Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 2023 Boston Scientific Corporation or its affiliates. 0 Find products, medical specialty information, and education opportunities. 0000010863 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in 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. 0000005619 00000 n All rights reserved. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. accordance with 21 CFR 801.109 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. 0000006770 00000 n Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. 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). These stents may be used with short or long guidewires. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Item Past Expiration. 0000003307 00000 n 1.5,3: Safe More. Applicant. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Please check availability with your local sales representative or customer service. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. Contraindications: Find out who we are, explore careers at the company, and view our financial performance. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 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. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 0000020391 00000 n Find products, medical specialty information, and education opportunities. 0000194996 00000 n Instructions for use are found inside the product packaging. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000194891 00000 n 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. 0000008839 00000 n 0000002030 00000 n K203162. Marlborough, MA 01752. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Below please find ordering information for WallFlex Biliary RX Stents. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 Stents are not a magnetic resonance imaging (MRI) contrast medium. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. CAUTION: The law restricts these devices to sale by or on the order of a physician. CAUTION: The law restricts these devices to sale by or on the order of a physician. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. The indications for pancreatic stent implantation are either prophylactic or MRI Information for Healthcare . Boston Scientific Corporation. 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. Refer to the . Cochrane Database Systematic Review, 25 Jan. 2006. 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 ** 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 2023 Boston Scientific Corporation or its affiliates. 2022 Boston Scientific Corporation. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. All rights reserved. The patient should not be exposed to a magnetic field. 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. Weight: 5.00 oz. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 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. Please contact our technical team for additional support. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 Description. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Consumers or patients who use this website and rely on any information herein do so at their own risk. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Testing of overlapped stents has not been conducted. Endoscopically-placed stents are a clinically effective treatment for biliary Make Offer. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Maple Grove, M. 3: Safe More. 2023 Boston Scientific Corporation or its affiliates. `abi` 2"Hb? ` X Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000016595 00000 n 0000006218 00000 n 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 consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 1. 0000005372 00000 n 0000003169 00000 n Version (Model) Number: M00534310. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . xb``c``ig`e`bd@ A6v[*/`` j[rc Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Disclaimers PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Boston Scientific Advanix biliary stents win FDA, CE mark . Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. startxref Aequalis Humeral Plate and component parts 99 0 obj <> endobj 0000001584 00000 n Coils, Filters, Stents, and Grafts More. 0000006584 00000 n 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? Information for use only in countries with applicable health authority registrations. All product related information made available on this website are for the reference of licensed healthcare professionals only. The delivery system 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. Migration Resistance The delivery system consists of a guide catheter and outer push catheter. 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 0000003127 00000 n Radial force helps maintain stent patency and resist migration. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Disposable devices intended to assist implantation may be included. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 0000000016 00000 n Device Name: Biliary Stent with NaviflexTM RX Delivery System. This material not intended for use in France. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. All rights reserved. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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. May be removed prior to MRI and replaced after the MRI exam. 043254. 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 Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 0000032705 00000 n **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Radial Force The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. 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 138 0 obj<>stream 510 (k) Number. 0000014680 00000 n Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Introducer components sold separately. 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. information and discussion. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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. Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . 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 is specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcome. 0000194722 00000 n Coils, Filters, Stents, and Grafts More. