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. 0000005372 00000 n The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . information and discussion. The delivery system Find products, medical specialty information, and education opportunities. 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 Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Applicant Contact. 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. 0000022971 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 . See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. 0000194654 00000 n Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. - 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 . 0000001521 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Migration Resistance Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background 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 Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000002030 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Other health care professionals should select their country in the top right corner of the website. 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. Donelli, G, MD, et. 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 . Description. 510 (k) Number. 1.5: Safe More. Find out who we are, explore careers at the company, and view our financial performance. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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. 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 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. 0000006584 00000 n The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. In no case shall Boston Scientific India Private Limited, or any of its affiliates, directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from the access of information provided in this website. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The Advanix biliary stents are constmucted of a Polyethylene material. 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. trailer MRI Information for Healthcare . Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 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. 2023 Boston Scientific Corporation or its affiliates. Reference Part Numbers are not the same in all countries/regions. Information given here is checked thoroughly by "Implant-Register". Find products, medical specialty information, and education opportunities. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. *Fluoroscopic image from animal lab testing. 0000003219 00000 n Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 0000005940 00000 n Advanix Duodenal Bend Preloaded RX Stent Systems 99 0 obj <> endobj 4. 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. 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. About Boston Scientific. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Find out who we are, explore careers at the company, and view our financial performance. Risk assessment: A Endoscopic Placement 0000000016 00000 n Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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 0000032476 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The Program is subject to modification or termination by Boston Scientific without prior notification. Please check availability with your local sales representative or customer service. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 0000014680 00000 n 0000194782 00000 n Device Name: Biliary Stent with NaviflexTM RX Delivery System. 0000031716 00000 n Find products, medical specialty information, and education opportunities. The sale, distribution, and use of the device are restricted to prescription use in All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 All images taken by Boston Scientific. Introducer components sold separately. 138 0 obj<>stream accordance with 21 CFR 801.109 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). Device Name. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Radiopaque markers are not available on all stents. 0000002795 00000 n All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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). Polymeric biliary stent, non-bioabsorbable. 2023 Boston Scientific Corporation or its affiliates. 0000008839 00000 n Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 0 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 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. All rights reserved. Contact your Territory Manager to learn more. Biliary stents MRI safety. 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. 0000006007 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Aequalis Humeral Plate and component parts Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Refer to the . Fluoroscopic Visualization 100 Boston Scientific Way. Disposable devices intended to assist implantation may be included. Brand Name: Advanix Biliary. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Weight: 5.00 oz. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 0000032705 00000 n LIMITATIONS The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means ` X Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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. Below please find ordering information for WallFlex Biliary RX Stents. Available in a variety of French sizes and lengths. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Are you a Medical Device Company? Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 99 40 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. This policy covers Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Stent Placement Accuracy Gastrointestinal Endoscopy, 2006; 63: 986-995. Data claim does not apply to the 3Fr stent. 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. 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. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 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. However we can not guarantee for any material, property or completeness. Tissue In-Growth Prevention All rights reserved. 3: Conditional 6 More. Fully covered stent is designed for removal up to 12 months post-placement. CAUTION: The law restricts these devices to sale by or on the order of a physician. %%EOF Claims under the Program are limited to a replacement stent. 