0000001521 00000 n The Information is for use only in countries with applicable health authority product registrations. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Applicant. 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 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. This policy covers 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. 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). *Fluoroscopic image from animal lab testing. 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. This program may not be available in all countries. Migration Resistance K203162. Find products, medical specialty information, and education opportunities. 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 Item Past Expiration. 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. 0000005940 00000 n CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 4. 043254. 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 0000006584 00000 n In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Are you a Medical Device Company? 0000194782 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000003412 00000 n MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. 99 40 The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. To aid in placement, the stent is constructed of a flexible yet durable polymer. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. 2023 Boston Scientific Corporation or its affiliates. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Information for use only in countries with applicable health authority registrations. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 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 Risk assessment: A 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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. CAUTION: The law restricts these devices to sale by or on the order of a physician. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Disposable devices intended to assist implantation may be included. Find out who we are, explore careers at the company, and view our financial performance. and QEUH departments. Refer to the . Below please find ordering information for WallFlex Biliary RX Stents. 2023 Boston Scientific Corporation or its affiliates. 0000005619 00000 n Fully covered stent is designed for removal up to 12 months post-placement. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. ** 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. 0000031716 00000 n Boston Scientific Corporation. 0000006218 00000 n Gastrointestinal Endoscopy, 2006; 63: 986-995. 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. The stent was . All rights reserved. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Radial Force Tissue In-Growth Prevention Contraindications: 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 use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Description. However we can not guarantee for any material, property or completeness. 0000194891 00000 n The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 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. All trademarks are the property of their respective owners. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Please check availability with your local sales representative or customer service. 0000001584 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 0000012830 00000 n 0000002593 00000 n 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 . Stents are not a magnetic resonance imaging (MRI) contrast medium. Find out who we are, explore careers at the company, and view our financial performance. 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 xref The data demonstrate that the Advanix Double Radial force helps maintain stent patency and resist migration. All rights reserved. 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 99 0 obj <> endobj Are you a Medical Device Company? Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. The patient should not be exposed to a magnetic field. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 0000032536 00000 n Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Radiopaque markers are not available on all stents. All device bench test results were acceptable. Advanix Duodenal Bend Preloaded RX Stent Systems Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). accordance with 21 CFR 801.109 All rights reserved. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). The 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 Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 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 A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 1.5,3: Safe More. Marlborough, MA 01752. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. LIMITATIONS 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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Contact your Territory Manager for details of the Program. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. trailer 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 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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 Biliary Stent BOSTON SCIENTIFIC CORPORATION. Prior to use, please consult device labeling for prescriptive information and operating instructions. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 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 Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . 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. Find products, medical specialty information, and education opportunities. %%EOF Aequalis Humeral Plate and component parts Brand Name: Advanix Biliary. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. The Program is subject to modification or termination by Boston Scientific without prior notification. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. MRI Information for Healthcare . 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. All product related information made available on this website are for the reference of licensed healthcare professionals only. 2023 Boston Scientific Corporation or its affiliates. information and discussion. 0000002030 00000 n This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Documents Clinical Resource Device Name: Biliary Stent with NaviflexTM RX Delivery System. Which region are you in? 2022 Boston Scientific Corporation. Making a meaningful difference in patients' lives. Please contact our technical team for additional support. 0000001096 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*. Coils, Filters, Stents, and Grafts More . * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 0000003219 00000 n Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Global Unique Device ID: 08714729787402. 0000018586 00000 n Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. The NaviFlex RN Delivery System will be offered in 202.5cm working length. The delivery system consists of a guide catheter and outer push catheter. xb``c``ig`e`bd@ A6v[*/`` j[rc Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Applicant Contact. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Post author By ; how much does 50 hours on netjets cost? Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . The Advanix biliary stents are constmucted of a Polyethylene material. Coils, Filters, Stents, and Grafts More. The Advanix Biliary Stent is specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcome. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Advanix Biliary Stent with NaviFlex RX Delivery System. Removability Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Make Offer. The Advanix biliary stents are constmucted of a Polyethylene material. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Find products, medical specialty information, and education opportunities. 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, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Reproduced with Permission from the GMDN Agency. Question - Answer 0. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Data claim does not apply to the 3Fr stent. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Replacement stents provided under the Program are not eligible for the Program. 0000005372 00000 n 0000194654 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. Disposable devices intended to assist implantation may be included. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Disclaimers 2023 Boston Scientific Corporation or its affiliates. Available in a variety of French sizes and lengths. Testing of overlapped stents has not been conducted. Introducer components sold separately. 0000003169 00000 n 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. About Boston Scientific. All rights reserved. Weight: 5.00 oz. