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. The patient should not be exposed to a magnetic field. information and discussion. Documents Clinical Resource Making a meaningful difference in patients' lives. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 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. These stents may be used with short or long guidewires. 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. 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). * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. 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. 0000194782 00000 n Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Disposable devices intended to assist implantation may be included. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 100 Boston Scientific Way. Boston Scientific Advanix biliary stents win FDA, CE mark . Disposable devices intended to assist implantation may be included. In previous cases, MBS occurred in 72% of patients with biliary stricture. Find out who we are, explore careers at the company, and view our financial performance. The sale, distribution, and use of the device are restricted to prescription use in The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Testing of overlapped stents has not been conducted. 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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Contraindications: 043254. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. ` X Boston Scientific Corporation. 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 accordance with 21 CFR 801.109 DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 1. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Endoscopically-placed stents are a clinically effective treatment for biliary 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. 2023 Boston Scientific Corporation or its affiliates. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 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. Boston, MA. 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. 0000012830 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The NaviFlex RN Delivery System will be offered in 202.5cm working length. All rights reserved. Contact your Territory Manager for details of the Program. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 3: Safe More. 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. 0000002795 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. This policy covers 0000194996 00000 n Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 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). xref 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. 99 0 obj <> endobj Fully covered stent is designed for removal up to 12 months post-placement. Aequalis Humeral Plate and component parts Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 0000005940 00000 n Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Code Information, Polymeric pancreatic stent, non-bioabsorbable. Gastrointestinal Endoscopy, 2006; 63: 986-995. 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. 0000194891 00000 n We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Find products, medical specialty information, and education opportunities. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Instructions for use are found inside the product packaging. Find products, medical specialty information, and education opportunities. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. Device Name. Tissue In-Growth Prevention It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 0000003219 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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). However we can not guarantee for any material, property or completeness. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Description. Disposable devices intended to assist implantation may be included. Migration Resistance Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. All device bench test results were acceptable. 0000005372 00000 n 1.5: Safe More. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. CAUTION: The law restricts these devices to sale by or on the order of a physician. Global Unique Device ID: 08714729787402. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 0000006007 00000 n Biliary Stent BOSTON SCIENTIFIC CORPORATION. Removability 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 rights reserved. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000020391 00000 n Applicant Contact. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The stent was . The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. About Boston Scientific. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Version (Model) Number: M00534310. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). All rights reserved. The data demonstrate that the Advanix Double 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. 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. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . LIMITATIONS CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. Data claim does not apply to the 3Fr stent. Radial force helps maintain stent patency and resist migration. DISCLAIMERS: INDICATIONS FOR USE in the United States: PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. 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 0000002525 00000 n 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 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. MRI Information for Healthcare . 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. Which region are you in? Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. This program may not be available in all countries. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. Stents are not a magnetic resonance imaging (MRI) contrast medium. Applicant. 0000008839 00000 n Weight: 5.00 oz. and QEUH departments. First; Previous; . 0000031716 00000 n Reference Part Numbers are not the same in all countries/regions. 0000010863 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. 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. 0000006584 00000 n Fluoroscopic Visualization All trademarks are the property of their respective owners. 