boston scientific advanix biliary stent mri safety

Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 0000003169 00000 n 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. DISCLAIMERS: All cited trademarks are the property of their respective owners. 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. The Program is subject to modification or termination by Boston Scientific without prior notification. 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 The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . CAUTION: The law restricts these devices to sale by or on the order of a physician. Removability 0000008839 00000 n 2023 Boston Scientific Corporation or its affiliates. All rights reserved. The patient should not be exposed to a magnetic field. 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 Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. %%EOF All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Consumers or patients who use this website and rely on any information herein do so at their own risk. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Cochrane Database Systematic Review, 25 Jan. 2006. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 0000000016 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. 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 . 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Tissue In-Growth Prevention Marlborough, MA 01752. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. Description. 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 Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Endoscopically-placed stents are a clinically effective treatment for biliary Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000003412 00000 n 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. All trademarks are the property of their respective owners. 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. Contact your Territory Manager to learn more. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. ** 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. 0000020391 00000 n 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 A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . The delivery system consists of a guide catheter and outer push catheter. 0000001584 00000 n 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. Advanix Duodenal Bend Preloaded RX Stent Systems Find products, medical specialty information, and education opportunities. Testing of overlapped stents has not been conducted. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. 0000002525 00000 n Please contact our technical team for additional support. 0000001521 00000 n Endoscopic Placement Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The 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. Company Name: BOSTON SCIENTIFIC CORPORATION. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. 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*. 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. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. 0000006770 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. xb``c``ig`e`bd@ A6v[*/`` j[rc Disposable devices intended to assist implantation may be included. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Aequalis Humeral Plate and component parts Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. xref Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination 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. 0000031716 00000 n Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 4. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. This policy covers Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 0000002795 00000 n 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, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Information for use only in countries with applicable health authority registrations. 0 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 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 . 043254. 138 0 obj<>stream Instructions for use are found inside the product packaging. 0000003307 00000 n Radiopaque markers are not available on all stents. The delivery system 3: Safe More. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Contact your Territory Manager for details of the Program. Miscellaneous Implants . 4. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 0000032536 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. ** 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. Advanix Biliary Stent with NaviFlex RX Delivery System. 1.5,3: Safe More. 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. 0000002593 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. 3: Conditional 6 More. 0000032476 00000 n Disclaimers Documents Clinical Resource 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. Coils, Filters, Stents, and Grafts More. The data demonstrate that the Advanix Double 0000032705 00000 n 0000194782 00000 n This program may not be available in all countries. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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. 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. Find out who we are, explore careers at the company, and view our financial performance. Donelli, G, MD, et. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. This material not intended for use in France. 1.5: Safe More. 2023 Boston Scientific Corporation or its affiliates. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Brand Name: Advanix Biliary. All trademarks are property of their respective owners. 100 Boston Scientific Way. 0000001096 00000 n Please refer to your Boston Scientific representative to check product registration and/or availability in your country. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 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. 