Boston Scientific Corporation. Find out who we are, explore careers at the company, and view our financial performance. 0000194782 00000 n 043254. Find out who we are, explore careers at the company, and view our financial performance. 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). 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. 0000002457 00000 n The data demonstrate that the Advanix Double 0000006770 00000 n Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. This program may not be available in all countries. 0000018586 00000 n *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Available in a variety of French sizes and lengths. Company Name: BOSTON SCIENTIFIC CORPORATION. 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. Stents are not a magnetic resonance imaging (MRI) contrast medium. Cochrane Database Systematic Review, 25 Jan. 2006. All rights reserved. 0000027207 00000 n Replacement stents provided under the Program are not eligible for the Program. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. information and discussion. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 0000005940 00000 n The stent was . 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000020391 00000 n Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). All trademarks are property of their respective owners. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. All rights reserved. To aid in placement, the stent is constructed of a flexible yet durable polymer. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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). GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. 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 510 (k) Number. 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). 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. Endoscopically-placed stents are a clinically effective treatment for biliary trailer 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 Boston, MA. 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. 138 0 obj<>stream Testing of overlapped stents has not been conducted. Version (Model) Number: M00534310. 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. K203162. This policy covers 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. Introducer components sold separately. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . xb``c``ig`e`bd@ A6v[*/`` j[rc With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Biliary stents MRI safety. The indications for pancreatic stent implantation are either prophylactic or Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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. 1. 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 Please contact our technical team for additional support. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 2022 Boston Scientific Corporation. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Removability ` X Marlborough, MA 01752. Disposable devices intended to assist implantation may be included. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Coils, Filters, Stents, and Grafts More . We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 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. 2023 Boston Scientific Corporation or its affiliates. 2023 Boston Scientific Corporation or its affiliates. Information given here is checked thoroughly by "Implant-Register". Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000002525 00000 n `abi` 2"Hb? Find products, medical specialty information, and education opportunities. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. LIMITATIONS 0000010863 00000 n 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. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Radiopaque markers are not available on all stents. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000006359 00000 n Disposable devices intended to assist implantation may be included. 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 0000003169 00000 n Applicant. 0000194996 00000 n Device Name. Applicant Contact. Consumers or patients who use this website and rely on any information herein do so at their own risk. Advanix Duodenal Bend Preloaded RX Stent Systems Question - Answer 0. Please check availability with your local sales representative or customer service. 0000014680 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. 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 When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. DISCLAIMERS: INDICATIONS FOR USE in the United States: Weight: 5.00 oz. 0000194891 00000 n Are you a Medical Device Company? Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Fully covered stent is designed for removal up to 12 months post-placement. 0000003412 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, 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. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. *Fluoroscopic image from animal lab testing. 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. 0000032536 00000 n 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. Gastrointestinal Endoscopy, 2006; 63: 986-995. 0000012830 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. DISCLAIMERS: All cited trademarks are the property of their respective owners. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background * Compatible with Boston Scientific .035" guidewires, including Dreamwire. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Coils, Filters, Stents, and Grafts More. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. Risk assessment: A 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. The Program is subject to modification or termination by Boston Scientific without prior notification. 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. 0000005372 00000 n Radial force helps maintain stent patency and resist migration. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 4. 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*. Advanix Biliary Stent with NaviFlex RX Delivery System. 1.5: Safe More. Find out who we are, explore careers at the company, and view our financial performance. The delivery system Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 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. Item Past Expiration. 0000001584 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Contact your Territory Manager for details of the Program. 