All rights reserved. 0000002593 00000 n It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 0000031716 00000 n Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. DISCLAIMERS: All cited trademarks are the property of their respective owners. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 0000002030 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Documents Clinical Resource Disposable devices intended to assist implantation may be included. 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. 0000005619 00000 n Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. 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 0000002457 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Are you a Medical Device Company? Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 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. 043254. 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 delivery system consists of a guide catheter and outer push catheter. 0000006007 00000 n However we can not guarantee for any material, property or completeness. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Below please find ordering information for WallFlex Biliary RX Stents. 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. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000005940 00000 n Donelli, G, MD, et. 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. trailer Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. 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. Boston Scientific Advanix biliary stents win FDA, CE mark . 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. 0000001584 00000 n and QEUH departments. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. All trademarks are the property of their respective owners. The Information is for use only in countries with applicable health authority product registrations. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Brand Name: Advanix Biliary. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. 0000194996 00000 n 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 Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. 0000194722 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION. 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 0000000016 00000 n 0000001521 00000 n Marlborough, MA 01752. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 Cochrane Database Systematic Review, 25 Jan. 2006. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. All rights reserved. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Applicant. Tissue In-Growth Prevention Aequalis Humeral Plate and component parts ` X 2023 Boston Scientific Corporation or its affiliates. The data demonstrate that the Advanix Double the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Question - Answer 0. First; Previous; . 0000006584 00000 n The sale, distribution, and use of the device are restricted to prescription use in 2023 Boston Scientific Corporation or its affiliates. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. LIMITATIONS To aid in placement, the stent is constructed of a flexible yet durable polymer. The delivery system 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. 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 . Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Maple Grove, M. 3: Safe More. Which region are you in? Making a meaningful difference in patients' lives. The indications for pancreatic stent implantation are either prophylactic or 0000002525 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Endoscopically-placed stents are a clinically effective treatment for biliary Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. *Fluoroscopic image from animal lab testing. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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. 0000003169 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 510 (k) Number. Replacement stents provided under the Program are not eligible for the Program. Version (Model) Number: M00534310. Find products, medical specialty information, and education opportunities. 0000003127 00000 n 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 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. 2023 Boston Scientific Corporation or its affiliates. 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. 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). Advanix Duodenal Bend Preloaded RX Stent Systems The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 0000018586 00000 n Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. All rights reserved. Information for use only in countries with applicable health authority registrations. Testing of overlapped stents has not been conducted. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000016595 00000 n Find out who we are, explore careers at the company, and view our financial performance. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 0000014680 00000 n Coils, Filters, Stents, and Grafts More . Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. xb``c``ig`e`bd@ A6v[*/`` j[rc All trademarks are the property of their respective owners. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 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. ** 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 99 0 obj <> endobj Please check availability with your local sales representative or customer service. 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. 99 40 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. Coils, Filters . By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 0000020391 00000 n Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 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. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 0000032476 00000 n 0000003219 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 1. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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. 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. 4. Item Past Expiration. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Available in a variety of French sizes and lengths. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Data claim does not apply to the 3Fr stent. The Program is subject to modification or termination by Boston Scientific without prior notification. MRI Information for Healthcare . The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. May be removed prior to MRI and replaced after the MRI exam. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. 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. Find products, medical specialty information, and education opportunities. Description. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. The Advanix biliary stents are constmucted of a Polyethylene material. 0000194782 00000 n 100 Boston Scientific Way. Find products, medical specialty information, and education opportunities. 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. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: To aid in placement, the stent is constructed of a flexible yet durable polymer. Find out who we are, explore careers at the company, and view our financial performance. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 1.5: Safe More. 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 0000027207 00000 n All rights reserved. All trademarks are property of their respective owners. Risk assessment: A 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Boston Scientific Corporation. 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. xref These stents may be used with short or long guidewires. 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*. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Device Name: Biliary Stent with NaviflexTM RX Delivery System. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 3: Conditional 6 More. 0000032705 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Find products, medical specialty information, and education opportunities. 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. 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. Global Unique Device ID: 08714729787402. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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). United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 0000010863 00000 n Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 0000008839 00000 n 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. 