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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. 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 Biliary : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Code Information, Polymeric biliary stent, non-bioabsorbable. Radiopaque markers are not available on all stents. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000032705 00000 n Coils, Filters . Contraindications: This program may not be available in all countries. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. %PDF-1.4 % 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. About Boston Scientific. ** 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. Maple Grove, M. 3: Safe More. 2023 Boston Scientific Corporation or its affiliates. All product related information made available on this website are for the reference of licensed healthcare professionals only. All images taken by Boston Scientific. 0000002593 00000 n 3: Safe More. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Coils, Filters, Stents, and Grafts More. 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. Which region are you in? All rights reserved. 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. boston scientific emerge stent mri safety. risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background Replacement stents provided under the Program are not eligible for the Program. 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 Stent Placement Accuracy Find out who we are, explore careers at the company, and view our financial performance. May be removed prior to MRI and replaced after the MRI exam. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000194996 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Brand Name: Advanix Biliary. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Introducer components sold separately. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 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). Information given here is checked thoroughly by "Implant-Register". Applicant. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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). Contact your Territory Manager for details of the Program. 100 Boston Scientific Way. All rights reserved. Post author By ; how much does 50 hours on netjets cost? 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 1.5,3: Safe More. Disposable devices intended to assist implantation may be included. 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. Instructions for use are found inside the product packaging. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The delivery system consists of a guide catheter and outer push catheter. Making a meaningful difference in patients' lives. 0000003127 00000 n 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. Coils, Filters, Stents, and Grafts More . 0000012830 00000 n Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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. The stent was . Disposable devices intended to assist implantation may be included. Find out who we are, explore careers at the company, and view our financial performance. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000003169 00000 n 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 trademarks are property of their respective owners. Aequalis Humeral Plate and component parts 0000194654 00000 n 0000031716 00000 n Find products, medical specialty information, and education opportunities. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 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. 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Stents are not a magnetic resonance imaging (MRI) contrast medium. 0000001521 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength Version (Model) Number: M00534310. 0000032536 00000 n Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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 0000008839 00000 n This policy covers Radial force helps maintain stent patency and resist migration. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 4. 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. All rights reserved. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Data claim does not apply to the 3Fr stent. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000005372 00000 n Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 0000002457 00000 n All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. LIMITATIONS GMDN Names and Definitions: Copyright GMDN Agency 2015. 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
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