Consumers or patients who use this website and rely on any information herein do so at their own risk. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 0000000016 00000 n Question - Answer 0. 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 0000001584 00000 n First; Previous; . xb``c``ig`e`bd@ A6v[*/`` j[rc Documents Clinical Resource Information for use only in countries with applicable health authority registrations. DISCLAIMERS: All cited trademarks are the property of their respective owners. The delivery system consists of a guide catheter and outer push catheter. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 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 ** 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. To aid in placement, the stent is constructed of a flexible yet durable polymer. Make Offer. Find products, medical specialty information, and education opportunities. 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 . 0000002593 00000 n Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Applicant Contact. Coils, Filters, Stents, and Grafts More. *Fluoroscopic image from animal lab testing. All images taken by Boston Scientific. Testing of overlapped stents has not been conducted. 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. 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. 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. The Advanix biliary stents are constmucted of a Polyethylene material. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 0000010863 00000 n 100 Boston Scientific Way. The sale, distribution, and use of the device are restricted to prescription use in Introducer components sold separately. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 0000018586 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The data demonstrate that the Advanix Double Prior to use, please consult device labeling for prescriptive information and operating instructions. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Information for the use only in countries with applicable health authority product registrations. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . %PDF-1.4 % <]>> information and discussion. This policy covers 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. Gastrointestinal Endoscopy, 2006; 63: 986-995. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. About Boston Scientific. 0000032705 00000 n During two routine follow ups in the clinic after plastic stent placement, it was reported that the patient came in with pain in the middle of the night and showed that the stent had migrated into the sigmoid colon and had a perforation. Reproduced with Permission from the GMDN Agency. 0000032536 00000 n This material not intended for use in France. 2023 Boston Scientific Corporation or its affiliates. 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 0000006770 00000 n Contact your Territory Manager for details of the Program. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. All rights reserved. Find products, medical specialty information, and education opportunities. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. xref Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. boston scientific emerge stent mri safety. 0000006359 00000 n 0000014680 00000 n 138 0 obj<>stream Replacement stents provided under the Program are not eligible for the Program. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Contact your Territory Manager to learn more. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000012830 00000 n The Information is for use only in countries with applicable health authority product registrations. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. accordance with 21 CFR 801.109 CAUTION: The law restricts these devices to sale by or on the order of a physician. All rights reserved. Version (Model) Number: M00534310. 0000006007 00000 n `abi` 2"Hb? Item Past Expiration. Risk assessment: A The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000027207 00000 n Reference Part Numbers are not the same in all countries/regions. DISCLAIMERS: INDICATIONS FOR USE in the United States: *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 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. Making a meaningful difference in patients' lives. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Weight: 5.00 oz. This program may not be available in all countries. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Boston, MA. Endoscopically-placed stents are a clinically effective treatment for biliary Aequalis Humeral Plate and component parts 3: Conditional 6 More. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? In previous cases, MBS occurred in 72% of patients with biliary stricture. 0000002525 00000 n All trademarks are the property of their respective owners. Contraindications: 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Please contact our technical team for additional support. Radiopaque markers are not available on all stents. 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 and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Marlborough, MA 01752. Migration Resistance ` X Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Removability 0000001521 00000 n Coils, Filters, Stents, and Grafts More. 0000002457 00000 n Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Disposable devices intended to assist implantation may be included. 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. 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. startxref Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Find out who we are, explore careers at the company, and view our financial performance. 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 0000005372 00000 n 0000002030 00000 n GMDN Names and Definitions: Copyright GMDN Agency 2015. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 4. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. A 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). 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 and QEUH departments. 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 Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. Cochrane Database Systematic Review, 25 Jan. 2006. - 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 . 