";s:4:"text";s:19414:"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. Claims under the Program are limited to a replacement stent. 0000002525 00000 n
About Boston Scientific. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. LIMITATIONS 0000008839 00000 n
Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. The NaviFlex RN Delivery System will be offered in 202.5cm working length. May be removed prior to MRI and replaced after the MRI exam. 0000000016 00000 n
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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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 Program is subject to modification or termination by Boston Scientific without prior notification.
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Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 2023 Boston Scientific Corporation or its affiliates. 0000003169 00000 n
Maple Grove, M. 3: Safe More. 100 Boston Scientific Way. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Testing of overlapped stents has not been conducted. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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. All rights reserved. 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. 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. Introducer components sold separately. All device bench test results were acceptable. Reproduced with Permission from the GMDN Agency. 3: Safe More. 0000003412 00000 n
Marlborough, MA 01752. Item Past Expiration. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 0000005940 00000 n
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. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. All trademarks are the property of their respective owners. Biliary stents MRI safety. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. However we can not guarantee for any material, property or completeness. 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. 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. This material not intended for use in France. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. In previous cases, MBS occurred in 72% of patients with biliary stricture. 0000031716 00000 n
Which region are you in? 1. %%EOF
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. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? ** 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. Question - Answer 0. Fluoroscopic Visualization Endoscopic Placement 0000018586 00000 n
Find out who we are, explore careers at the company, and view our financial performance. Radial force helps maintain stent patency and resist migration. 0000022971 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*. Disposable devices intended to assist implantation may be included. 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. The Information is for use only in countries with applicable health authority product registrations. 0000014680 00000 n
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Advanix Duodenal Bend Preloaded RX Stent Systems Below please find ordering information for WallFlex Biliary RX Stents. - 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 . Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. ` X
The sale, distribution, and use of the device are restricted to prescription use in This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. ** 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Contact your Territory Manager for details of the Program. The stent was . 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. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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 Advanix biliary stents are constmucted of a Polyethylene material. 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 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). 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 Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Instructions for use are found inside the product packaging. 0000027207 00000 n
CAUTION: The law restricts these devices to sale by or on the order of a physician. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Stent Placement Accuracy 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. 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. Fully covered stent is designed for removal up to 12 months post-placement. 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 . 1.5: Safe More. 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. These stents may be used with short or long guidewires. 0000006770 00000 n
Company Name: BOSTON SCIENTIFIC CORPORATION. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Disposable devices intended to assist implantation may be included. 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 All rights reserved. This policy covers 2023 Boston Scientific Corporation or its affiliates. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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 We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Find products, medical specialty information, and education opportunities. 510 (k) Number. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Information for the use only in countries with applicable health authority product registrations. Global Unique Device ID: 08714729787402. Refer to the . 0000020391 00000 n
Endoscopically-placed stents are a clinically effective treatment for biliary Consumers or patients who use this website and rely on any information herein do so at their own risk. Cochrane Database Systematic Review, 25 Jan. 2006. Description. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. *Fluoroscopic image from animal lab testing. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. All images taken by Boston Scientific. 3: Conditional 6 More. All rights reserved. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. trailer
Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000012830 00000 n
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 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). Weight: 5.00 oz. xb``c``ig`e`bd@ A6v[*/`` j[rc Available in a variety of French sizes and lengths. 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. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 0000003307 00000 n
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Information for use only in countries with applicable health authority registrations. 0000032476 00000 n
Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Other health care professionals should select their country in the top right corner of the website. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. Device Name. 0000010863 00000 n
Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000002795 00000 n
Migration Resistance Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 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. 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. 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. Polymeric biliary stent, non-bioabsorbable. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. ";s:7:"keyword";s:50:"boston scientific advanix biliary stent mri safety";s:5:"links";s:853:"Slow Decline Impacts On The Person,
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