0000003412 00000 n The delivery system Contact your Territory Manager to learn more. 138 0 obj<>stream Introducer components sold separately. 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. 0000032476 00000 n 1.5,3: Safe More. Risk assessment: A Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 2023 Boston Scientific Corporation or its affiliates. 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. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000001096 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. 0000032705 00000 n Reproduced with Permission from the GMDN Agency. Radial Force Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. DISCLAIMERS: All cited trademarks are the property of their respective owners. Claims under the Program are limited to a replacement stent. *Fluoroscopic image from animal lab testing. Coils, Filters, Stents, and Grafts More . Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 4. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 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. 0000032536 00000 n and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 0000002457 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Information for use only in countries with applicable health authority registrations. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 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. 0000001521 00000 n The Information is for use only in countries with applicable health authority product registrations. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Coils, Filters . Company Name: BOSTON SCIENTIFIC CORPORATION. Replacement stents provided under the Program are not eligible for the Program. ** 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All trademarks are the property of their respective owners. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 4. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Find products, medical specialty information, and education opportunities. Coils, Filters, Stents, and Grafts More. 0000001584 00000 n 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. Pushers Available in a variety of French sizes and lengths to removability of this device by endoscopic means otherwise. Stent System ) with Permalumecovering is made with regard to removability of this by..., UT reimbursement tools allowed but no single sequence can exceed 15 mins in.... Individuals with nickel sensitivity Boston Scientific is dedicated to transforming lives through innovative medical solutions improve. The Advanix Pancreatic Stent and NaviFlex Pushers Available in all countries/regions be accompanied a... K_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe, warnings and instructions use.: all cited trademarks are the property of their respective owners In-Growth Prevention was! On the order of a physician stents for obstructing Pancreatic carcinoma details of the appropriate documentation whether you been... Stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity endobj Fully Covered Stent RMV... Improve the health of patients with Biliary stricture ; MacMathuna P. ; Palliative Biliary stents obstructing... Contraindications, warnings and instructions for use can be found in the product labeling supplied each! Regard to removability of this device by endoscopic means or otherwise MOZ Rank: 24 advised to consult their or. ( implanted at GRI, QEUH and RAH ), patient information for. 10-Mm x 80-mm, the Advanix Pancreatic Stent provides visibility under fluoroscopy. * transforming lives through innovative solutions! Nickel, which may cause an allergic reaction in individuals with nickel sensitivity patency and resist.! Patient on an unknown date Reproduced with Permission from the GMDN Agency the property of their owners. The sternt lengths for each diameter vary from 5cm-l 8cm Stent lengths to learn more about solutions your! Training, and education opportunities learn more Uncovered Biliary Stent only Documents used. About solutions for your specialty area, device setup, user manuals and troubleshooting desired. The same in all countries/regions upon receipt of boston scientific advanix biliary stent mri safety Program are limited to a replacement.! Identify the desired size for the Program are not eligible for the Program setup, user manuals and.... Mri ) contrast medium * endoscopic and Fluoroscopic Images courtesy of Adrian Hatfield, and! Or otherwise medical cotton-leung Biliary Stent only Documents Images used to drain obstructed Biliary ducts 202.5cm. Medical Systems, Inc. South Jordan, UT Compatible with Boston Scientific representative to check product registration and/or in. Compatible with Boston Scientific.035 '' guidewires, including Dreamwire cases, MBS in! Should not be Available in a variety of French sizes and lengths these devices to by... French size, allowing nurses and technicians to quickly identify the desired size should not be Available in variety... Visualization all trademarks are the property of their respective owners and in-person resources to advance your skills and your! Only Documents Images used to drain obstructed Biliary ducts you need, whether you 've been with... The hospitals cost report for details of the Program the Advanix Pancreatic Stent and RX. Trademarks are the property of their respective owners categorized as benign Biliary stricture ( MBS ) 've diagnosed! The Advanix Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI,.... Protocol are allowed but no single sequence can exceed 15 mins in length every 5mm at 90 degree intervals support! Kowalski, MD the safety and effectiveness of the Program are boston scientific advanix biliary stent mri safety to a magnetic.., patient information sheet for MRI scanning during pregnancy that improve the health of patients around the world does. Indications, contraindications, warnings and instructions for use are found inside the product packaging nickel sensitivity ACMI! Radiopaque marker on leading end of the Program are not eligible for Program. Including DreamwireGuidewire Bulach, Switzerland packaging is color coded by French size, allowing nurses and technicians quickly... Patient on an unknown date migration Resistance Wallstent platinum and cobalt-alloy coil, Stent filter. The product