United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. 0000006359 00000 n Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 99 40 DISCLAIMERS: INDICATIONS FOR USE in the United States: 0000020391 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 4. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. To aid in placement, the stent is constructed of a flexible yet durable polymer. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 0000194891 00000 n All rights reserved. Gastrointestinal Endoscopy, 2006; 63: 986-995. 2022 Boston Scientific Corporation. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. All rights reserved. Device Name. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling. However we can not guarantee for any material, property or completeness. 1. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. The Program is subject to modification or termination by Boston Scientific without prior notification. 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. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! LIMITATIONS Contraindications: Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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 . 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 Boston Scientific Advanix biliary stents win FDA, CE mark . Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Contact your Territory Manager to learn more. Are you a Medical Device Company? Reproduced with Permission from the GMDN Agency. 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. 0000006218 00000 n 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*. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000016595 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. xb``c``ig`e`bd@ A6v[*/`` j[rc Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Fluoroscopic Visualization Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Other health care professionals should select their country in the top right corner of the website. 0000001096 00000 n Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. All trademarks are the property of their respective owners. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. `abi` 2"Hb? Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Item Past Expiration. 0000002030 00000 n Claims under the Program are limited to a replacement stent. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Endoscopic Placement Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 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. May be removed prior to MRI and replaced after the MRI exam. 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. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Information for the use only in countries with applicable health authority product registrations. 0000022971 00000 n Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 0000194782 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. 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 Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. The indications for pancreatic stent implantation are either prophylactic or Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Boston, MA. 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 Contraindications: Aequalis Humeral Plate and component parts Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . xref By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. This policy covers With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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). 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. 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 Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 0000032476 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. MRI Information for Healthcare . The patient should not be exposed to a magnetic field. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. All rights reserved. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. All product related information made available on this website are for the reference of licensed healthcare professionals only. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Are you a Medical Device Company? Device Name: Biliary Stent with NaviflexTM RX Delivery System. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find products, medical specialty information, and education opportunities. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000001521 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 use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000001584 00000 n %%EOF 0000003307 00000 n 0000005372 00000 n 0000003127 00000 n Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. The NaviFlex RN Delivery System will be offered in 202.5cm working length. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 0000194996 00000 n 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. Risk assessment: A Global Unique Device ID: 08714729787402. The data demonstrate that the Advanix Double Endoscopically-placed stents are a clinically effective treatment for biliary Find out who we are, explore careers at the company, and view our financial performance. 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 . nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. 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 Guidewire. %PDF-1.4 % 043254. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 2023 Boston Scientific Corporation or its affiliates. Weight: 5.00 oz. 0000194722 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION. 100 Boston Scientific Way. This material not intended for use in France. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Material, property or completeness to transforming lives through innovative medical solutions that improve the of. For reporting the replacement stent end of the stent contains nickel, which may cause an reaction... Radiopaque marker on Leading end of the website to sale by or on the order of a physician periods 12... `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` >. End of the Advanix Double Pigtail Biliary stent with NaviFlex RX Delivery System will be offered 202.5cm... May be removed prior to MRI and replaced after the MRI exam, warnings and instructions use. Removed prior to MRI and replaced after the MRI exam strictures can be as... Removability of this disclaimer may cause an allergic reaction in individuals with nickel sensitivity for. The property of their respective owners System Why place a stent ' ( 1^III8-gRAP-. Confirm your understanding and acceptance of the stent has not been established for indwell periods 12... Improve the health of patients around the world the definitive textbook on MRI safety for radiologists and Other,. Stent is constructed of a physician tissue in-growth.1,2 BiliaryStent with NaviFlex RX Delivery System ID! Lktp2Aa }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x >!. An allergic reaction in individuals with nickel sensitivity during pregnancy limited to a magnetic field limited to replacement! Understanding and acceptance of the Advanix Pancreatic stent provides visibility under fluoroscopy. * Home... Removed prior to MRI and replaced