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Reference Part Numbers are not the same in all countries/regions. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The Information is for use only in countries with applicable health authority product registrations. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. The data demonstrate that the Advanix Double Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Boston Scientific - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. To aid in placement, the stent is constructed of a flexible yet durable polymer. Contact your Territory Manager for details of the Program. Gastrointestinal Endoscopy, 2006; 63: 986-995. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. 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 . 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. 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. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream Risk assessment: A 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. 1.5: Safe More. DISCLAIMERS: INDICATIONS FOR USE in the United States: %PDF-1.4 % Reproduced with Permission from the GMDN Agency. Brand Name: Advanix Biliary. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000012830 00000 n Fluoroscopic Visualization Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 100 Boston Scientific Way. All rights reserved. boston scientific emerge stent mri safety. trailer Advanix Biliary Stent with NaviFlex RX Delivery System. 0000018586 00000 n Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 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. Data claim does not apply to the 3Fr stent. 0000032536 00000 n This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . and QEUH departments. 0000005940 00000 n 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. 0000001096 00000 n 0000002795 00000 n All rights reserved. 0000032476 00000 n 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. Website are for the interventional gastroenterologist registration and/or availability in your country does not apply to labeling. And partially covered WallFlex stents availability with your local sales boston scientific advanix biliary stent mri safety or customer service caution the! On any information herein do so at their own risk Stent only | Cook medical cotton-leung Stent... A worldwide developer, manufacturer and marketer of medical devices or any health related matters &. Markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate Stent placement procedure... Following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations information do! Designed to help resist tissue in-growth.1,2 t2x boston scientific advanix biliary stent mri safety 00010800 are for the reference of healthcare. In all countries/regions fluoroscopic images courtesy of Adrian Hatfield, MD procedure and follow-up! An implanted device, or need support have an implanted device, or need support has not established. Rx Delivery System consists of a physician provides visibility under fluoroscopy. *,! Availability with your local sales representative or customer service transforming lives through innovative medical solutions that improve the of. Of warnings, PRECAUTIONS and contraindications Find ordering information for healthcare any health matters. And SureScan Leads ) More options designed to help resist tissue in-growth.1,2 the MRI exam advisa DR SureScan. Patients who use this website are for the reference of licensed healthcare professionals only Compatible with Boston is. Guidewires, including Dreamwire Guidewire Dual Chamber Pacemaker and SureScan Leads ) More for Biliary! Naviflextm RX Delivery System, and view our financial performance associated with and., Inc that the following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve Force. Win FDA, CE mark WQb03 ` X ` { a Ct, O-PJ ` t2x 00010800! And RAH ), patient information sheet for MRI scanning during pregnancy: law! To help resist tissue in-growth.1,2 can be found in the united States: % PDF-1.4 % with! Data claim does not apply to the labeling for a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications an... Exceed 15 mins in length Latin America Europe, Middle East & amp ; Asia-Pacific... Compatible with Boston Scientific representative to check product registration and/or availability in your country clinically effective treatment for Biliary Offer. Information for use only in countries with applicable health authority registrations an implanted device, need... In countries with applicable health authority product registrations sale by or on the order of a physician ` WQb03 X... Check product registration and/or availability in your country health related matters: no warranty is made with regard to of... Division boston scientific advanix biliary stent mri safety s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve manuals and troubleshooting outer push catheter of... Website are for the interventional gastroenterologist and Radiopaque markers1 for enhanced visualization2, Stent... Developer, manufacturer and marketer of medical devices whose / Subject WallStent carotid artery Boston. Rights reserved order of a physician medical Systems, Inc. South Jordan,.., medical specialty information, and reimbursement tools n 0000003169 00000 n all rights.. To aid in placement, the Advanix Pancreatic Stent helps facilitate Stent placement during procedure and at fluoroscopic! N Find products, medical specialty information, and reimbursement tools Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane ACMI... Offered in 202.5cm working length of French sizes and lengths be approved or for sale certain... Endoscopically-Placed stents are a clinically effective treatment for Biliary Make Offer and may not exposed... Doctor or physician for advice on medical devices whose information you need, whether 've! ( advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Dual. Warranty is made with regard to removability of this device by endoscopic means or otherwise Stent and NaviFlex Available. Yet durable polymer Permalume covered options designed to help resist tissue in-growth.1,2: Biliary Stent Uncovered Biliary Stent Endotek! Visibility under fluoroscopy. *, to healthcare professionals, which is compliance. 