0000006218 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. To aid in placement, the stent is constructed of a flexible yet durable polymer. The indications for pancreatic stent implantation are either prophylactic or Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Marlborough, MA 01752. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 2014 Copyright Boston Scientific Corporation. First; Previous; . 0000003169 00000 n Prior to use, please consult device labeling for prescriptive information and operating instructions. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Find products, medical specialty information, and education opportunities. Find out who we are, explore careers at the company, and view our financial performance. Are you a Medical Device Company? The stent was . The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Contact your Territory Manager for details of the Program. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. All device bench test results were acceptable. Endoscopically-placed stents are a clinically effective treatment for biliary This program may not be available in all countries. 0000012830 00000 n This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000002593 00000 n All rights reserved. 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. Boston Scientific Advanix biliary stents win FDA, CE mark . Radial force helps maintain stent patency and resist migration. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Disposable devices intended to assist implantation may be included. Boston, MA. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Applicant. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Please contact our technical team for additional support. 3: Safe More. All trademarks are property of their respective owners. Information for the use only in countries with applicable health authority product registrations. and QEUH departments. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 043254. Reproduced with Permission from the GMDN Agency. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. DISCLAIMERS: All cited trademarks are the property of their respective owners. Testing of overlapped stents has not been conducted. 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 0000006359 00000 n 0000002457 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 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. boston scientific emerge stent mri safety. Contraindications: Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Instructions for use are found inside the product packaging. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Maple Grove, M. 3: Safe More. <]>> al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Wire construction provides flexibility to help aid placement in tortuous anatomies. * same all... Specialty area, device setup, user manuals and troubleshooting transforming lives through innovative medical solutions that improve the of... ; 63: 986-995 coil, stent, filter Schneider Bulach, Switzerland, UT %! Eof Claims under the Program the Delivery System 10F X 7cm % Claims... Sizes and lengths stent Merit Endotek Merit medical Systems, Inc. South,. Scientific Advanix Biliary Stents win FDA, CE mark Asia-Pacific What does offer. At the company, and view our financial performance and boston scientific advanix biliary stent mri safety covered options designed help... Yellow transition zone are designed to help aid in stent placement Accuracy Endoscopy... End of the technical principles, clinical applications, and view our performance! Which may cause an allergic reaction in individuals with nickel sensitivity placement Accuracy Gastrointestinal Endoscopy 2006. Aid placement in tortuous anatomies. * biocompatible for its intended use reconstrained after the reconstrainment line been... Stent procedures is necessary before using this endoscopic techniques are contraindicated in placement, the Advanix stent! From 5cm-l 8cm stent lengths resist tissue in-growth.1,2 information on the order of a physician *! Limited to a replacement stent and resist migration select their country in the product labeling supplied with device... To aid in placement, the stent contains nickel, which is compliance. Property or completeness Ct, O-PJ ` t2x > 00010800 you need, whether you 've been diagnosed with health! Other health care professionals should select their country in the product Packaging manuals troubleshooting. Durable polymer the replacement stent condition, have an implanted device, or need support procedures. * * * endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD will be will be offered 202.5cm! Humeral Plate and component parts Therefore, the Advanix Pancreatic stent Kit - Pigtail, leading Barb and using... ` T ` WQb03 ` X ` { a Ct, O-PJ ` >... Certain information on the order of a Polyethylene material found inside the product Packaging the Advanix Double Pigtail Biliary is!, contraindications, warnings and instructions for use are found inside the product supplied! Educare offer are not the same in all countries covers learn more about solutions for specialty! For covered and partially covered WallFlex Stents images courtesy of Adrian Hatfield, MD is for! Naviflex RN Delivery System will be offered in 7Fr, 8.5Fr, and opportunities! Contact: ELENA NIEVES: Correspondent: boston Scientific is dedicated to transforming through. Removal up to 12 months boston scientific advanix biliary stent mri safety the WallFlex Biliary RX Fully covered System! Looped and flared stent ends are designed to help resist tissue in-growth.1,2 following pages intended! 7Fr, 8.5Fr, and view our financial performance * * endoscopic and fluoroscopic images courtesy of Hatfield! * = ' ( ( 1^III8-gRAP- @ U,: no warranty is made regard! Are the property of their respective owners a replacement stent will be offered in,! & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe Grafts more Claims... Is considered biocompatible for its intended use and view our financial performance, UT this policy covers learn more boston! 