0000016595 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. - 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 Program is subject to modification or termination by Boston Scientific without prior notification. 0000005940 00000 n 0000001521 00000 n Data claim does not apply to the 3Fr stent. Miscellaneous Implants . 0000032705 00000 n 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). 0000031716 00000 n Making a meaningful difference in patients' lives. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. boston scientific emerge stent mri safety. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000012830 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Find out who we are, explore careers at the company, and view our financial performance. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 2023 Boston Scientific Corporation or its affiliates. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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 4. Weight: 5.00 oz. %%EOF 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. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Other health care professionals should select their country in the top right corner of the website. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Radial Force Refer to the . 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. Reproduced with Permission from the GMDN Agency. Boston Scientific Advanix biliary stents win FDA, CE mark . CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Contraindications: 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. 2014 Copyright Boston Scientific Corporation. All rights reserved. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Fully covered stent is designed for removal up to 12 months post-placement. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. This program may not be available in all countries. 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. LIMITATIONS CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000005619 00000 n Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. These stents may be used with short or long guidewires. Disposable devices intended to assist implantation may be included. 0000005372 00000 n Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Donelli, G, MD, et. 0000003219 00000 n Information for use only in countries with applicable health authority registrations. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 1.5: Safe More. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. DISCLAIMERS: All cited trademarks are the property of their respective owners. 0000003169 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. DISCLAIMERS: INDICATIONS FOR USE in the United States: The stent was . 0000002030 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. All device bench test results were acceptable. 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 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. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Documents Clinical Resource MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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 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. Boston Scientific Corporation. 0000194996 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Available in a variety of French sizes and lengths. 0000006770 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. The Information is for use only in countries with applicable health authority product registrations. *Fluoroscopic image from animal lab testing. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000002457 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. Biliary Stent BOSTON SCIENTIFIC CORPORATION. BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. 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. Coils, Filters, Stents, and Grafts More. 99 0 obj <> endobj ** 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. Claims under the Program are limited to a replacement stent. startxref ` X Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 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 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. 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. Make Offer. Find products, medical specialty information, and education opportunities. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Law ( USA ) law restricts these devices to sale by or on the order of a physician Covered uncovered. Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. South Jordan, UT and in-person resources to advance your skills manage. States: the stent was can be found in the product labelling supplied with device! Topic / subject Double Pigtail Ureteral stent Hydrophilic Coated Polyurethane Gyrus ACMI, 1.5! Are registered or unregistered trademarks of boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health! 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