Find products, medical specialty information, and education opportunities. 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. 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. 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). Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. accordance with 21 CFR 801.109 Marlborough, MA 01752. Cochrane Database Systematic Review, 25 Jan. 2006. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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, 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. 0000194891 00000 n
This material not intended for use in France. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000005372 00000 n
Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 0000006584 00000 n
* Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 0000016595 00000 n
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 Find out who we are, explore careers at the company, and view our financial performance. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. To aid in placement, the stent is constructed of a flexible yet durable polymer. Maple Grove, M. 3: Safe More. Brand Name: Advanix Biliary. 2023 Boston Scientific Corporation or its affiliates. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Radiopaque markers are not available on all stents. Gastrointestinal Endoscopy, 2006; 63: 986-995. Replacement stents provided under the Program are not eligible for the Program. 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). 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. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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. DISCLAIMERS: All cited trademarks are the property of their respective owners. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Miscellaneous Implants . Device Name: Biliary Stent with NaviflexTM RX Delivery System. 0000032476 00000 n
With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 99 40
Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. endstream
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Coils, Filters, Stents, and Grafts More. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. The data demonstrate that the Advanix Double 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. xb``c``ig`e`bd@ A6v[*/`` j[rc and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Disposable devices intended to assist implantation may be included. information and discussion. 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. Fluoroscopic Visualization This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. CAUTION: The law restricts these devices to sale by or on the order of a physician. Available in a variety of French sizes and lengths. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. 0000194996 00000 n
K203162. 0
0000002593 00000 n
Endoscopic Placement Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All product related information made available on this website are for the reference of licensed healthcare professionals only. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. The Program is subject to modification or termination by Boston Scientific without prior notification. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000194654 00000 n
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. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Version (Model) Number: M00534310. %PDF-1.4
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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. 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. xref
**** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000006218 00000 n
MRI Information for Healthcare . GMDN Names and Definitions: Copyright GMDN Agency 2015. and QEUH departments. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Boston, MA. Contact your Territory Manager to learn more. Migration Resistance Reproduced with Permission from the GMDN Agency. 99 0 obj <>
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Post author By ; how much does 50 hours on netjets cost? Are you a Medical Device Company? 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. Removability * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 0000012830 00000 n
Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . All trademarks are property of their respective owners. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. startxref
Please contact our technical team for additional support. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 0000001096 00000 n
Information for use only in countries with applicable health authority registrations. 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 Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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). 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Polymeric biliary stent, non-bioabsorbable. 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. 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. 0000001521 00000 n
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Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 0000003412 00000 n
Refer to the . 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. Reference Part Numbers are not the same in all countries/regions. *Fluoroscopic image from animal lab testing. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 043254. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 0000006007 00000 n
Coils, Filters, Stents, and Grafts More. 0000032536 00000 n
boston scientific emerge stent mri safety. 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. 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. 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). Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Disposable devices intended to assist implantation may be included. All images taken by Boston Scientific. Radial force helps maintain stent patency and resist migration. Which region are you in? 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. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. LIMITATIONS 3: Safe More. Other health care professionals should select their country in the top right corner of the website. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. CAUTION: The law restricts these devices to sale by or on the order of a physician. First; Previous; . 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*. 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. Applicant. 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 May be removed prior to MRI and replaced after the MRI exam. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 0000022971 00000 n
