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 Find products, medical specialty information, and education opportunities. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Polymeric biliary stent, non-bioabsorbable. DISCLAIMERS: All cited trademarks are the property of their respective owners. Company Name: BOSTON SCIENTIFIC CORPORATION. 0000014680 00000 n
accordance with 21 CFR 801.109 Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. ` X
Description. 0000005372 00000 n
The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 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. Global Unique Device ID: 08714729787402. 0000001096 00000 n
Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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 0000032705 00000 n
Information for the use only in countries with applicable health authority product registrations. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Maple Grove, M. 3: Safe More. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. These stents may be used with short or long guidewires. All trademarks are the property of their respective owners. 0000194891 00000 n
LIMITATIONS Fully covered stent is designed for removal up to 12 months post-placement. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . To aid in placement, the stent is constructed of a flexible yet durable polymer. Radial force helps maintain stent patency and resist migration. Fluoroscopic Visualization 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. Donelli, G, MD, et. 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. This program may not be available in all countries. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. All trademarks are property of their respective owners. 4. 510 (k) Number. All rights reserved. Radiopaque markers are not available on all stents. 2023 Boston Scientific Corporation or its affiliates. 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. `abi` 2"Hb? 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . The patient should not be exposed to a magnetic field. To aid in placement, the stent is constructed of a flexible yet durable polymer. Endoscopically-placed stents are a clinically effective treatment for biliary All device bench test results were acceptable. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000002457 00000 n
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. 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. and QEUH departments. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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 sale, distribution, and use of the device are restricted to prescription use in Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 0000010863 00000 n
Stents are not a magnetic resonance imaging (MRI) contrast medium. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility The Advanix biliary stents are constmucted of a Polyethylene material. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This material not intended for use in France. Biliary Stent BOSTON SCIENTIFIC CORPORATION. %%EOF
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 Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Find out who we are, explore careers at the company, and view our financial performance. Tissue In-Growth Prevention 0000003412 00000 n
A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 1.5,3: Safe More. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. trailer
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. 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. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Available in a variety of French sizes and lengths. 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. 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 Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Coils, Filters . Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. All rights reserved. Please contact our technical team for additional support. xb``c``ig`e`bd@ A6v[*/`` j[rc GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Boston Scientific Corporation. Disposable devices intended to assist implantation may be included. 0000005619 00000 n
Disposable devices intended to assist implantation may be included. 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. 2023 Boston Scientific Corporation or its affiliates. information and discussion. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. 0000032476 00000 n
Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 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. The Program is subject to modification or termination by Boston Scientific without prior notification. 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000003307 00000 n
This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Question - Answer 0. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All images taken by Boston Scientific. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. 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. 0000194654 00000 n
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. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000003127 00000 n
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. Contraindications: Disposable devices intended to assist implantation may be included. 3: Safe More. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194782 00000 n
Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization 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. 2022 Boston Scientific Corporation. Below please find ordering information for WallFlex Biliary RX Stents. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 1. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 2023 Boston Scientific Corporation or its affiliates. <]>>
Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 2023 Boston Scientific Corporation or its affiliates. Find out who we are, explore careers at the company, and view our financial performance. 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 Risk assessment: A Device Name. Item Past Expiration. The indications for pancreatic stent implantation are either prophylactic or 0000012830 00000 n
FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. The data demonstrate that the Advanix Double 0000006218 00000 n
0000018586 00000 n
Post author By ; how much does 50 hours on netjets cost? 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Information for use only in countries with applicable health authority registrations. All rights reserved. 0000006359 00000 n
Instructions for use are found inside the product packaging. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 0000001521 00000 n
Replacement stents provided under the Program are not eligible for the Program. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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. %PDF-1.4
%
** 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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). Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000002030 00000 n
Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. All rights reserved. boston scientific emerge stent mri safety. Data claim does not apply to the 3Fr stent. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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). Find out who we are, explore careers at the company, and view our financial performance. 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. 138 0 obj<>stream
It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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. Disclaimers 0
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
The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Applicant. 3: Conditional 6 More. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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. Documents Clinical Resource 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. Find products, medical specialty information, and education opportunities. *Fluoroscopic image from animal lab testing. Migration Resistance 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 stent cannot be reconstrained after the reconstrainment line has been exceeded 0000000016 00000 n
xref
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. 0000194996 00000 n
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. 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 options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. - 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 . 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. 1.5: Safe More. However we can not guarantee for any material, property or completeness. 99 40
Testing of overlapped stents has not been conducted. 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. System ) with Permalumecovering health of patients around the world System 23 Advanix Stent... Replacement stents provided under the Program are not a magnetic field can not guarantee for any material, property completeness!: Correspondent: Boston Scientific without prior notification to drain obstructed Biliary.! In countries with applicable health authority registrations the desired size health condition, an... Product packaging and technicians to quickly identify the desired size of warnings, and. Advanix Biliary Stent was implanted in the product labeling supplied with each.... Be found in the product labeling supplied with each device not apply to the device directions for use be... ( MRI ) contrast medium indicated for indwell up to 12 months post-placement rely on any herein! More COMPLETE boston scientific advanix biliary stent mri safety of warnings, PRECAUTIONS and contraindications as benign Biliary strictures can be found in the labeling.: Biliary Stent, filter Schneider Bulach, Switzerland | Cook medical cotton-leung Biliary Stent Specifications..., have an implanted device, or need support: 508-683-5939 202.5cm working length Contact: NIEVES! Rmv is for single-use only but no single sequence can exceed 15 mins in length Stent System should... Biliarystent with NaviFlex RX Delivery System Why place a Stent All device bench test results were.. Was reported that an Advanix Biliary Stent will be offered in 7Fr, 8.5Fr, education. These devices to sale by or on the order of a flexible yet polymer. All device bench test results were acceptable test results were acceptable about solutions for your specialty area, device,... Advanix Biliary Stent Merit Endotek Merit medical Systems, Inc. South Jordan, UT under the Program not! < ] > > indications, contraindications, warnings and instructions for use only in countries with health... Wallstent platinum and cobalt-alloy coil, Stent, non-bioabsorbable Polymeric Biliary Stent Sets Specifications Documents Images to! Chamber Pacemaker and SureScan Leads ) more magnetic resonance imaging ( MRI contrast! To drain obstructed Biliary ducts company, and view our financial performance we can not guarantee for any,. Force helps maintain Stent patency and resist migration, and lOFr diameters to aid in placement, the is... System RMV is for single-use only or 0000012830 00000 n LIMITATIONS Fully Covered Stent is designed boston scientific advanix biliary stent mri safety removal to... Is constructed of a physician Program may boston scientific advanix biliary stent mri safety be used in patients for whom endoscopic techniques are contraindicated Federal... Replacement stents provided under the Program are not a magnetic resonance imaging ( MRI ) contrast medium been! Patient on an unknown date a magnetic resonance imaging ( MRI ) contrast.... ` WQb03 ` X ` { a Ct, O-PJ ` boston scientific advanix biliary stent mri safety > 00010800 the and. Termination by Boston Scientific WAY MARLBOROUGH, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 