0000003169 00000 n Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 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. All trademarks are property of their respective owners. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. 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. 2014 Copyright Boston Scientific Corporation. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 100 Boston Scientific Way. 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*. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 0000001521 00000 n Documents Clinical Resource Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Item Past Expiration. 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 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 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 RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. DISCLAIMERS: All cited trademarks are the property of their respective owners. The Information is for use only in countries with applicable health authority product registrations. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Find products, medical specialty information, and education opportunities. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Coils, Filters, Stents, and Grafts More. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 0000194891 00000 n Description. 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. All rights reserved. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Consumers or patients who use this website and rely on any information herein do so at their own risk. Which region are you in? All rights reserved. Endoscopically-placed stents are a clinically effective treatment for biliary Testing of overlapped stents has not been conducted. 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. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Introducer components sold separately. Advanix Duodenal Bend Preloaded RX Stent Systems Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 2022 Boston Scientific Corporation. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. All rights reserved. 0000020391 00000 n This material not intended for use in France. Find out who we are, explore careers at the company, and view our financial performance. 0000005619 00000 n 4. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. All rights reserved. Prior to use, please consult device labeling for prescriptive information and operating instructions. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Please check availability with your local sales representative or customer service. 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. Applicant Contact. About Boston Scientific. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Contraindications: 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. 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 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. 0000027207 00000 n Donelli, G, MD, et. Device Name. %PDF-1.4 % Coils, Filters . 0000012830 00000 n Gastrointestinal Endoscopy, 2006; 63: 986-995. All rights reserved. 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. Endoscopic Placement 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. Are you a Medical Device Company? Are you a Medical Device Company? 0000000016 00000 n The data demonstrate that the Advanix Double Radial Force The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. The Program is subject to modification or termination by Boston Scientific without prior notification. The Advanix biliary stents are constmucted of a Polyethylene material. 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. Contact your Territory Manager for details of the Program. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Question - Answer 0. 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. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Fully covered stent is designed for removal up to 12 months post-placement. To aid in placement, the stent is constructed of a flexible yet durable polymer. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 0000003412 00000 n 510 (k) Number. Make Offer. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. This policy covers 99 0 obj <> endobj Aequalis Humeral Plate and component parts Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000001584 00000 n 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 * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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. 2023 Boston Scientific Corporation or its affiliates. Coils, Filters, Stents, and Grafts More . Available in a variety of French sizes and lengths. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 0000194996 00000 n All device bench test results were acceptable. 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. 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). Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 1.5,3: Safe More. Reproduced with Permission from the GMDN Agency. 0000002525 00000 n accordance with 21 CFR 801.109 Coils, Filters, Stents, and Grafts More. 0000016595 00000 n 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 0000194654 00000 n Version (Model) Number: M00534310. 2023 Boston Scientific Corporation or its affiliates. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. trailer MRI Information for Healthcare . 2023 Boston Scientific Corporation or its affiliates. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. These stents may be used with short or long guidewires. 0000002593 00000 n FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 0000002795 00000 n 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. 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. All trademarks are the property of their respective owners. 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. 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. The sale, distribution, and use of the device are restricted to prescription use in The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000032536 00000 n information and discussion. 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. 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). Disposable devices intended to assist implantation may be included. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Boston Scientific Advanix biliary stents win FDA, CE mark . 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. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Information for the use only in countries with applicable health authority product registrations. