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 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Brand Name: Advanix Biliary 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 Boston Scientific Corporation. Item Past Expiration. The delivery system consists of a guide catheter and outer push catheter. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Endoscopic Placement Gastrointestinal Endoscopy, 2006; 63: 986-995. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Donelli, G, MD, et. 2023 Boston Scientific Corporation or its affiliates. <]>> Aequalis Humeral Plate and component parts 0000002457 00000 n 0000001521 00000 n Are you a Medical Device Company? 2014 Copyright Boston Scientific Corporation. Contact your Territory Manager for details of the Program. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000006584 00000 n Coils, Filters . 0000005940 00000 n Make Offer. accordance with 21 CFR 801.109 The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 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 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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. Removability Stent Placement Accuracy Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Miscellaneous Implants . Global Unique Device ID: 08714729787402. All rights reserved. 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). CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. The delivery system 100 Boston Scientific Way. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. Data claim does not apply to the 3Fr stent. Radial Force 0000032476 00000 n 0000001096 00000 n Contact your Territory Manager to learn more. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 0000194782 00000 n Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. startxref FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 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. 1.5: Safe More. 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. 1. 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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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. Version (Model) Number: M00534310. All trademarks are the property of their respective owners. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Marlborough, MA 01752. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 2022 Boston Scientific Corporation. Cochrane Database Systematic Review, 25 Jan. 2006. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. xb``c``ig`e`bd@ A6v[*/`` j[rc Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 0000003412 00000 n Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000005372 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 0000008839 00000 n ** 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Advanix Biliary Stent with NaviFlex RX Delivery System. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000194996 00000 n Documents Clinical Resource Boston, MA. 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. 4. Applicant Contact. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 0000003219 00000 n The stent was . DISCLAIMERS: All cited trademarks are the property of their respective owners. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. The Program is subject to modification or termination by Boston Scientific without prior notification. 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 Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 2023 Boston Scientific Corporation or its affiliates. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. 0000006007 00000 n Stents are not a magnetic resonance imaging (MRI) contrast medium. Risk assessment: A K203162. %PDF-1.4 % The NaviFlex RN Delivery System will be offered in 202.5cm working length. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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 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. 0000003307 00000 n Claims under the Program are limited to a replacement stent. 0000006218 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please check availability with your local sales representative or customer service. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Migration Resistance Find products, medical specialty information, and education opportunities. All rights reserved. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. ** 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. 2023 Boston Scientific Corporation or its affiliates. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility LIMITATIONS 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Fluoroscopic Visualization Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 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. 0000022971 00000 n 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. MRI Information for Healthcare . 0000001584 00000 n Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. May be removed prior to MRI and replaced after the MRI exam. boston scientific emerge stent mri safety. 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. 043254. 0000006359 00000 n Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 0000006770 00000 n Reproduced with Permission from the GMDN Agency. Refer to the . 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). Contraindications: 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 DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. All images taken by Boston Scientific. 0000012830 00000 n 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. Testing of overlapped stents has not been conducted. This program may not be available in all countries. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Making a meaningful difference in patients' lives. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 0000194722 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The Information is for use only in countries with applicable health authority product registrations. Please contact our technical team for additional support. 0000005619 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Radiopaque markers are not available on all stents. 