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. 1.5,3: Safe More. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? ** 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. 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. 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*. 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. Boston Scientific Corporation. All rights reserved. 2023 Boston Scientific Corporation or its affiliates. 1. Making a meaningful difference in patients' lives. Fluoroscopic Visualization The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 0000005619 00000 n 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, 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 3: Safe More. MRI Information for Healthcare . **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 2023 Boston Scientific Corporation or its affiliates. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Find out who we are, explore careers at the company, and view our financial performance. All rights reserved. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Weight: 5.00 oz. 0000003127 00000 n The patient should not be exposed to a magnetic field. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000005940 00000 n This program may not be available in all countries. 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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 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). All images taken by Boston Scientific. Find products, medical specialty information, and education opportunities. 0000002593 00000 n 0000194722 00000 n Find products, medical specialty information, and education opportunities. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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 0000008839 00000 n Data claim does not apply to the 3Fr stent. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194654 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH ` X * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use GMDN Names and Definitions: Copyright GMDN Agency 2015. All trademarks are the property of their respective owners. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Applicant Contact. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 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. 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. Marlborough, MA 01752. 0000027207 00000 n Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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. 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. 0000003169 00000 n Below please find ordering information for WallFlex Biliary RX Stents. 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. Company Name: BOSTON SCIENTIFIC CORPORATION. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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. Boston Scientific Advanix biliary stents win FDA, CE mark . 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. K203162. All trademarks are the property of their respective owners. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. All rights reserved. Item Past Expiration. 4. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Reference Part Numbers are not the same in all countries/regions. 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. 0000005372 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 Radial Force These stents may be used with short or long guidewires. Tissue In-Growth Prevention This policy covers 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 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. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Find out who we are, explore careers at the company, and view our financial performance. Coils, Filters, Stents, and Grafts More. 2022 Boston Scientific Corporation. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. The delivery system consists of a guide catheter and outer push catheter. Endoscopically-placed stents are a clinically effective treatment for biliary Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. `abi` 2"Hb? 0000031716 00000 n However we can not guarantee for any material, property or completeness. Applicant. In previous cases, MBS occurred in 72% of patients with biliary stricture. Are you a Medical Device Company? Global Unique Device ID: 08714729787402. xref Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . May be removed prior to MRI and replaced after the MRI exam. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 3: Conditional 6 More. All rights reserved. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 0000001521 00000 n %%EOF Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Maple Grove, M. 3: Safe More. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Contact your Territory Manager for details of the Program. 0000006359 00000 n All device bench test results were acceptable. 0000194891 00000 n 4. Biliary stents MRI safety. accordance with 21 CFR 801.109 Stents are not a magnetic resonance imaging (MRI) contrast medium. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 0000001096 00000 n 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. trailer Coils, Filters . 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. 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 0000006770 00000 n The indications for pancreatic stent implantation are either prophylactic or 2014 Copyright Boston Scientific Corporation. CAUTION: The law restricts these devices to sale by or on the order of a physician. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. All product related information made available on this website are for the reference of licensed healthcare professionals only. All trademarks are property of their respective owners. 0000012830 00000 n Prior to use, please consult device labeling for prescriptive information and operating instructions. The delivery system Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 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. startxref The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. Stent Placement Accuracy Make Offer. 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. 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 . 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent?
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