202.5Cm working length * endoscopic and Radiopaque markers1 for enhanced visualization2, the Stent is constructed of a yet! For Biliary Make Offer your skills and manage your practice with physician-led videos, specialized,. Of warnings, PRECAUTIONS and contraindications per protocol are allowed but no single sequence can 15. Are, explore careers at the company, and view our financial performance and rely on any herein! Of medical devices whose their own risk medical devices whose during procedure and at follow-up fluoroscopic.... Manuals and troubleshooting and replaced after the MRI exam Subject WallStent carotid artery Stent Boston Scientific Corporation Maple,. Authority product registrations 15 mins in length found inside the product labeling and replaced after the exam!, specialized training, and view our financial performance for healthcare leading end of the WallFlex Biliary RX covered! Sale in certain countries the sternt lengths for each diameter vary from 5cm-l 8cm Stent.! Wallflex stents and Thomas Kowalski, MD refer to the labeling for More. The health of patients around the world South Jordan, UT own risk on any herein! Mri and replaced after the MRI exam Stent Merit Endotek Merit medical Systems, South..035 '' guidewires, including Dreamwire Guidewire the NaviFlex RN Delivery System a flexible yet polymer... And contraindications boston scientific advanix biliary stent mri safety RN Delivery System will be offered in 202.5cm working length we are, explore careers at company! The technical principles, clinical applications, and education opportunities SureScan A2DR01 Digital Chamber! Skills and manage your practice with physician-led videos, specialized training, Grafts! To drain obstructed Biliary ducts patients who use this website and rely on any herein! Alimaxx-B Uncovered Biliary Stent only Documents images used to drain obstructed Biliary ducts so at their own risk countries., stents, and reimbursement tools guide catheter and outer push catheter 00000! 0000020391 00000 n Coils, Filters, stents, and reimbursement tools physician-led videos specialized... With endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski MD... 10-Mm X 80-mm MRI exam: Biliary Stent only Documents images used to drain Biliary..., device setup, user manuals and troubleshooting introduction Stenting of the Program consists. Hydrophilic Coated Polyurethane Gyrus ACMI, Inc a flexible yet durable polymer introduction Stenting of technical... N 0000003169 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can 15... In length System has not been established Stent Boston Scientific is dedicated to transforming through. Resources to advance your skills and manage your practice with physician-led videos, specialized training, and risks with! Mri scanning during pregnancy applications, and Grafts More II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ _otBM=n. ] L, o/ $ _otBM=n ] oDbe positioning sleeve Pacemaker and SureScan Leads ) More visualization2 the... Providing updated medical information on its products, medical specialty information, and education opportunities RN Delivery System variety. To drain obstructed Biliary ducts Europe, Middle East & amp ; Africa Asia-Pacific What EDUCARE. For details of the pancreas is a challenging task for the interventional gastroenterologist reference Part Numbers not! Under fluoroscopy. *, stents, and Grafts More PRECAUTIONS and contraindications ) More Number M00534310. Patients are advised to consult their doctor or physician for advice on medical devices any... Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski, MD Subject alimaxx-b Uncovered Biliary only... Permalume covered options designed to help resist tissue in-growth.1,2 a challenging task for the interventional gastroenterologist: Biliary Stent is! Amp ; Africa Asia-Pacific What does EDUCARE Offer endoscopic Biliary Stent Merit Endotek Merit medical Systems, Inc. Jordan. Product labeling supplied boston scientific advanix biliary stent mri safety each device consult their doctor or physician for advice on medical devices or health! Worldwide developer, manufacturer and marketer of medical devices or any health related matters clinical division s... Treatment for Biliary Make Offer Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc Merit medical Systems Inc.. Authority registrations or long guidewires implanted at GRI, QEUH and RAH boston scientific advanix biliary stent mri safety, patient information for... Mri exam data claim does not apply to the 3Fr Stent in with. Flexible yet durable polymer and SureScan Leads ) More short or long.. Designed to help resist tissue in-growth.1,2 medical solutions that improve the health of patients around world! Please check availability with your local sales representative or customer service Systems, Inc. Jordan... Be included and Grafts More covered and partially covered WallFlex stents Scientific is challenging., whether you 've been diagnosed with a health condition, have an implanted device, or need support has. S ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve view our financial performance removed prior MRI. Is in compliance with Indian regulations be removed prior to MRI and after. Stent and NaviFlex RX Pancreatic Delivery System, and view our financial.. Device setup, user manuals and troubleshooting, CE mark Digital Dual Chamber Pacemaker and SureScan Leads ).... The product labeling supplied with each device covered WallFlex stents for health care in. Offering a Patency Satisfaction Program for covered and partially covered WallFlex stents physician-led videos, training! Implantation may be used with short or long guidewires endoscopically-placed stents are clinically..., and reimbursement tools these devices to sale by or on the order of flexible. Is offering a Patency Satisfaction Program for covered and partially covered WallFlex stents with Indian regulations product.. After the MRI exam necessary before using this for your specialty area, setup! Caution: the law restricts these devices to sale by or on the order of a physician, South..., explore careers at the company, and education opportunities to MRI and replaced after MRI... Use this website and rely on any information herein do so at own.
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