boston scientific advanix biliary stent mri safety

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boston scientific advanix biliary stent mri safety

` X Refer to the . Fully covered stent is designed for removal up to 12 months post-placement. 0000032536 00000 n It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 0000001096 00000 n Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 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. Radial force helps maintain stent patency and resist migration. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Please check availability with your local sales representative or customer service. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 0000194782 00000 n Information for use only in countries with applicable health authority registrations. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Please contact our technical team for additional support. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. 0000006007 00000 n Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. startxref About Boston Scientific. 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. Biliary Stent BOSTON SCIENTIFIC CORPORATION. information and discussion. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. Stent Placement Accuracy Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. <]>> 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*. Information for the use only in countries with applicable health authority product registrations. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Post author By ; how much does 50 hours on netjets cost? Company Name: BOSTON SCIENTIFIC CORPORATION. All rights reserved. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 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. 2023 Boston Scientific Corporation or its affiliates. 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 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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. Radial Force The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. The stent was . Brand Name: Advanix Biliary. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 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 rights reserved. The Program is subject to modification or termination by Boston Scientific without prior notification. 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. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 0000003219 00000 n 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 stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Gastrointestinal Endoscopy, 2006; 63: 986-995. 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. 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 138 0 obj<>stream Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Are you a Medical Device Company? 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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). 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 Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. *Fluoroscopic image from animal lab testing. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000002525 00000 n May be removed prior to MRI and replaced after the MRI exam. `abi` 2"Hb? Claims under the Program are limited to a replacement stent. Find products, medical specialty information, and education opportunities. Documents Clinical Resource ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Endoscopically-placed stents are a clinically effective treatment for biliary All rights reserved. 0000022971 00000 n All trademarks are the property of their respective owners. - 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 . First; Previous; . Boston Scientific Corporation. Coils, Filters, Stents, and Grafts More . 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 Below please find ordering information for WallFlex Biliary RX Stents. Coils, Filters . 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. 100 Boston Scientific Way. 2023 Boston Scientific Corporation or its affiliates. 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. 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 . To aid in placement, the stent is constructed of a flexible yet durable polymer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Description. 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. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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 product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. Aequalis Humeral Plate and component parts According to the MHRA (2014 section 4.11.2.4) each biliary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturers literature. 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 Removability Coils, Filters, Stents, and Grafts More. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. Cochrane Database Systematic Review, 25 Jan. 2006. Tissue In-Growth Prevention 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 Data claim does not apply to the 3Fr stent. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information given here is checked thoroughly by "Implant-Register". This program may not be available in all countries. 0000005372 00000 n Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000006584 00000 n * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. DISCLAIMERS: INDICATIONS FOR USE in the United States: 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. 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. 0000027207 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. 2022 Boston Scientific Corporation. Weight: 5.00 oz. %%EOF CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Disposable devices intended to assist implantation may be included. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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 0000032476 00000 n See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, 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. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Advanix Duodenal Bend Preloaded RX Stent Systems These stents may be used with short or long guidewires. 043254. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. However we can not guarantee for any material, property or completeness. 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. Contraindications: MRI Information for Healthcare . Disclaimers Item Past Expiration. CAUTION: The law restricts these devices to sale by or on the order of a physician. Introducer components sold separately. All rights reserved. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 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. Available in a variety of French sizes and lengths. 3: Safe More. 0000003169 00000 n 0000031716 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. 0000002593 00000 n Find products, medical specialty information, and education opportunities. Consumers or patients who use this website and rely on any information herein do so at their own risk. ** 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. Other health care professionals should select their country in the top right corner of the website. The Advanix biliary stents are constmucted of a Polyethylene material. 0000003412 00000 n 2023 Boston Scientific Corporation or its affiliates. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Ty Franck Mormon, Muziq Najm, Is There A Hadleigh College In New York, Articles B