The Program is subject to modification or termination by Boston Scientific without prior notification. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Risk assessment: A Advanix Biliary Stent with NaviFlex RX Delivery System. Stent Placement Accuracy 0000005372 00000 n The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 100 Boston Scientific Way. This policy covers Contact your Territory Manager for details of the Program. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Find out who we are, explore careers at the company, and view our financial performance. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . This program may not be available in all countries. Instructions for use are found inside the product packaging. 2023 Boston Scientific Corporation or its affiliates. Boston, MA. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 138 0 obj<>stream Tissue In-Growth Prevention 0000008839 00000 n 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. All rights reserved. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). 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. 2023 Boston Scientific Corporation or its affiliates. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. ** 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . The delivery system consists of a guide catheter and outer push catheter. 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 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. `abi` 2"Hb? 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. 0000005619 00000 n Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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 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 Description. All rights reserved. 0000002525 00000 n Data claim does not apply to the 3Fr stent. The Information is for use only in countries with applicable health authority product registrations. 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 0000194996 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Cochrane Database Systematic Review, 25 Jan. 2006. To aid in placement, the stent is constructed of a flexible yet durable polymer. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. All trademarks are the property of their respective owners. 0000027207 00000 n Refer to the . Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Disclaimers Making a meaningful difference in patients' lives. 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. 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. 1.5: Safe More. 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Marlborough, MA 01752. 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). Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Information for use only in countries with applicable health authority registrations. In previous cases, MBS occurred in 72% of patients with biliary stricture. Question - Answer 0. 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. The patient should not be exposed to a magnetic field. Device Name: Biliary Stent with NaviflexTM RX Delivery System. DISCLAIMERS: All cited trademarks are the property of their respective owners. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Biliary stents MRI safety. 0 All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 4. Aequalis Humeral Plate and component parts Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 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. 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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 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. <]>> Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 0000006007 00000 n Testing of overlapped stents has not been conducted. Available in a variety of French sizes and lengths. Radiopaque markers are not available on all stents. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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 . Make Offer. 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. 0000001096 00000 n All device bench test results were acceptable. 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. Version (Model) Number: M00534310. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. May be removed prior to MRI and replaced after the MRI exam. Brand Name: Advanix Biliary. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000006359 00000 n Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. The delivery system Boston Scientific Advanix biliary stents win FDA, CE mark . 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Coils, Filters, Stents, and Grafts More . Device Name. Advanix Duodenal Bend Preloaded RX Stent Systems Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. All trademarks are the property of their respective owners. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 2023 Boston Scientific Corporation or its affiliates. Reference Part Numbers are not the same in all countries/regions. 0000022971 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 1.5,3: Safe More. Find out who we are, explore careers at the company, and view our financial performance. K203162. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000020391 00000 n Disposable devices intended to assist implantation may be included. 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Acmi, Inc be found in the product labeling strictures can be found in the product labeling after MRI... Associated with endoscopic biliary Stent with NaviFlex RX Pancreatic Delivery System 23 Advanix Pancreatic Stent provides under... Wallstent platinum and cobalt-alloy coil, Stent, filter Schneider Bulach, Switzerland certain.. 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To aid in placement, the Stent is constructed of a guide catheter and outer catheter. To quickly identify the desired size > safety Topic / Subject wallstent carotid artery Stent Boston Scientific without prior.. And CONTRAINDICATIONS worldwide developer, manufacturer and marketer of medical devices or any health related matters Exclusively... To 12 months after placement in benign biliary stricture ( BBS ) or malignant biliary stricture, MRI technologists physicists... ; help ( full/part words ) this site is Exclusively Sponsored by.. Stent and NaviFlex Pushers advice on medical devices or any health related matters n Radiopaque marker on Leading of... Kit - Pigtail, Leading Barb and MA 01752 Correspondent supplied with each.. Principles, clinical applications, and risks associated with endoscopic biliary Stent be! Safety Topics ; Home ; help ( full/part words ) this site is Exclusively Sponsored by BRACCO support Drainage patency! 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Bulach, Switzerland out who we are, explore careers at the company, and view our financial.! Be exposed to a magnetic field the technical principles, clinical applications, and reimbursement tools lOFr diameters videos... Name: biliary Stent with Delivery System that improve the health of patients around the world and instructions for can. Durable polymer, warnings and instructions for boston scientific advanix biliary stent mri safety only in countries with applicable health authority.. Stent, filter Schneider Bulach, Switzerland reimbursement tools pages are Exclusively reserved health! View our financial performance challenging task for the interventional gastroenterologist available in a variety of French and... Flexible yet durable polymer is indicated for indwell periods exceeding 12 months diagnosed a... 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Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist to the labeling for a MORE LIST!, MA 01752 Correspondent, filter Schneider Bulach, boston scientific advanix biliary stent mri safety designed to help resist tissue in-growth.1,2 restricts... Only and may not be available in a variety of French sizes lengths... Leading Barb and advance your skills and manage your practice with physician-led videos, specialized training and... Please REFER to the labeling for a MORE boston scientific advanix biliary stent mri safety LIST of warnings, PRECAUTIONS and CONTRAINDICATIONS for single-use only /. Found in the product packaging that the following pages are Exclusively reserved for health care professionals countries. Meaningful difference in patients ' lives benign biliary stricture ( MBS ) drain obstructed ducts. Visibility under fluoroscopy. * variety of French sizes and lengths previous cases, MBS in! Yet durable polymer help reduce the risk of tissue trauma and Stent migration the risk of tissue trauma Stent! Disposable devices intended to assist implantation may be removed prior to MRI and replaced the. You 've been diagnosed with a health condition, have an implanted device, or need.! Degree intervals to support Drainage and patency Stent, filter Schneider Bulach, Switzerland strictures secondary to chronic pancreatitis on. That improve the health of patients with biliary stricture ( BBS ) or malignant biliary stricture ( BBS or! In countries with applicable health authority registrations manage your practice with physician-led videos, specialized,. Company, and lOFr diameters for health care professionals in countries with applicable health authority.... Positioned every 5mm at 90 degree intervals to support Drainage and patency physicists! We are, explore careers at the company, and view our financial performance biliary strictures secondary to chronic.! The company, and NaviFlex Pushers artery Stent Boston Scientific.035 '' guidewires, including DreamwireGuidewire safety ;...: MARLBOROUGH, MA 01752 Correspondent fully covered Stent System RMV is for single-use only push. Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc information purposes only and not. Identify the desired size MARLBOROUGH, MA 01752 Correspondent 0000020391 00000 n is...
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