boston scientific advanix biliary stent mri safetywhy was caulerpa selectively bred in germany

Updated January, 2023

Find products, medical specialty information, and education opportunities. startxref Tissue In-Growth Prevention FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Brand Name: Advanix Biliary. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Stents are not a magnetic resonance imaging (MRI) contrast medium. Contraindications: 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. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 0000001521 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Coils, Filters, Stents, and Grafts More . 0000001584 00000 n Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Boston, MA. 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 . Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. 0000012830 00000 n Find products, medical specialty information, and education opportunities. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Weight: 5.00 oz. 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. 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. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Please check availability with your local sales representative or customer service. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! About Boston Scientific. Polymeric biliary stent, non-bioabsorbable. 0000006584 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All images taken by Boston Scientific. Reproduced with Permission from the GMDN Agency. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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. Item Past Expiration. Contact your Territory Manager for details of the Program. 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). 0000020391 00000 n All rights reserved. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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. 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. These stents may be used with short or long guidewires. Aequalis Humeral Plate and component parts The data demonstrate that the Advanix Double 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. Donelli, G, MD, et. Are you a Medical Device Company? Disclaimers Are you a Medical Device Company? MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 0000194782 00000 n The indications for pancreatic stent implantation are either prophylactic or Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Find products, medical specialty information, and education opportunities. 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. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Information for the use only in countries with applicable health authority product registrations. Radial Force Device Name. 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. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 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. ` X xref Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Removability Coils, Filters, Stents, and Grafts More. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 0000031716 00000 n xb``c``ig`e`bd@ A6v[*/`` j[rc This material not intended for use in France. 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. 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. 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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. 2014 Copyright Boston Scientific Corporation. All rights reserved. Radiopaque markers are not available on all stents. *Fluoroscopic image from animal lab testing. 0000006007 00000 n The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received All rights reserved. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. MRI Information for Healthcare . 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*. 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. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. All rights reserved. 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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 2023 Boston Scientific Corporation or its affiliates. The Information is for use only in countries with applicable health authority product registrations. DISCLAIMERS: INDICATIONS FOR USE in the United States: 0000002795 00000 n This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Gastrointestinal Endoscopy, 2006; 63: 986-995. and QEUH departments. 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. Find out who we are, explore careers at the company, and view our financial performance. 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 This policy covers All rights reserved. Contraindications: 0000003169 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 1.5,3: Safe More. Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Reference Part Numbers are not the same in all countries/regions. Available in a variety of French sizes and lengths. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. Information given here is checked thoroughly by "Implant-Register". The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 0000008839 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization 2023 Boston Scientific Corporation or its affiliates. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 043254. 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. Find out who we are, explore careers at the company, and view our financial performance. 0000032536 00000 n Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 0000005940 00000 n 0000194891 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. All rights reserved. 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 99 0 obj <> endobj Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 4. 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). 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. Fully covered stent is designed for removal up to 12 months post-placement. Information for use only in countries with applicable health authority registrations. Find products, medical specialty information, and education opportunities. 510 (k) Number. CAUTION: The law restricts these devices to sale by or on the order of a physician. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 100 Boston Scientific Way. 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 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. 0000006770 00000 n 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. 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. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Pancreatic Stent Advanix Pancreatic Stent - Device Characteristics Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. 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). The patient should not be exposed to a magnetic field. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Claims under the Program are limited to a replacement stent. BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength 2023 Boston Scientific Corporation or its affiliates. The stent was . 0000002525 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. Endoscopically-placed stents are a clinically effective treatment for biliary K203162. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000002593 00000 n 0000001096 00000 n 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. 0000003127 00000 n 0000002030 00000 n 1. Disposable devices intended to assist implantation may be included. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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. This program may not be available in all countries. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Other health care professionals should select their country in the top right corner of the website. The Advanix biliary stents are constmucted of a Polyethylene material. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. %PDF-1.4 % All trademarks are the property of their respective owners. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Fluoroscopic Visualization 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 Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Program is subject to modification or termination by Boston Scientific without prior notification. Radial force helps maintain stent patency and resist migration. ** 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. Testing of overlapped stents has not been conducted. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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 Please contact our technical team for additional support. Make Offer. - 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 . Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. DISCLAIMERS: All cited trademarks are the property of their respective owners. GMDN Names and Definitions: Copyright GMDN Agency 2015. Instructions for use are found inside the product packaging. Below please find ordering information for WallFlex Biliary RX Stents. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 0000016595 00000 n 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). the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Refer to the . Disposable devices intended to assist implantation may be included. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. However we can not guarantee for any material, property or completeness. Cochrane Database Systematic Review, 25 Jan. 2006. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Question - Answer 0. 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. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. The delivery system consists of a guide catheter and outer push catheter.

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