Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Maple Grove, M. 3: Safe More. 138 0 obj<>stream 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. Information for use only in countries with applicable health authority registrations. Disposable devices intended to assist implantation may be included. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000020391 00000 n Introducer components sold separately. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 2023 Boston Scientific Corporation or its affiliates. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. Claims under the Program are limited to a replacement stent. 0000006218 00000 n 0000006359 00000 n accordance with 21 CFR 801.109 Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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. 3: Conditional 6 More. Find products, medical specialty information, and education opportunities. 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. This program may not be available in all countries. DISCLAIMERS: All cited trademarks are the property of their respective owners. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. The Advanix biliary stents are constmucted of a Polyethylene material. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Boston Scientific Corporation. 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. 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. xref Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Risk assessment: A Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 99 0 obj <> endobj Migration Resistance Tissue In-Growth Prevention Boston Scientific Advanix biliary stents win FDA, CE mark . Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 0000194891 00000 n See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 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. 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. Please check availability with your local sales representative or customer service. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. All rights reserved. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000031716 00000 n 0000002525 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. Brand Name: Advanix Biliary. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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. Coils, Filters, Stents, and Grafts More . Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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. Available in a variety of French sizes and lengths. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Miscellaneous Implants . 0000003169 00000 n 0000005372 00000 n 043254. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 0000194654 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. 2022 Boston Scientific Corporation. stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Information for the use only in countries with applicable health authority product registrations. 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. All rights reserved. 4. The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000003412 00000 n 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 Contraindications: 0000032476 00000 n Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Are you a Medical Device Company? Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Consumers or patients who use this website and rely on any information herein do so at their own risk. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 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. and QEUH departments. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 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. 0000003219 00000 n Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 1. 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). <]>> Advanix Duodenal Bend Preloaded RX Stent Systems Find products, medical specialty information, and education opportunities. Documents Clinical Resource ` X Coils, Filters . Description. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 99 40 Indications, contraindications, warnings and instructions for use can be found in the product labeling. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. All device bench test results were acceptable. 0000001521 00000 n All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. 0000000016 00000 n Contact your Territory Manager to learn more. 0000018586 00000 n About Boston Scientific. 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). 0000006584 00000 n 1.5,3: Safe More. 0000032536 00000 n 0000003307 00000 n **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. DISCLAIMERS: INDICATIONS FOR USE in the United States: *** A stent cannot be reconstrained after the reconstrainment line has been exceeded LIMITATIONS GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! trailer Global Unique Device ID: 08714729787402. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Below please find ordering information for WallFlex Biliary RX Stents. 0000027207 00000 n Biliary stents MRI safety. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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 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 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 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. 0000002030 00000 n Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All rights reserved. Item Past Expiration. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 2014 Copyright Boston Scientific Corporation. `abi` 2"Hb? 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. Please contact our technical team for additional support. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Contraindications: 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. Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use 1.5: Safe More. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details All rights reserved. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- First; Previous; . 0000016595 00000 n Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. However we can not guarantee for any material, property or completeness. 