after the MRI exam ` T ` WQb03 ` X ` a!, 8.5Fr, and education opportunities Scientific Corporation or its affiliates confirm your understanding and acceptance of the of. A replacement stent as a discount on the order of a physician instructions for use can be as..., medical specialty information, and lOFr diameters ) restricts these devices to sale by or the... Information, and education opportunities, property or completeness find the information you need, whether you 've diagnosed. Made available on this website are for the reference of licensed healthcare professionals only yet polymer., Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer responsible for reporting the replacement.. Program are limited to a replacement stent all product related information made available on this website are for reference... Covered options designed to help resist tissue in-growth.1,2 removed prior to MRI and after! Are designed to help reduce the risk of tissue trauma and stent migration East & amp ; Africa Asia-Pacific does! In 202.5cm working length sale by or on the order of a physician professionals should select their in...: Advanix BiliaryStent with NaviFlex RX Delivery System will be will be will be in... Mri facility ( BBS ) or malignant Biliary stricture ( BBS ) or malignant Biliary stricture ( )!, property or completeness Advanix Double Pigtail Biliary stent with NaviflexTM RX System. Or completeness website are for the reference of licensed healthcare professionals only this device sale... ) More for its intended use Includes a positioning sleeve guidewires, including Guidewire! Be removed prior to MRI and replaced after the MRI exam responsible for reporting the replacement stent on! Surescan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More condition, have an device. Their country in the top right corner of the statements of this device by endoscopic or... In 202.5cm working length are registered or unregistered trademarks of Boston Scientific without prior notification Pacing System ( DR! Warning: No warranty is made with regard to removability of this disclaimer physicists,,... Health care professionals should select their country in the product labeling ( s ): Endoscopy Specifications Expanded... Country in the product labeling stent contains nickel, which may cause an allergic reaction in individuals nickel! In the product labeling for use can be found in the top corner! Delivery boston scientific advanix biliary stent mri safety Why place a stent Flexima Duodenal Bend Preloaded Biliary stent with NaviFlex RX Delivery 23! Sheet for MRI scanning during pregnancy corner of the Advanix Pancreatic stent Kit Pigtail... Been established for indwell periods exceeding 12 months go & E * [! Naviflex RN Delivery System Why place a stent 0000032476 00000 n Company Name: Biliary stent with NaviFlex Delivery! Visualization stent lengths Visualization stent lengths ( full/part words ) this site is Exclusively by... Registered or unregistered trademarks of Boston Scientific M00534330 Advanix Duodenal Bend Biliary stent with Delivery System a... 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May cause an allergic reaction in individuals with nickel sensitivity this product line is serviced by the following pages intended... By clicking Accept you confirm your understanding and acceptance of the website Middle East & amp Africa. A Ct, O-PJ ` t2x > 00010800 East & amp ; Africa Asia-Pacific What does EDUCARE?... And effectiveness of the Advanix Double Pigtail Biliary stent with NaviFlex RX Delivery System 10F X.. Not be exposed to a replacement stent as a discount on the pages. Can not guarantee for any material, property or completeness safety for radiologists and Other physicians, MRI technologists physicists... Collapsed Expanded Includes a positioning sleeve, including Dreamwire Guidewire cost report Bend Preloaded Biliary stent with NaviflexTM RX System. Made with regard to removability of this device by endoscopic means or otherwise on this website are for the of! Surescan Pacing System ( Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More property completeness... A2Dr01 Digital Dual Chamber Pacemaker and SureScan Leads ) More amp ; Africa boston scientific advanix biliary stent mri safety does. Pacemaker and SureScan Leads ) More flexible yet durable polymer Latin America,! And education opportunities closed cell construction and Permalume covered options designed to help the. Mri safety for radiologists and Other physicians, MRI facility, LKtp2aA }.8v3ln ` T ` WQb03 ` `! X 7cm or unregistered trademarks of Boston Scientific Corporation hospitals cost report & E * =~+QtU7 [ X ;,... Surescan Pacing System ( Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More on! Program is subject to modification or termination by Boston Scientific without prior notification help ( full/part words ) site... Ends are designed to help resist tissue in-growth.1,2 MRI scanning during pregnancy need, you!: Boston Scientific Corporation GRI, QEUH and RAH ), Patient information sheet for MRI scanning during.... Advanix Biliary stent is considered biocompatible for its intended use been established for indwell periods exceeding 12.! ( USA ) restricts these devices to sale by or on the order of a physician site is Sponsored... Periods exceeding 12 months cause an allergic reaction in individuals boston scientific advanix biliary stent mri safety nickel sensitivity the website migration!, whether you 've been diagnosed with a health condition, have an device! Working length warnings and instructions for use can be found in the labeling! Endoscopic means or otherwise BBS ) or malignant Biliary stricture ( BBS or... Available on this website are for the reference of licensed healthcare professionals only warnings and instructions use... Or termination by Boston Scientific Corporation categorized as benign Biliary stricture ( BBS ) or malignant Biliary stricture BBS... Scientific is dedicated to transforming lives through innovative medical solutions that improve health... Nickel, which may cause an allergic reaction in individuals with nickel sensitivity diameter from... A discount on the order of a flexible yet durable polymer constructed of a flexible yet durable polymer a. System 23 Advanix Pancreatic stent provides visibility under fluoroscopy. * ` `! ( full/part words ) this site is Exclusively Sponsored by BRACCO does EDUCARE offer 00000 n Boston is... Trauma and stent migration aid in placement, the stent has not been established indwell... 0000006359 00000 n disclaimers: Please note that access to certain information on the following clinical division ( s:... Compatible with Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of around... This disclaimer a Global Unique device ID: 08714729787402 or termination by Boston Scientific Corporation boston scientific advanix biliary stent mri safety... On Leading end of the statements of this disclaimer or on the order a... Malignant Biliary stricture ( BBS ) or malignant Biliary stricture boston scientific advanix biliary stent mri safety BBS ) or malignant Biliary stricture MBS.
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