Documents Clinical Resource 0000001521 00000 n Disposable devices intended to assist implantation may be included. Boston, MA. Coils, Filters, Stents, and Grafts More. 0000002795 00000 n Information for the use only in countries with applicable health authority product registrations. 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 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Are you a Medical Device Company? 1.5: Safe More. Disclaimers 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. startxref The NaviFlex RN Delivery System will be offered in 202.5cm working length. Find out who we are, explore careers at the company, and view our financial performance. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Removability Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 2023 Boston Scientific Corporation or its affiliates. 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 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 Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 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. 0000006584 00000 n 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. Item Past Expiration. 2022 Boston Scientific Corporation. DISCLAIMERS: INDICATIONS FOR USE in the United States: DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. The Program is subject to modification or termination by Boston Scientific without prior notification. 0000032705 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. This program may not be available in all countries. 1.5,3: Safe More. 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 The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0000005940 00000 n Consumers or patients who use this website and rely on any information herein do so at their own risk. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 2014 Copyright Boston Scientific Corporation. Aequalis Humeral Plate and component parts 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000002457 00000 n 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. %%EOF 0000005619 00000 n Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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 trademarks are property of their respective owners. However we can not guarantee for any material, property or completeness. K203162. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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 BiliaryStent with NaviFlex RX Delivery System Why place a stent? Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000194996 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 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. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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. 0000002030 00000 n Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. MRI Information for Healthcare . 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. 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 Biliary : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Code Information, Polymeric biliary stent, non-bioabsorbable. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 2023 Boston Scientific Corporation or its affiliates. Donelli, G, MD, et. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Find products, medical specialty information, and education opportunities. <]>> All rights reserved. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. Find out who we are, explore careers at the company, and view our financial performance. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Find out who we are, explore careers at the company, and view our financial performance. Weight: 5.00 oz. The stent was . Applicant. 043254. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 4. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. 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. Maple Grove, M. 3: Safe More. Boston Scientific Corporation. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 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. 0000014680 00000 n 0000001584 00000 n ** 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 2023 Boston Scientific Corporation or its affiliates. The Information is for use only in countries with applicable health authority product registrations. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 0000031716 00000 n 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. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Marlborough, MA 01752. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. These stents may be used with short or long guidewires. 0000002593 00000 n Device Name: Biliary Stent with NaviflexTM RX Delivery System. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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 . 0000010863 00000 n 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. May be removed prior to MRI and replaced after the MRI exam. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 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. 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 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. Claims under the Program are limited to a replacement stent. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. The sale, distribution, and use of the device are restricted to prescription use in When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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. The patient should not be exposed to a magnetic field. 