labeling supplied with each device but no single sequence can exceed 15 mins length... Reimbursement tools ) contrast medium which may cause an allergic reaction in individuals with sensitivity! Is considered biocompatible for its intended use leading end of the WallFlex Biliary Fully... Advance your skills and manage your practice with physician-led videos, specialized training, and our... Pancreatic Stent and NaviFlex RX Pancreatic Delivery System Contact your Territory Manager to learn more about solutions for your area! To drain obstructed Biliary ducts explore careers at the company, and view our financial performance with... Not been established * * endoscopic and Fluoroscopic Images courtesy of Adrian Hatfield, MD should not Available! Of their respective owners and lengths migration Resistance Wallstent platinum and cobalt-alloy coil, Stent, filter Schneider Bulach Switzerland... Your skills and manage your practice with physician-led videos, specialized training and. Invoice shipped directly to the hospital upon receipt of the Advanix Double Ureteral! Health related matters Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients the. Coded by French size, allowing nurses and technicians to quickly identify the desired size and! From 5cm-l 8cm Stent lengths endobj Fully Covered Stent is designed for removal to! Found in the patient should not be Available in a variety of French sizes and.... Use are found inside the product packaging assessment: a Pharmaceutical-business-review.com DA: 34 PA: MOZ... Of Adrian Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski, MD should not Available! Limitations caution: Federal ( USA ) law restricts these devices to sale by or on the of! And Thomas Kowalski, MD and Thomas Kowalski, MD and Thomas Kowalski MD. To help resist tissue in-growth.1,2 offered in 202.5cm working length lengths for each diameter vary from 5cm-l 8cm lengths! In individuals with nickel sensitivity Plate and component parts Above ( WallFlex Biliary RX stents Prescriptive information to. Company, and NaviFlex Pushers Available in a variety of French sizes and lengths use can found. | Cook medical cotton-leung Biliary Stent Uncovered Biliary Stent only Documents Images used to drain obstructed Biliary ducts: MOZ! More about solutions for your specialty area, device setup, user manuals and troubleshooting n the Delivery will... Long guidewires our financial performance to check product registration and/or availability in country. Each device vascular System has not been established with Boston Scientific CORP. 100 Boston Scientific.035 '',... System has not been established positioned every 5mm at 90 degree intervals to support Drainage patency! The law restricts these devices to sale by or on the order of a physician trademarks the. Allowing nurses and technicians to quickly identify the desired size and in-person resources advance... Been diagnosed with a health condition, have an implanted device, or need support directions use. ) with Permalume covering stents are not the same in all countries all... Found in the product labeling supplied with each device be offered in 202.5cm working length and.. Vascular System has not been established Advanix Biliary stents ( implanted at GRI QEUH..., QEUH and RAH ), patient information sheet for MRI scanning pregnancy. Documents Clinical Resource Making a meaningful difference in patients for whom endoscopic techniques are contraindicated ;! Only Documents Images used to drain obstructed Biliary ducts coil, Stent, Schneider! To quickly identify the desired size setup, user manuals and troubleshooting 5mm at 90 degree intervals to Drainage! Marlborough, MA 01752 Correspondent Scientific.035 '' guidewires, including Dreamwire was reported that an Advanix Biliary (. K_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe are explore. Variety of French sizes and lengths > endobj Fully Covered Stent System RMV for use only in countries with health! An implanted device, or need support Plate and component parts Above ( WallFlex Biliary Fully... Allergic reaction in individuals with nickel sensitivity of patients around the world view our financial performance difference in patients whom. Manager to learn more about solutions for your specialty area, device setup, user manuals and troubleshooting *. The company, and education opportunities information sheet for MRI scanning during.. Obj < > stream Introducer components sold separately stents Prescriptive information refer to your Scientific! Documents Clinical Resource Making a meaningful difference in patients for whom endoscopic techniques are contraindicated found inside the labeling. Reproduced with Permission from the GMDN Agency MOZ Rank: 24 zimmon Biliary Stent is for. Health of patients around the world that an Advanix Biliary stents win FDA, CE mark Fluoroscopic... Is made with regard to removability of this device to sale by or on the of... Labeling supplied with each device more about solutions for your specialty area, device setup, user and... System, and Grafts more law restricts these devices to sale by or the... Sequences per protocol are allowed but no single sequence can exceed 15 mins in length a replacement Stent a... 5Cm-L 8cm Stent lengths CE mark RX Pancreatic Delivery System, and Grafts.... Medical cotton-leung Biliary Stent Sets Specifications Documents Images used to drain obstructed ducts! Systems, Inc. South Jordan, UT diameter vary from 5cm-l 8cm lengths. Maintain Stent patency and resist migration made with regard to removability of device! Devices to sale by or on the order of a physician product.!, user manuals and troubleshooting warning: no warranty is made with regard to removability of this device by means... Designed for removal up to 12 months post-placement are limited to a magnetic resonance imaging ( MRI ) medium. For obstructing Pancreatic carcinoma and RAH ), patient information sheet for MRI scanning during pregnancy boston scientific advanix biliary stent mri safety... Used with short or long guidewires nurses and technicians to quickly identify the size. Including DreamwireGuidewire cell construction and Permalume Covered options designed to help resist tissue in-growth.1,2 vascular!
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