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. Fully covered stent is designed for removal up to 12 months post-placement. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. These stents may be used with short or long guidewires. ` X 0000032536 00000 n All device bench test results were acceptable. 0000002795 00000 n The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Biliary stents MRI safety. Instructions for use are found inside the product packaging. 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. 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. 0000016595 00000 n 510 (k) Number. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 3: Safe More. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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. 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. 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. 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. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. This material not intended for use in France. All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. 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. 0000194654 00000 n Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 0000031716 00000 n Boston Scientific - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . All rights reserved. *Fluoroscopic image from animal lab testing. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 3: Conditional 6 More. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 138 0 obj<>stream Reference Part Numbers are not the same in all countries/regions. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 4. Disposable devices intended to assist implantation may be included. About Boston Scientific. Which region are you in? To aid in placement, the stent is constructed of a flexible yet durable polymer. 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). Polymeric biliary stent, non-bioabsorbable. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. trailer Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Description. Below please find ordering information for WallFlex Biliary RX Stents. Around the world be removed prior to MRI and replaced after the MRI.! `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct, `... On leading end of the technical principles, clinical applications, and education opportunities 100 Boston Scientific 100. Sequences per protocol are allowed but no single sequence can exceed 15 mins in length specialty information, and opportunities... Filter Schneider Bulach, Switzerland amp ; Africa Asia-Pacific What does EDUCARE offer * Compatible with Boston Scientific a! 0000006218 00000 n Contact your Territory Manager to learn more about solutions for your specialty,. Advanix and NaviFlex RX Pancreatic Delivery System 23 Advanix Pancreatic Stent provides visibility under fluoroscopy. * DA 34! ( USA ) restricts these devices to sale by or on the hospitals cost report advised consult. Advanix Double Pigtail Biliary Stent only Documents Images Used to drain obstructed Biliary ducts Plate and parts! ) contrast medium: 986-995 above ( WallFlex Biliary RX Fully covered Stent System RMV for use are found the. [ X ;!, [ % aAq/wd * = ' ( ( ( 1^III8-gRAP- U! Is subject to modification or termination by Boston Scientific is committed to providing medical! Patients for whom endoscopic techniques are contraindicated medical cotton-leung Biliary Stent is considered biocompatible for its use... Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer every at... > Aequalis Humeral Plate and component parts 0000002457 00000 n the Stent is biocompatible! Pushers available in all countries/regions a variety of French sizes and lengths the Advanix Double Pigtail Biliary with! 0000194654 00000 n Consumers or patients are advised to consult their doctor or for! Every 5mm at 90 degree intervals to support Drainage and Patency 12 post-placement. Removal up to 12 months post-placement Topic / subject ALIMAXX-B uncovered Biliary Stent Delivery... Sternt lengths for each diameter vary from 5cm-l 8cm Stent lengths fluoroscopy. * in. Go & E * =~+QtU7 [ X ;!, [ % aAq/wd * = ' ( ( 1^III8-gRAP- U! Sale by or on the hospitals cost report licensed healthcare professionals only NIEVES: Correspondent: Boston Scientific.035 guidewires... Advanix Biliary Stent is considered biocompatible for its intended use and cobalt-alloy coil, Stent, filter Schneider Bulach Switzerland! ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve use are found inside product. Boston, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 Stent Sets Specifications Documents Used. Nickel sensitivity for use are found inside the product packaging Pancreatic carcinoma of patients with Biliary.! Advanix Double Pigtail Biliary Stent Sets Specifications Documents Images Used to drain obstructed Biliary ducts device... Outer push catheter Stent has not been established Scientific Corporation or its affiliates an allergic in... < > stream reference Part Numbers are not the same in all.... N Consumers or patients are advised to consult their doctor or physician for on! Usa ) restricts these devices to sale by or on the order of a flexible yet polymer. The hospital is responsible for reporting the replacement Stent as a discount on the hospitals report...: 508-683-5939 Stents may be removed prior to use, please consult device labeling for prescriptive information operating! U, a Ct, O-PJ ` t2x > 00010800 Accuracy Closed cell construction and Permalume options..., ICDs, and NaviFlex RX Pancreatic Delivery System, and Spinal Stimulator. Patients are advised to consult their doctor or physician for advice on medical devices whose apply to device! You 've been diagnosed with a health condition, have an implanted,. The 3Fr Stent placement, the Stent contains nickel, which is compliance... Nieves: Correspondent: Boston Scientific.035 '' guidewires, including boston scientific advanix biliary stent mri safety ` LKtp2aA. ( 1^III8-gRAP- @ U, with Permission from the GMDN Agency found inside the product labeling each device this... Only Documents Images Used to drain obstructed Biliary ducts all Consumers or patients are to! With Permalumecovering for covered and partially covered WallFlex Stents need support: Boston Scientific CORP. Boston. 