2014 Copyright Boston Scientific Corporation. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Advanix Biliary Stent with NaviFlex RX Delivery System. Radial Force 0000002457 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Post author By ; how much does 50 hours on netjets cost? 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. 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 0000032476 00000 n Global Unique Device ID: 08714729787402. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Risk assessment: A Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 3: Conditional 6 More. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. 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. 510 (k) Number. Find out who we are, explore careers at the company, and view our financial performance. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Endoscopically-placed stents are a clinically effective treatment for biliary Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. K203162. This material not intended for use in France. ** 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. Endo-232507-AA April 2014, 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*. 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. Maple Grove, M. 3: Safe More. 0000032536 00000 n Find products, medical specialty information, and education opportunities. Below please find ordering information for WallFlex Biliary RX Stents. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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 About Boston Scientific. 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 . MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 0000006584 00000 n Contraindications: Refer to the . Make Offer. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Biliary stents MRI safety. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Radiopaque markers are not available on all stents. 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. xref 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 Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility accordance with 21 CFR 801.109 Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Contact your Territory Manager for details of the Program. Weight: 5.00 oz. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000031716 00000 n 2022 Boston Scientific Corporation. May be removed prior to MRI and replaced after the MRI exam. 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. This program may not be available in all countries. In previous cases, MBS occurred in 72% of patients with biliary stricture. DISCLAIMERS: All cited trademarks are the property of their respective owners. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0000005619 00000 n 1. 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. Find products, medical specialty information, and education opportunities. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. *Fluoroscopic image from animal lab testing. Item Past Expiration. Find out who we are, explore careers at the company, and view our financial performance. Tissue In-Growth Prevention 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 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). 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. EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. Applicant Contact. ` X Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Contact your Territory Manager to learn more. Disclaimers Fluoroscopic Visualization Device Name. 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. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 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). 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. 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. Reference Part Numbers are not the same in all countries/regions. Find products, medical specialty information, and education opportunities. Coils, Filters, Stents, and Grafts More. Gastrointestinal Endoscopy, 2006; 63: 986-995. 0000006359 00000 n 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 Boston Scientific Advanix biliary stents win FDA, CE mark . CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The delivery system We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Making a meaningful difference in patients' lives. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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 All rights reserved. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. information and discussion. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 043254. 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. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 0000006770 00000 n 1.5: Safe More. Coils, Filters . Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. The NaviFlex RN Delivery System will be offered in 202.5cm working length. `abi` 2"Hb? 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 Are you a Medical Device Company? All rights reserved. Disposable devices intended to assist implantation may be included. 0 Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Coils, Filters, Stents, and Grafts More . The patient should not be exposed to a magnetic field. Other health care professionals should select their country in the top right corner of the website. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Stents are not a magnetic resonance imaging (MRI) contrast medium. startxref The Advanix biliary stents are constmucted of a Polyethylene material. This policy covers Device Name: Biliary Stent with NaviflexTM RX Delivery System. All device bench test results were acceptable. 0000003127 00000 n 0000001521 00000 n 0000194996 00000 n 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. All rights reserved. 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 2023 Boston Scientific Corporation or its affiliates. 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 0000002525 00000 n The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Applicant. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. %%EOF 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. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Instructions for use are found inside the product packaging. 4. Company Name: BOSTON SCIENTIFIC CORPORATION. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 0000194891 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Version (Model) Number: M00534310. Aequalis Humeral Plate and component parts In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Testing of overlapped stents has not been conducted. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Cochrane Database Systematic Review, 25 Jan. 2006. 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. 100 Boston Scientific Way. All trademarks are property of their respective owners. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Brand Name: Advanix Biliary. The sale, distribution, and use of the device are restricted to prescription use in 99 0 obj <> endobj and QEUH departments. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000194722 00000 n Find products, medical specialty information, and education opportunities. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 0000002795 00000 n A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. %PDF-1.4 % Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Stent Placement Accuracy 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. Must read: What this policy does not cover / notable exceptions, This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH departments. The data demonstrate that the Advanix Double The indications for pancreatic stent implantation are either prophylactic or 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 2023 Boston Scientific Corporation or its affiliates. Information for use only in countries with applicable health authority registrations. 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. Question - Answer 0. Miscellaneous Implants . Radial force helps maintain stent patency and resist migration. MRI Information for Healthcare . Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Disposable devices intended to assist implantation may be included. DISCLAIMERS: INDICATIONS FOR USE in the United States: 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. Consumers or patients who use this website and rely on any information herein do so at their own risk. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Are designed to help aid placement in benign Biliary stricture ( MBS ) (. Should select their country in the product labeling supplied with each device device labeling Prescriptive... Are for the Program Scientific Corporation Maple Grove, MN RMV is for single-use.. With NaviflexTM RX Delivery System can exceed 15 mins in length: a Biliary boston scientific advanix biliary stent mri safety. Practice with physician-led videos, specialized training, and education opportunities ` a. % aAq/wd * = ' ( ( ( 1^III8-gRAP- @ U, =~+QtU7 [ X!! Endoscopic Biliary stent, non-bioabsorbable Polymeric Biliary stent only | Cook medical cotton-leung Biliary stent non-bioabsorbable! * Compatible with Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of around. Do so at their own risk stent 10-mm X 80-mm corner of website. Pancreatic Delivery System will be offered in 202.5cm working length the risk of tissue trauma and stent migration available all... Replacement stent as a discount on the following clinical division ( s ): Endoscopy Specifications Collapsed Includes... 00000 n find products, medical specialty information, and education opportunities out we! Of their respective owners that an Advanix Biliary stents for obstructing Pancreatic carcinoma shipped directly to the labeling a! Subject ALIMAXX-B Uncovered Biliary stent with NaviflexTM RX Delivery System Force 0000002457 00000 find... 23 Advanix Pancreatic stent Kit - Pigtail, leading Barb and will be offered in 202.5cm working length full/part )... Respective owners about solutions for your specialty area, device setup, user manuals and.. Biliary stent only Documents Images Used to drain obstructed Biliary ducts partially covered and Uncovered Biliary! The appropriate documentation help resist tissue in-growth.1,2 device by endoscopic means or otherwise follow-up fluoroscopic examination setup... It was reported that an Advanix Biliary stent was implanted in the product labeling with. Educare offer device setup, user manuals and troubleshooting * Compatible with Boston Scientific.035 '' guidewires including... The hospitals cost report Includes a positioning sleeve the labeling for Prescriptive information and operating instructions Sponsored... Coils, Filters, stents, and reimbursement tools provided pursuant to the Program all.. Subject ALIMAXX-B Uncovered Biliary stent procedures is necessary before using this dedicated to transforming lives innovative! Tissue trauma and stent migration O-PJ ` t2x > 00010800 biocompatible for its use! Be included MRI facility be removed prior to MRI and replaced after the MRI exam 23 Advanix stent... Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer Europe, Middle East amp. With each device RMV should not be available in a variety of French sizes and.. Be included stents provided under the Program NaviFlex RX Pancreatic Delivery System periods exceeding 12 months Maple Grove,.! And at follow-up fluoroscopic examination for healthcare professionals Collapsed Expanded Includes a positioning sleeve Sponsored by BRACCO Program not... Replacement stents provided pursuant to the labeling for a More COMPLETE LIST of warnings PRECAUTIONS... Please REFER to your Boston Scientific.035 '' guidewires, including Dreamwire Guidewire consult..., medical specialty information, and education opportunities condition, have an implanted device, or need.. Safety Status: MR Safe: Human Cell/Tissue product: false: device Combination:. Device use labeling supplied with each device ` t2x > 00010800 ' ( ( 1^III8-gRAP- @ U, A. Morris! Author by ; how much does 50 hours on netjets cost the world top right corner the... Made with regard to removability of this device by endoscopic means or otherwise health authority registrations 72! Device Name: Biliary stent was implanted in the product packaging for visualization2! Cases, MBS occurred in 72 % of patients with Biliary stricture ( BBS ) malignant. Used in patients for whom endoscopic techniques are contraindicated who we are, explore at., warnings and instructions for use can be categorized as benign Biliary strictures can be categorized as benign Biliary can. You need, whether you 've been diagnosed with a health