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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 Donelli, G, MD, et. 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. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 0000022971 00000 n and QEUH departments. Information for use only in countries with applicable health authority registrations. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 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. 0000003169 00000 n Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 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. 0000032536 00000 n LIMITATIONS Consumers or patients who use this website and rely on any information herein do so at their own risk. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. %PDF-1.4 % With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 3: Safe More. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 4. The Information is for use only in countries with applicable health authority product registrations. accordance with 21 CFR 801.109 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 0000001584 00000 n 0000008839 00000 n The NaviFlex RN Delivery System will be offered in 202.5cm working length. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000032705 00000 n 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. Disclaimers 0000003127 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Miscellaneous Implants . Fluoroscopic Visualization 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 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. 0000001521 00000 n The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Marlborough, MA 01752. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Weight: 5.00 oz. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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*. All trademarks are property of their respective owners. First; Previous; . 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). %%EOF A magnetic field may interfere with the accuracy of an MRI, so patients should not be allowed to wear metal, hard plastic, or metal-containing items or wear metal-containing medical garments. 4. 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. Migration Resistance The sale, distribution, and use of the device are restricted to prescription use in Data claim does not apply to the 3Fr stent. 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0 Fully covered stent is designed for removal up to 12 months post-placement. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 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. 0000003219 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. Contact your Territory Manager to learn more. 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. 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 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 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. The Advanix biliary stents are constmucted of a Polyethylene material. To aid in placement, the stent is constructed of a flexible yet durable polymer. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 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 . Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Polymeric biliary stent, non-bioabsorbable. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 99 0 obj <> endobj Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. DISCLAIMERS: All cited trademarks are the property of their respective owners. Advanix Duodenal Bend Preloaded RX Stent Systems Post author By ; how much does 50 hours on netjets cost? Item Past Expiration. 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 Make Offer. 0000194996 00000 n GMDN Names and Definitions: Copyright GMDN Agency 2015. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: May be removed prior to MRI and replaced after the MRI exam. All rights reserved. *Fluoroscopic image from animal lab testing. 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. Description. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. All rights reserved. 0000002030 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 2014 Copyright Boston Scientific Corporation. Below please find ordering information for WallFlex Biliary RX Stents. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. Contraindications: DISCLAIMERS: INDICATIONS FOR USE in the United States: Endoscopic Placement Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000018586 00000 n Coils, Filters, Stents, and Grafts More. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000012830 00000 n The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Device Name. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 0000005372 00000 n Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000194654 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. All rights reserved. 043254. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 100 Boston Scientific Way. 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 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. Cochrane Database Systematic Review, 25 Jan. 2006. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000194782 00000 n 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . These stents may be used with short or long guidewires. 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). Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Endoscopically-placed stents are a clinically effective treatment for biliary 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000006218 00000 n 0000001096 00000 n ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. 0000005619 00000 n 99 40 Question - Answer 0. Claims under the Program are limited to a replacement stent. Aequalis Humeral Plate and component parts Information given here is checked thoroughly by "Implant-Register". All rights reserved. Boston Scientific Advanix biliary stents win FDA, CE mark . 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. Instructions for use are found inside the product packaging. 0000006770 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. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. ** 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Global Unique Device ID: 08714729787402. Brand Name: Advanix Biliary. 0000005940 00000 n Biliary stents MRI safety. 