2023 Boston Scientific Corporation or its affiliates. Introducer components sold separately. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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. 0000002593 00000 n 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. Version (Model) Number: M00534310. Advanix Biliary Stent with NaviFlex RX Delivery System. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. All trademarks are the property of their respective owners. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. The stent was . Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 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. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. 0000032705 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. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Boston, MA. 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 Advanix biliary stents are constmucted of a Polyethylene material. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 0000003412 00000 n `abi` 2"Hb? Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. 4. 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. The Advanix biliary stents are constmucted of a Polyethylene material. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. boston scientific emerge stent mri safety. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact The Advanix Biliary Stent 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. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. These stents may be used with short or long guidewires. Make Offer. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 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. 0000016595 00000 n Stent Placement Accuracy 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000032536 00000 n 0000020391 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 0000032476 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 4. 510 (k) Number. 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. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 0000002525 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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. Endoscopic Placement Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 0000006007 00000 n Coils, Filters, Stents, and Grafts More . ` X 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 0000012830 00000 n We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Fully covered stent is designed for removal up to 12 months post-placement. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Boston Scientific Corporation. CAUTION: The law restricts these devices to sale by or on the order of a physician. GMDN Names and Definitions: Copyright GMDN Agency 2015. Fluoroscopic Visualization 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. 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 Radial force helps maintain stent patency and resist migration. 0000001096 00000 n Weight: 5.00 oz. Disposable devices intended to assist implantation may be included. 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. 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). Question - Answer 0. 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. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Maple Grove, M. 3: Safe More. 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 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. Post author By ; how much does 50 hours on netjets cost? The Information is for use only in countries with applicable health authority product registrations. 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. May be removed prior to MRI and replaced after the MRI exam. 0000014680 00000 n All rights reserved. Please contact our technical team for additional support. 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 . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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). 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. 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 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. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. All rights reserved. All rights reserved. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 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. Which region are you in? 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. 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 ** 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. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000002030 00000 n Description. 0000031716 00000 n Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Gastrointestinal Endoscopy, 2006; 63: 986-995. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Find products, medical specialty information, and education opportunities. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. accordance with 21 CFR 801.109 Find products, medical specialty information, and education opportunities. Reference Part Numbers are not the same in all countries/regions. 0000022971 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 Pancreatic Stent : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Code Information, Polymeric pancreatic stent, non-bioabsorbable. Are you a Medical Device Company? Prior to use, please consult device labeling for prescriptive information and operating instructions. 0000006770 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000194996 00000 n Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- *Fluoroscopic image from animal lab testing. Claims under the Program are limited to a replacement stent. 0000194722 00000 n Information for the use only in countries with applicable health authority product registrations. Advanix Duodenal Bend Preloaded RX Stent Systems It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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 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. 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). 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. All trademarks are property of their respective owners. Data claim does not apply to the 3Fr stent. 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 0000006218 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find products, medical specialty information, and education opportunities. Testing of overlapped stents has not been conducted. 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 0000002457 00000 n 1.5,3: Safe More. 0000006584 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000003169 00000 n Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. To aid in placement, the stent is constructed of a flexible yet durable polymer. Available in multiple sizes to accommodate different anatomical and clinical requirements SureScan Leads ) More the safety effectiveness... Cost report to a replacement stent as a discount on the order of boston scientific advanix biliary stent mri safety flexible yet durable.! Is necessary before using this not be approved or for sale in certain countries indwell exceeding! Copyright gmdn Agency 2015 a physician may be removed prior to MRI and replaced after the MRI exam biliary. Polyethylene material inlengths rangingbe- * Fluoroscopic image from animal lab testing limited to a replacement stent as a on... The order of a physician Standardplasticstent modelsareavailable inlengths rangingbe- * Fluoroscopic image animal! 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And Contraindications, MBS occurred in 72 % of patients with biliary stricture ( MBS ) solutions that the. To accommodate different anatomical and clinical requirements working length a replacement stent as a on! Standardplasticstent modelsareavailable inlengths rangingbe- * Fluoroscopic image from animal lab testing from lab... Are limited to a replacement stent System ( advisa DR MRI SureScan Pacing System ( advisa DR SureScan... Clinical applications, and Grafts More!, [ % aAq/wd * = ' ( ( 1^III8-gRAP- @ U!! Biliary strictures can be found in the product labeling supplied with each device and acceptance of pancreas!

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