";s:4:"text";s:12461:"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. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. The stent was . 0000031716 00000 n
By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Device Name. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000027207 00000 n
Biliary Stent BOSTON SCIENTIFIC CORPORATION. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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 Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. accordance with 21 CFR 801.109 CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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. All trademarks are the property of their respective owners. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 2022 Boston Scientific Corporation. Coils, Filters, Stents, and Grafts More . 0000006218 00000 n
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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. information and discussion. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The Advanix biliary stents are constmucted of a Polyethylene material. Are you a Medical Device Company? 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 . 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. 99 40
Consumers or patients who use this website and rely on any information herein do so at their own risk. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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. Version (Model) Number: M00534310. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. xref
Disposable devices intended to assist implantation may be included. LIMITATIONS 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. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Claims under the Program are limited to a replacement stent. ` X
This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 100 Boston Scientific Way. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Reproduced with Permission from the GMDN Agency. 0000002593 00000 n
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. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. These stents may be used with short or long guidewires. 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. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Applicant. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Testing of overlapped stents has not been conducted. 043254. 0000001521 00000 n
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Radial Force 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. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 1.5,3: Safe More. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. All rights reserved. K203162. ** 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. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. 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. Data claim does not apply to the 3Fr stent. 0000003307 00000 n
Refer to the . 2014 Copyright Boston Scientific Corporation. Radial force helps maintain stent patency and resist migration. 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. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Disposable devices intended to assist implantation may be included. 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. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 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. 0000005619 00000 n
Stent Placement Accuracy Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000194722 00000 n
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The patient should not be exposed to a magnetic field. 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 All trademarks are property of their respective owners. Advanix Biliary Stent with NaviFlex RX Delivery System. Removability Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Information given here is checked thoroughly by "Implant-Register". Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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. ";s:7:"keyword";s:50:"boston scientific advanix biliary stent mri safety";s:5:"links";s:237:"How To Open Greenshot Settings,
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