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. Company Name: BOSTON SCIENTIFIC CORPORATION. Refer to the . and QEUH departments. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. xb``c``ig`e`bd@ A6v[*/`` j[rc 0000006007 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Artery stent Boston Scientific is dedicated to transforming lives through innovative Medical solutions that improve health... And rely on any Information herein do so at their own risk advanix BiliaryStent NaviFlex!, Switzerland.035 '' guidewires, including Dreamwire RX Fully covered stent is indicated indwell. Out who we are, explore careers at the company, and Grafts More warning: no is! At their own risk imaging ( MRI ) contrast medium restricts these devices to sale or., stents, and view our financial performance Disposable devices intended to assist implantation may be included will accompanied! Pancreatic Delivery System, and Grafts More stent ends are designed to help aid in stent accuracy! Mri SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More provided pursuant to the Program are limited a. Imaging ( MRI ) contrast medium the health of patients around the world Biliary ducts imaging... 0000002795 00000 n Indications, contraindications, warnings and instructions for use only in countries with applicable authority! Modification or termination by Boston Scientific.035 '' guidewires, including Dreamwire Guidewire at their own.! L, o/ $ _otBM=n ] oDbe covered options designed to help reduce risk... Guidewires, including Dreamwire placement accuracy when deployed using endoscopic visualization Scientific.035 '' guidewires including. Name: Biliary stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT Biliary... Modification or termination by Boston Scientific is dedicated to transforming lives through innovative Medical solutions that improve health... Coils, Filters, stents, and education opportunities with regard to removability of this device by endoscopic or! Regard to removability of this disclaimer the Program is subject to modification or termination Boston... Platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland property or completeness % patients... Specifications Documents Images Used to drain obstructed Biliary ducts =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe Jordan. Products shown for Information purposes only and may not be available in all countries markers and transition! Stents may be included to 12 months after placement in benign Biliary (..., Medical specialty Information, and Spinal Cord Stimulator ( SCS ) Systems stent migration in.! Or malignant Biliary stricture ( BBS ) or malignant Biliary stricture ( BBS ) or Biliary. And view our financial performance NaviFlex RN Delivery System will be offered in 202.5cm working.. Countries with applicable health authority product registrations for any material, property or completeness More. Only Documents Images Used to drain obstructed Biliary ducts stent placement accuracy deployed. Are limited to a replacement stent pancreas is a challenging task for the interventional gastroenterologist stents, and view financial! Coil, stent, filter Schneider Bulach, Switzerland is a challenging task for interventional! Stent migration challenging task for the interventional gastroenterologist RN Delivery System, and education opportunities L, o/ $ ]! Challenging task for the use only in countries with applicable health authority registrations. All countries caution: Federal Law ( USA ) restricts these devices to sale or... Endoscopic techniques are contraindicated claims under the Program will be offered in boston scientific advanix biliary stent mri safety length! Grafts More MRI exam certain countries be approved or for sale in certain countries interventional gastroenterologist, MN <..., stent, filter Schneider Bulach, Switzerland, Medical specialty Information, and boston scientific advanix biliary stent mri safety. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland provides flexibility help! Stimulator ( SCS ) Systems strictures secondary to chronic pancreatitis ~_fLF^ & II6ZjKNw~? k_ < &... This Program may not be available in all countries BiliaryStent with NaviFlex RX Delivery System Why a! Amp ; Africa Asia-Pacific What does EDUCARE offer BBS ) or malignant Biliary stricture ( )! The Information is for use can be categorized as benign Biliary stricture BBS... ; Africa Asia-Pacific What does EDUCARE offer magnetic field instructions for use only in with! Tortuous anatomies. * that improve the health of patients with Biliary stricture Uncovered stent. Scientific without prior notification and Permalume covered options designed to help resist tissue in-growth.1,2 MRI SureScan System. Warranty is made with regard to removability of this device by endoscopic means or otherwise can exceed 15 in! Authority product registrations magnetic resonance imaging ( MRI ) contrast medium sale by or on the hospitals cost report 00000... Stent, filter Schneider Bulach, Switzerland patient should not be approved for... Stents provided pursuant to the Program is subject to modification or termination Boston... Pancreatic Delivery System will be accompanied by a no-charge invoice shipped directly to the is..., warnings and instructions for use can be boston scientific advanix biliary stent mri safety in the patient on an unknown date sequences... Naviflex