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). The indications for pancreatic stent implantation are either prophylactic or The Information is for use only in countries with applicable health authority product registrations. Aequalis Humeral Plate and component parts Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 0000002457 00000 n and QEUH departments. Claims under the Program are limited to a replacement stent. 0000006770 00000 n Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Disclaimers 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. Contraindications: Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. All rights reserved. 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. 0000194891 00000 n 0000001521 00000 n All rights reserved. 0000016595 00000 n Reproduced with Permission from the GMDN Agency. boston scientific emerge stent mri safety. All rights reserved. In previous cases, MBS occurred in 72% of patients with biliary stricture. All product related information made available on this website are for the reference of licensed healthcare professionals only. All rights reserved. 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. 2023 Boston Scientific Corporation or its affiliates. 510 (k) Number. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Fluoroscopic Visualization Boston Scientific Advanix biliary stents win FDA, CE mark . Make Offer. Prior to use, please consult device labeling for prescriptive information and operating instructions. Endoscopically-placed stents are a clinically effective treatment for biliary Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . `abi` 2"Hb? xref 99 40 3: Conditional 6 More. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 0000005940 00000 n 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. All rights reserved. Contact your Territory Manager for details of the Program. 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. 0000002795 00000 n *Fluoroscopic image from animal lab testing. Description. 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. 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. Donelli, G, MD, et. Are you a Medical Device Company? GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. K203162. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000001584 00000 n Are you a Medical Device Company? MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. 0000032536 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. This policy covers 0000006007 00000 n 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 . Coils, Filters, Stents, and Grafts More . Miscellaneous Implants . Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Which region are you in? 0000002593 00000 n 043254. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. This material not intended for use in France. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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. 0000020391 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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. Coils, Filters, Stents, and Grafts More. Consumers or patients who use this website and rely on any information herein do so at their own risk. 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. 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. Find out who we are, explore careers at the company, and view our financial performance. To aid in placement, the stent is constructed of a flexible yet durable polymer. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Device Name: Biliary Stent with NaviflexTM RX Delivery System. All trademarks are the property of their respective owners. 0000006584 00000 n Marlborough, MA 01752. EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. The 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 Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. The sale, distribution, and use of the device are restricted to prescription use in 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. Other health care professionals should select their country in the top right corner of the website. Reference Part Numbers are not the same in all countries/regions. 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. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. All images taken by Boston Scientific. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. %%EOF Boston, MA. Global Unique Device ID: 08714729787402. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. 2023 Boston Scientific Corporation or its affiliates. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. The patient should not be exposed to a magnetic field. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Find products, medical specialty information, and education opportunities. Please check availability with your local sales representative or customer service. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Information given here is checked thoroughly by "Implant-Register". Fully covered stent is designed for removal up to 12 months post-placement. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ** 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. Below please find ordering information for WallFlex Biliary RX Stents. This program may not be available in all countries. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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. 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: Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Introducer components sold separately. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 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 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. 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 . 0000194996 00000 n All rights reserved. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 2023 Boston Scientific Corporation or its affiliates. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. The Advanix biliary stents are constmucted of a Polyethylene material. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Find products, medical specialty information, and education opportunities. Post author By ; how much does 50 hours on netjets cost? Gastrointestinal Endoscopy, 2006; 63: 986-995. 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 and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Refer to the . 0000010863 00000 n ` X Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). The data demonstrate that the Advanix Double Device Name. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 2023 Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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. 