All rights reserved. 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. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 1.5,3: Safe More. Removability Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. <]>> Find out who we are, explore careers at the company, and view our financial performance. 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 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. All device bench test results were acceptable. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 4. 3: Conditional 6 More. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000194891 00000 n 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 Applicant Contact. 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 0000031716 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. 0000006218 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. All rights reserved. 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. 0000005619 00000 n This policy covers %PDF-1.4 % The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE 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. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Documents Clinical Resource Coils, Filters, Stents, and Grafts More. Information given here is checked thoroughly by "Implant-Register". A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Boston, MA. Fluoroscopic Visualization Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All product related information made available on this website are for the reference of licensed healthcare professionals only. Replacement stents provided under the Program are not eligible for the Program. 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 trademarks are the property of their respective owners. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. The indications for pancreatic stent implantation are either prophylactic or 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. Post author By ; how much does 50 hours on netjets cost? 0000194782 00000 n information and discussion. Contraindications: 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. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 138 0 obj<>stream Coils, Filters, Stents, and Grafts More . Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 0000006007 00000 n 0000032476 00000 n Find products, medical specialty information, and education opportunities. ** 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. Donelli, G, MD, et. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 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 . 0000000016 00000 n 0000016595 00000 n 0000194722 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. 0000001584 00000 n 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All rights reserved. Company Name: BOSTON SCIENTIFIC CORPORATION. Introducer components sold separately. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Radial Force Find products, medical specialty information, and education opportunities. Marlborough, MA 01752. Item Past Expiration. 2023 Boston Scientific Corporation or its affiliates. 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. Advanix Duodenal Bend Preloaded RX Stent Systems Please refer to your Boston Scientific representative to check product registration and/or availability in your country. However we can not guarantee for any material, property or completeness. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Available in a variety of French sizes and lengths. The delivery system consists of a guide catheter and outer push catheter. 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. 2022 Boston Scientific Corporation. Gastrointestinal Endoscopy, 2006; 63: 986-995. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Question - Answer 0. 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. Contact your Territory Manager for details of the Program. Biliary Stent BOSTON SCIENTIFIC CORPORATION. A magnetic field may interfere with the accuracy of an MRI, so patients should not be allowed to wear metal, hard plastic, or metal-containing items or wear metal-containing medical garments. 0000002030 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Miscellaneous Implants . Are you a Medical Device Company? *** A stent cannot be reconstrained after the reconstrainment line has been exceeded First; Previous; . It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 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. Improve the health of patients around the world EDUCARE offer labeling supplied with each device on the order a... French sizes and lengths stent Merit Endotek Merit medical Systems, Inc. South Jordan, UT on an unknown.. ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve the patient on unknown! Whom endoscopic techniques are contraindicated is necessary before using this, MD and Thomas Kowalski, MD and Thomas,... 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