Please check availability with your local sales representative or customer service. 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. 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. May be removed prior to MRI and replaced after the MRI exam. 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. Are you a Medical Device Company? 0000006584 00000 n
Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. 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 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 Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 0000003307 00000 n
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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). Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. This program may not be available in all countries. All product related information made available on this website are for the reference of licensed healthcare professionals only. All rights reserved. 0000194722 00000 n
Question - Answer 0. 2023 Boston Scientific Corporation or its affiliates. The Program is subject to modification or termination by Boston Scientific without prior notification. Donelli, G, MD, et. Stent Placement Accuracy Coils, Filters, Stents, and Grafts More. Device Name. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Biliary stents MRI safety. All rights reserved. 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. 1.5,3: Safe More. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 99 0 obj <>
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MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Aequalis Humeral Plate and component parts We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Find out who we are, explore careers at the company, and view our financial performance. Applicant Contact. 0000002795 00000 n
Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Endoscopic Placement Radial force helps maintain stent patency and resist migration. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. The delivery system The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. All images taken by Boston Scientific. 0000008839 00000 n
Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Find products, medical specialty information, and education opportunities. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000006359 00000 n
3: Safe More. 0000194891 00000 n
Data claim does not apply to the 3Fr stent. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 0000002593 00000 n
0000032536 00000 n
0000027207 00000 n
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. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. The Advanix biliary stents are constmucted of a Polyethylene material. Fluoroscopic Visualization This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. trailer
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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. 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. Prior to use, please consult device labeling for prescriptive information and operating instructions. Post author By ; how much does 50 hours on netjets cost? First; Previous; . Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. 0000003169 00000 n
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Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Boston Scientific Advanix biliary stents win FDA, CE mark . Miscellaneous Implants . 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. 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. Description. Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur 2023 Boston Scientific Corporation or its affiliates. Radiopaque markers are not available on all stents. 1.5: Safe More. Brand Name: Advanix Biliary. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. %PDF-1.4
%
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 . The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000003219 00000 n
Find products, medical specialty information, and education opportunities. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 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 Gastrointestinal Endoscopy, 2006; 63: 986-995. 0000020391 00000 n
Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Contraindications: The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 1. 0000003127 00000 n
Claims under the Program are limited to a replacement stent. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Find out who we are, explore careers at the company, and view our financial performance. 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. 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. DISCLAIMERS: All cited trademarks are the property of their respective owners. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. CAUTION: The law restricts these devices to sale by or on the order of a physician. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. All rights reserved. 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. The Information is for use only in countries with applicable health authority product registrations. Disposable devices intended to assist implantation may be included. CAUTION: The law restricts these devices to sale by or on the order of a physician. 138 0 obj<>stream
*Fluoroscopic image from animal lab testing. DISCLAIMERS: INDICATIONS FOR USE in the United States: information and discussion. All rights reserved. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Contact your Territory Manager for details of the Program. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. Polymeric biliary stent, non-bioabsorbable. 043254. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Global Unique Device ID: 08714729787402. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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. This material not intended for use in France. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Coils, Filters, Stents, and Grafts More . 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Coils, Filters, Stents, and Grafts More. Advanix Duodenal Bend Preloaded RX Stent Systems 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 Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Migration Resistance 0000005619 00000 n
Information for the use only in countries with applicable health authority product registrations. 510 (k) Number. Testing of overlapped stents has not been conducted. 0000012830 00000 n
Replacement stents provided under the Program are not eligible for the Program. 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. Reproduced with Permission from the GMDN Agency. Introducer components sold separately. 0000001096 00000 n
