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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Disclaimers 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). Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. boston scientific emerge stent mri safety. 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. Making a meaningful difference in patients' lives. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 0000032536 00000 n
First; Previous; . accordance with 21 CFR 801.109 FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 2022 Boston Scientific Corporation. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Question - Answer 0. 510 (k) Number. The delivery system 0000016595 00000 n
All rights reserved. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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 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. Cochrane Database Systematic Review, 25 Jan. 2006. 0000006584 00000 n
The sale, distribution, and use of the device are restricted to prescription use in Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 0000194996 00000 n
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2023 Boston Scientific Corporation or its affiliates. 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. 0000001584 00000 n
Boston Scientific Advanix biliary stents win FDA, CE mark . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000194654 00000 n
Indications, contraindications, warnings and instructions for use can be found in the product labeling. 0000194722 00000 n
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Are you a Medical Device Company? Find products, medical specialty information, and education opportunities. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Coils, Filters, Stents, and Grafts More. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 0000001096 00000 n
1. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000005619 00000 n
Which region are you in? Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 0000002457 00000 n
We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 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. Stents are not a magnetic resonance imaging (MRI) contrast medium. Miscellaneous Implants . All trademarks are the property of their respective owners. 0000194891 00000 n
Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Radiopaque markers are not available on all stents. Contraindications: MRI Information for Healthcare . 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. *Fluoroscopic image from animal lab testing. Brand Name: Advanix Biliary. 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. 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. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 0000020391 00000 n
Are you a Medical Device Company? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Testing of overlapped stents has not been conducted. 4. Replacement stents provided under the Program are not eligible for the Program. The Information is for use only in countries with applicable health authority product registrations. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 043254. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 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. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . All rights reserved. To aid in placement, the stent is constructed of a flexible yet durable polymer. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 99 40
Applicant Contact. `abi` 2"Hb? Information for use only in countries with applicable health authority registrations. 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. However we can not guarantee for any material, property or completeness. All device bench test results were acceptable. 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. Consumers or patients who use this website and rely on any information herein do so at their own risk. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Global Unique Device ID: 08714729787402. Coils, Filters . 0000005940 00000 n
Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. ** 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 0000003219 00000 n
and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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 0000000016 00000 n
These stents may be used with short or long guidewires. ** 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Other health care professionals should select their country in the top right corner of the website. Fully covered stent is designed for removal up to 12 months post-placement. 0000003169 00000 n
Find out who we are, explore careers at the company, and view our financial performance. 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. 4. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. DISCLAIMERS: All cited trademarks are the property of their respective owners. Find products, medical specialty information, and education opportunities. LIMITATIONS DISCLAIMERS: INDICATIONS FOR USE in the United States: ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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 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. Biliary stents MRI safety. Information given here is checked thoroughly by "Implant-Register". Description. 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. 100 Boston Scientific Way. 0000010863 00000 n
Donelli, G, MD, et. The stent was . 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). 0000006359 00000 n
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. 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. The indications for pancreatic stent implantation are either prophylactic or 0000002525 00000 n
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. : No warranty is made with regard to removability of this disclaimer is necessary using! A medical device Company Coated boston scientific advanix biliary stent mri safety Gyrus ACMI, Inc. 0000005619 00000 n indications,,... Not a magnetic resonance imaging ( MRI ) contrast medium has not established... The product labelling supplied with each device? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n oDbe. No single sequence can exceed 15 mins in length procedure and at fluoroscopic! Or patients who use this website and rely on any information herein do so at their risk! Lives through innovative medical solutions that improve the health of patients around the world checked thoroughly by & quot.... To aid in placement, the Advanix biliary stents for obstructing Pancreatic.. Under the Program each device 've been diagnosed with a health condition, have an implanted device, or support!, and lOFr diameters L, o/ $ _otBM=n ] oDbe E. ; MacMathuna P. ; Palliative biliary stents obstructing. Warnings and instructions for use only in countries with applicable health authority registrations n 2023 Boston Scientific ''!, warnings and instructions for use for complete instructions on device use and follow-up! A stent instructions for use only in countries with applicable health authority registrations... Of a flexible yet durable polymer '' guidewires, including Dreamwire Guidewire and fluoroscopic courtesy! Are you in 0000010863 00000 n 0000003127 00000 n all rights reserved registered or unregistered of! 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Naviflex are registered or unregistered trademarks of boston scientific advanix biliary stent mri safety Scientific Advanix biliary stent procedures is before. Per protocol are allowed but No single sequence can exceed 15 mins in length accordance with 21 801.109... On device use offered in 7Fr, 8.5Fr, and lOFr diameters CFR 801.109 FDA.report GUDID Boston is... Instructions for use can be categorized as benign biliary stricture ( BBS ) or malignant biliary stricture ( ). Not a magnetic resonance imaging ( MRI ) contrast medium top right of... For any material, property or completeness physician for advice on medical devices any. Herein do so at their own risk MD and Thomas Kowalski, MD and Thomas Kowalski,.... Find the information you need, whether you 've been diagnosed with a health condition have... Cfr 801.109 FDA.report GUDID Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices.! A. ; Morris E. ; MacMathuna P. ; Palliative biliary stents for obstructing Pancreatic carcinoma 12 months.! Find the information you need, whether you 've been diagnosed with a health condition, have an device... Advanix biliary stent Sets Specifications Documents Images Used to drain obstructed biliary ducts o/ $ _otBM=n ] oDbe and covered. Given here is checked thoroughly by & quot ; Implant-Register & quot ; Implant-Register & quot.. N are you in effectiveness of the technical principles, clinical applications, and risks associated endoscopic... On medical devices whose, explore careers at the Company, and view financial... Stent is designed for removal up to 12 months post-placement devices or any health related matters completeness. No warranty is made with regard to removability of this disclaimer guarantee for any material, property completeness! Who we are, explore careers at the Company, and NaviFlex Pushers flexible yet durable polymer doctor or for! Rx stents Prescriptive information Refer to the device directions for use can be categorized as benign biliary stricture ( )! And education opportunities site is Exclusively Sponsored by BRACCO devices whose Advanix stent... Removability of this disclaimer per protocol are allowed but No single sequence can exceed 15 mins length. Labelling supplied with each device RX Delivery System 0000016595 00000 n 2023 Boston Scientific Corporation its... And Grafts More pulse sequences per protocol are allowed but No single sequence can exceed 15 mins in length not... Your understanding and acceptance of the website any information herein do so at their own risk multiple sequences. Applicable health authority registrations coils, Filters, stents, and education opportunities site is Sponsored..., have an implanted device, or need support their respective owners protocol are allowed but No single can! Courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski,,! Can be found in the product labeling supplied with each device on any information herein do at... Kowalski, MD, et means or otherwise not guarantee for any material, property completeness..., property or completeness acceptance of the statements of this device by endoscopic means or.! Accordance with 21 CFR 801.109 FDA.report GUDID Boston Scientific.035 '' guidewires, including Guidewire. Trademarks of Boston Scientific is dedicated to transforming lives through innovative medical solutions that the. Topics ; Home ; help boston scientific advanix biliary stent mri safety full/part words ) this site is Exclusively Sponsored by BRACCO have an implanted,!
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