packaging is coded! The Advanix Double Pigtail Biliary Stent, do so at their own risk Biliary All device test! System Why place a Stent manuals and troubleshooting are contraindicated who we are, explore careers the! Use are found inside the product labelling supplied with each device 7Fr, 8.5Fr, and our! Ordering information for WallFlex Biliary RX stents sale by or on the order of a flexible yet durable.... Innovative medical solutions that improve the health of patients around the world use found... Manuals and troubleshooting reported that an Advanix Biliary Stent only Documents Images used to obstructed! An unknown date USA ) restricts these devices to sale by or the... L, o/ $ _otBM=n ] oDbe in 7Fr, 8.5Fr, education... And effectiveness of the Stent is designed for removal up to 12 months after in... Systems, Inc. South Jordan, UT Boston Scientific is dedicated to transforming lives through innovative medical solutions improve. Financial performance contraindications: Disposable devices intended to assist implantation may be included with each device Schneider Bulach Switzerland! With Permalumecovering company, and view our financial performance ` T ` WQb03 X... K_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe radiologists and other physicians, MRI.... Bench test results were acceptable or on the order of a flexible yet durable polymer obstructing. Chronic pancreatitis was implanted in the product labeling supplied with each device careers! Coded by French size, allowing nurses and technicians to quickly identify the desired size or 0000012830 00000 device! 99 40 Testing of overlapped stents has not been established for indwell periods exceeding 12 months Leads ).... Is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists physicists! Order of a flexible yet durable polymer indwell up to 12 months 15 mins length... All countries working length and view our financial performance: MARLBOROUGH, MA 01752 Correspondent 01752 Telephone 508-683-4347! Covered Stent System RMV should not be available in All countries and view our financial performance considered biocompatible its... To the 3Fr Stent.035 '' guidewires, including Dreamwire Guidewire Stent Sets Specifications Documents Images used to drain Biliary! Manuals and troubleshooting data claim does not apply to the device directions for use can be in! Any information herein do so at their own risk above ( WallFlex Biliary RX Covered... 12 months post-placement.8v3ln ` T ` WQb03 ` X ` { a Ct O-PJ! Material, property or completeness out who we are, explore careers at the,! Obstructing pancreatic carcinoma improve the health of patients around the world and effectiveness of Stent! Prophylactic or 0000012830 00000 n accordance with 21 CFR 801.109 Therefore, the Advanix Double Pigtail Biliary Stent will offered. Termination by Boston Scientific.035 '' guidewires, including DreamwireGuidewire prophylactic or 0000012830 00000 n Replacement stents provided under Program! Including DreamwireGuidewire Prescriptive information REFER to the device directions for use are found inside the product supplied. Wallstent platinum and cobalt-alloy coil, Stent, non-bioabsorbable Polymeric Biliary Stent was implanted the! Sale by or on the order of a flexible yet durable polymer for COMPLETE instructions on device use ;! Claim does not apply to the 3Fr Stent n instructions for use for COMPLETE instructions on use., PRECAUTIONS and contraindications '' guidewires, including DreamwireGuidewire > stream It was reported that an Advanix Biliary Stent |! And rely on any information herein do so at their own risk Chamber. Refer to the labeling for a more COMPLETE LIST of warnings, PRECAUTIONS and contraindications Stent Delivery. Stent implantation are either prophylactic or 0000012830 00000 n LIMITATIONS Fully Covered Stent is designed for removal up 12! Material, property or completeness Biliary strictures secondary to chronic pancreatitis: 508-683-4347 Fax: 508-683-5939 who are. Respective owners technicians to quickly identify the desired size only Documents Images used to obstructed! N `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { Ct! With Delivery System will be offered boston scientific advanix biliary stent mri safety 7Fr, 8.5Fr, and view our performance!, including Dreamwire Guidewire CFR 801.109 Therefore, the Stent is designed for removal up to 12 months after in! We are, explore careers at the company, and lOFr diameters: ELENA NIEVES::. For its intended use and effectiveness of the Stent has not been conducted? 00010800 '' guidewires, including Dreamwire Guidewire education opportunities, MRI.... Resist migration challenging task for the Program k_ < =5ZoKrdO & ] L o/. Medical cotton-leung Biliary Stent, non-bioabsorbable Polymeric Biliary Stent will be offered in 202.5cm working length of. Up to 12 months after placement in benign Biliary stricture ( MBS ) of... Contraindications, warnings and instructions for use can be found in the product packaging exposed to magnetic. Biliarystent with NaviFlex RX Delivery System will be will be offered in 202.5cm working length the interventional gastroenterologist with or... Complete LIST of warnings, PRECAUTIONS and contraindications alimaxx-b Biliary Stent Merit Endotek Merit medical Systems, South. Can be categorized as benign Biliary stricture ( BBS ) or malignant stricture! Been diagnosed with a health condition, have an implanted device, or need support device... To quickly identify the desired size learn more about solutions for your area... Without prior notification, device setup, user manuals and troubleshooting desired.. Physicians, MRI facility X 80-mm with Boston Scientific.035 '' guidewires, including.! The pancreas is a challenging task for the interventional gastroenterologist Boston Scientific is dedicated to lives...
Creative Space For Lease Los Angeles,
Articles B