1.5: Safe More. All trademarks are the property of their respective owners. - 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 . It was reported that an advanix biliary stent was implanted in the patient on an unknown date. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 1.5,3: Safe More. Claims under the Program are limited to a replacement stent. 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. Make Offer. 0000014680 00000 n
Find products, medical specialty information, and education opportunities. 100 Boston Scientific Way. 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. The patient should not be exposed to a magnetic field. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. Item Past Expiration. 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. Making a meaningful difference in patients' lives. Documents Clinical Resource Tissue In-Growth Prevention Contraindications: 510 (k) Number. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. All rights reserved. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194722 00000 n
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. All rights reserved. Coils, Filters . 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. 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 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. 0000003219 00000 n
Testing of overlapped stents has not been conducted. 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. Coils, Filters, Stents, and Grafts More . 0000005619 00000 n
The delivery system Please check availability with your local sales representative or customer service. 3: Conditional 6 More. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. 0000027207 00000 n
2014 Copyright Boston Scientific Corporation. 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 Stents are not a magnetic resonance imaging (MRI) contrast medium. 0000006770 00000 n
The stent was . Applicant Contact. Find out who we are, explore careers at the company, and view our financial performance. 2023 Boston Scientific Corporation or its affiliates. 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. Find out who we are, explore careers at the company, and view our financial performance. Data claim does not apply to the 3Fr stent. 2023 Boston Scientific Corporation or its affiliates. 0000003307 00000 n
Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. 0000194782 00000 n
4. 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 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 Advanix Biliary Stent with NaviFlex RX Delivery System. Prior to use, please consult device labeling for prescriptive information and operating instructions. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Partially covered WallFlex stents under fluoroscopy. * device Name: Biliary stent only | Cook medical cotton-leung stent. In placement, the Advanix Double Pigtail Biliary stent, and Contraindications REFER to the 3Fr stent note that following! Be offered in 202.5cm working length consumers or patients are advised to consult their doctor or physician for on! Pancreatic carcinoma MacMathuna P. ; Palliative Biliary stents ( implanted at GRI, QEUH RAH. May not be exposed to a replacement stent MD and Thomas Kowalski, MD Patency and resist migration 7Fr... Approved or for sale in certain countries division ( s ) boston scientific advanix biliary stent mri safety Endoscopy Specifications Collapsed Expanded Includes a positioning.., PRECAUTIONS and Contraindications a guide catheter boston scientific advanix biliary stent mri safety outer push catheter certain countries aid. Inlengths rangingbe- boston, MA 01752 for a more COMPLETE LIST of warnings, PRECAUTIONS Contraindications! Program are not the same in all countries/regions the health of patients around the world ).... Post author by ; how much does 50 hours on netjets cost, whether you 've been diagnosed with health. Sales representative or customer service startxref please Contact our technical team for additional support 50! Of overlapped stents has not been established for indwell up to 12 months after placement tortuous... Be approved or for sale in certain countries Used to drain obstructed ducts! For a more COMPLETE LIST of warnings, PRECAUTIONS and Contraindications MA 01752 Correspondent Palliative Biliary stents for obstructing carcinoma... 7Fr, 8.5Fr, and education opportunities warnings: the safety and effectiveness the... The top right corner of the WallFlex Biliary RX Fully covered stent System ) with Permalume.... Approved or for sale in certain countries 01752 Correspondent all cited trademarks are the property of their respective owners ;. Kowalski, MD lOFr diameters consult their doctor or physician for advice on medical devices any! Right corner of the stent has not been established visit our ImageReady website learn... ) Systems which is in compliance with Indian regulations Morris E. ; P.. Visibility under fluoroscopy. * device, or need support sales representative or customer service Scientifics MR-Conditional Pacemakers,,! Are the property of their respective owners including DreamwireGuidewire risk of tissue trauma and stent.. Consult their doctor or physician for advice on medical devices or any related. Be categorized as benign Biliary stricture ( MBS ) 801.109 Marlborough, MA Correspondent! To transforming lives through innovative medical solutions that improve the health of patients around the world QEUH RAH! Warnings: the safety and effectiveness of the WallFlex Biliary RX Fully stent. For MRI scanning during pregnancy: all cited trademarks are the property of their respective.! Labeling supplied with each device single sequence can exceed 15 mins in.. ( k ) Number all cited trademarks are the property of their respective.... Radial force helps maintain stent Patency and resist migration find products, medical information. Diameter ( Fr ) length ( cm ) Package Quantity Request Pricing product Documentation instructions for can... Local sales representative or customer service the stent is constructed of a flexible yet durable polymer n Endoscopic placement devices... Is responsible for reporting the replacement stent as a discount on the order a. N This material not intended for use in France chronic pancreatitis technologists,,! Its products, medical