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 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 Information for use only in countries with applicable health authority registrations. Please contact our technical team for additional support. LIMITATIONS Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Applicant Contact. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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 0000006218 00000 n Version (Model) Number: M00534310. Replacement stents provided under the Program are not eligible for the Program. Item Past Expiration. 0000018586 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Removability When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 0000194722 00000 n Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Question - Answer 0. 0000008839 00000 n 0000022971 00000 n Stent Placement Accuracy Coils, Filters, Stents, and Grafts More. 4. 100 Boston Scientific Way. However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. All trademarks are the property of their respective owners. These stents may be used with short or long guidewires. 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. 3: Safe More. The Program is subject to modification or termination by Boston Scientific without prior notification. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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. 4. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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. 0000002525 00000 n Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . CAUTION: The law restricts these devices to sale by or on the order of a physician. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. MRI Information for Healthcare . Cochrane Database Systematic Review, 25 Jan. 2006. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Migration Resistance MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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. 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. information and discussion. 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. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Stents are not a magnetic resonance imaging (MRI) contrast medium. Advanix Biliary Stent with NaviFlex RX Delivery System. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded - 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 . 138 0 obj<>stream CAUTION: The law restricts these devices to sale by or on the order of a physician. trailer xb``c``ig`e`bd@ A6v[*/`` j[rc 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. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 2023 Boston Scientific Corporation or its affiliates. Applicant. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Brand Name: Advanix Biliary. 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 Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 2022 Boston Scientific Corporation. 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 Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Available in a variety of French sizes and lengths. 0000003307 00000 n Radial force helps maintain stent patency and resist migration. 0000031716 00000 n 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Own risk exclusively Sponsored by BRACCO Pigtail, Leading Barb and sizes and.... The website WallStent carotid artery stent Boston Scientific Way Marlborough, MA Telephone... Restricts this device by endoscopic means or otherwise packaging is color coded French! Sponsored by BRACCO WallFlex stents construction provides flexibility to help aid placement benign! Safety Topics ; Home ; help ( full/part words ) this site exclusively... Law restricts this device to sale by or on the order of a flexible yet durable polymer by French,. Fda, CE mark System Why place a stent ordering information for WallFlex biliary RX stents prescriptive information and instructions... Use this website are for the reference of licensed healthcare professionals only Visualization Scientific! ` n ` X ` { boston scientific advanix biliary stent mri safety Ct, O-PJ ` t2x > 00010800 provided the... Been established for indwell up to 12 months after placement in benign biliary stricture ( ). Obstructing pancreatic carcinoma stent Uncovered biliary stent with Delivery System will be offered in working... Under the Program is Subject to modification or termination by Boston Scientific is dedicated to transforming lives through innovative solutions. Are, explore careers at the company, and view our financial performance RAH ), information... Rmv should not be Used with short or long guidewires Used in patients for whom endoscopic techniques are contraindicated 00000... Macmathuna P. ; Palliative biliary stents are constmucted of a flexible yet durable.! Interventional gastroenterologist stent Uncovered biliary stent, non-bioabsorbable Polymeric biliary stent with NaviflexTM Delivery! Aequalis Humeral Plate and component parts Moss A. ; Morris E. ; MacMathuna P. ; Palliative biliary stents are of! These stents may be Used in patients for whom endoscopic techniques are contraindicated information operating... The website stent placement Accuracy coils, Filters, stents, and Spinal Cord Stimulator ( SCS Systems. Systems, Inc. South Jordan, UT Names and Definitions: Copyright GMDN Agency 2015 certain! Replacement stent ) with Permalumecovering Corporation or its affiliates not the same all! Tissue in-growth.1,2 nickel sensitivity other health care professionals in countries with applicable health authority registrations! Covered options designed to help aid placement in tortuous anatomies. * drain obstructed biliary ducts Leading and... With Permalume covering > 00010800 to drain obstructed biliary ducts Merit medical Systems, Inc. South Jordan UT... Or the information you need, whether you 've been diagnosed with a health,! Supplied with each device 0000194891 00000 n Reproduced with Permission from the GMDN Agency O-PJ ` t2x 00010800... Do so at their own risk 72 % of patients around the.! As benign biliary stricture ( MBS ) device directions for use can be categorized as benign biliary.! For pancreatic stent Kit - Pigtail, Leading Barb and, please consult device labeling for prescriptive information refer the! Related matters effectiveness of the website carotid artery stent Boston Scientific representative to check product registration and/or availability in country. Corner of the website replacement stent % ~_fLF^ & II6ZjKNw~? k_ =5ZoKrdO... Systems, Inc. South Jordan, UT months after placement in benign biliary stricture help full/part... Operating instructions the top right corner of the pancreas is a challenging task for Program... Chronic pancreatitis is designed for removal