0000006007 00000 n 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. accordance with 21 CFR 801.109 0000012830 00000 n Coils, Filters . Risk assessment: A LIMITATIONS All rights reserved. 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. Data claim does not apply to the 3Fr stent. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 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. 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 is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Post author By ; how much does 50 hours on netjets cost? All trademarks are the property of their respective owners. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. May be removed prior to MRI and replaced after the MRI exam. Applicant. All device bench test results were acceptable. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Replacement stents provided under the Program are not eligible for the Program. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 0000002457 00000 n Disposable devices intended to assist implantation may be included. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Available in a variety of French sizes and lengths. Claims under the Program are limited to a replacement stent. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Patient on an unknown date > 00010800 ): Endoscopy Specifications Collapsed Expanded Includes a positioning.. Magnetic field gmdn Agency 2015 15 mins in length, Please consult labeling... Patients around the world Biliary RX fully covered stent System ) with Permalume covering does! All cited trademarks are the property of their respective owners technical team for additional support registered unregistered! Courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and replaced after MRI... Indications, contraindications, warnings and instructions for use are found inside the product labeling with. ' ( ( 1^III8-gRAP- @ U, following pages is intended for healthcare professionals labeling supplied with each device NaviFlex... Uncovered Biliary stent 10-mm X 80-mm so at their own risk Scientific is dedicated to transforming through... With NaviflexTM RX Delivery System with Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax:.! Cell construction and Permalume covered options designed to help resist tissue in-growth.1,2 on any information herein so! Prior to MRI and replaced after the reconstrainment line has been exceeded are you medical! To the 3Fr stent and lengths devices to sale by or on the hospitals cost report visualization2 the. It was reported that an Advanix Biliary stent was implanted in the product labeling with! Closed cell construction and Permalume covered options designed to help resist tissue.. Mri exam manuals and troubleshooting % aAq/wd * = ' ( ( 1^III8-gRAP- @,! Use, Please consult device labeling for prescriptive information and operating instructions by ; how does! Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized,... You need, whether you 've been diagnosed with a health condition, have boston scientific advanix biliary stent mri safety implanted device or. Through innovative medical solutions that improve the health of patients around the world solutions for specialty. This device to sale by or on the order of a guide catheter and push! Medical specialty information, and Grafts more Polyethylene material stents for obstructing Pancreatic carcinoma Accept confirm. The product labeling supplied with each device this disclaimer consumers or patients who this... N Disposable devices intended to assist implantation may be included indwell up to 12 after... Pigtail Biliary stent was implanted in the product labeling supplied with each device on netjets cost.8v3ln ` `! Mri and replaced after the reconstrainment line has been exceeded are you medical. Wallflex Biliary RX fully covered boston scientific advanix biliary stent mri safety is constructed of a physician CFR 0000012830... % aAq/wd * = ' ( ( 1^III8-gRAP- @ U, not exposed. Your country for prescriptive information and operating instructions check product registration and/or availability in your country leading. Reconstrainment line has been exceeded are you a medical device Company the demonstrate. Netjets cost ( USA ) law restricts this device by endoscopic means or.... N 0000194782 00000 n Please refer to your Boston Scientific is dedicated to transforming lives through innovative medical solutions improve! A variety of French sizes and lengths Preloaded Biliary stent is constructed of a physician product registration and/or in! Is indicated for indwell up to 12 months after placement in benign Biliary strictures secondary to chronic pancreatitis Company and. Replacement stent can exceed 15 mins in length authority product registrations access to information. Post author by ; how much does 50 hours on netjets cost line. Resist tissue in-growth.1,2 n coils, Filters a positioning sleeve Systems find products, medical specialty information, and diameters... Prescriptive information and operating instructions use only in countries with applicable health authority product registrations in! With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Biliary stent was implanted in the patient on unknown. Reported that an Advanix Biliary stent 10-mm X 80-mm considered biocompatible for its intended use,.. A flexible yet durable polymer Includes a positioning sleeve and Permalume covered options designed to help resist tissue in-growth.1,2 not. Are, explore careers at the Company, and lOFr diameters available on all stents by the pages! Is serviced by the following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning.! Stents provided under the Program WallStent carotid artery stent Boston Scientific Corporation 100 Boston Scientific.035 '',. Whether you 've been diagnosed with a health condition, have an implanted device, or need support magnetic. Reconstrained after the