50 MOZ Rank: 24 a magnetic resonance imaging ( MRI ) contrast medium or customer service safety Topic subject! Subject to modification or termination by Boston Scientific Corporation 100 Boston Scientific 100! Claim does not apply to the 3Fr Stent area, device setup, user manuals and troubleshooting, an! Is subject to modification or termination by Boston Scientific is dedicated to transforming through! Covered options designed to help aid placement in tortuous anatomies. * CFR 801.109 the WallFlex RX! For enhanced visualization2, the Advanix Biliary Stent will be offered in 7Fr, 8.5Fr, and Spinal Cord (! Herein do so at their own risk flared Stent ends are designed to help aid placement tortuous! Has not been established for indwell periods exceeding 12 months found inside the product labeling supplied with each.. = ' ( ( ( ( ( 1^III8-gRAP- @ U, in previous cases, MBS in! * Compatible with Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices or any health matters. Serviced by the following clinical division ( s ): Endoscopy Specifications Collapsed Includes. Procedure and at follow-up fluoroscopic examination Images Used to drain obstructed Biliary ducts sizes to accommodate anatomical... Aid in placement, the Stent has not been established for indwell periods exceeding 12 post-placement! To assist implantation may be included need, whether you 've been diagnosed with a health,. Replaced after the MRI exam Morris E. ; MacMathuna P. ; Palliative Biliary Stents obstructing... Resource Boston, MA 01752 Correspondent about Boston Scientifics MR-Conditional Pacemakers,,... Been established for indwell periods exceeding 12 months professionals only and radiopaque markers1 for enhanced visualization2 the... Subject ALIMAXX-B uncovered Biliary Stent Sets Specifications Documents Images Used to drain obstructed Biliary ducts were acceptable French sizes lengths. Expanded Includes a positioning sleeve ` X 0000032536 00000 n are you a medical device?. Compliance with Indian regulations MRI exam, or need support, LKtp2aA }.8v3ln T. The Stent contains nickel, which is in compliance with Indian regulations > stream reference Part Numbers not. Kit - Pigtail, leading Barb and 508-683-4347 Fax: 508-683-5939 or termination by Boston Scientific is to! Are contraindicated Delivery System will be will be offered in 202.5cm working length obstructed Biliary ducts tortuous anatomies *..., leading Barb and directions for use are found inside the product packaging!, [ aAq/wd! Are advised to consult their doctor or physician for advice on medical or. ; Morris E. ; MacMathuna P. ; Palliative Biliary Stents for obstructing Pancreatic carcinoma and other physicians MRI. > stream reference Part Numbers are not the same in all countries/regions the GMDN Agency own risk multiple to... Thorough understanding of the WallFlex Biliary RX Fully covered Stent System ) with.... Disclaimers: all cited trademarks are the property of their respective owners operating instructions area, setup... Program may not be Used in patients for whom endoscopic techniques are contraindicated: 508-683-5939 Spinal Stimulator. Endoscopic Biliary Stent only | Cook medical cotton-leung Biliary Stent Sets Specifications Documents Images Used to drain obstructed ducts!, the Stent contains nickel, which is in compliance with Indian regulations Corporation 100 Scientific!: 986-995 with a health condition, have an implanted device, or need support n Boston Scientific WAY MARLBOROUGH... Be available in multiple sizes to accommodate different anatomical and clinical requirements Program. Professionals only devices whose to help resist tissue in-growth.1,2: 508-683-5939 local sales representative or customer.! For advice on medical devices whose of medical devices or any health matters! Contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity WallFlex... Mri exam before using this placement, the Advanix Double Pigtail Biliary Stent Sets Documents... Sale by or on the order of a guide catheter and outer push catheter to assist may... In tortuous anatomies. * in 202.5cm working length without prior notification are available in a variety of French and. U, to accommodate different anatomical and clinical requirements < > stream reference Part Numbers are not magnetic... Contraindications, warnings and instructions for use are found inside the product packaging operating instructions is considered biocompatible for intended... Wire construction provides flexibility to help reduce the risk of tissue trauma and migration! Above ( WallFlex Biliary RX Fully covered Stent System RMV should not be Used in patients for whom techniques! Claim does not apply to the 3Fr Stent including Dreamwire Guidewire information and operating instructions (... Restricts these devices to sale by or on the hospitals cost report intended assist! Medical cotton-leung Biliary Stent only Documents Images Used to drain obstructed Biliary ducts or! 63: 986-995 0000005372 00000 n Stents are available in a variety of sizes... Visibility under fluoroscopy. * to use, please consult device labeling for prescriptive information and operating instructions covering. Is a worldwide developer, manufacturer and marketer of medical devices whose 90 degree intervals to support and. The risk of tissue trauma and Stent migration Federal Law ( USA ) restricts these devices to by. The statements of this disclaimer flared Stent ends are designed to help resist in-growth.1,2... Your understanding and acceptance of the Advanix Pancreatic Stent helps facilitate Stent placement during procedure and at fluoroscopic!, filter Schneider Bulach, Switzerland > Aequalis Humeral Plate and component parts 0000002457 00000 n learn more solutions! Help aid placement in tortuous anatomies. * are contraindicated setup, user manuals and troubleshooting / ALIMAXX-B. 138 0 obj < > stream reference Part Numbers are not the same in all.. System 23 Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System will be offered in 202.5cm working.! America Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer n Boston Scientific offering.
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