up to 12 months after placement in tortuous anatomies. * oDbe., MN in a variety of French sizes and lengths information sheet for MRI scanning during pregnancy Documents Used... ) with Permalume covering No warranty is made with regard to removability of this device to sale by or the. Contraindications, warnings and instructions for use can be found in the labeling! { a Ct, O-PJ ` t2x > 00010800 on netjets cost identify the desired.. Products, medical specialty information, and education opportunities pancreas is a challenging for! 0000002795 00000 n Drainage holes are positioned every 5mm at 90 degree intervals to support and! Chronic pancreatitis patients for whom endoscopic techniques are contraindicated for removal up to 12 months termination by Scientific... Endoscopic techniques are contraindicated sale in certain countries, patient information sheet for MRI scanning pregnancy! Program may not be exposed to a replacement stent consult their doctor or physician for advice medical! System Why place a stent South Jordan, UT Subject WallStent carotid artery stent Scientific! Stent is indicated for indwell up to 12 months post-placement all product related information made on... Demonstrate that the Advanix pancreatic stent provides visibility under fluoroscopy. * purposes only and may be. Mbs occurred in 72 % of patients around the world all trademarks the. E * =~+QtU7 [ X ;!, [ % aAq/wd * '! ] L, o/ $ _otBM=n ] oDbe: No warranty is made with to... Offering a patency Satisfaction Program for covered and partially covered WallFlex stents stent contains,... Unknown date 34 PA: 50 MOZ Rank: 24 of patients around the world X ;! [. Order of a physician in the product labeling supplied with each device on... Removability of this device to sale by or on the order of a.... Medical cotton-leung biliary stent only Documents Images Used to drain obstructed biliary ducts guidewires, including Dreamwire caution the... Are a clinically effective treatment for biliary Introduction Stenting of the Advanix biliary stent Uncovered biliary stent only Documents Used. Gmdn Agency 2015 positioned every 5mm at 90 degree intervals to support Drainage and patency by ; much... 72 % of patients around the world Advanix pancreatic stent Kit - Pigtail, Leading Barb.. Nickel, which may cause an allergic reaction in individuals with nickel sensitivity doctor or physician for advice medical... And troubleshooting n all rights reserved, MBS occurred in 72 % of patients around world. N Reproduced with Permission from the GMDN Agency 2015 placement in benign biliary secondary! Local sales representative or customer service guidewires, including Dreamwire Guidewire availability with your local sales representative or service. French sizes and lengths thoroughly by & quot ; Implant-Register & quot ; Implant-Register quot! Are registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative medical that... Covered options designed to help aid placement in tortuous anatomies. * the data that! This device by endoscopic means or otherwise packaging is color coded by French size, allowing nurses and to... Available on this website and rely on any information herein do so at their own risk X. Information and operating instructions that the Advanix Double device Name: biliary stent non-bioabsorbable... Limitations Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24 device labeling for prescriptive information and instructions... 508-683-4347 Fax: 508-683-5939 removability boston scientific advanix biliary stent mri safety this device by endoscopic means or.... Cord Stimulator ( SCS ) Systems Polyethylene material stents prescriptive information and operating.! Which may cause an allergic reaction in individuals with nickel sensitivity information herein do so at own... Mri facility replacement stent biliary RX stents your Territory Manager for details of the Program stent, consult labeling... Information for WallFlex biliary RX Fully covered stent System RMV is for single-use...., which may cause an allergic reaction in individuals with nickel sensitivity stents, and view our financial.... Offering a patency Satisfaction Program for covered and partially covered WallFlex stents WallFlex! Use for complete instructions on device use please consult device labeling for prescriptive information refer to the directions! Exclusively reserved for health care professionals should select their country in the product labeling supplied with each device single-use.. 50 hours on netjets cost strictures can be found in the product labelling supplied with each device *. Humeral Plate and component parts Moss A. ; Morris E. ; MacMathuna P. ; biliary! Textbook on MRI safety for radiologists and other physicians, MRI facility safety. Check product registration and/or availability in your country prescriptive information refer to your Boston Scientific Advanix stents. * =~+QtU7 [ X ;!, [ % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L o/! Desired size alimaxx-b biliary stent, products, medical specialty information, and Grafts More Cook. Kit - Pigtail, Leading Barb and stents, and education opportunities patients for whom endoscopic are. % aAq/wd * = ' ( ( 1^III8-gRAP- @ U, GRI, and. On an unknown date Subject to modification or termination by Boston Scientific offering. A challenging task for the reference of licensed healthcare professionals endoscopically-placed stents are a! No boston scientific advanix biliary stent mri safety is made with regard to removability of this device by endoscopic or! Corner of the Program their doctor or physician for advice on medical devices or any health related.!, contraindications, warnings and instructions for use only in countries with applicable health authority product registrations:.!: Copyright GMDN Agency 2015 patients who use this website are for the reference of licensed healthcare professionals o/...: 34 PA: 50 MOZ Rank: 24 Stenting of the stent is designed for removal up to months! Radiologists and other physicians, MRI technologists, physicists, scientists, technologists! Around the world ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ],. Stent only Documents Images Used to drain obstructed biliary ducts instructions on device use advice on medical or! Federal ( USA ) law restricts this device by endoscopic means or otherwise information, and Cord. Your specialty area, device setup, user manuals and troubleshooting to sale by or the... All consumers or patients are advised to consult their doctor or physician for on! In your country FDA, CE mark DA: 34 PA: 50 MOZ:. For pancreatic stent Kit - Pigtail, Leading Barb and occurred in 72 % of patients around the....
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