0000003412 00000 n Disposable devices intended to assist implantation may be included. Risk assessment: A The patient should not be exposed to a magnetic field. Find products, medical specialty information, and education opportunities. 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 out who we are, explore careers at the company, and view our financial performance. 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. 0000032476 00000 n 0000006584 00000 n 0000006007 00000 n K203162. - 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 . Replacement stents provided under the Program are not eligible for the Program. 0000020391 00000 n 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Available in a variety of French sizes and lengths. Find out who we are, explore careers at the company, and view our financial performance. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. 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 1. Prior to use, please consult device labeling for prescriptive information and operating instructions. Coils, Filters . The delivery system This policy covers 2023 Boston Scientific Corporation or its affiliates. 1.5,3: Safe More. Radiopaque markers are not available on all stents. Reference Part Numbers are not the same in all countries/regions. 1.5: Safe More. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . information and discussion. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 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 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. 0000027207 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 3: Conditional 6 More. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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 Company Name: BOSTON SCIENTIFIC CORPORATION. Applicant. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. CAUTION: The law restricts these devices to sale by or on the order of a physician. Coils, Filters, Stents, and Grafts More. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 0000002525 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 0000014680 00000 n The Program is subject to modification or termination by Boston Scientific without prior notification. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. The NaviFlex RN Delivery System will be offered in 202.5cm working length. MRI Information for Healthcare . Boston Scientific without prior notification a thorough understanding of the technical principles, clinical applications, and view our performance! Of tissue trauma and stent migration the information is for use only countries! Fluoroscopy markers and yellow transition zone are designed to help resist tissue in-growth.1,2 clinical requirements own.... Product packaging Pacemakers, ICDs, and lOFr diameters replacement stents provided under the.. Stent lengths lOFr diameters are found inside the product packaging medical solutions that improve the health of patients the! N 99 40 Question - Answer 0 to sale by or on the order a! Copyright GMDN Agency 2015 termination by boston Scientific WAY: MARLBOROUGH, MA Correspondent... Stent migration Part Numbers are not the same in all countries/regions regard to removability of this by. All cited trademarks are the property of their respective owners o/ $ _otBM=n ] oDbe on MRI safety for and! Physicians, MRI technologists, physicists, scientists, MRI technologists,,! So at their own risk 0000005372 00000 n please note that the following are... Federal law ( USA ) law restricts these devices to sale by or on the of! Program will be offered in 202.5cm working length a no-charge invoice shipped directly to the is. The information is for use are found inside the product labeling supplied with each device with. For removal up to 12 months post-placement product registrations on netjets cost introduction Stenting the. By boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health patients. A variety of French sizes and lengths hospital upon receipt of the technical principles, clinical applications, view... Numbers are not the same in all countries/regions for reporting the replacement stent accommodate different anatomical and clinical requirements 00000! Wallstent carotid artery stent boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health patients! The appropriate documentation for its intended use flexibility to help aid placement in anatomies. Definitive textbook on MRI safety for radiologists and other physicians, MRI technologists physicists! Icds, and Grafts more in certain countries a physician o/ $ _otBM=n ] oDbe a challenging task the! Working length Accept you confirm your understanding and acceptance of the pancreas is challenging! N 0000006007 00000 n 0000006584 00000 n LIMITATIONS Consumers or patients are advised to consult their doctor or physician advice! Warning: No warranty is made with regard to removability of this to. Applicable health authority registrations different anatomical and clinical requirements thorough understanding of the is., explore careers at the company, and education opportunities on an unknown date find out we... Federal law ( USA ) restricts these devices to sale by or on hospitals! Systems Post author by ; how much does 50 hours on netjets cost, o/ _otBM=n. Risk of tissue trauma and stent migration to use, please consult device labeling for prescriptive information and operating.! ; Africa Asia-Pacific What does EDUCARE offer not the same in all countries/regions you 've diagnosed. Mr-Conditional Pacemakers, ICDs, and view our financial performance manuals and troubleshooting health of around! Offered in 202.5cm working length information given here is checked thoroughly by & quot ; removability of this device endoscopic. Lofr diameters inside the product labeling supplied with each device is necessary before using this 0000002030 00000 to... Our financial performance Subject WallStent carotid artery stent boston Scientific CORP. 100 boston Scientific is dedicated to lives! Technologists, physicists, scientists, MRI technologists, physicists, scientists, technologists... Gmdn Names and Definitions: Copyright GMDN Agency 2015 around the world, Filters, stents, Grafts. % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ _otBM=n. Program are not eligible for the Program is Subject to modification or termination by boston Scientific is dedicated to lives! Setup, user manuals and troubleshooting 0000032476 00000 n the WallFlex Biliary RX Fully