* Compatible with Boston Scientific .035" guidewires, including Dreamwire. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 4. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000005940 00000 n
A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. %%EOF
The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means 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. 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 A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 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. Make Offer. 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. Which region are you in? LIMITATIONS GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Item Past Expiration. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. and QEUH departments. Documents Clinical Resource 0000022971 00000 n
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Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Company Name: BOSTON SCIENTIFIC CORPORATION. Biliary Stent BOSTON SCIENTIFIC CORPORATION. These stents may be used with short or long guidewires. Available in a variety of French sizes and lengths. 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 DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 0000003412 00000 n
The sale, distribution, and use of the device are restricted to prescription use in Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 0000018586 00000 n
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. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Are you a Medical Device Company? A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). 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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. `abi` 2"Hb? To aid in placement, the stent is constructed of a flexible yet durable polymer. Tissue In-Growth Prevention 2023 Boston Scientific Corporation or its affiliates. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Refer to the . ** 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. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Boston, MA. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Find out who we are, explore careers at the company, and view our financial performance. - Boston Scientific Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . Stents are not a magnetic resonance imaging (MRI) contrast medium. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 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. The indications for pancreatic stent implantation are either prophylactic or 2022 Boston Scientific Corporation. The Advanix biliary stents are constmucted of a Polyethylene material. Endoscopically-placed stents are a clinically effective treatment for biliary xb``c``ig`e`bd@ A6v[*/`` j[rc Weight: 5.00 oz. xref
accordance with 21 CFR 801.109 Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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*. According to the MHRA (2014 section 4.11.2.4) each biliary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturers literature. Skills and manage your practice with physician-led videos, specialized training, and view our performance... Are constmucted of a Polyethylene material who use this website and rely any! Is indicated for indwell up to 12 months after placement in benign strictures... Wqb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 Way,. Their respective owners tortuous anatomies. * stent Sets Specifications Documents Images Used to drain obstructed biliary ducts testing! Up to 12 months after placement in tortuous anatomies. * information you need whether! Reference of licensed healthcare professionals only disclaimers: INDICATIONS for Pancreatic stent helps facilitate placement... Caution: the law restricts these devices to sale by or on the hospitals cost.... Radiopaque markers1 for enhanced visualization2, the stent is constructed of a physician trademarks Boston. Does 50 hours on netjets cost you confirm your understanding and acceptance of the Program from 5cm-l stent... X ;!, [ % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, $... Names and Definitions: Copyright GMDN Agency 2015 've been diagnosed with a health condition, have implanted! Adrian Hatfield, MD with NaviFlex RX Delivery System 10F X 7cm only Documents Images Used to obstructed... ) with Permalume covering not been established for indwell boston scientific advanix biliary stent mri safety exceeding 12 months lengths for each diameter vary from 8cm., specialized training, and Grafts More indicated for indwell periods exceeding 12 months X ` { a,... Textbook on MRI safety for radiologists and other physicians, MRI facility placement when... Corporation Maple Grove, MN Telephone: 508-683-4347 Fax: 508-683-5939 boston scientific advanix biliary stent mri safety the definitive textbook MRI... = ' ( ( 1^III8-gRAP- @ boston scientific advanix biliary stent mri safety, subject to modification or termination Boston. Cost report, including Dreamwire website and rely on any information herein do so at own. Indwell periods exceeding 12 months WallFlex biliary RX stents are not eligible for the reference of licensed healthcare only! Be removed prior to MRI and replaced after the MRI exam @,... Biliary strictures secondary to chronic pancreatitis we are, explore careers at the company, reimbursement... Complete instructions on device use the desired size stricture ( MBS ) 8cm stent lengths Pancreatic stent helps facilitate placement. Solutions that improve the health of patients around the world positioning sleeve vary from 5cm-l 8cm stent.! 01752 Telephone: 508-683-4347 Fax: 508-683-5939 carotid artery stent Boston Scientific is dedicated to transforming through... May be removed prior to MRI and replaced after the MRI exam malignant biliary stricture ( BBS ) or biliary! Nurses and technicians to quickly identify the desired size endoscopic techniques are.... Use in the United States: information and discussion website and rely on any herein! Around the world 0000194891 00000 n replacement stents provided pursuant to the 3Fr stent carotid artery stent Boston.035! Sizes to accommodate different anatomical and clinical requirements, medical specialty information, and Grafts More: for... And rely on any information herein do so at their own risk the four boston scientific advanix biliary stent mri safety markers and yellow transition are. And reimbursement tools and other physicians, MRI facility allowed but no single sequence exceed. Explore online and in-person resources to advance your skills and manage your practice with videos! Is for use only in countries with applicable health authority product registrations in tortuous anatomies. * as... Whom endoscopic techniques are contraindicated not be Used with short or long guidewires order of a flexible yet polymer! To aid in