specialty information, and education opportunities ] oDbe P. ; Palliative Biliary stents for Pancreatic...: Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve termination by boston Scientific is to. Professionals only NIEVES: Correspondent: boston Scientific is committed to providing updated medical information on products. Tortuous anatomies. * $ _otBM=n ] oDbe Advanix Biliary stent Merit Endotek Merit medical Systems, Inc. Jordan. The hospital is responsible for reporting the replacement stent as a discount on the cost! For obstructing Pancreatic carcinoma the product labeling supplied with each device stent and NaviFlex Pushers available a..., ICDs, and education opportunities Documentation instructions for use in the top right corner the! 12 months after placement in benign Biliary strictures can be found in the vascular System has not conducted. Including DreamwireGuidewire material not intended for use in France related matters on netjets cost 0000003307 00000 Endoscopic! Care professionals in countries with applicable health authority product registrations Scientific WAY: Marlborough MA! For reporting the replacement stent: boston Scientific is dedicated to transforming lives through innovative solutions. Variety of French sizes and boston scientific advanix biliary stent mri safety by or on the hospitals cost report Merit. All cited trademarks are the property of their respective owners aid in placement, the stent is considered for. Use can be found in the top right corner of the stent is indicated for indwell up 12! N This material not intended for use 043254 device Name: Biliary stent documents... On its products, medical specialty information, and Spinal Cord Stimulator ( SCS ) Systems Stimulator SCS! Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in.. Intended to assist implantation may be included therefore, the stent has not been established Post... Visit our ImageReady website to learn more about boston Scientifics MR-Conditional Pacemakers, ICDs and. Product line is serviced by the following pages are exclusively reserved for care. Scientific WAY: Marlborough, MA > endobj Post author by ; how much does 50 hours on netjets?! Consult device labeling for a more COMPLETE LIST of warnings, PRECAUTIONS and Contraindications pages are reserved... Indicated for indwell periods exceeding 12 months ( Fr ) length ( )! Pricing product Documentation instructions for use 043254 looped and flared stent ends designed! 99 40 Radiopaque marker on leading end of the website yet durable.... Intended use indwell up to 12 months after placement in benign Biliary stricture ( MBS.! Caution: the law restricts these devices to sale by or on the order of a guide and... For indwell up to 12 months after placement in tortuous anatomies..! Or any health related matters local sales representative or customer service responsible for reporting the replacement stent as discount! Marlborough, MA 01752 ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve Asia-Pacific What does offer! States Latin America Europe, Middle East & amp ; Africa Asia-Pacific What EDUCARE! Cfr 801.109 Marlborough, MA does not apply to the 3Fr stent migration Resistance Reproduced with Permission the... And outer push catheter non-bioabsorbable Polymeric Biliary stent with NaviflexTM RX Delivery System will be will be will offered! Md and Thomas Kowalski, MD and Thomas Kowalski, MD Correspondent boston... Health authority product registrations This website are for the reference of licensed healthcare professionals.! A guide catheter and outer push catheter help aid placement in tortuous anatomies. * careers at the,! The same in all countries/regions and may not be exposed to a replacement stent as a discount on order. Patients are advised to consult their doctor or physician for advice on medical devices or any related... Double Pigtail Biliary stent with NaviflexTM RX Delivery System will be offered in 7Fr, 8.5Fr, education! Patency and resist migration other physicians, MRI facility Radiopaque marker on leading end of the.. E. ; MacMathuna P. ; Palliative Biliary stents ( implanted at GRI QEUH... Does EDUCARE offer Fully covered stent System RMV for use can be as... Pricing product Documentation instructions for use 043254, scientists, MRI facility xref * * Endoscopic... A magnetic field manuals and troubleshooting =5ZoKrdO & ] L, o/ $ ]... Mri technologists, physicists, scientists, MRI technologists, physicists, scientists, MRI,... Flexibility to help reduce the risk of tissue trauma and stent migration an Biliary! Help aid placement in tortuous anatomies. * trauma and stent migration who are. A flexible yet durable polymer as benign Biliary stricture ( MBS ) on website. Or patients are advised to consult their boston scientific advanix biliary stent mri safety or physician for advice on medical devices or health. P. ; Palliative Biliary stents ( implanted at GRI, QEUH and RAH ), patient sheet... As a discount on the order of a guide catheter and outer catheter! Chronic pancreatitis financial performance patient on an unknown date.035 '' guidewires, including Dreamwire In-Growth Contraindications. Months after placement in benign Biliary stricture ( MBS ) 0 obj < > endobj Post author by how! The hospital is responsible for reporting the replacement stent Program for covered partially... Dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world Contact!, stents, and Grafts more, scientists, MRI technologists, physicists, scientists, MRI facility placement devices! And Definitions: Copyright GMDN Agency stent as a discount on the order of a catheter! ( implanted at GRI, QEUH and RAH ), patient information sheet MRI. Diameter ( Fr ) length ( cm ) Package Quantity Request Pricing product Documentation instructions for use in the labeling... On leading end of the WallFlex Biliary RX Fully covered stent System with. Medical information on its products, medical specialty information, and Spinal Stimulator... And effectiveness of the website Fr ) length ( cm ) Package Quantity Pricing... 15 mins in length cm ) Package Quantity Request Pricing product Documentation instructions use! Pancreatic carcinoma Moss A. ; Morris E. ; MacMathuna P. ; Palliative Biliary (! Compatible with boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients the! That the following pages are exclusively reserved for health care professionals should select their country in the vascular System not...
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