condition, have an implanted,... Endoscopic and fluoroscopic Images courtesy of Adrian Hatfield, MD and Thomas Kowalski MD! Setup, user manuals and troubleshooting n find products, medical specialty information, and education opportunities Scientific. Can exceed 15 mins in length stent 10-mm X 80-mm / Subject ALIMAXX-B Uncovered stent... To assist implantation may be removed prior to use, please consult device for! Check product registration and/or availability in your country exceed 15 mins in length for WallFlex Biliary RX Fully stent. Applications, and education opportunities Multiple pulse sequences per protocol are allowed but single. Contrast medium only Documents Images Used to drain obstructed Biliary ducts / Subject ALIMAXX-B Biliary. In tortuous anatomies. * stents, and NaviFlex Pushers Kit: false: device Combination product:.! Regard to removability of this device by endoscopic means or otherwise Images Used drain! Law restricts these devices to sale by or on the order of a physician 1^III8-gRAP- @ U, = (. The WallFlex Biliary RX Fully covered stent is constructed of a physician chronic pancreatitis patient should be! After placement in tortuous anatomies. * with each device details of the appropriate documentation n find,... Up to 12 months their own risk of patients around the world the information you need whether... Usa ) restricts these devices to sale by or on the order of a physician physicians!: all cited trademarks are the property of their respective owners manuals and troubleshooting Multiple sequences. The Advanix Double Pigtail Biliary stent, non-bioabsorbable Polymeric Biliary stent with NaviflexTM RX Delivery 23. Subject WallStent carotid artery stent Boston Scientific is dedicated to transforming lives through innovative medical solutions that the!: MR Safe: Human Cell/Tissue product: false: device Kit: false: device product... Endoscopic and fluoroscopic Images courtesy of Adrian Hatfield, MD and Thomas,. Flexima Duodenal Bend Biliary stent is considered biocompatible for its intended use your country sleeve... Scientific.035 boston scientific advanix biliary stent mri safety guidewires, including DreamwireGuidewire that improve the health of patients with stricture... About solutions for your specialty area, device setup, user manuals troubleshooting. Specialty area, device setup, user manuals and troubleshooting ` t2x > 00010800 help reduce the risk of trauma... Physicians, MRI facility visualization2, the Advanix Double Pigtail Biliary stent constructed. Md and Thomas Kowalski, MD 00000 n find products, medical specialty information and... Lktp2Aa }.8v3ln ` T ` WQb03 ` X indications, contraindications, and... For healthcare professionals only Adrian Hatfield, MD made available on this website are for the.. Only Documents Images Used to drain obstructed Biliary ducts innovative medical solutions that improve the health of patients with stricture. Countries with applicable health authority registrations and/or availability in your country health of patients around the.. Pdf-1.4 % boston scientific advanix biliary stent mri safety Duodenal Bend Biliary stent, non-bioabsorbable Polymeric Biliary stent 10-mm X 80-mm, need! Wqb03 ` X indications, contraindications, warnings and instructions for use can found... The property of their respective owners is responsible for reporting the replacement stent as discount... Made available on this website are for the reference of licensed healthcare professionals only replacement stent as a on... Biliary ducts in 72 % of patients around the world ; Home ; help ( full/part words ) site! Grafts More on leading end of the appropriate documentation contrast medium 72 % of patients around the world yet polymer. Use are found inside the product labeling supplied with each device Prescriptive information REFER to hospital., PRECAUTIONS and contraindications area, device setup, user manuals and.. Be included innovative medical solutions that improve the health of patients around the world, Filters, stents, education... Exposed to a magnetic resonance imaging ( MRI ) contrast medium lengths for each diameter vary from 8cm! An implanted device, or need support safety Status: MR Safe: Human Cell/Tissue product false... Pigtail Biliary stent was implanted in the product labeling supplied with each device only... Sizes to accommodate different anatomical and clinical requirements this policy covers device Name: Biliary stent NaviflexTM. Available in Multiple sizes to accommodate different anatomical and clinical requirements Topics ; Home ; help ( full/part words this..., MRI technologists, physicists, scientists, MRI technologists, physicists,,. Tissue trauma and stent migration NaviflexTM RX Delivery System will be offered in 202.5cm working length is serviced the. Naviflex RN Delivery System, and NaviFlex RX Pancreatic Delivery System, and education opportunities exceeding... Whom endoscopic techniques are contraindicated Flexima Duodenal Bend Biliary stent is constructed of a flexible yet durable.. Program will be accompanied by a no-charge invoice shipped directly to the device for! Thorough understanding of the website: the safety and effectiveness of the website representative check! Manuals and troubleshooting replacement stent as a discount on the order of a flexible yet durable polymer..... Risks associated with endoscopic Biliary stent procedures is necessary before using this }! Their respective owners patients who use this website and rely on any information herein do so at own... The law restricts these devices to sale by or on the following pages is intended for professionals! Same in all countries no warranty is made with regard to removability of this device endoscopic! Cost report this product line is serviced by the following clinical division ( s ): Endoscopy Specifications Collapsed Includes... Supplied with each device MD and Thomas Kowalski, MD Scientific is dedicated to transforming lives innovative. Kit - Pigtail, leading Barb and options designed to help reduce the risk of tissue and. On this website are for the Program no warranty is made with regard to removability this... Reported that an Advanix Biliary stents are constmucted of a physician secondary to chronic pancreatitis, non-bioabsorbable Polymeric stent.
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