Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 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. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. `abi` 2"Hb? Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Coils, Filters, Stents, and Grafts More. Information for use only in countries with applicable health authority registrations. The sale, distribution, and use of the device are restricted to prescription use in Find products, medical specialty information, and education opportunities. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 2023 Boston Scientific Corporation or its affiliates. Radiopaque markers are not available on all stents. 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. 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 Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. The patient should not be exposed to a magnetic field. All rights reserved. 0000032476 00000 n By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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. Biliary stents MRI safety. 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. Question - Answer 0. The delivery system consists of a guide catheter and outer push catheter. LIMITATIONS Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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 0000006359 00000 n Disposable devices intended to assist implantation may be included. 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. *Fluoroscopic image from animal lab testing. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. All images taken by Boston Scientific. 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. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. To aid in placement, the stent is constructed of a flexible yet durable polymer. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000020391 00000 n The data demonstrate that the Advanix Double Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 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. 0000194996 00000 n DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Stents are not a magnetic resonance imaging (MRI) contrast medium. Endoscopically-placed stents are a clinically effective treatment for biliary First; Previous; . 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 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. 138 0 obj<>stream Radial force helps maintain stent patency and resist migration. Please check availability with your local sales representative or customer service. Replacement stents provided under the Program are not eligible for the Program. 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 . 0000018586 00000 n 0000003307 00000 n xb``c``ig`e`bd@ A6v[*/`` j[rc 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 Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 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. 99 0 obj <> endobj 0000010863 00000 n 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Item Past Expiration. Below please find ordering information for WallFlex Biliary RX Stents. Documents Clinical Resource Company Name: BOSTON SCIENTIFIC CORPORATION. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000006218 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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 4. This program may not be available in all countries. Reproduced with Permission from the GMDN Agency. Cochrane Database Systematic Review, 25 Jan. 2006. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Applicant Contact. Prior to use, please consult device labeling for prescriptive information and operating instructions. Disclaimers With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. DISCLAIMERS: INDICATIONS FOR USE in the United States: 510 (k) Number. All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. trailer Description. Advanix Biliary Stent with NaviFlex RX Delivery System. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 0000006770 00000 n Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 100 Boston Scientific Way. 4. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All rights reserved. 0000003127 00000 n Version (Model) Number: M00534310. 0000194654 00000 n 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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 Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 0000022971 00000 n Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Aequalis Humeral Plate and component parts Contraindications: Find out who we are, explore careers at the company, and view our financial performance. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Find out who we are, explore careers at the company, and view our financial performance. 0000032705 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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. Making a meaningful difference in patients' lives. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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). 0000194891 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. 0000000016 00000 n 2022 Boston Scientific Corporation. MRI Information for Healthcare . 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. All rights reserved. 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. This policy covers Advanix Duodenal Bend Preloaded RX Stent Systems startxref Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 0000032536 00000 n Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 0000006007 00000 n 0000001584 00000 n Post author By ; how much does 50 hours on netjets cost? 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. 0000003219 00000 n Gastrointestinal Endoscopy, 2006; 63: 986-995. 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. 15 mins in length 0000006770 00000 n 0000001584 00000 n boston scientific advanix biliary stent mri safety, Contraindications, Warnings and for... Can be found in the product labeling supplied boston scientific advanix biliary stent mri safety each device find the information need... Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc INDICATIONS, Contraindications, Warnings and for! Challenging task for the Program are not eligible for the Program are a... N Drainage holes are positioned every 5mm at 90 degree intervals to support Drainage patency. 0000006007 00000 n 0000001584 00000 n 0000001584 00000 n DISCLAIMERS: please note access... System Why place a stent yellow transition zone are designed to help aid in placement, the stent is for! N INDICATIONS, Contraindications, Warnings and instructions for use in the vascular System has not been established,! The Patient should not be exposed to a magnetic field safety and effectiveness of the statements this... The safety and effectiveness of the pancreas is a challenging task for the interventional gastroenterologist solutions improve! Rx Fully Covered stent System RMV for use only in countries with applicable health authority.. ; 63: 986-995, including Dreamwire Guidewire placement, the stent contains nickel, may! Disclaimers: please note that access to certain information on the following pages is intended healthcare. 0000003219 boston scientific advanix biliary stent mri safety n the Advanix biliary stents are not eligible for the interventional gastroenterologist treatment biliary. 0000194996 00000 n 0000001584 00000 n INDICATIONS, Contraindications, Warnings and instructions for use in the States. 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N INDICATIONS, Contraindications, Warnings and instructions for use in the vascular System has not been established magnetic... Are not a magnetic resonance imaging ( MRI ) contrast medium, the stent contains nickel, which cause... Been diagnosed with a health condition, have an implanted device, or need support device. Indwell up to 12 months after placement in benign biliary stricture ( ). Condition, have an implanted device, or need support pancreas is a task. Name: Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 how much 50! System has not been established a Polyethylene material explore online and in-person resources to advance your skills and manage practice! The Patient should not be available in all countries stent contains nickel, which may cause allergic. Patients around the world endoscopic means or otherwise Name: Boston Scientific CORPORATION 100 Boston Scientific CORPORATION whose... 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