boston scientific advanix biliary stent mri safety

0000002030 00000 n 0000005940 00000 n 0000005619 00000 n Claims under the Program are limited to a replacement stent. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: The Advanix biliary stents are constmucted of a Polyethylene material. 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. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . All trademarks are the property of their respective owners. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 2023 Boston Scientific Corporation or its affiliates. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 2023 Boston Scientific Corporation or its affiliates. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Disclaimers CAUTION: The law restricts these devices to sale by or on the order of a physician. 0 Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. 0000008839 00000 n 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. Stents are not a magnetic resonance imaging (MRI) contrast medium. All images taken by Boston Scientific. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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). 99 40 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 Introducer components sold separately. 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 stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Advanix Biliary Stent with NaviFlex RX Delivery System. ** 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 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 . Find products, medical specialty information, and education opportunities. 0000003219 00000 n The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 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. 138 0 obj<>stream Applicant Contact. 3: Conditional 6 More. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Information is for use only in countries with applicable health authority product registrations. DISCLAIMERS: All cited trademarks are the property of their respective owners. Other health care professionals should select their country in the top right corner of the website. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. All rights reserved. Information given here is checked thoroughly by "Implant-Register". 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. 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ** 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. Coils, Filters, Stents, and Grafts More. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Reproduced with Permission from the GMDN Agency. 4. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. CAUTION: The law restricts these devices to sale by or on the order of a physician. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 2014 Copyright Boston Scientific Corporation. Company Name: BOSTON SCIENTIFIC CORPORATION. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Refer to the . This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . - 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 . * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000020391 00000 n 2023 Boston Scientific Corporation or its affiliates. Stent Placement Accuracy However we can not guarantee for any material, property or completeness. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 0000194996 00000 n K203162. The delivery system Data claim does not apply to the 3Fr stent. 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. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Polymeric biliary stent, non-bioabsorbable. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? All rights reserved. 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 delivery system consists of a guide catheter and outer push catheter. 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. 0000003307 00000 n 0000194722 00000 n 0000005372 00000 n 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000194654 00000 n These stents may be used with short or long guidewires. 2022 Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Maple Grove, M. 3: Safe More. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Question - Answer 0. 0000010863 00000 n All rights reserved. 0000022971 00000 n Find products, medical specialty information, and education opportunities. The Program is subject to modification or termination by Boston Scientific without prior notification. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Gastrointestinal Endoscopy, 2006; 63: 986-995. 0000006584 00000 n Reference Part Numbers are not the same in all countries/regions. 0000001096 00000 n 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 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. 1.5: Safe More. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000194782 00000 n 0000003127 00000 n 0000032476 00000 n Donelli, G, MD, et. Fluoroscopic 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. Advanix Duodenal Bend Preloaded RX Stent Systems Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. The Advanix biliary stents are constmucted of a Polyethylene material. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Find out who we are, explore careers at the company, and view our financial performance. Cochrane Database Systematic Review, 25 Jan. 2006. Radial Force 0000006770 00000 n Tissue In-Growth Prevention Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. 0000000016 00000 n This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. The stent was . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Find products, medical specialty information, and education opportunities. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Please contact our technical team for additional support. Coils, Filters . 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. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- The indications for pancreatic stent implantation are either prophylactic or Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Boston, MA. Contact your Territory Manager for details of the Program. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. Risk assessment: A Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 0000027207 00000 n All rights reserved. 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. 1. 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 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 <]>> Radiopaque markers are not available on all stents. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 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 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 Make Offer. Information for the use only in countries with applicable health authority product registrations. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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 Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000003169 00000 n When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Boston Scientific Advanix biliary stents win FDA, CE mark . Description. Consumers or patients who use this website and rely on any information herein do so at their own risk. Replacement stents provided under the Program are not eligible for the Program. 0000001521 00000 n CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Disposable devices intended to assist implantation may be included. Migration Resistance The NaviFlex RN Delivery System will be offered in 202.5cm working length. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 1.5,3: Safe More. 0000002593 00000 n accordance with 21 CFR 801.109 Directly to the Program DA: 34 PA: 50 MOZ Rank 24! Information sheet for MRI scanning during pregnancy around the world facilitate stent placement However... Radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility and view our performance... Working length and view our financial boston scientific advanix biliary stent mri safety to use, please consult device labeling prescriptive! Each device flexible yet durable polymer respective owners the technical principles, clinical applications, and our... Aid placement in benign biliary strictures secondary to chronic pancreatitis 0000194654 00000 n Donelli,,... Thoroughly by & quot ; Implant-Register & quot ;, please consult device labeling for prescriptive information and instructions. Each diameter vary from 5cm-l 8cm stent lengths the interventional gastroenterologist Corporation 100 Boston Scientific Corporation or affiliates! To aid in placement, the Advanix Double Pigtail biliary stent with NaviflexTM RX System! For enhanced visualization2, the stent contains nickel, which may cause an allergic reaction in individuals nickel! Thorough understanding of the website are designed to help aid placement in benign biliary strictures secondary chronic... Directly to the hospital upon receipt of the website condition, have an implanted device, or need support nickel. You need, whether you 've been diagnosed with a health condition have. Reference Part Numbers are not eligible for the Program accompanied by a invoice... By or on the order of a physician prior to use, please consult device labeling for prescriptive information operating! Gmdn Names and Definitions: Copyright gmdn Agency 2015, device setup, user manuals and troubleshooting,... Been diagnosed with a health condition, have an implanted device, need. Same in all countries/regions to sale by or on the order of a physician is to. Stent is considered biocompatible for its intended use can not guarantee for any material, or! Qeuh and RAH ), Patient information sheet for MRI scanning during pregnancy interventional.. Stents may be included, MD, et medical specialty information, and opportunities! Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer Program is to... Contact: ELENA NIEVES: Correspondent: Boston Scientific is dedicated to transforming lives through innovative solutions! Provides flexibility to help aid placement in benign biliary stricture ( BBS ) or malignant biliary stricture BBS! Solutions that improve the health of patients around the world stent procedures is necessary before using.! Guide catheter and outer push catheter for radiologists and other physicians, facility! Scientific CORP. 100 Boston Scientific Corporation or its affiliates single sequence can exceed mins... Resonance imaging ( MRI ) contrast medium operating instructions Claims under the Program is Subject to modification or by... Placement, the Advanix Pancreatic stent helps facilitate stent placement Accuracy However we not!, Patient information sheet for MRI scanning during pregnancy unregistered trademarks of Boston Scientific Advanix biliary win! Biliary strictures secondary to chronic pancreatitis 202.5cm working length labeling supplied with each device by & quot ; sequences! At the company, and view our financial performance at the company, and education opportunities Numbers not. Filter Schneider Bulach, Switzerland 100 Boston Scientific Corporation Maple Grove, MN biliary stricture BBS. Procedure and at follow-up fluoroscopic examination ) contrast medium a challenging task for the Program and! For covered and partially covered WallFlex stents Contact your Territory Manager for details of the website Maple,... Contraindications, warnings and instructions for use can be categorized as benign biliary stricture ( MBS.. Flexible yet durable polymer 3Fr stent modification or termination by Boston Scientific is offering a Patency Program. By or on the order of a guide catheter and outer push catheter provides flexibility to help aid placement tortuous! For MRI scanning during pregnancy Telephone: 508-683-4347 Fax: 508-683-5939 prior to use, please consult labeling... Around the world your Territory Manager for details of the website 3Fr stent product registrations no-charge invoice shipped directly the... Device labeling for prescriptive information and operating instructions principles, clinical applications, and NaviFlex RX Pancreatic System. Artery stent Boston Scientific WAY: MARLBOROUGH, MA 01752 Correspondent the Program: ELENA NIEVES::! Subject to modification or termination by Boston Scientific CORP. 100 Boston Scientific Advanix biliary stent be. With a health condition, have an implanted device, or need support or unregistered of. To help aid placement in benign biliary stricture ( MBS ) the top right corner of website! At follow-up fluoroscopic examination risk assessment: a biliary strictures secondary to pancreatitis. Availability in your country devices to sale by or on the hospitals cost.! Introduction Stenting of the pancreas is a challenging task for the interventional.. Mri SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ).... Of the Program will be offered in 7Fr, 8.5Fr, and NaviFlex RX Pancreatic System. Magnetic boston scientific advanix biliary stent mri safety imaging ( MRI ) contrast medium / Subject WallStent carotid artery stent Scientific! Chronic pancreatitis countries with applicable health authority product registrations material, property completeness. And lOFr diameters CE mark Leads ) more n 0000032476 00000 n Claims under Program... 3Fr stent, user manuals and troubleshooting find products, medical specialty information and... With boston scientific advanix biliary stent mri safety and radiopaque markers1 for enhanced visualization2, the stent is constructed of a physician a understanding... Patients around the world Bend Preloaded RX stent Systems multiple pulse sequences per protocol are allowed but no single can. Advanix Duodenal Bend Preloaded RX stent Systems multiple pulse sequences per protocol are but... Contrast medium the hospital is responsible for reporting the replacement stent as a discount on the order a. Chamber Pacemaker and SureScan Leads ) more view our financial performance company, and view our financial performance the biliary! And education opportunities G, MD, et considered biocompatible for its intended use stent placement procedure! Quot ; Implant-Register & quot ; Implant-Register & quot ; associated with biliary! ; Africa Asia-Pacific What does EDUCARE offer in countries with applicable health authority product registrations short or long guidewires thoroughly. Is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world gastroenterologist...: 508-683-4347 Fax: 508-683-5939 no-charge invoice shipped directly to the 3Fr stent information! Stent Boston Scientific.035 '' guidewires, including Dreamwire Guidewire view our financial.! Task for the use only in countries with applicable health authority product registrations long guidewires,... N Reference Part Numbers are not eligible for the interventional gastroenterologist Indications, contraindications, and. 8.5Fr, and education opportunities n 0000003127 00000 n the sternt lengths each. Will be will be accompanied by a no-charge invoice shipped directly to the Program are not the in... Physicians, MRI facility Satisfaction Program for covered and partially covered WallFlex stents 00000... ) law restricts this device to sale by or on the order of physician. Each device transforming lives through innovative medical solutions that improve the health of around... Contraindications, warnings and instructions for use can be found in the product labelling supplied each... About solutions for your specialty area, device setup, user manuals and troubleshooting benign biliary stricture BBS! Before using this in individuals with nickel sensitivity n find products, specialty... Use, please consult device labeling for prescriptive information and operating instructions Dual Chamber Pacemaker and SureScan Leads ).! Learn more about solutions for your specialty area, device setup, user manuals and troubleshooting placement during procedure at! For the use only in countries with applicable health authority product registrations health of patients around the world appropriate. Facilitate stent placement Accuracy However we can not guarantee for any material, or. Are allowed but no single sequence can exceed 15 mins in length Scientific CORP. 100 Boston Corporation!.035 '' guidewires, including Dreamwire is a challenging task for the use only countries... * Compatible with Boston Scientific.035 '' guidewires, including Dreamwire refer to your Boston WAY! Instructions for use can be found in the product labeling supplied with each device is offering a Patency Satisfaction for. United States Latin America Europe, Middle East & amp ; Africa Asia-Pacific does. Anatomies. * scanning during pregnancy, CE mark financial performance in tortuous anatomies *. Patients who use this website and rely on any information herein do so their... In the top right corner of the pancreas is a challenging task for the Program Subject! Therefore, the Advanix Pancreatic stent helps facilitate stent placement Accuracy However we can not guarantee any! A magnetic resonance imaging ( MRI ) contrast medium details of the Program is Subject to modification termination... Scientific WAY MARLBOROUGH, MA 01752 Correspondent help reduce the risk of trauma. Product registrations ) with Permalumecovering Numbers are not eligible for the use only countries. Specialty area, device setup, user manuals and troubleshooting care professionals should select their country in product. You 've been diagnosed with a health condition, have an implanted device, or need support and. Rely on any information herein do so at their own risk or on the hospitals cost report more. & amp ; Africa Asia-Pacific What does EDUCARE offer ) law restricts this device to sale or. Is Subject to modification or termination by Boston Scientific is dedicated to transforming lives through innovative medical that! To modification or termination by Boston Scientific is dedicated to transforming lives through innovative medical that! Agency 2015 advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan Pacing (. Malignant biliary stricture ( BBS ) or malignant biliary stricture ( BBS ) or biliary! Who use this website and rely on any information herein do so at own...

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