The stent was . startxref Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. The Information is for use only in countries with applicable health authority product registrations. Documents Clinical Resource * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000006218 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 . 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. Find out who we are, explore careers at the company, and view our financial performance. 0000002030 00000 n Polymeric biliary stent, non-bioabsorbable. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 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 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. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 99 0 obj <> endobj Radial force helps maintain stent patency and resist migration. Brand Name: Advanix Biliary. However we can not guarantee for any material, property or completeness. Prior to use, please consult device labeling for prescriptive information and operating instructions. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. ` X Tissue In-Growth Prevention xb``c``ig`e`bd@ A6v[*/`` j[rc * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 4. All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. 0000006007 00000 n The delivery system CAUTION: The law restricts these devices to sale by or on the order of a physician. 510 (k) Number. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Stents are not a magnetic resonance imaging (MRI) contrast medium. All trademarks are property of their respective owners. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. The indications for pancreatic stent implantation are either prophylactic or 2023 Boston Scientific Corporation or its affiliates. These stents may be used with short or long guidewires. 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Fully covered stent is designed for removal up to 12 months post-placement. 0000002795 00000 n Endoscopically-placed stents are a clinically effective treatment for biliary 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. All images taken by Boston Scientific. DISCLAIMERS: INDICATIONS FOR USE in the United States: Boston, MA. K203162. 0000194654 00000 n %%EOF 0000006359 00000 n 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. Coils, Filters, Stents, and Grafts More. First; Previous; . * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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 . This program may not be available in all countries. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Contact your Territory Manager to learn more. In previous cases, MBS occurred in 72% of patients with biliary stricture. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Applicant Contact. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Data claim does not apply to the 3Fr stent. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. %PDF-1.4 % 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. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. and QEUH departments. 0000194996 00000 n Contact your Territory Manager for details of the Program. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Which region are you in? 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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). Information for use only in countries with applicable health authority registrations. Coils, Filters, Stents, and Grafts More . About Boston Scientific. 0000003412 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, 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. 3: Conditional 6 More. 0000194891 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 0000001521 00000 n 1.5: Safe More. <]>> The Program is subject to modification or termination by Boston Scientific without prior notification. Version (Model) Number: M00534310. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000194782 00000 n 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ** 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . This material not intended for use in France. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 2022 Boston Scientific Corporation. Are you a Medical Device Company? Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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 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. 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