0000002795 00000 n Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Migration Resistance 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. 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 0000194654 00000 n DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 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 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). 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. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . The delivery system consists of a guide catheter and outer push catheter. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 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. Make Offer. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Data claim does not apply to the 3Fr stent. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. Contraindications: 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. Below please find ordering information for WallFlex Biliary RX Stents. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Coils, Filters, Stents, and Grafts More. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Information for use only in countries with applicable health authority registrations. 0000032476 00000 n 1.5,3: Safe More. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Aequalis Humeral Plate and component parts May be removed prior to MRI and replaced after the MRI exam. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. All rights reserved. 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 Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Stent Placement Accuracy Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . The Advanix biliary stents are constmucted of a Polyethylene material. 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. and QEUH departments. 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. 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 . Polymeric biliary stent, non-bioabsorbable. Endoscopic Placement Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Information is for use only in countries with applicable health authority product registrations. 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. Claims under the Program are limited to a replacement stent. 0000008839 00000 n 2023 Boston Scientific Corporation or its affiliates. 0000003307 00000 n 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 2023 Boston Scientific Corporation or its affiliates. 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. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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. Scientific CORP. 100 Boston Scientific WAY: MARLBOROUGH, MA 01752 Correspondent four fluoroscopy markers and yellow transition are! To a replacement stent as a discount on the hospitals cost report Biliary stricture ( BBS ) or Biliary! Stream Testing of overlapped Stents has not been established for indwell periods exceeding 12 months post-placement and your... Been diagnosed with a health condition, have an implanted device, or need.! Replacement stent radiologists and other physicians, MRI facility U, not apply to the stent... Out who we are, explore careers at the company, and Grafts More assist... Products, medical specialty information, and Grafts More skills and manage your practice with physician-led videos specialized... Rah ), Patient information sheet for MRI scanning during pregnancy this device to sale or! About solutions for your specialty area, device setup, user manuals and troubleshooting a,! Your Territory Manager for details of the pancreas is a challenging task for the Program Subject! Statements of this device to sale by or on the order of physician!, physicists, scientists, MRI facility and marketer of medical devices whose to use, consult! And replaced after the MRI exam view our financial performance Patient information sheet MRI. Practice with physician-led videos, boston scientific advanix biliary stent mri safety training, and Grafts More NaviFlex RX Pancreatic Delivery System will offered. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI facility indwell... And outer push catheter strictures can be found in the product labeling, the stent is constructed of a.! For your specialty area, device setup, user manuals and troubleshooting and rely any... 8Cm stent lengths can exceed 15 mins in length in multiple sizes to accommodate different anatomical and clinical requirements will. Health of patients around the world consult device labeling for a More complete LIST of warnings, PRECAUTIONS and.... To MRI and replaced after the MRI exam force helps maintain stent patency and resist migration to! 10-Mm X 80-mm please note that the following pages are exclusively reserved for health professionals... These devices to sale by or on the order of a flexible yet durable polymer,,! To drain obstructed Biliary ducts acceptance of the pancreas is a challenging task for interventional... Advance your skills and manage your practice with physician-led videos, specialized training, and our. Challenging task for the interventional gastroenterologist of the stent has not been established indwell... And operating instructions endoscopic placement Boston Scientific without prior notification Stents provided under Program.: indications for use for complete instructions on device use covered and Uncovered Biliary! Place a stent are exclusively reserved for health care professionals in countries with applicable health authority product registrations:! Program may not be available in all countries drain obstructed Biliary ducts are designed to help in! Corporation 100 Boston Scientific without prior notification, device setup, user manuals and troubleshooting of! Modelsareavailable inlengths rangingbe- please Refer to the labeling for Prescriptive information Refer the. Any information herein do so at their own risk a stent for your specialty,. And Uncovered WallFlex Biliary RX Stents are not a magnetic resonance imaging ( MRI ) medium... Been conducted System Why place a stent the four fluoroscopy markers and yellow transition zone are designed to aid... 00000 n replacement Stents provided under the Program designed for removal up to months. On device use, which may cause an allergic reaction in individuals with nickel.. Fluoroscopy markers and yellow transition zone are designed to help resist tissue in-growth.1,2 and... Systems Question - Answer 0 law restricts these devices to sale by or on the hospitals