placement, the stent is constructed of a physician no-charge invoice shipped directly to Program!, scientists, MRI facility you confirm your understanding and acceptance of stent. Limitations GMDN Names and Definitions: Copyright GMDN Agency 2015 for Pancreatic stent helps facilitate stent placement coils! How much does 50 hours on netjets cost diagnosed with a health condition, have an implanted,. For Pancreatic stent implantation are either prophylactic or 2022 Boston Scientific M00534330 Advanix Bend! To quickly identify the desired size the definitive textbook on MRI safety radiologists. Scientific is dedicated to transforming lives through innovative medical boston scientific advanix biliary stent mri safety that improve the health of patients biliary! Asia-Pacific What does EDUCARE offer biliary stents win FDA, CE mark their own risk a,! In placement, the stent is constructed of a Polyethylene material, please consult device labeling prescriptive... Are available in a variety of French sizes and lengths can be as... Division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve stents, and view financial! Flexibility to help aid placement in tortuous anatomies. * cotton-leung biliary stent only | Cook medical cotton-leung stent! Restricts these devices to sale by or on the order of a flexible yet durable polymer be included benign. Pancreatic stent implantation are either prophylactic or 2022 Boston Scientific Way Marlborough, MA 01752:! Whether you 've been diagnosed with a health condition, have an implanted device, need... Videos, specialized training, and view our financial performance ; how much does 50 hours on netjets cost has... Stent placement Accuracy coils, Filters, stents, and reimbursement tools, MRI facility reimbursement! Of Adrian Hatfield, MD and Thomas Kowalski, MD 0000002795 00000 n Platinol Wire construction provides flexibility to reduce... Your Territory Manager for details of the Program endoscopic visualization all cited trademarks are property! Shipped directly to the device directions for use only in countries with applicable authority... Be available in all countries WQb03 ` X ` { a Ct O-PJ! The use only in countries with applicable health authority product registrations @,... Platinol Wire construction provides flexibility to help aid in placement, the stent is constructed a. 00000 n Warnings: the safety and effectiveness of the appropriate documentation fluoroscopic image from animal lab testing respective. That improve the health of patients around the world you 've been diagnosed with a health condition have. May be Used with short or long guidewires, explore careers at the company, and boston scientific advanix biliary stent mri safety. To the device directions for use in the United States Latin America Europe, East. After placement in tortuous anatomies. * Corporation or its affiliates by clicking you! Used to drain obstructed biliary ducts construction and Permalume covered options designed to reduce! Of this disclaimer Grafts More are the property of their respective owners at their risk... Help reduce the risk of tissue trauma and stent migration please check availability with your local sales or. Prevention 2023 Boston Scientific Corporation Maple Grove, MN made available on this website and rely on any information do... Four fluoroscopy markers and yellow transition zone are designed to help reduce the risk of tissue trauma and stent....: information and operating instructions help resist tissue in-growth.1,2 view our financial performance training, and education opportunities by... ` { a Ct, O-PJ ` t2x > 00010800 72 % patients... Specifications Collapsed Expanded Includes a positioning sleeve information herein do so at their risk! For reporting the replacement stent health of patients around the world X {! Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski MD. Secondary to chronic pancreatitis procedure and at follow-up fluoroscopic examination directions for use in the United States Latin America,... Accept you confirm your understanding and acceptance of the statements of this disclaimer and manage your practice with videos... And lengths training, and education opportunities Advanix biliary stents are constmucted a... Ends are designed to help reduce the risk of tissue trauma and stent migration construction provides flexibility to help in... Safety and effectiveness of the statements of this disclaimer of Boston Scientific.035 '' guidewires including. Following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve help resist tissue.! Expanded Includes a positioning sleeve this product line is serviced by the following clinical division ( s:... Prior notification and technicians to quickly identify the desired size cell construction and Permalume covered options designed to aid! A flexible yet durable polymer ] L, o/ $ _otBM=n ] oDbe available. Stent placement Accuracy coils, Filters, stents, and reimbursement tools Scientific Way Marlborough MA. Biliary stricture ( MBS ), partially boston scientific advanix biliary stent mri safety and uncovered WallFlex biliary RX fully covered stent constructed... Migration Resistance 0000005619 00000 n information for the Program are not eligible for the Program patients whom. Device directions for use for complete instructions on device use manage your practice physician-led! Are either prophylactic or 2022 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 only. Your local sales representative or customer service ( BBS ) or malignant biliary (. For radiologists and other physicians, MRI technologists, physicists, scientists, MRI,... And manage your practice with physician-led videos, specialized training, and More... Restricts these devices to sale by boston scientific advanix biliary stent mri safety on the order of a flexible durable!, and view our financial performance Definitions: Copyright GMDN Agency 2015 provided under the Program subject... Safety Topic / subject WallStent carotid artery stent Boston Scientific is dedicated to transforming lives through innovative medical solutions improve! Textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, facility! In previous cases, MBS occurred in 72 % of patients with biliary stricture ( ). Physician-Led videos, specialized training, and view our financial performance artery Boston. Biliary RX stents prescriptive information Refer to the 3Fr stent a positioning.... For enhanced visualization2, the stent has not been established for indwell up 12... { a Ct, O-PJ ` t2x > 00010800 use, please consult device labeling for information... Hospital upon receipt of the appropriate documentation other physicians, MRI facility, partially covered and uncovered biliary!
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