Cochrane Database Systematic Review, 25 Jan. 2006. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. 2023 Boston Scientific Corporation or its affiliates. 1. All trademarks are property of their respective owners. The delivery system consists of a guide catheter and outer push catheter. *Fluoroscopic image from animal lab testing. Advanix Biliary Stent with NaviFlex RX Delivery System. 0000008839 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000006584 00000 n All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Tissue In-Growth Prevention Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Find products, medical specialty information, and education opportunities. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 2023 Boston Scientific Corporation or its affiliates. 0000005940 00000 n 510 (k) Number. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Contact your Territory Manager for details of the Program. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 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. 100 Boston Scientific Way. Radial Force Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream 0000018586 00000 n Instructions for use are found inside the product packaging. Find out who we are, explore careers at the company, and view our financial performance. 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. All product related information made available on this website are for the reference of licensed healthcare professionals only. 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 0000002525 00000 n 0000002593 00000 n 0000003127 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded To aid in placement, the stent is constructed of a flexible yet durable polymer. Are you a Medical Device Company? 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. ** 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. 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. 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. %%EOF Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Coils, Filters, Stents, and Grafts More. Refer to the . 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. 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). 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. Removability Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 0000002795 00000 n The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. The delivery system 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. Advanix Duodenal Bend Preloaded RX Stent Systems Prior to use, please consult device labeling for prescriptive information and operating instructions. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Consumers or patients who use this website and rely on any information herein do so at their own risk. 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 Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. 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. Below please find ordering information for WallFlex Biliary RX Stents. 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. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The data demonstrate that the Advanix Double 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. 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