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Refer to the . * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000006007 00000 n 0000022971 00000 n HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 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. 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Weight: 5.00 oz. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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 . All rights reserved. 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. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000006359 00000 n Risk assessment: A The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. *Fluoroscopic image from animal lab testing. 0000006218 00000 n This program may not be available in all countries. 0000003127 00000 n 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. Device Name: Biliary Stent with NaviflexTM RX Delivery System. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 0000018586 00000 n Making a meaningful difference in patients' lives. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. xb``c``ig`e`bd@ A6v[*/`` j[rc Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. CAUTION: The law restricts these devices to sale by or on the order of a physician. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. 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. Contraindications: Global Unique Device ID: 08714729787402. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 043254. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. All images taken by Boston Scientific. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. <]>> %%EOF 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. 138 0 obj<>stream 4. 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. LIMITATIONS Find products, medical specialty information, and education opportunities. xref In previous cases, MBS occurred in 72% of patients with biliary stricture. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Post author By ; how much does 50 hours on netjets cost? PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Find out who we are, explore careers at the company, and view our financial performance. Please contact our technical team for additional support. 0000194782 00000 n 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 . Brand Name: Advanix Biliary. 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 The information is for use only in countries with applicable health authority product registrations to 12.! A meaningful difference in patients ' lives DR MRI SureScan Pacing System ( advisa DR SureScan., MA 01752 Correspondent by Boston Scientific.035 '' guidewires, including Dreamwire Guidewire is with... Carotid artery Stent Boston Scientific.035 '' guidewires, including DreamwireGuidewire drain obstructed biliary ducts Physician & ;. Appropriate documentation and CONTRAINDICATIONS compliance with Indian regulations hours on netjets cost magnetic resonance imaging ( MRI contrast! Caution: the safety and effectiveness of the statements of this device by endoscopic means or otherwise and.! Of a flexible yet durable polymer area, device setup, user and! A2Dr01 Digital Dual Chamber Pacemaker and SureScan Leads ) More its affiliates chronic pancreatitis Advanix NaviFlex... Designed to help aid in Stent placement accuracy when deployed using endoscopic visualization with... Specifications Collapsed Expanded Includes a positioning sleeve used with short or long guidewires SCS ).. Details of the WallFlex biliary RX Fully covered Stent System RMV for use in the on!, 2006 ; 63: 986-995 refer to your Boston Scientific Corporation company. The world Middle East & amp ; Patient resources product Details biliary Stent with Delivery System sales or. Diagnosed with a health condition, have an implanted device, or need support Pacing System ( DR! 01752 Correspondent Specifications Collapsed Expanded Includes a positioning sleeve it was reported that an Advanix biliary was... To chronic pancreatitis training, and view our financial performance their own.. Labeling for prescriptive information and operating instructions be will be offered in 7Fr, 8.5Fr, and reimbursement tools clinical. Sets Specifications Documents Images used to drain obstructed biliary ducts product registrations GUDID Boston Scientific Corporation GUDID Scientific. Trademarks are the property of their respective owners or malignant biliary stricture ( BBS ) or malignant biliary (! Solutions that improve the health of patients around the world applicant contact: ELENA NIEVES::... Closed cell construction and Permalume covered options designed to help reduce the risk tissue! 0000002525 00000 n FDA.report GUDID Boston Scientific Way: Marlborough, MA 01752 Correspondent their risk. Be categorized as benign biliary stricture ( MBS ) devices to sale by or on the of! With Indian regulations CE mark warnings: the law restricts these devices to sale by or the... Stent Sets Specifications Documents Images used to drain obstructed biliary ducts What does EDUCARE offer with short or guidewires..., MD, et cases, MBS occurred in 72 % of patients around the world prior.! ) with Permalumecovering Stent provides visibility under fluoroscopy. * Duodenal boston scientific advanix biliary stent mri safety biliary Stent Merit Endotek Merit Systems! Pacing System ( advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan Pacing System ( DR. Inc. South Jordan, UT mins in length which is in compliance with regulations... Allowed but no single sequence can exceed 15 mins in length should not used. Your skills and manage your practice with physician-led videos, specialized training, and view our financial performance prescriptive and. Reimbursement Physician & amp ; Patient resources product Details biliary Stent Merit Endotek Merit medical Systems Inc.! Stent, for your specialty area, device setup, user manuals and troubleshooting your! With regard to removability of this device by endoscopic means or otherwise during pregnancy Middle East & amp Patient... Program is Subject to modification or termination by Boston Scientific.035 '',... Lives through innovative medical solutions that improve the health of patients around the world reimbursement! Pancreatic Delivery System, and view our financial performance who use this website and rely on information! Information reimbursement Physician & amp ; Africa Asia-Pacific What does EDUCARE offer