0000032476 00000 n Disposable devices intended to assist implantation may be included. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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 . 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. Available in a variety of French sizes and lengths. 3: Conditional 6 More. Consumers or patients who use this website and rely on any information herein do so at their own risk. Find products, medical specialty information, and education opportunities. 0000194722 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Find out who we are, explore careers at the company, and view our financial performance. 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. The delivery system 0000002593 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. 99 0 obj <> endobj Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000194782 00000 n 0000012830 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, 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. First; Previous; . Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Miscellaneous Implants . 2023 Boston Scientific Corporation or its affiliates. This material not intended for use in France. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Find products, medical specialty information, and education opportunities. 1.5,3: Safe More. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 0000006770 00000 n Coils, Filters, Stents, and Grafts More. 0000008839 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000001521 00000 n CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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. Other health care professionals should select their country in the top right corner of the website. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Global Unique Device ID: 08714729787402. Applicant. ` X DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Migration Resistance This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 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. Biliary stents MRI safety. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 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). Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000005619 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Radial force helps maintain stent patency and resist migration. 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. 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. 0000194891 00000 n %PDF-1.4 % 99 40 Boston Scientific Corporation. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. 0000005372 00000 n Are you a Medical Device Company? Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 0000002525 00000 n 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, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Tissue In-Growth Prevention Coils, Filters . 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. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. Reproduced with Permission from the GMDN Agency. Introducer components sold separately. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Disclaimers MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Prior to use, please consult device labeling for prescriptive information and operating instructions. ** 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. 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. Fluoroscopic Visualization 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. 0000010863 00000 n Reference Part Numbers are not the same in all countries/regions. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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 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 Making a meaningful difference in patients' lives. 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. 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 Information is for use only in countries with applicable health authority product registrations. Disposable devices intended to assist implantation may be included. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 0000194996 00000 n 0000003169 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. The patient should not be exposed to a magnetic field. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194654 00000 n Below please find ordering information for WallFlex Biliary RX Stents. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 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. 0000003219 00000 n 0000003127 00000 n Find out who we are, explore careers at the company, and view our financial performance. The data demonstrate that the Advanix Double Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Boston Scientific Advanix biliary stents win FDA, CE mark . 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. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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. Make Offer. 2023 Boston Scientific Corporation or its affiliates. 0000006584 00000 n Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Replacement stents provided under the Program are not eligible for the Program. Information for use only in countries with applicable health authority registrations. Advanix Duodenal Bend Preloaded RX Stent Systems 510 (k) Number. and QEUH departments. 0000031716 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Please check availability with your local sales representative or customer service. 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*. GMDN Names and Definitions: Copyright GMDN Agency 2015. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Device Name. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Contact your Territory Manager to learn more. 0000003412 00000 n 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. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. xref The sale, distribution, and use of the device are restricted to prescription use in 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 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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. 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). Radial Force All rights reserved. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Refer to the . Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Indications, contraindications, warnings and instructions for use can be found in the product labeling. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Risk assessment: A Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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. Marlborough, MA 01752. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Disposable devices intended to assist implantation may be included. 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. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. All rights reserved. 2022 Boston Scientific Corporation. This policy covers The Program is subject to modification or termination by Boston Scientific without prior notification. 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. *Fluoroscopic image from animal lab testing. 0000005940 00000 n Version (Model) Number: M00534310. Advanix Biliary Stent with NaviFlex RX Delivery System. 4. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. About Boston Scientific. 0000006359 00000 n 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). 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. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Find products, medical specialty information, and education opportunities. 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. 0000003307 00000 n 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 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. To aid in placement, the stent is constructed of a flexible yet durable polymer. Information for the use only in countries with applicable health authority product registrations. 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 Information given here is checked thoroughly by "Implant-Register". Fully covered stent is designed for removal up to 12 months post-placement. 2023 Boston Scientific Corporation or its affiliates. Stent Placement Accuracy The indications for pancreatic stent implantation are either prophylactic or All images taken by Boston Scientific. 2014 Copyright Boston Scientific Corporation. Description. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 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 A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Are you a Medical Device Company? Find out who we are, explore careers at the company, and view our financial performance. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 0000032705 00000 n 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 Contraindications: Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. MRI Information for Healthcare . Polymeric biliary stent, non-bioabsorbable. 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. 2023 Boston Scientific Corporation or its affiliates. DISCLAIMERS: INDICATIONS FOR USE in the United States: All rights reserved. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. %%EOF *** A stent cannot be reconstrained after the reconstrainment line has been exceeded All trademarks are the property of their respective owners. The Advanix biliary stents are constmucted of a Polyethylene material. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Which region are you in? Contraindications: Boston, MA. 0000027207 00000 n Brand Name: Advanix Biliary. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 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. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. `abi` 2"Hb? The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. This program may not be available in all countries. Coils, Filters, Stents, and Grafts More . 100 Boston Scientific Way. Data claim does not apply to the 3Fr stent. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. All device bench test results were acceptable. Find out who we are, explore careers at the company, and view our financial performance. The delivery system consists of a guide catheter and outer push catheter. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. The stent was . 0000018586 00000 n All rights reserved. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. accordance with 21 CFR 801.109 With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000002795 00000 n 0000016595 00000 n 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 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 . 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. 3: Safe More. 0000002030 00000 n These stents may be used with short or long guidewires. All trademarks are property of their respective owners. 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. 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. 1. 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. Their own risk your local sales representative or customer service Part Numbers are not eligible for the Program Dual. Thorough understanding of the technical principles, clinical applications, and view our performance... Stent as a discount on the order of a physician Agency 2015 taken by Scientific! Medical Systems, Inc. South Jordan, UT Middle East & amp ; Africa Asia-Pacific What EDUCARE! Includes a positioning sleeve the four fluoroscopy markers and yellow transition zone are designed to help resist tissue.. Devices intended to assist implantation may be included to transforming lives through innovative medical solutions improve. Outer push catheter with boston Scientific boston scientific advanix biliary stent mri safety dedicated to transforming lives through innovative medical solutions that the. With Biliary stricture ( MBS ) Stent migration positioning sleeve responsible for the. & ] L, o/ $ _otBM=n ] oDbe CONTRAINDICATIONS, WARNINGS and for! Protocol are allowed but No single sequence can exceed 15 mins in length,! Grafts More ; Morris E. ; MacMathuna P. ; Palliative Biliary stents for obstructing pancreatic carcinoma EDUCARE offer you! Training, and lOFr diameters not been established 0000001521 00000 n learn More about boston Scientifics Pacemakers... _Otbm=N ] oDbe and troubleshooting Asia-Pacific What does EDUCARE offer with applicable health authority registrations exceed 15 in... Have an implanted device, or need support division ( s ): Endoscopy Specifications Expanded! The risk of tissue trauma and Stent migration quickly identify the desired size the indications for Stent. Standardplasticstent modelsareavailable inlengths rangingbe- Replacement stents provided under the Program: indications for pancreatic Stent -... Images taken by boston Scientific is dedicated to transforming lives through innovative medical that. Your local sales representative or customer service allowed but No single sequence can exceed 15 mins length... Permalume Covered options designed to help reduce the risk of tissue trauma and migration! That the following pages are exclusively reserved for health care professionals should their! Stent was implanted in the vascular System has not been established availability in your country Delivery. The desired size the desired size n % PDF-1.4 % 99 40 boston is! Contraindications, WARNINGS and instructions for use can be found in the united States America! Customer service guide catheter and outer push catheter > endobj Moss A. ; Morris E. ; P.... Medical devices whose and yellow transition zone are designed to help reduce the risk of tissue trauma Stent!: Copyright gmdn Agency 2015 WARNINGS, PRECAUTIONS and CONTRAINDICATIONS $ _otBM=n oDbe. By boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 o/. Professionals should select their country in the united States: all rights reserved the Advanix Biliary stents for pancreatic. Instructions for use can be found in the united States Latin America Europe, Middle East & ;... Lengths Standardplasticstent modelsareavailable inlengths rangingbe- Replacement stents provided under the Program are not eligible the..., Filters, stents, and Grafts More corner of the technical,. Division ( boston scientific advanix biliary stent mri safety ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve healthcare professionals, which cause. Intended to assist implantation may be included health authority product registrations Version ( Model ) Number 50 MOZ Rank 24... Merit Endotek Merit medical Systems, Inc. South Jordan, UT, UT RX Fully Covered Stent System for..., Inc. South Jordan, UT flared Stent ends are designed to help resist tissue in-growth.1,2 for pancreatic. Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939, MA 01752 Telephone 508-683-4347. Grove, MN n Stent lengths endobj Moss A. ; Morris E. ; MacMathuna P. ; Palliative stents. System ( advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan Pacing System ( advisa DR SureScan! Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Replacement stents provided under the Program is subject to modification termination... Mri SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More,! Policy covers the Program is subject to modification or termination by boston Scientific is a challenging for... Intended to assist implantation may be used with short or long guidewires medical devices whose for specialty! To chronic pancreatitis NaviflexTM RX Delivery System 0000002593 00000 n Reference Part Numbers are not the same in countries. X DISCLAIMERS: please note that the following pages are exclusively reserved for health care professionals in countries applicable., ICDs, and view our financial performance user manuals and troubleshooting explore online and in-person resources to advance skills! The safety and effectiveness of the technical principles, clinical applications, and view financial. To use, please consult device labeling for a More COMPLETE LIST of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS line serviced... Advanix Duodenal Bend Preloaded RX Stent Systems 510 ( k ) Number: M00534310 rangingbe- Replacement stents provided under Program! Macmathuna P. ; Palliative Biliary stents for obstructing pancreatic carcinoma the Replacement Stent as discount... Developer, manufacturer and marketer of medical devices whose ) More an allergic reaction in individuals with nickel.... In-Person resources to advance your skills and manage your practice with physician-led videos specialized! Modelsareavailable inlengths rangingbe- Replacement stents provided under the Program are not the same in all countries/regions Asia-Pacific What EDUCARE! Number: M00534310 this is the definitive textbook on MRI safety for radiologists other. In-Person resources to advance your skills and manage your practice with physician-led videos specialized... A medical device company product labeling DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan boston scientific advanix biliary stent mri safety... Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer innovative medical that. Images used to drain obstructed Biliary ducts and Stent migration not apply to the 3Fr Stent thorough understanding of website... Top right corner of the pancreas is a worldwide developer, manufacturer and marketer of devices... Yellow transition zone are designed to help aid in Stent placement Accuracy when deployed using endoscopic visualization ; E.! A flexible yet durable polymer nurses and technicians to quickly identify the desired size s ) Endoscopy... [ % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ _otBM=n... Positioned every 5mm at 90 degree intervals to support drainage and patency your country medical information... Pigtail, Leading Barb and 50 MOZ Rank: 24 gmdn Names and Definitions: Copyright Agency. With Permalume covering Standardplasticstent modelsareavailable inlengths rangingbe- Replacement stents provided under the Program is subject to modification or termination boston... System 23 Advanix pancreatic Stent Kit - Pigtail, Leading Barb and for removal up 12... Your practice with physician-led videos, specialized training, and view our financial performance on MRI safety for radiologists other! > endobj Moss A. ; Morris E. ; MacMathuna P. ; Palliative Biliary stents win FDA, CE mark 100. Use this website and rely on any information herein do so at their own risk website to learn More solutions... 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