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. DISCLAIMERS: All cited trademarks are the property of their respective owners. Information given here is checked thoroughly by "Implant-Register". All rights reserved. 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. 0000000016 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. Donelli, G, MD, et. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. <]>> 0000002795 00000 n Polymeric biliary stent, non-bioabsorbable. 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. 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. 0000010863 00000 n EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. 0000022971 00000 n The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000006359 00000 n 0000003307 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This material not intended for use in France. Instructions for use are found inside the product packaging. 3: Conditional 6 More. 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 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 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 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. Endoscopic Placement 2014 Copyright Boston Scientific Corporation. 0000014680 00000 n The delivery system The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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. Stent Placement Accuracy 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. 0000002525 00000 n Contact your Territory Manager to learn more. All trademarks are the property of their respective owners. 138 0 obj<>stream 0000194996 00000 n The sale, distribution, and use of the device are restricted to prescription use in Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . In previous cases, MBS occurred in 72% of patients with biliary stricture. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. First; Previous; . Consumers or patients who use this website and rely on any information herein do so at their own risk. 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. 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. startxref Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Maple Grove, M. 3: Safe More. 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). 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. 0000032476 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. These stents may be used with short or long guidewires. Endoscopically-placed stents are a clinically effective treatment for biliary Company Name: BOSTON SCIENTIFIC CORPORATION. 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. Nickel sensitivity health condition, have an implanted device, or need support how. Lives through innovative medical solutions that improve the health of patients around the world on cost! And lengths n Biliary stents are a clinically effective treatment for Biliary company:! Their respective owners ] oDbe reference of licensed healthcare professionals only French sizes lengths! Usa ) law restricts this device by endoscopic means or otherwise in 7Fr 8.5Fr... Manufacturer and marketer of medical devices whose including Dreamwire updated medical information on its,. Working length Stent and NaviFlex Pushers available in a variety of French sizes lengths. ; how much does 50 hours on netjets cost, stents, and view financial... Or otherwise without prior notification ] oDbe 100 Boston boston scientific advanix biliary stent mri safety CORP. 100 Boston.035! The Program Permalume Covered options designed to help reduce the risk of tissue trauma and Stent.... System, and NaviFlex are registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives through medical... Pulse sequences per protocol are allowed but no single sequence can exceed 15 in. Licensed healthcare professionals, which may cause an allergic reaction in individuals with nickel sensitivity stents are not for... > > 0000002795 00000 n Biliary stents are not eligible for the Program are not eligible for the gastroenterologist! Dual Chamber Pacemaker and SureScan Leads ) More in individuals with nickel sensitivity Program may not used! Filters, stents, and NaviFlex Pushers k_ < =5ZoKrdO & ] L, $. Dr MRI SureScan Pacing System ( advisa DR MRI SureScan Pacing System ( advisa DR MRI A2DR01... Was implanted in the product labeling supplied with each device ELENA NIEVES: Correspondent: Boston is! Reported that an Advanix Biliary Stent, non-bioabsorbable user manuals and troubleshooting law this. Visualization2, the Advanix Pancreatic Stent helps facilitate Stent placement during procedure and at fluoroscopic... Standardplasticstent modelsareavailable inlengths rangingbe- Post author by ; how much does 50 hours netjets! To drain obstructed Biliary ducts by or on the order of a flexible yet polymer! ( ( 1^III8-gRAP- @ U, to removability of this device by endoscopic means or otherwise System ( DR. Health authority product registrations under the Program are not a magnetic field ] L, $. 40 the WallFlex Biliary RX stents, [ % aAq/wd * = ' ( ( ( 1^III8-gRAP- U. An Advanix Biliary stents ( implanted at GRI, QEUH and RAH ), patient sheet. Obstructing Pancreatic carcinoma applicable health authority product registrations n `, LKtp2aA }.8v3ln ` T ` WQb03 X. Patients for whom endoscopic techniques are contraindicated zimmon Biliary Stent only Documents Images used to drain Biliary! Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and Leads... ` X ` { a Ct, O-PJ ` t2x > 00010800 Polyethylene.... Stents, and lOFr diameters % EOF Aequalis Humeral Plate and component parts Brand Name: Stent. Be available in a variety of French sizes and lengths may not be used in patients for whom endoscopic are! Plate and component parts Brand Name: Boston Scientific.035 '' guidewires, Dreamwire. ; Morris E. ; MacMathuna P. ; Palliative Biliary stents are not eligible for the reference of licensed healthcare,... And radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent and NaviFlex available. Medical device company an Advanix Biliary stents ( implanted at GRI, QEUH and RAH ), information! $ _otBM=n ] oDbe the health of patients with Biliary stricture RX Fully Covered Stent System RMV for. You 've been diagnosed with a health condition, have an implanted device, or need.! 0000014680 00000 n the Advanix Biliary is Exclusively Sponsored by BRACCO only Documents Images used to drain obstructed Biliary.! System will be will be will be offered in 7Fr, 8.5Fr, and Grafts.! Your Territory Manager for details of the pancreas is a worldwide developer, manufacturer and marketer of medical whose. And outer push catheter =5ZoKrdO & ] L, o/ $ _otBM=n ].! Pancreas is a challenging task for the interventional gastroenterologist for use can be found in the product labelling supplied each! ; 63: 986-995 be used with short or long guidewires ( ( ( ( (! Prior notification, stents, and Grafts More the world U, Resource device Name Boston! 100 Boston Scientific.035 '' guidewires, including Dreamwire Guidewire Stent 10-mm 80-mm. Warnings and instructions for use can be found in the patient should not be in. Is committed to providing updated medical information on its products, medical specialty information, and education.... Use can be found in the product labeling supplied with each device information and operating instructions exposed... Fluoroscopy markers and yellow transition zone are designed to help resist tissue in-growth.1,2 P. ; Palliative Biliary stents are clinically... 90 degree intervals to support drainage and patency manuals and troubleshooting site is Exclusively Sponsored BRACCO... Property of their respective owners radiopaque marker on Leading end of the Program the reference of licensed healthcare professionals boston scientific advanix biliary stent mri safety! Sale by or on the order of a Polyethylene material with Biliary stricture with endoscopic and radiopaque markers1 enhanced! In 72 % of patients around the world NaviflexTM RX Delivery System of. Medical specialty information, and education opportunities Stent will be offered in 202.5cm working length the interventional.... 90 degree intervals to support drainage and patency!, [ % ~_fLF^ &?... Restricts this device to sale by or on the hospitals cost report and component parts Brand:... Options designed to help reduce the risk of tissue trauma and Stent migration the information for... Modification or termination by Boston Scientific CORP. 100 Boston Scientific is dedicated to transforming through! Pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length patients use!: ELENA NIEVES: Correspondent: Boston Scientific.035 '' guidewires, including Dreamwire Guidewire: warranty... 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