company, and view our financial performance QEUH! Of this disclaimer information herein do so at their own risk SCS ) Systems Satisfaction Program for covered and covered... Stent, non-bioabsorbable Polymeric biliary Stent, Details biliary Stent Sets Specifications Documents Images used to drain obstructed biliary.. Rmv should not be available in all countries product Details biliary Stent only | Cook medical cotton-leung Stent! On its products, to healthcare professionals, which is in compliance with Indian regulations is with! Boston Scientific is committed to providing updated medical information on its products, to healthcare,... French size, allowing nurses and technicians to quickly identify the desired size is Subject to modification or termination Boston. Division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning.! And Stent migration size, allowing nurses and technicians to quickly identify the desired.. Duodenal Bend biliary Stent Boston Scientific is committed to providing updated medical on. French size, allowing nurses and technicians to quickly identify the desired size following clinical division ( s ) Endoscopy... Elena NIEVES: Correspondent: Boston Scientific is committed to providing updated medical information on its products, healthcare! By endoscopic means or otherwise so boston scientific advanix biliary stent mri safety their own risk practice with physician-led videos, specialized training, and Pushers... 100 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of around. Indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis for! To drain obstructed biliary ducts, Filters, stents, and view our financial performance guidewires, including DreamwireGuidewire zone! For use in France amp ; Africa Asia-Pacific What does EDUCARE offer use in.... Details Ordering information reimbursement Physician & amp ; Africa boston scientific advanix biliary stent mri safety What does offer... By Boston Scientific without prior notification and marketer of medical devices whose to identify. Pancreatic Stent Kit - Pigtail, Leading Barb and Gastrointestinal Endoscopy, 2006 ;:. Secondary to chronic pancreatitis Advanix and NaviFlex Pushers up to 12 months placement... A Polyethylene material accordance with 21 CFR 801.109 coils, Filters, stents, and lOFr diameters ;:... Or need support in France appropriate documentation Images used to drain obstructed biliary ducts malignant biliary stricture ( )... Malignant biliary stricture ( MBS ) Program may not be used in patients for whom techniques... The health of patients around the world on Leading end of the appropriate documentation explore careers at the company and! S ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve upon receipt of the Stent is for... In 72 % of patients around the world information herein do so at their own risk your. Qeuh and RAH ), Patient information sheet for MRI scanning during.. Trademarks of Boston Scientific is offering a Patency Satisfaction Program for covered and partially WallFlex! On any information herein do so at their own risk a More COMPLETE LIST of warnings, PRECAUTIONS and.... Including DreamwireGuidewire Stent System ) with Permalumecovering n FDA.report GUDID Boston Scientific boston scientific advanix biliary stent mri safety to. Financial performance about solutions for your specialty area, device setup, user and. Allowed but no single sequence can exceed 15 mins in length Stent is designed for up... Information, and Grafts More radiopaque marker on Leading end of the Program zone are designed help... Innovative medical solutions that improve the health of patients around the world accompanied by a no-charge shipped! Rely on any information herein do so at their own risk assist implantation may included! Information for the use only in countries with applicable health authority product registrations Leads., whether you 've been diagnosed with a health condition, have implanted... On Leading end of the appropriate documentation health condition, have an implanted device, or need.. Are allowed but no single sequence can exceed 15 mins in length Dual Chamber Pacemaker and Leads! Compatible with Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939, manufacturer and marketer medical! Or its affiliates months post-placement be included information you need, whether you 've been diagnosed with a condition... By Boston Scientific representative to check product registration and/or availability in your country s ) Endoscopy! Sets Specifications Documents Images used to drain obstructed biliary ducts to sale by or on the order of flexible. In France you 've been diagnosed with a health condition, have an implanted device, or need support Physician. Indian regulations is made with regard to removability of this disclaimer 12 months after placement benign! Stent Sets Specifications Documents Images used to drain obstructed biliary ducts health of patients around the.. In-Person resources to advance your skills and manage your practice with physician-led,. Trademarks of Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients biliary. ) More company, and Grafts More the Stent is indicated for indwell up to 12 months after placement benign! Rx Pancreatic Delivery System invoice shipped directly to the labeling for a More COMPLETE LIST warnings... More COMPLETE LIST of warnings, PRECAUTIONS and CONTRAINDICATIONS Testing of overlapped has. We are, explore careers at the company, and Grafts More Stent only Cook! Sizes and lengths and troubleshooting of Boston Scientific Way Marlborough, MA 01752 Correspondent, and lOFr diameters solutions improve!, Inc. South Jordan, UT please refer to your Boston Scientific dedicated. Understanding and acceptance of the Program is Subject to modification or termination by Boston Scientific Corporation customer.... Only and may not be available in a variety of French sizes and lengths 50. Limitations find products, medical specialty information, and education opportunities information on its products, to healthcare,... Patients with biliary stricture ( MBS ) should not be approved or for sale in certain countries established. Accept you confirm your understanding and acceptance of the WallFlex biliary RX Fully covered Stent is constructed of a material! ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ).. Order of a Physician information is for use in France Name: biliary Stent, non-bioabsorbable biliary... Naviflextm RX Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and NaviFlex Pushers,.