99 0 obj <> endobj 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. All rights reserved. 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. A biliary metal stent (also known as a "bile duct stent") is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. 0000005372 00000 n The Information is for use only in countries with applicable health authority product registrations. 2014 Copyright Boston Scientific Corporation. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Contact your Territory Manager for details of the Program. 0 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 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 . 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Question - Answer 0. 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. `abi` 2"Hb? Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 2023 Boston Scientific Corporation or its affiliates. Fluoroscopic Visualization ` X Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Brand Name: Advanix Biliary. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. To aid in placement, the stent is constructed of a flexible yet durable polymer. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Find products, medical specialty information, and education opportunities. 3: Safe More. Contraindications: 0000020391 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. The data demonstrate that the Advanix Double 0000002525 00000 n Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000003219 00000 n First; Previous; . All rights reserved. 0000014680 00000 n 0000194782 00000 n All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. Find products, medical specialty information, and education opportunities. LIMITATIONS 0000022971 00000 n 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. Risk assessment: A 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. 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. All rights reserved. Advanix Duodenal Bend Preloaded RX Stent Systems boston scientific emerge stent mri safety. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Disclaimers Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. 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. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. ** 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. Find products, medical specialty information, and education opportunities. Boston, MA. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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. 0000012830 00000 n Radial Force Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. This policy covers 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. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Information for use only in countries with applicable health authority registrations. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0000031716 00000 n The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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 . **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. This material not intended for use in France. MRI Information for Healthcare . The NaviFlex RN Delivery System will be offered in 202.5cm working length. The indications for pancreatic stent implantation are either prophylactic or Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Tissue In-Growth Prevention CAUTION: The law restricts these devices to sale by or on the order of a physician. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Coils, Filters, Stents, and Grafts More . Documents Clinical Resource Endoscopic Placement Weight: 5.00 oz. 1. 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 1.5,3: Safe More. 0000194722 00000 n 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. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis.

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