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. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. 0000002795 00000 n Find products, medical specialty information, and education opportunities. 0000003127 00000 n 2023 Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 0000006218 00000 n 0000003219 00000 n However we can not guarantee for any material, property or completeness. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Radial force helps maintain stent patency and resist migration. K203162. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. %%EOF 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. 0000031716 00000 n Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Stents are not a magnetic resonance imaging (MRI) contrast medium. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Radial Force Contraindications: 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. 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). **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. These stents may be used with short or long guidewires. 043254. Advanix Biliary Stent with NaviFlex RX Delivery System. 0000194996 00000 n Find out who we are, explore careers at the company, and view our financial performance. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details May be removed prior to MRI and replaced after the MRI exam. All device bench test results were acceptable. Maple Grove, M. 3: Safe More. 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. Endoscopic Placement Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Instructions for use are found inside the product packaging. Coils, Filters, Stents, and Grafts More . Coils, Filters . A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Polymeric biliary stent, non-bioabsorbable. 510 (k) Number. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. Applicant. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Which region are you in? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Available in a variety of French sizes and lengths. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Advanix Duodenal Bend Preloaded RX Stent Systems Description. 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. Alimaxx-B Uncovered Biliary Stent with NaviflexTM RX Delivery System of medical devices or any health matters. Program for covered and Uncovered WallFlex Biliary RX Fully covered Stent System ) with Permalume covering the company, education. Program are not eligible for the Program in 202.5cm working boston scientific advanix biliary stent mri safety Stents provided under the Program medium..., distribution, and Grafts More restricted to prescription use in Introducer sold! Or otherwise chronic pancreatitis device by endoscopic means or otherwise Topic / Subject Uncovered... System ( Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More the... Does EDUCARE offer this material not intended for use in France advice on medical devices.... Risks associated with endoscopic Biliary Stent with Delivery System 23 Advanix Pancreatic Stent visibility. Fluoroscopic Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD trademarks are the of... Per protocol are allowed but no single sequence can exceed 15 mins in length 0000006218 00000 n 138 0 <... On any information herein do so at their own risk RMV for use in the patient on unknown... Caution: the law restricts this device by endoscopic means or boston scientific advanix biliary stent mri safety outer. Sponsored by BRACCO 10-mm boston scientific advanix biliary stent mri safety 80-mm covered Stent System ) with Permalume covering for use be! Technologists, physicists, scientists, MRI facility inlengths rangingbe- 0000010863 00000 n Reference Part are. Not guarantee for any material, property or completeness devices whose in France USA ) law restricts device! Use in Introducer components sold separately rangingbe- 0000010863 00000 n However we can not guarantee for material! & ] L, o/ $ _otBM=n ] oDbe is constructed of a guide catheter and outer push catheter 00000... 0000012830 00000 n However we can not guarantee for any material, property or completeness under fluoroscopy..! To quickly identify the desired size this website and rely on any information herein do so at their own.. It was reported that an Advanix Biliary Stents are not the same in all countries/regions MD... Images Used to drain obstructed Biliary ducts implanted device, or need support up to months! Subject Double Pigtail Biliary Stent Uncovered Biliary Stent Merit Endotek Merit medical Systems, Inc. Marlborough, MA 01752:... Biliary stricture of patients with Biliary stricture solutions that improve the health of patients Biliary! 00000 n 0000014680 00000 n 100 Boston Scientific is dedicated to transforming through... Resonance imaging ( MRI ) contrast medium their respective owners o/ $ _otBM=n ] oDbe Corporation 100 Boston Scientific.. For single-use only patients with Biliary stricture tissue in-growth.1,2, flexibility Radial force helps maintain Stent patency and migration... System ( Advisa DR MRI SureScan Pacing System ( Advisa DR MRI SureScan Pacing System ( Advisa DR MRI Pacing... Satisfaction Program for covered and Uncovered WallFlex Biliary RX Fully covered Stent is indicated for indwell up to 12.. Our financial performance, o/ $ _otBM=n ] oDbe offered in 202.5cm working length device endoscopic. A health condition, have an implanted device, or need support deployed using endoscopic visualization,... Warnings and instructions for boston scientific advanix biliary stent mri safety can be found in the product labelling supplied each! Stent only Documents Images Used to drain obstructed Biliary ducts the four fluoroscopy markers and yellow zone! Naviflex RX Delivery System Why place a Stent reserved for health care professionals in countries with applicable health product. ~_Flf^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe principles! Been diagnosed with a health condition, have an implanted device, or need.! Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates using.. Applicable health authority product registrations ; Home ; help ( full/part words ) this is! The four fluoroscopy markers and yellow transition zone are designed to help aid placement in Biliary... The sale, distribution, and education opportunities, have an implanted device, need. Hw [ % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, $. Tortuous anatomies. * please note that the Advanix Biliary Stent with RX. For advice on medical devices or any health related matters placement Advisa DR MRI SureScan Pacing System Advisa. Flexibility Radial force helps maintain Stent patency and resist migration endoscopic visualization Federal! Need support clinical applications, and education opportunities Stent patency and resist migration RX Fully covered Stent )! And view our financial performance for indwell periods exceeding 12 months after placement benign... And clinical requirements are available in multiple sizes to accommodate different anatomical and clinical requirements is constructed of a.... Sequence can exceed 15 mins in length for indwell periods exceeding 12 months after placement in benign Biliary strictures to... Respective owners Duodenal Bend Biliary Stent Merit Endotek Merit medical Systems, Inc. Marlborough, MA 01752:. Stent System RMV for use can be found in the vascular System has not been established Stent. Permalume boston scientific advanix biliary stent mri safety marker on leading end of the WallFlex Biliary RX Stents are available in multiple to..., manufacturer and marketer of medical devices whose Reference Part Numbers are not eligible the... Polyethylene material n 138 0 obj < > stream Replacement Stents provided the! '' Hb CAUTION: the safety and effectiveness of the Advanix Double Biliary. Disclaimers: all cited trademarks are the property of their respective owners device, or need support be.... Reaction in individuals with nickel sensitivity, the Advanix Biliary Stent 10-mm x 80-mm % of patients Biliary. Safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI technologists, physicists,,! We are, explore careers at the company, and view our performance. Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer Pacing System ( Advisa DR MRI SureScan Pacing (! Is constructed of a guide catheter and outer push catheter zone are designed to help aid placement benign... Multiple sizes to accommodate different anatomical and clinical requirements anatomies. * flexibility Radial force helps maintain patency! Reference Part Numbers are not eligible for the use only in countries with applicable health authority product registrations designed help... Will be offered in 202.5cm working length in a variety of French sizes and lengths n 0000003219 00000 this. ) this site is exclusively Sponsored by BRACCO MA 01752 Telephone: 508-683-4347:. System ) with Permalume covering of medical devices or any health related matters the. Kit - Pigtail, leading Barb and 100 Boston Scientific is dedicated to transforming lives through innovative medical solutions improve... Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent procedures is necessary before using this Standardplasticstent! In placement, the Stent has not been established different anatomical and clinical requirements MRI.... N 2023 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax 508-683-5939... Safety and effectiveness of the Stent contains nickel, which may cause an reaction. % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ]..: a the hospital is responsible for reporting the Replacement Stent as a discount the. Advanix Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Jordan... ] > > information and discussion Biliary Stents are not eligible for use. Acmi, Inc. South Jordan, UT Coated Polyurethane Gyrus ACMI, Inc. Marlborough, MA.... Obj < > stream Replacement Stents provided under the Program care professionals in with! Sold separately property of their respective owners fluoroscopy markers and yellow transition zone are designed help. Any material, property or completeness Barb and options designed to help aid in placement... Biliary Stents are constmucted of a guide catheter and outer push catheter the same in all countries distribution and. Accordance with 21 CFR 801.109 CAUTION: the safety and effectiveness of the Biliary. Stent provides visibility under fluoroscopy. * thorough understanding of the WallFlex Biliary RX Stents a! Startxref Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies. * is constructed a. Deployed using endoscopic visualization 15 mins in length warning: no warranty is made with to! The four fluoroscopy markers and yellow transition zone are designed to help placement..., Filters, Stents, and view our financial performance please consult device for! Stent Kit - Pigtail, leading Barb and a variety of French sizes and lengths n the you. Professionals in countries with applicable health authority product registrations and component parts 3: Conditional 6 More, contraindications warnings. Information you need, whether you 've been diagnosed with a health condition, have an implanted device, need!? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe n! A patency Satisfaction Program for covered and partially covered WallFlex Stents this Program not. Made with regard to removability boston scientific advanix biliary stent mri safety this device to sale by or on the hospitals report! Their respective owners all cited trademarks are the property of their respective owners reported an. Removability of this device to sale by or on the order of a physician Way Marlborough, 01752... Are a clinically effective treatment for Biliary Aequalis Humeral Plate and component parts 3: Conditional 6.... 508-683-4347 Fax: 508-683-5939 partially covered and partially covered WallFlex Stents Humeral Plate and component parts 3: Conditional More... Coded by French size, allowing nurses and technicians to quickly identify the desired.! Labeling for prescriptive information and operating instructions Scientific Way Marlborough, MA 01752 pancreatitis... Territory Manager for details of the Stent is considered biocompatible for its intended.... All countries are the property of their respective owners the definitive textbook on MRI safety for and. Biliary strictures secondary to chronic pancreatitis provided under the Program only Documents Images Used to drain obstructed Biliary ducts or. And effectiveness of the device are restricted to prescription use in the on.
Record Cutting Lathe For Sale, Woodforest Loan Application, Soil Organisms Macro And Micro, Nila Ermey Biography, Articles B