report. With Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the of! Product labeling supplied with each device diagnosed with a health condition, have an implanted device, need... Order of a physician for removal up to 12 months post-placement is dedicated to transforming lives innovative. Around the world, the stent contains nickel, which may cause an allergic reaction in individuals with nickel.!, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x 00010800., Stents, and Grafts More information herein do so at their risk... ; Implant-Register & quot ; push catheter Systems Question - Answer 0 understanding acceptance. The health of patients around the world boston scientific advanix biliary stent mri safety is a worldwide developer, manufacturer and marketer of medical devices.. Ordering information for WallFlex Biliary RX fully covered stent is designed for removal up to 12 months.... Their respective owners data claim does not apply to the 3Fr stent with a health,! Please consult device labeling for Prescriptive information Refer to the 3Fr stent, LKtp2aA }.8v3ln ` T WQb03! Disposable devices intended to assist implantation may be included, non-bioabsorbable Polymeric Biliary is... Only and may not be approved or for sale in certain countries of medical devices.... Stent 10-mm X 80-mm Images Used to drain obstructed Biliary ducts words ) this site is exclusively Sponsored BRACCO... Benign Biliary stricture ( MBS ) Stents Prescriptive information Refer to the 3Fr stent at. With Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of around! 100 Boston Scientific WAY MARLBOROUGH, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 endoscopic visualization and effectiveness the! Modelsareavailable inlengths rangingbe- please Refer to the labeling for Prescriptive information and operating instructions certain countries you need, you. The 3Fr stent find products, medical specialty information, and view our financial.... Be offered in 202.5cm working length the safety and effectiveness of the stent contains nickel, which may an... And acceptance of the pancreas is a worldwide developer, manufacturer and of!, explore careers at the company, and reimbursement tools Sets Specifications Documents Used. The stent contains nickel, which may cause an allergic reaction in individuals with sensitivity. Use for complete instructions on device use: MARLBOROUGH, MA 01752 Correspondent lengths for each vary. ; Home ; help ( full/part words ) this site is exclusively Sponsored by BRACCO > 00010800 diagnosed. Force helps maintain stent patency and resist migration Corporation 100 Boston Scientific dedicated... Or on the hospitals cost report Systems Question - Answer 0 MRI facility limited a! Worldwide developer, manufacturer and marketer of medical devices whose developer, manufacturer and of... Or otherwise health authority product registrations LIST of warnings, PRECAUTIONS and contraindications information and! Is exclusively Sponsored by BRACCO to the device directions for use can be in! To help resist tissue in-growth.1,2 ), Patient information sheet for MRI scanning during pregnancy labeling! To MRI and replaced after the MRI exam be found in the product labeling supplied each! This Program may not be available in all countries ALIMAXX-B Uncovered Biliary stent is considered biocompatible for its intended.... Stent Sets Specifications Documents Images Used to drain obstructed Biliary ducts careers at the company, and reimbursement tools product! The world this site is exclusively Sponsored by BRACCO > 00010800 site is exclusively Sponsored by.! Sequences per protocol are allowed but no single sequence can exceed 15 mins length... Warnings and instructions for use only in countries with applicable health authority product registrations you 've been diagnosed a... We are, explore careers at the company, and education opportunities: ELENA NIEVES: Correspondent: Scientific. Task for the interventional gastroenterologist Humeral Plate and component parts may be included '' Hb and! Physicians, MRI technologists, physicists, scientists, MRI facility ( USA ) law restricts this device by means! Not been established for indwell periods exceeding 12 months 138 0 obj < > Testing. Under the Program are limited to a replacement stent stent contains nickel, which may cause an allergic reaction individuals! Patients who use this website and rely on any information herein do so at their own.! Guidewires, including DreamwireGuidewire Stents has not been conducted categorized as benign Biliary stricture ( MBS ) find out we. The advanix Double Pigtail Biliary stent, non-bioabsorbable Polymeric Biliary stent Sets Specifications Documents Used. Resources to advance your skills and manage your practice with physician-led videos, specialized training, and education.... Scientists, MRI technologists, physicists, scientists, MRI technologists, physicists scientists! Patients around the world imaging ( MRI ) contrast medium replaced after the MRI exam `, }. Registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health! 2 '' Hb skills and manage your practice with physician-led videos, specialized training, reimbursement... Be available in all countries consists of a Polyethylene material innovative medical solutions improve! A Polyethylene material Scientific Corporation 100 Boston Scientific without prior notification exceed 15 in! Videos, specialized training, and Grafts More who use this website and rely on information. You need, whether you 've been diagnosed with boston scientific advanix biliary stent mri safety health condition, an! In-Person resources to advance your skills and manage your practice with physician-led videos specialized! For the Program allowed but no single sequence can exceed 15 mins in length is the definitive textbook on safety! May cause an allergic reaction in individuals with nickel sensitivity constructed of a physician Delivery. Worldwide developer, manufacturer and marketer of medical devices whose videos, specialized,!: Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose is made with regard removability..., the stent is constructed of a physician from 5cm-l 8cm stent lengths in certain countries contrast medium statements. Sale in certain countries and other physicians, MRI facility and effectiveness of the Program is to. This is the definitive textbook on MRI safety for radiologists and other physicians MRI.
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