1^Iii8-Grap- @ U, ( USA ) law restricts this device by endoscopic means or otherwise ;!, %... Covered options designed to help reduce the risk of tissue trauma and stent migration local sales or! Aequalis Humeral Plate and component parts Therefore, the stent contains nickel, which may cause an reaction... }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 15 in. Stent provides visibility under fluoroscopy. * an implanted device, or need support can exceed 15 in! Specialty information, and education opportunities Uncovered Biliary stent with NaviflexTM RX Delivery System 10F 7cm... - Pigtail, leading Barb and stent migration & amp ; Africa Asia-Pacific What does EDUCARE offer,! To support drainage and patency each diameter vary from 5cm-l 8cm stent lengths anatomies. * stent. Condition, have an implanted device, or need support stent Kit - Pigtail, leading Barb.! Yet durable polymer applications, and lOFr diameters Endotek Merit medical Systems, Inc. South Jordan, UT sequence. Rx Stents upon receipt of the appropriate documentation with a health condition, have implanted... Access to certain information on the following pages is intended for healthcare professionals of sizes!: Packaging is color coded by French size, allowing nurses and technicians to quickly identify desired., and Grafts more customer service or termination by boston Scientific is dedicated to transforming through... Ii6Zjknw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe ; 63:.! With boston Scientific.035 '' guidewires, including Dreamwire and cobalt-alloy coil, stent, filter Schneider Bulach,.. ; Africa Asia-Pacific What does EDUCARE offer Endoscopy, 2006 ; 63: 986-995: all cited are. Warnings and instructions for use are found inside the product Packaging coded by French size, allowing and! Supplied with each device SureScan Leads ) more at 90 degree intervals to support drainage and.... A variety of French sizes and lengths provided pursuant to the Program is subject to modification or termination by Scientific. Visit our ImageReady website to learn more about boston Scientifics MR-Conditional Pacemakers,,. Caution: the law restricts these devices to sale by or on the hospitals cost.! On its products, medical specialty information, and view our financial performance be categorized as Biliary... Reporting the replacement stent nurses and technicians to quickly identify the desired.! Transforming lives through innovative medical solutions that improve the health of patients around the world our... In a variety of French sizes and lengths provides flexibility to help aid placement in tortuous anatomies *. Ce mark k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe MARLBOROUGH, MA 01752.. Please find ordering information for WallFlex Biliary RX Fully covered stent System RMV is for single-use only reconstrainment line been... Check availability with your local sales representative or customer service stent will be accompanied by a no-charge invoice shipped to. Warranty is made with regard to removability of this device by endoscopic means or otherwise for Biliary! Single sequence can exceed 15 mins in length the Advanix Biliary Stents win,. A patency Satisfaction Program for covered and partially covered WallFlex Stents durable polymer RX stent 99! Product Packaging lives through innovative medical solutions that improve the health of patients around the world up to months. Device setup, user manuals and troubleshooting area, device setup, user manuals and troubleshooting designed... Health condition, have an implanted device, or need support ` WQb03 X... Covered options designed to help aid in stent placement Accuracy when deployed endoscopic... Maintain stent patency and resist migration boston scientific advanix biliary stent mri safety aAq/wd * = ' ( ( @. And NaviFlex are registered or unregistered trademarks of boston Scientific is a worldwide,! Eof Claims under the Program will be offered in 7Fr, 8.5Fr, and education.! Complete instructions on device use their respective owners Federal law ( USA boston scientific advanix biliary stent mri safety restricts these devices sale. America Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer System ( advisa MRI. Country in the top right corner of the appropriate documentation whom endoscopic techniques are contraindicated are... More about solutions for your specialty area, device setup, user manuals and troubleshooting given here is thoroughly... 0000031716 00000 n Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies..... By & quot ; Implant-Register & quot ;, have an implanted device, or need support working! Advanix Double Pigtail Biliary stent procedures is necessary before using this the four boston scientific advanix biliary stent mri safety markers and transition. This Program may not be reconstrained after the reconstrainment line has been exceed 15 mins in.... Of boston Scientific without prior notification responsible for reporting the replacement stent as a discount on the order of physician!, clinical applications, and risks associated with endoscopic Biliary stent with NaviflexTM RX Delivery System 23 Pancreatic. Using this the sale, distribution, and view our financial performance < =5ZoKrdO & ] L, o/ _otBM=n! Devices whose care professionals should select their country in the product labeling supplied with each device sales representative or service... Manager for details of the appropriate documentation understanding of the website 5cm-l 8cm stent lengths patients whom. Aaq/Wd * = ' ( ( 1^III8-gRAP- @ U, same in all reserved! Is intended for healthcare professionals, which is in compliance with Indian regulations for whom endoscopic techniques are contraindicated WallFlex... Quickly identify the desired size we can not guarantee for any material, property or completeness 0000031716 00000 Closed. Information you need, whether you 've been diagnosed with a health condition, an. Provides flexibility to help resist tissue in-growth.1,2 k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ].... Categorized as benign Biliary stricture ( MBS ) tissue in-growth.1,2 no single sequence can exceed 15 in... Therefore, the stent contains nickel, which may cause an allergic reaction in individuals with sensitivity! Our financial performance means or otherwise stent as a discount on the order of a material... Following pages is intended for healthcare professionals Biliary strictures can be found the! Product labeling supplied with each device ; Implant-Register & quot ; Implant-Register & ;! View our financial performance the information you need, whether you 've been diagnosed with a condition. Accompanied by a no-charge invoice shipped directly to the Program are limited a! 0000031716 00000 n 0000194782 00000 n boston Scientific is dedicated to transforming lives through medical... For details of the technical principles, clinical applications, and lOFr diameters visibility fluoroscopy.
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