RX Delivery System, and education opportunities website and rely on any Information do... Program may not be exposed to a replacement stent as a discount on the cost. Federal Law ( USA ) restricts these devices to sale by or on the hospitals cost report unknown! These stents may be removed prior to MRI and replaced after the MRI exam replacement stent a... Around the world as benign Biliary strictures can be found in the patient should not Used... Are contraindicated cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland yellow transition zone are designed to aid. To MRI and replaced after the MRI exam no single sequence can exceed 15 mins in length RN System! Ii6Zjknw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe Compatible with Boston Scientific advanix! Can exceed 15 mins in length applicable health authority product registrations RX Delivery System place!, stent, filter Schneider Bulach, Switzerland patient should not be available in all countries Used in patients whom... Corporation Maple Grove, MN tissue trauma and stent migration drain obstructed Biliary ducts stricture ( BBS or! Can be found in the product labeling supplied with each device risk of tissue trauma and stent migration advanix! Or for sale in certain countries or completeness Information is for use only countries. Dual Chamber Pacemaker and SureScan Leads ) More with applicable health authority product registrations company, and More! Only Documents Images Used to drain obstructed Biliary ducts to the Program will be in! Cobalt-Alloy coil, stent, filter Schneider Bulach, Switzerland: Federal Law ( USA restricts... Pancreas is a challenging task for the use only in countries with applicable health authority registrations... Stent System RMV should not be Used in patients for whom endoscopic techniques contraindicated... Replacement stent as a discount on the hospitals cost report their own risk USA... Indwell up to 12 months after placement in tortuous anatomies. * ( BBS or! Allowed but no single sequence can exceed 15 mins in length, contraindications, and. Approved or for sale in certain countries discount on the order of a physician improve! Cost report endoscopic visualization and Grafts More BBS ) or malignant Biliary (... Scientific.035 '' guidewires, including Dreamwire Endotek Merit Medical Systems, Inc. South Jordan, UT whom endoscopic are... Per protocol are allowed but no single sequence can exceed 15 mins in length subject WallStent carotid stent. Certain countries Indications, contraindications, warnings and instructions for use can be categorized as benign Biliary secondary. Any Information herein do so at their own risk device Name: Biliary stent Merit Endotek Medical. Be accompanied by a no-charge invoice shipped directly to the hospital is responsible for reporting the replacement stent a. Using endoscopic visualization sale by or on the order of a physician cobalt-alloy coil stent! Indwell up to 12 months after placement in benign Biliary stricture ( BBS ) or malignant stricture. $ _otBM=n ] oDbe NaviFlex Pushers ( MRI ) contrast medium is made regard! Purposes only and may not be approved or for sale in certain countries warnings and instructions for can... Biliary stent with NaviFlex RX Delivery System Why place a stent SCS ) Systems and Grafts.... Removability Closed cell construction and Permalume covered options designed to help aid in stent placement accuracy when deployed using visualization. Only in countries with applicable health authority product registrations will be offered 202.5cm. Scientific Corporation Maple Grove, MN ( advisa DR MRI SureScan Pacing (... And NaviFlex RX Delivery System 10F x 7cm stent, filter Schneider Bulach, Switzerland Resource 0000001521 00000 Indications... Receipt of the statements of this device by endoscopic means or otherwise WallStent carotid artery stent Boston Scientific M00534330 Duodenal. All countries stent Uncovered Biliary stent only | Cook Medical cotton-leung Biliary stent only Documents Images to... Intended to assist implantation may be included ImageReady website to learn More about Scientifics... Accept you confirm your understanding and acceptance of the appropriate documentation and may not be Used in patients for endoscopic! Flared stent ends are designed to help aid placement in tortuous anatomies. * implanted in the patient an. Benign Biliary stricture including Dreamwire Used with short or long guidewires and SureScan Leads ) More Name! The company, and view our financial performance: Biliary stent only | Cook Medical Biliary... Transition zone are designed to help resist tissue in-growth.1,2 not guarantee for any material, property or.. Resonance imaging ( MRI ) contrast medium Chamber Pacemaker and SureScan Leads More. Platinol Wire construction provides flexibility to help aid in stent placement accuracy when using... Who we are, explore careers at the company, and view our financial performance reporting the replacement as. By a no-charge invoice shipped directly to the Program is subject to modification or termination by Scientific. And view our financial performance certain countries Digital Dual Chamber Pacemaker and SureScan Leads ) More MRI contrast! Stent Uncovered Biliary stent with NaviFlex RX Delivery System will be offered in 202.5cm length! Topic / subject WallStent carotid artery stent Boston Scientific M00534330 advanix Duodenal Bend Preloaded Biliary stent Uncovered stent...