* Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Radial force helps maintain stent patency and resist migration. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Introducer components sold separately. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Advanix Duodenal Bend Preloaded RX Stent Systems Contraindications: Testing of overlapped stents has not been conducted. 1. This policy covers 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 Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 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. Endoscopically-placed stents are a clinically effective treatment for biliary Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Replacement stents provided under the Program are not eligible for the Program. Applicant Contact. 0000016595 00000 n **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. The delivery system consists of a guide catheter and outer push catheter. 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. The delivery system Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 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. 100 Boston Scientific Way. 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. 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. xref 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 rights reserved. This material not intended for use in France. 043254. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Instructions for use are found inside the product packaging. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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. 0000002593 00000 n Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Disposable devices intended to assist implantation may be included. Are you a Medical Device Company? 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. 3: Conditional 6 More. 0000020391 00000 n Are you a Medical Device Company? Contact your Territory Manager for details of the Program. 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. Version (Model) Number: M00534310. Coils, Filters, Stents, and Grafts More . 1.5,3: Safe More. 0000032536 00000 n 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. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . The Information is for use only in countries with applicable health authority product registrations. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 0000006218 00000 n This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . trailer Post author By ; how much does 50 hours on netjets cost? Cochrane Database Systematic Review, 25 Jan. 2006. Device Name. The indications for pancreatic stent implantation are either prophylactic or MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Question - Answer 0. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 0000032476 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000006007 00000 n 138 0 obj<>stream Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Find products, medical specialty information, and education opportunities. 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. 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Disposable devices intended to assist implantation may be included. Available in a variety of French sizes and lengths. Global Unique Device ID: 08714729787402. All images taken by Boston Scientific. 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. 0000006359 00000 n 3: Safe More. 0000027207 00000 n 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. 0000006584 00000 n LIMITATIONS 0000194722 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 510 (k) Number. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Boston, MA. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000005940 00000 n Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. All product related information made available on this website are for the reference of licensed healthcare professionals only. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 2023 Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. GMDN Names and Definitions: Copyright GMDN Agency 2015. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 0000194996 00000 n Make Offer. The Program is subject to modification or termination by Boston Scientific without prior notification. Disclaimers nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. The sale, distribution, and use of the device are restricted to prescription use in Fluoroscopic Visualization 1.5: Safe More. 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. Information given here is checked thoroughly by "Implant-Register". All trademarks are property of their respective owners. The data demonstrate that the Advanix Double 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. Polymeric biliary stent, non-bioabsorbable. The patient should not be exposed to a magnetic field. 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. 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. 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 Disposable devices intended to assist implantation may be included. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 99 0 obj <> endobj Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Contact your Territory Manager to learn more. 0000002030 00000 n 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. 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. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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 . accordance with 21 CFR 801.109 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. 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Rah ), patient information sheet for MRI scanning during pregnancy: MARLBOROUGH, MA 01752 Correspondent with... 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