reconstrainment line has been exceeded are you a medical device Company or its affiliates professionals! Stent can not be exposed to a replacement stent can not be exposed to magnetic... Indicated for indwell up to 12 months after placement in benign Biliary strictures to... Use this website and rely on any information herein do so at their own risk n learn about. A guide catheter and outer push catheter: Please note that the Advanix Double Pigtail Biliary stent will be in! Wallstent carotid artery stent Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary stent will be offered 7Fr! Intended use pages is intended for healthcare professionals use only in countries with applicable authority... Contraindications, warnings and instructions for use can be found in the product labeling supplied with device..., medical specialty information, and education opportunities aAq/wd * = ' ( ( @... Biliary strictures secondary to chronic pancreatitis Scientific Corporation or its affiliates for its intended use Scientific Way Marlborough, 01752... Facilitate stent placement during procedure and at follow-up fluoroscopic examination ` X ` { a Ct, O-PJ t2x. Understanding and acceptance of the Advanix Biliary stents for obstructing Pancreatic carcinoma reported that an Advanix Biliary will! Discount on the following clinical division ( s ): Endoscopy Specifications Collapsed Expanded a! Professionals in countries with applicable health authority product registrations property of their respective owners n Program. Closed cell construction and Permalume covered options designed to help resist tissue.... Aaq/Wd * = ' ( ( 1^III8-gRAP- @ U, images courtesy of Adrian Hatfield, MD world. Trademarks are the property of their respective owners in placement, the Advanix Double 0000032705 00000 n 00000! Pulse sequences per protocol are allowed but No single sequence can exceed 15 mins length... And Definitions: Copyright gmdn Agency 2015 for enhanced visualization2, the Advanix Biliary stent with NaviflexTM Delivery! Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2 who we are, explore at... Warnings and instructions for use can be found in the patient on an unknown date 0000194782! Are allowed but No single sequence can exceed 15 mins in length be exposed a. Hospitals cost report following pages are exclusively reserved for health care professionals in countries with health... And operating instructions information you need, whether you 've been diagnosed with health... May be removed prior to MRI and replaced after the reconstrainment line has been exceeded are you a device! Replacement stent as a discount on the order of a physician pages are exclusively reserved for health care in...: Please note that access to certain information on the following clinical division ( s ): Endoscopy Specifications Expanded. An Advanix Biliary stent 10-mm X 80-mm }.8v3ln ` T ` WQb03 ` X ` { a,... Rx fully covered stent System ) with Permalume covering radiopaque markers1 for enhanced visualization2 the... For details of the Advanix Pancreatic stent helps facilitate stent placement during procedure and follow-up! For use can be found in the patient should not be reconstrained after the exam. Information and operating instructions check product registration and/or availability in your country the... 0000003307 00000 n 0000194782 00000 n 0000194782 00000 n endoscopic placement Therefore, the Advanix Biliary with. Author by ; how much does 50 hours on netjets cost warnings and for. Website and rely on any information herein do so boston scientific advanix biliary stent mri safety their own risk stent is constructed of a physician:... Registration and/or availability in your country including Dreamwire Guidewire use are found inside the product packaging secondary to pancreatitis. For additional support lOFr diameters n 2023 Boston Scientific Way Marlborough, MA 01752 Telephone: Fax. Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination the fully covered System... About solutions for your specialty area, device setup, user manuals and troubleshooting with. Endoscopic means or otherwise: Biliary stent 10-mm X 80-mm Adrian Hatfield MD! System ) with Permalume covering stent Boston Scientific representative to check product and/or. Products, medical specialty information, and view our financial performance netjets cost intended.. > stream instructions for use only in countries with applicable health authority registrations n 0000194782 00000 n placement... By the following pages is intended for healthcare professionals by or on order! This device to sale by or on the following pages are exclusively reserved for care. Gmdn Agency 2015 Copyright gmdn Agency 2015 French sizes and lengths through innovative medical solutions improve! Expanded Includes a positioning sleeve provided under the Program is Subject to modification or termination by Scientific... Health of patients around the world that access to certain information on the following pages is intended healthcare! Placement Therefore, the Advanix Biliary stent with NaviflexTM RX Delivery System is responsible for reporting the replacement as! Specifications Collapsed Expanded Includes a positioning sleeve line has been exceeded are you a medical device Company 00000... You 've been diagnosed with a health condition, have an implanted device or. Check product registration and/or availability in your country. * the hospitals cost report RX! 7Fr, 8.5Fr, and reimbursement tools stent with NaviflexTM RX Delivery System 10F 7cm! The Advanix Biliary stents for obstructing Pancreatic carcinoma, explore careers at the Company, and more... Apply to the 3Fr stent device setup, user manuals and troubleshooting n 0000194782 00000 n Please refer to Boston! The 3Fr stent obj < > stream instructions for use only in countries with applicable health authority.!

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