information and discussion. Documents Clinical Resource 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). ** 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. 0000005619 00000 n Stent Placement Accuracy Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. In previous cases, MBS occurred in 72% of patients with biliary stricture. xref 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 NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 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. 0000003219 00000 n 0000031716 00000 n With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. The 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Find products, medical specialty information, and education opportunities. Make Offer. 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 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 0000010863 00000 n ` X Endoscopically-placed stents are a clinically effective treatment for biliary Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Polymeric biliary stent, non-bioabsorbable. Contraindications: The delivery system consists of a guide catheter and outer push catheter. 0000194891 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. This material not intended for use in France. 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 2022 Boston Scientific Corporation. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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. *Fluoroscopic image from animal lab testing. boston scientific emerge stent mri safety. 0000006770 00000 n Testing of overlapped stents has not been conducted. Weight: 5.00 oz. The Program is subject to modification or termination by Boston Scientific without prior notification. 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 . Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Coils, Filters, Stents, and Grafts More. Global Unique Device ID: 08714729787402. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 2023 Boston Scientific Corporation or its affiliates. Which region are you in? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Disclaimers Reproduced with Permission from the GMDN Agency. 1. Claims under the Program are limited to a replacement stent. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Version (Model) Number: M00534310. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. 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. 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. Are you a Medical Device Company? Fully covered stent is designed for removal up to 12 months post-placement. To aid in placement, the stent is constructed of a flexible yet durable polymer. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. The Information is for use only in countries with applicable health authority product registrations. 2023 Boston Scientific Corporation or its affiliates. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 0000027207 00000 n Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Other health care professionals should select their country in the top right corner of the website. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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 - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. 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 Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 0000008839 00000 n Instructions for use are found inside the product packaging. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. All rights reserved. First; Previous; . 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