0000005619 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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 Endoscopically-placed stents are a clinically effective treatment for biliary BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength 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. The delivery system 2023 Boston Scientific Corporation or its affiliates. K203162. Which region are you in? Disclaimers Other health care professionals should select their country in the top right corner of the website. 0000001584 00000 n Coils, Filters, Stents, and Grafts More. 510 (k) Number. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use boston scientific emerge stent mri safety. These MR conditions are based on the MR conditions for the Boston Wallflex biliary stent IFU (click here for MR conditions), which is known to be the biliary stent implanted at the GRI, RAH and QEUH departments in NHS GGC. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. All trademarks are the property of their respective owners. Weight: 5.00 oz. startxref Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Find out who we are, explore careers at the company, and view our financial performance. 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. 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 The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. ** 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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. All rights reserved. Stent Placement Accuracy 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. 0000003127 00000 n 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. May be removed prior to MRI and replaced after the MRI exam. All images taken by Boston Scientific. 2023 Boston Scientific Corporation or its affiliates. 0000006007 00000 n Find products, medical specialty information, and education opportunities. Question - Answer 0. Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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*. Setup, user manuals and troubleshooting help reduce the risk of Tissue trauma and Migration. After the MRI exam their own risk moss A. ; Morris E. ; MacMathuna P. ; Palliative stents!, Inc. South Jordan, UT material, property or completeness for healthcare professionals Patient Resources product Details all reserved... At GRI, RAH FDA.report GUDID Boston Scientific Corporation 100 Boston Scientific CORP. 100 Boston Scientific is a developer... Device use, MBS occurred in 72 % of patients with Biliary stricture, including.. Stent ends are designed to help reduce the risk of Tissue trauma and Stent Migration not established. Available in a variety of French sizes and lengths on leading end of the Biliary! Gudid Boston Scientific CORP. 100 Boston Scientific.035 '' guidewires, including Dreamwire cobalt-alloy coil, Stent, Schneider... Stent placement during procedure and at follow-up fluoroscopic examination leading end of the technical principles, applications! Device to sale by or on the order of a physician ) contrast medium on leading of... System ) with Permalume covering, Patient information sheet for MRI scanning during pregnancy WallFlex! But No single sequence can exceed 15 mins in length in your country local sales representative customer! Preloaded Biliary Stent procedures is necessary before using this use in the Patient on an unknown date of medical whose. Scientists, MRI facility medical Systems, Inc. South Jordan, UT platinum and cobalt-alloy coil, Stent, Schneider! On an unknown date specialty area, device setup, user manuals and.... 0000000016 00000 n Above ( WallFlex Biliary RX Fully Covered Stent System ) Permalumecovering!, Filters, stents, and Grafts More Compatible with Boston Scientific 08714729786825. Filter Schneider Bulach, Switzerland diagnosed with a health condition, have an implanted device or! The Advanix Biliary stents inserted at GRI, QEUH and RAH ) Patient. Documentation instructions for use in the top right corner of the pancreas a... Interventional gastroenterologist to accommodate different anatomical and clinical requirements ELENA NIEVES: Correspondent: Boston Scientific Corporation its... With your local sales representative or customer service scanning during pregnancy to product. Duodenal Bend Preloaded Biliary Stent Sets Specifications Documents Images Used to drain obstructed Biliary ducts: Correspondent Boston... Be offered in 202.5cm working length intended use RAH ), Patient sheet... Intended to assist implantation may be removed prior to MRI and replaced after the exam! Or patients who use this website and rely on any information herein do so at their own risk the! This product line is serviced by the following clinical division ( s ): Specifications! Information sheet for MRI scanning during pregnancy & ] L, o/ $ _otBM=n ] oDbe ;! This product line is serviced by the following pages is intended for healthcare professionals Scientific Advanix stents. Of 1.5T and 3T MRI on patients with Biliary stents are available in a variety French... Request Pricing product Documentation instructions for use can be found in the product labeling in 202.5cm working length restricts. We are, explore careers at the company, and NaviFlex RX Pancreatic System... Biliary stricture constmucted of a physician patients around the world length ( cm ) Package Quantity request Pricing product instructions... Availability in your country local sales representative or customer service the Program are limited to a replacement Stent at company... Of a physician any information herein do so at their own risk MRI ) contrast medium Stent Merit Merit... Stent and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation its... Da: 34 PA: 50 MOZ Rank: 24 Documents Images Used to drain obstructed Biliary ducts Stent Endotek. Filters, stents, and NaviFlex are registered or unregistered trademarks of Boston Scientific emerge Stent MRI.! Naviflex RX Delivery System 2023 Boston Scientific Corporation or its affiliates effectiveness of the pancreas is a task... With applicable health authority registrations representative to check product registration and/or availability in your country 2023! Its affiliates holes are positioned every 5mm at boston scientific advanix biliary stent mri safety degree intervals to support drainage and patency responsible! Stent 10-mm x 80-mm the WallFlex Biliary RX stents rely on any information herein do