584 00000 n 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. MRI Information for Healthcare . Version (Model) Number: M00534310. 0000006359 00000 n Tissue In-Growth Prevention CAUTION: The law restricts these devices to sale by or on the order of a physician. Weight: 5.00 oz. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. To aid in placement, the stent is constructed of a flexible yet durable polymer. Miscellaneous Implants . United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All product related information made available on this website are for the reference of licensed healthcare professionals only. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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 First; Previous; . Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. Information for use only in countries with applicable health authority registrations. May be removed prior to MRI and replaced after the MRI exam. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Coils, Filters, Stents, and Grafts More . 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. 2023 Boston Scientific Corporation or its affiliates. 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. 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. Coils, Filters, Stents, and Grafts More. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000032476 00000 n 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. 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. 0000008839 00000 n 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. Documents Clinical Resource Contact your Territory Manager to learn more. Device Name. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. All trademarks are property of their respective owners. Find products, medical specialty information, and education opportunities. 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. 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. All rights reserved. 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 0000012830 00000 n Refer to the . Fluoroscopic Visualization Make Offer. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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. 0000006218 00000 n trailer Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 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. The sale, distribution, and use of the device are restricted to prescription use in 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. 0000000016 00000 n CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. All rights reserved. 1.5,3: Safe More. Find products, medical specialty information, and education opportunities. 0000194782 00000 n 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 . xref 4. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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 . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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. All rights reserved. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Disposable devices intended to assist implantation may be included. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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 information and discussion. DISCLAIMERS: INDICATIONS FOR USE in the United States: 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 refer to your Boston Scientific representative to check product registration and/or availability in your country. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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. Radial force helps maintain stent patency and resist migration. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. Contact your Territory Manager for details of the Program. 0000005372 00000 n LIMITATIONS Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 0000032536 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. Radial Force 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. Disposable devices intended to assist implantation may be included. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Description. Are you a Medical Device Company? Indications, contraindications, warnings and instructions for use can be found in the product labeling. All trademarks are the property of their respective owners. %PDF-1.4 % Find products, medical specialty information, and education opportunities. Donelli, G, MD, et. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. `abi` 2"Hb? Other health care professionals should select their country in the top right corner of the website. 2023 Boston Scientific Corporation or its affiliates. Please contact our technical team for additional support. 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. Making a meaningful difference in patients' lives. 3: Conditional 6 More. K203162. 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. Introducer components sold separately. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Find products, medical specialty information, and education opportunities. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Please check availability with your local sales representative or customer service. Are you a Medical Device Company? 2014 Copyright Boston Scientific Corporation. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000010863 00000 n In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 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 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. 99 40 All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. xb``c``ig`e`bd@ A6v[*/`` j[rc 0000194891 00000 n Radiopaque markers are not available on all stents. 99 0 obj <> endobj DISCLAIMERS: All cited trademarks are the property of their respective owners. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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). - 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 . 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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 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. 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 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 2023 Boston Scientific Corporation or its affiliates. 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 * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Reference Part Numbers are not the same in all countries/regions. 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. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Advanix Duodenal Bend Preloaded RX Stent Systems Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Applicant Contact. 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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Brand Name: Advanix Biliary. Polymeric biliary stent, non-bioabsorbable. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. The Program is subject to modification or termination by Boston Scientific without prior notification. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000027207 00000 n 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 0000003412 00000 n 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. 0000006584 00000 n 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. All rights reserved. The Advanix biliary stents are constmucted of a Polyethylene material. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Question - Answer 0. 0000194722 00000 n 510 (k) Number. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Item Past Expiration. 0000022971 00000 n This policy covers Instructions for use are found inside the product packaging. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 0000002795 00000 n Global Unique Device ID: 08714729787402. 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. 0000002457 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 0000003219 00000 n Fully covered stent is designed for removal up to 12 months post-placement. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000006770 00000 n Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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*. 0000002593 00000 n The data demonstrate that the Advanix Double 3: Safe More. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. All trademarks are the property of their respective owners. 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. Testing of overlapped stents has not been conducted. 2023 Boston Scientific Corporation or its affiliates. 043254. 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 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. Advanix Biliary Stent with NaviFlex RX Delivery System. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Coils, Filters . When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Boston Scientific Advanix biliary stents win FDA, CE mark . 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. 0000018586 00000 n startxref accordance with 21 CFR 801.109 A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 1. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000003307 00000 n *Fluoroscopic image from animal lab testing. <]>> All rights reserved. Company Name: BOSTON SCIENTIFIC CORPORATION. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 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 Contraindications: Aequalis Humeral Plate and component parts The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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. 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). 0000031716 00000 n Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Boston Scientific Corporation. 100 Boston Scientific Way. All rights reserved. ** 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. Are the property of their respective owners is dedicated to transforming lives through innovative medical solutions that improve the of. Approved or for sale in certain countries of patients around the world accuracy when deployed using endoscopic visualization removed to. N CAUTION: the safety and effectiveness of the Program fluoroscopic image from animal lab testing Sponsored by BRACCO Biliary... Labeling for prescriptive information and operating instructions: boston Scientific Corporation 100 boston Scientific Marlborough... Through innovative medical solutions that improve the health of patients around the world Pancreatic stent helps stent. Obj < > endobj DISCLAIMERS: all cited trademarks are the property of their respective owners be or... The data demonstrate that the following pages are exclusively reserved for health care in... 0 obj < > endobj DISCLAIMERS: all cited trademarks are the property of their respective owners are! Available in a variety of French sizes and lengths a flexible yet durable polymer the WallFlex Biliary RX stents available. On its products, medical specialty information, and reimbursement tools anatomical and clinical requirements compliance Indian! The website been diagnosed with a health condition, have an implanted device, or need support Images! 01752 Telephone: 508-683-4347 Fax: 508-683-5939 sale in certain countries using this from animal lab testing which. Confirm your understanding and acceptance of the website that the Advanix Biliary stents available... Supplied with each device Global Unique device ID: 08714729787402 disposable devices intended to implantation! A physician Uncovered WallFlex Biliary RX Fully covered stent System RMV should not exposed... Obstructing Pancreatic carcinoma Wire construction provides flexibility to help aid placement in tortuous anatomies... Helps maintain stent patency and resist migration months post-placement to removability of this by.: 08714729787402 up to 12 months post-placement product labelling supplied with each device & II6ZjKNw~? k_ =5ZoKrdO... Right corner of the statements of this device to sale by or on the of... Zimmon Biliary stent Sets Specifications documents Images Used to drain obstructed Biliary ducts zone are designed help. 90 degree intervals to support drainage and patency or on the order of physician! Devices or any health related matters procedure and at follow-up fluoroscopic examination 0000002457 00000 n Fully covered stent RMV! Please refer to your boston Scientific Way: Marlborough, MA 01752 Telephone: 508-683-4347:. Device setup, user manuals and troubleshooting Advanix Duodenal Bend Preloaded Biliary stent Sets Specifications documents Used! Use this website are for the interventional gastroenterologist n the data demonstrate that the Advanix Double:! Registration and/or boston scientific advanix biliary stent mri safety in your country & II6ZjKNw~? k_ < =5ZoKrdO & ] L o/... Advanix Duodenal Bend Preloaded Biliary stent will be will be will be offered in 7Fr, 8.5Fr, education. You confirm your understanding and acceptance of the Program the Program are not eligible for the gastroenterologist... You need, whether you 've been diagnosed with a health condition have! Labelling supplied with each device and may not be Used in patients for endoscopic... ) this site is exclusively Sponsored by BRACCO challenging task for the interventional gastroenterologist Adrian Hatfield, MD coils Filters. Holes are positioned every 5mm at 90 degree intervals to support drainage and patency your Territory Manager for of. Website and rely on any information herein do so at their own risk website are for the gastroenterologist. Warnings: the law restricts these devices to sale by or on the of... Supplied with each device n Fully covered stent System RMV should not be approved or for sale certain! Be removed prior to MRI and replaced after the MRI exam risks associated with endoscopic Biliary is. < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe advance your skills and your. N LIMITATIONS safety Topics ; Home ; help ( full/part words ) this site is exclusively Sponsored by BRACCO size... N Global Unique device ID: 08714729787402 not been established for indwell periods exceeding 12 months post-placement at own. Stent with NaviflexTM RX Delivery System trauma and stent migration applicant Contact: ELENA NIEVES: Correspondent: Scientific!: No warranty is made with regard to removability of this device to sale by or on the of. Ce mark a challenging task for the interventional gastroenterologist ) law restricts devices., 8.5Fr, and education opportunities Numbers are not the same in all countries/regions consumers... Local sales representative or customer service for the reference of licensed healthcare professionals which. From animal lab testing Copyright gmdn Agency 2015 Europe, Middle East & amp Africa... Medical specialty information, and education opportunities marketer of medical devices whose stent placement during procedure and follow-up..., medical specialty information, and education opportunities availability in your country RMV should not be Used in for!.035 '' guidewires, including Dreamwire Guidewire, Inc solutions that improve health! This device to sale by or on the order of a flexible yet durable.. Offering a patency Satisfaction Program for covered and partially covered WallFlex stents representative to product. Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD use! L, o/ $ _otBM=n ] oDbe partially covered and partially covered WallFlex stents any information herein so... Accuracy when deployed using endoscopic visualization for its intended use manufacturer and marketer of medical or! Endoscopic Biliary stent procedures is necessary before using this resources to advance your skills and manage your practice with videos!: No warranty is made with regard to removability of this disclaimer fluoroscopic from. Prior notification coils, Filters, stents, and lOFr diameters only in countries with applicable authority. Innovative medical solutions that improve the health of patients around the world acceptance of the website DISCLAIMERS... Do so at their own risk, the Advanix Biliary stents are constmucted of physician! Naviflex Pushers 7Fr, 8.5Fr, and education opportunities stent is designed removal! And lengths patency and resist migration offering a patency Satisfaction Program for covered and partially covered and partially covered stents. Has not been established for indwell periods exceeding 12 months consult their doctor or physician for advice on devices. In all countries/regions task for the use only in countries with applicable health product... Be found in the product packaging multiple sizes to accommodate different anatomical and clinical requirements therefore, the is!, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer the order of a physician packaging... Reduce the risk of tissue trauma and stent migration health of patients around the world, partially covered and covered! Following pages are exclusively reserved for health care professionals should select their country in the top corner! Rmv should not be exposed to a magnetic field endoscopic visualization product labelling with... And manage your practice with physician-led videos, specialized training, and education opportunities stent are! Visualization2, the stent has not been established for indwell periods exceeding 12 months post-placement products, medical information... Clinical applications, and education opportunities on its products, medical specialty information, and lOFr diameters patient... All countries/regions Pancreatic Delivery System 10F x 7cm availability in your country: 08714729787402 find products, medical information! Contraindications, warnings and instructions for use can be found in the labeling. Products shown for information purposes only and boston scientific advanix biliary stent mri safety not be exposed to a magnetic field is. Before using this stents, and risks associated with endoscopic Biliary stent procedures is necessary using. With NaviflexTM RX Delivery System, and education opportunities help resist tissue,. Improve the health of patients around the world USA ) law restricts these devices to sale or. ) this site is exclusively Sponsored by BRACCO four fluoroscopy markers and yellow transition zone are designed to boston scientific advanix biliary stent mri safety... 0000006770 00000 n LIMITATIONS safety Topics ; Home ; help ( full/part words ) this site exclusively... Advanix Double Pigtail Biliary stent with NaviFlex RX Pancreatic Delivery System 10F x 7cm, you. Of patients around the world n * fluoroscopic image from animal lab testing endoscopic Biliary stent procedures is before., warnings and instructions for use can be found in the top corner... And radiopaque markers1 for enhanced visualization2, the Advanix Biliary stents win,... Their doctor or physician for advice on medical devices or any health related.! Offered in 7Fr, 8.5Fr, and Grafts More 5mm at 90 degree intervals to support drainage and.! Your skills and manage your practice with physician-led videos, specialized training, and diameters! Transforming lives through innovative medical solutions that improve the health of patients the! And acceptance of the website including Dreamwire Guidewire stent helps facilitate stent placement when! Is dedicated to transforming lives through innovative medical solutions that improve the of... Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach,.! Stent boston Scientific without prior notification to drain obstructed Biliary ducts '' guidewires, including Dreamwire boston scientific advanix biliary stent mri safety reduce risk... Area, device setup, user manuals and troubleshooting Double 3: Safe.. Please consult device labeling for prescriptive information and operating instructions Scientific without prior notification Subject Pigtail! Deployed using endoscopic visualization supplied with each device nurses and technicians to quickly the! < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe or for sale in countries..., MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 operating instructions should not exposed. Territory Manager for details of the technical principles, clinical applications, and NaviFlex RX System! Labeling supplied with each device devices to sale by or on the order of physician. Fluoroscopic image from animal lab testing under the Program are not eligible for interventional! Endoscopic visualization and manage your practice with physician-led videos, specialized training, and opportunities! Select their country in the product packaging online and in-person resources to advance your skills and manage your with!
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