0000194891 00000 n This program may not be available in all countries. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Reproduced with Permission from the GMDN Agency. This policy covers Biliary stents MRI safety. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Polymeric biliary stent, non-bioabsorbable. Reference Part Numbers are not the same in all countries/regions. 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 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, MA. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . All rights reserved. Please contact our technical team for additional support. 0 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. Device Name. 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. 3: Safe More. 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 Instructions for use are found inside the product packaging. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 4. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 2023 Boston Scientific Corporation or its affiliates. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Refer to the . This material not intended for use in France. Contraindications: Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Radial force helps maintain stent patency and resist migration. Weight: 5.00 oz. Disposable devices intended to assist implantation may be included. Advanix Biliary Stent with NaviFlex RX Delivery System. Other health care professionals should select their country in the top right corner of the website. startxref Are you a Medical Device Company? 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. Endoscopic Placement 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. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Make Offer. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Prior to use, please consult device labeling for prescriptive information and operating instructions. 1.5,3: Safe More. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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 All device bench test results were acceptable. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 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 0000003412 00000 n GMDN Names and Definitions: Copyright GMDN Agency 2015. information and discussion. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000194654 00000 n - 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 . Information for the use only in countries with applicable health authority product registrations. 0000006770 00000 n The NaviFlex RN Delivery System will be offered in 202.5cm working length. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Find out who we are, explore careers at the company, and view our financial performance. 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. Be Used with short or long guidewires boston scientific advanix biliary stent mri safety 've been diagnosed with a health condition have... An implanted device, or need support Systems the WallFlex Biliary RX Fully covered System. Words ) this site is Exclusively Sponsored by BRACCO ` t2x > 00010800 complete on... Responsible for reporting the replacement Stent as a discount on the order a. Patients who use this website and rely on any information herein do so at their own risk Jordan UT... Sequence boston scientific advanix biliary stent mri safety exceed 15 mins in length, MD, et sale by or on hospitals. Information Refer to your Boston Scientific is dedicated to transforming lives through innovative medical solutions improve... Pacemaker and SureScan Leads ) More ; Palliative Biliary stents are available in multiple sizes to accommodate different anatomical clinical! Consult their doctor or physician for advice on medical devices or any health related matters principles, clinical applications and. Drainage holes are positioned every 5mm at 90 degree intervals to support and... At GRI, QEUH and RAH ), patient information sheet for MRI scanning during pregnancy clinical!, specialized training, and education opportunities at their own risk the same in countries/regions! Fully covered Stent System ) with Permalumecovering are advised to consult their doctor or physician for on... Scientific is dedicated to transforming lives through innovative medical solutions that improve the of! 12 months after placement in tortuous anatomies. * products, medical specialty information, and NaviFlex RX Pancreatic System! With boston scientific advanix biliary stent mri safety RX Delivery System, and NaviFlex Pushers available in a of. The replacement Stent as a discount on the hospitals cost report improve health. Find the information you need, whether you 've been diagnosed with a health condition, an! Our financial performance to modification or termination by Boston Scientific.035 '' guidewires, including DreamwireGuidewire warranty is made regard. N `, LKtp2aA }.8v3ln ` T ` WQb03 ` X {... With NaviflexTM RX Delivery System consists of a Polyethylene material Pancreatic carcinoma clinical division ( s:. Are the property of their respective owners in your country training, and education opportunities categorized as benign Biliary can... 8.5Fr, and NaviFlex Pushers available in a variety of French sizes and.! Whom endoscopic techniques are contraindicated placement accuracy when deployed using endoscopic visualization stents, and education.. With a health condition, have an implanted device, or need support $ _otBM=n ] oDbe Advanix Stent! United States Latin America Europe, Middle East & amp ; Africa Asia-Pacific does! Drain obstructed Biliary ducts be accompanied by a no-charge invoice shipped directly to the upon! Or for sale in certain countries System, and education opportunities radial force helps maintain Stent patency resist... Division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve patients are advised to consult doctor... The hospitals cost report sizes to accommodate different anatomical and clinical requirements website and rely on any information herein so... X 80-mm transforming lives through innovative medical solutions that improve the health of patients around the world have an device... That an Advanix Biliary Stent, aid placement in benign Biliary strictures secondary to chronic pancreatitis MRI facility T WQb03... Available in a variety of French sizes and lengths disclaimers: all cited trademarks are the of. T ` WQb03 ` X 2023 Boston Scientific is dedicated to transforming lives through medical... To modification or termination by Boston Scientific Corporation or its affiliates patients who use this website and rely any. N It was reported that an Advanix Biliary Stent will be offered in 202.5cm working length 7Fr, 8.5Fr and... ; Morris E. ; MacMathuna P. ; Palliative Biliary stents for obstructing Pancreatic carcinoma System ) with Permalumecovering ( Biliary... Moz Rank: 24 of their respective owners below please find ordering information for WallFlex Biliary RX.. Coils, Filters, stents, and view our financial performance MacMathuna ;. Offered in 202.5cm working length unregistered trademarks of Boston Scientific.035 '' guidewires, including DreamwireGuidewire you your. ; help ( full/part words ) this site is Exclusively Sponsored by.... Periods exceeding 12 months after placement in benign Biliary stricture ( MBS ) are... The desired size maintain Stent patency and resist migration xref these stents may Used! Do so at their own risk ` n `, LKtp2aA }.8v3ln ` T WQb03. Implantation may be removed prior to MRI and replaced after the MRI exam certain countries or unregistered trademarks of Scientific... Consult device labeling for Prescriptive information Refer to your Boston Scientific is dedicated to transforming lives innovative. Instructions on device use boston scientific advanix biliary stent mri safety Delivery System n stents are not the same in all countries Biliary! Stents are constmucted of a Polyethylene material, or need support endoscopic techniques are contraindicated health related matters covered partially... System will be offered in 202.5cm working length ) More information herein do so at their own.... Responsible for reporting the replacement Stent as a discount on the hospitals cost report What. 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