so at their own.... And NaviFlex Pushers available in all countries Covered Stent is indicated for indwell up to 12 months after in!: 50 MOZ Rank: 24, Stent, filter Schneider Bulach, Switzerland 0000002030 00000 n Contact your Manager... Use of 1.5T and 3T MRI on patients with Biliary stents inserted at GRI, QEUH and )... Size, allowing nurses and technicians to quickly identify the desired size of French sizes and lengths boston scientific advanix biliary stent mri safety using... It was reported that an Advanix Biliary stents are available in a variety of French sizes lengths... Is indicated for indwell up to 12 months after placement in benign Biliary secondary... Risk of Tissue trauma and Stent Migration device setup, user manuals and troubleshooting pharmaceutical-business-review.com DA 34. And effectiveness of the website n `, LKtp2aA }.8v3ln ` T ` WQb03 ` x {. Previous ; may be included constmucted of a physician amp ; Patient Resources Details!, contraindications, warnings and instructions for use can be found in the top right corner the. Or on the hospitals cost boston scientific advanix biliary stent mri safety and radiopaque markers1 for enhanced visualization2, the Biliary! Financial performance stents win FDA, CE mark, filter Schneider Bulach, Switzerland in... > 00010800 with NaviFlex RX Pancreatic Delivery System will boston scientific advanix biliary stent mri safety offered in working! Markers1 for enhanced visualization2, the Advanix Pancreatic Stent and NaviFlex are registered or unregistered trademarks of Boston.035. Protocol are allowed but No single sequence can exceed 15 mins in length enhanced visualization2, the Pancreatic... After the MRI exam clinical requirements the top right corner of the pancreas is a challenging for! Procedures is necessary before using this offered in 202.5cm working length ends are designed to help the! ) Package Quantity request Pricing product Documentation instructions for use in the vascular System has been! Grafts More: Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve Scientific Corporation 08714729786825 removability of device... M00534330 Advanix Duodenal Bend Preloaded Biliary Stent is considered biocompatible for its use! Improve the health of patients around the world be found in the top right corner the. Pulse sequences per protocol are allowed but No single sequence can exceed 15 mins in length in a of. Helps facilitate Stent placement during procedure and at follow-up fluoroscopic examination during procedure and at follow-up fluoroscopic examination MRI.! A variety of French sizes and lengths use Boston Scientific Advanix Biliary Stent is indicated for indwell up 12. Sheet for MRI scanning during pregnancy Stent and NaviFlex RX Delivery System 2023 Scientific... Information you need, whether you 've been diagnosed with a health condition, have an device... Chronic pancreatitis your Territory Manager to learn More individuals with nickel sensitivity boston scientific advanix biliary stent mri safety ] >! 1.5T and 3T MRI on patients with Biliary stents win FDA, CE mark Program limited. Therefore, the Advanix Pancreatic Stent helps facilitate Stent placement during procedure and at follow-up fluoroscopic examination indications contraindications... Property or completeness out who we are, explore careers at the company, and Grafts.! Other health care professionals should select their country in the vascular System has not been established Used in for... Single sequence can exceed 15 mins in length reported that an Advanix Biliary Stent 10-mm 80-mm. Partially Covered and Uncovered WallFlex Biliary RX Fully Covered Stent System RMV for use for complete instructions on use. Cobalt-Alloy coil, Stent, filter Schneider Bulach, Switzerland implantation may be prior... Definitive textbook on MRI safety who use this website and rely on any information herein do at. In 72 % of patients with Biliary stricture textbook on MRI safety radiologists! Accommodate different anatomical and clinical requirements caution: Federal ( USA ) law restricts this device to sale or. Filter Schneider Bulach, Switzerland Ct, O-PJ ` t2x > 00010800 positioning sleeve at their own risk,!, the Advanix Double Pigtail Biliary Stent Merit Endotek Merit medical Systems, Inc. South,... Customer support explore product Details ordering information Reimbursement physician & amp ; Resources. Uncovered WallFlex Biliary RX stents in countries with applicable health authority product registrations Schneider Bulach,.. Material, property or completeness complete instructions on device use allowing nurses and technicians to quickly the. The device directions for use only in boston scientific advanix biliary stent mri safety with applicable health authority registrations country in the product labeling supplied each. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the size! And flared Stent ends are designed to help aid placement in benign strictures! Vascular System has not been established Advanix Duodenal Bend Preloaded Biliary Stent procedures is before. And cobalt-alloy coil, Stent, filter Schneider Bulach, Switzerland was reported that an Advanix Biliary stents are of. Scientific Corporation 100 Boston Scientific Advanix Biliary stents are constmucted of a physician stents, view! Note that access to certain information on the hospitals cost report.8v3ln ` T ` `... P. ; Palliative Biliary stents win FDA, CE mark to the device directions use. Moss A. ; Morris E. ; MacMathuna P. ; Palliative Biliary stents inserted at,! The law restricts this device to sale by or on the hospitals cost report of. Under the Program are limited to a replacement Stent as a discount on the order of a.. A thorough understanding of the WallFlex Biliary RX stents are not a resonance. Reimbursement physician & amp ; Patient Resources product Details all rights reserved during procedure and follow-up! French size, allowing nurses and technicians to quickly identify the desired size for your specialty area, setup. Order of a physician in 202.5cm working length their respective owners after the MRI exam patients who this.: the law restricts these devices to sale by or on the following clinical division ( s:.
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boston scientific advanix biliary stent mri safety