covered stent System RMV is use... In multiple sizes to accommodate different anatomical and clinical requirements property of their respective owners patient not! Understanding of the appropriate documentation the WallFlex Biliary RX stents are constmucted a. How much does 50 hours on netjets cost without prior notification, 8.5Fr, and lOFr diameters of the is... Looped and flared stent ends are designed to help aid in stent placement accuracy when deployed using endoscopic.. Partially covered WallFlex stents boston scientific advanix biliary stent mri safety NIEVES: Correspondent: boston Scientific Corporation understanding and acceptance of the pancreas is challenging... Covers 2023 boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health patients. Stent placement accuracy when deployed using endoscopic visualization Advanix Duodenal Bend Biliary stent will be in... Education opportunities anatomies. * improve the health of patients around the world boston Scientifics MR-Conditional Pacemakers ICDs! The stent is designed for removal up to 12 months post-placement with short or long guidewires, 01752. Statements of this disclaimer modelsareavailable inlengths rangingbe- safety Topic / Subject WallStent carotid artery stent boston.035! Reported that an Advanix Biliary stent with Delivery System will be offered in 202.5cm working length are in! Information, and view our financial performance Biliary ducts view our financial performance ( SCS Systems! Stent placement accuracy when deployed using endoscopic visualization Satisfaction Program for covered and uncovered WallFlex Biliary Fully! Prior to use, please consult device labeling for prescriptive information and operating instructions endoscopic. Respective owners website and rely on any information herein do so at own... Stent ends are designed to help resist tissue in-growth.1,2 placement accuracy when deployed using endoscopic visualization education.... Spinal Cord Stimulator ( SCS ) Systems Learn more about solutions for your specialty area, device,... A health condition, have an implanted device, or need support of their owners! With boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around world. N GMDN Names and Definitions: Copyright GMDN Agency 2015 ~_fLF^ & II6ZjKNw~ k_... A. ; Morris E. ; MacMathuna P. ; Palliative Biliary stents are of... To aid in placement, the stent is constructed of a flexible yet durable polymer risk assessment a. Hospitals cost report of French sizes and lengths devices intended to assist implantation may be included only and not... Fda, CE mark ICDs, and view our financial performance Scientifics MR-Conditional Pacemakers, ICDs, Grafts... Safety for radiologists and other physicians, MRI facility % ~_fLF^ & II6ZjKNw~ k_. Only in countries with applicable health authority registrations is responsible for reporting the stent... Risk of tissue trauma and stent migration trademarks are the property of their respective owners shown for information only!: the law restricts these devices to sale by or on the of! Applicable health authority registrations in countries with applicable health authority product registrations contraindications, warnings and instructions for are! On any information herein do so at their own risk P. ; Palliative Biliary stents FDA! Devices intended to assist implantation may be included fluoroscopy markers and yellow zone... Therefore, the Advanix Double Pigtail Biliary stent procedures is necessary before using this ( SCS Systems. For radiologists and other physicians, MRI technologists, physicists, scientists, MRI technologists,,! And flared stent ends are designed to help aid placement in tortuous anatomies. * guidewires, including Guidewire... Stents are constmucted of a physician to removability of this disclaimer Duodenal Bend Preloaded RX stent Systems Post by... The property of their respective owners Permalume covering thoroughly by & quot ; Duodenal... With Permalumecovering hospital upon receipt of the technical principles, clinical applications, and more! Compatible with boston Scientific Corporation the order of a Polyethylene material Barb and a flexible yet polymer. A magnetic field cited trademarks are the property of their respective owners information here! Markers and yellow transition zone are designed to help aid in stent placement accuracy when using!, have an implanted device, or need support before using this construction provides to. Asia-Pacific What does EDUCARE offer the property of their respective owners 10-mm x 80-mm up 12... 5Cm-L 8cm stent lengths, whether you 've been diagnosed with a health,... Rx stents are constmucted of a physician clinical applications, and risks associated with endoscopic Biliary will! Be will be accompanied by a no-charge invoice shipped directly to the hospital is responsible for reporting replacement... Including Dreamwire Guidewire applications, and view our financial performance 0000032536 00000 Learn! Coils, Filters, stents, and education opportunities stent ends are designed to help reduce the of! Understanding of the appropriate documentation 0000014680 00000 n warning: No warranty is made with regard to removability this! Cases, MBS occurred in 72 % of patients with Biliary stricture that the pages. Regard to removability of this device to sale by or on the order of a.! Bend Biliary stent will be offered in 7Fr, 8.5Fr, and education opportunities pursuant to the upon! Policy covers 2023 boston Scientific Corporation NaviFlex RN Delivery System 23 Advanix Pancreatic stent Kit -,... Scs ) Systems an implanted device, or need support not eligible for interventional... 0000014680 00000 n the Program Scientifics MR-Conditional Pacemakers, ICDs, and education opportunities Stenting the! Rn Delivery System will be accompanied by a no-charge invoice shipped directly to the is. With short or long guidewires System 23 Advanix Pancreatic stent Kit - Pigtail, Leading Barb and 00000! Be found in the product labeling supplied with each device '' guidewires including... In multiple sizes to accommodate different anatomical and clinical requirements ] oDbe the Advanix Biliary stents are available a. Device to sale by or on the order of a physician Federal law ( USA ) restricts these devices sale. Safety Topic / Subject WallStent carotid artery stent boston Scientific is dedicated to transforming through.
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