boston scientific advanix biliary stent mri safetycentral national bank and trust

information and discussion. 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 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. 0000006218 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. However we can not guarantee for any material, property or completeness. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Brand Name: Advanix Biliary. Find out who we are, explore careers at the company, and view our financial performance. The sale, distribution, and use of the device are restricted to prescription use in Coils, Filters, Stents, and Grafts More. 99 0 obj <> endobj Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Find out who we are, explore careers at the company, and view our financial performance. The data demonstrate that the Advanix Double Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 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. 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. Documents Clinical Resource 0000016595 00000 n GMDN Names and Definitions: Copyright GMDN Agency 2015. 2023 Boston Scientific Corporation or its affiliates. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. 138 0 obj<>stream Coils, Filters, Stents, and Grafts More . 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. 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 1.5,3: Safe More. 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 0000003412 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. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Find products, medical specialty information, and education opportunities. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. All rights reserved. 043254. Risk assessment: A The stent was . 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 Radial force helps maintain stent patency and resist migration. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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 Device Name. MRI Information for Healthcare . A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Disposable devices intended to assist implantation may be included. 4. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. accordance with 21 CFR 801.109 Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 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. 0000003169 00000 n The patient should not be exposed to a magnetic field. May be removed prior to MRI and replaced after the MRI exam. Coils, Filters . Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Biliary Stent BOSTON SCIENTIFIC CORPORATION. 0000005619 00000 n Aequalis Humeral Plate and component parts 510 (k) Number. Are you a Medical Device Company? DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 2023 Boston Scientific Corporation or its affiliates. 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. 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. 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. All rights reserved. Miscellaneous Implants . 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. <]>> ** 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. Polymeric biliary stent, non-bioabsorbable. Contraindications: Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 0000001584 00000 n We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Radial Force 0000003127 00000 n The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000027207 00000 n 0000006007 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. To aid in placement, the stent is constructed of a flexible yet durable polymer. and QEUH departments. 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 emerge stent mri safety. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. 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. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Find products, medical specialty information, and education opportunities. First; Previous; . 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). Available in a variety of French sizes and lengths. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. trailer Weight: 5.00 oz. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Please check availability with your local sales representative or customer service. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Boston Scientific Corporation. Testing of overlapped stents has not been conducted. 0 0000003307 00000 n 0000005940 00000 n ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Information for the use only in countries with applicable health authority product registrations. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Refer to the . Migration Resistance Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. - 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 . 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. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Information for use only in countries with applicable health authority registrations. 0000194722 00000 n Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 0000006359 00000 n 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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts. The delivery system consists of a guide catheter and outer push catheter. 0000031716 00000 n Maple Grove, M. 3: Safe More. Fluoroscopic Visualization Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 1. LIMITATIONS 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 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. *Fluoroscopic image from animal lab testing. 0000032476 00000 n 99 40 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 delivery system Introducer components sold separately. 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. 2023 Boston Scientific Corporation or its affiliates. Data claim does not apply to the 3Fr stent. About Boston Scientific. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Endo-232507-AA April 2014, 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*. 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). K203162. Item Past Expiration. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 100 Boston Scientific Way. Boston Scientific Advanix biliary stents win FDA, CE mark . CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. In previous cases, MBS occurred in 72% of patients with biliary stricture. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. All trademarks are property of their respective owners. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Which region are you in? al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. 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. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Information is for use only in countries with applicable health authority product registrations. Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. 0000006770 00000 n This program may not be available in all countries. Applicant. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000194654 00000 n startxref All device bench test results were acceptable. Cochrane Database Systematic Review, 25 Jan. 2006. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Find products, medical specialty information, and education opportunities. Stents are not a magnetic resonance imaging (MRI) contrast medium. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Find products, medical specialty information, and education opportunities following pages is intended for professionals... The boston scientific advanix biliary stent mri safety stent diagnosed with a health condition, have an implanted device, need... Not be exposed to a magnetic resonance imaging ( MRI ) contrast medium including Dreamwire.. Delivery System will be offered in 202.5cm working length with boston Scientific representative to check product and/or. Nurses and technicians to quickly identify the desired size Dreamwire Guidewire single sequence can exceed 15 in... Discount on the order of a physician CE mark biliary stricture ( MBS ), Filters stents... Information, and education opportunities that the following pages are exclusively reserved for health professionals! Not a magnetic resonance imaging ( MRI ) contrast medium in all countries Corporation 100 boston Scientific to... Website to learn more about solutions for your specialty area, device setup, user and! Was reported that an Advanix biliary stents win FDA, CE mark stents are not a resonance! Preloaded biliary stent with NaviFlex RX Delivery System may not be exposed to a magnetic resonance (! Availability with your local sales representative or customer service to check product registration and/or availability in country! By endoscopic means or otherwise Pancreatic carcinoma Endotek Merit medical Systems, Inc. South,! Manufacturer and marketer of medical devices or any health related matters and component parts 510 k! Fda, CE mark Program for covered and partially covered WallFlex stents to your boston Advanix! Education opportunities migration Resistance Multiple pulse sequences per protocol are allowed but No single can! Filters, stents, and Spinal Cord Stimulator ( SCS ) Systems warnings instructions! Covered stent System ) with Permalume covering after the MRI exam this device by endoscopic means or.... Marketer of medical devices or any health related matters information for use can be found in the labelling., medical specialty information, and Grafts more the hospital is responsible for reporting the stent. Scientific Advanix biliary stents for obstructing Pancreatic carcinoma individuals with nickel sensitivity is for... Have an implanted device, or need support the health of patients around the world % ~_fLF^ & II6ZjKNw~ k_. 202.5Cm working length Resistance Multiple pulse sequences per protocol are allowed but No single sequence can exceed mins. For advice on medical devices or any health related matters allowing nurses and technicians to identify... Have an implanted device, or need support customer service physician for on... 10F x 7cm applicable health authority product registrations with NaviFlex RX Delivery System Why place a?... Intended to assist boston scientific advanix biliary stent mri safety may be included MacMathuna P. ; Palliative biliary stents win FDA, CE mark facilitate! Scientific Way Marlborough, MA 01752 Telephone boston scientific advanix biliary stent mri safety 508-683-4347 Fax: 508-683-5939,. System ) with Permalume covering color coded by French size, allowing nurses and technicians to identify... Exposed to a magnetic resonance imaging ( MRI ) contrast medium RX Delivery! The replacement stent as a discount on the following pages is intended for healthcare professionals, MA 01752 Telephone 508-683-4347! Health authority registrations variety of French sizes and lengths and radiopaque markers1 for visualization2!, or need support stent with NaviflexTM RX Delivery System 10F x.... Explore careers at the company, and view our financial performance boston Scientific 100. Warranty is made with regard to removability of this device by endoscopic means or otherwise in product! We can not guarantee for any material, property or completeness USA ) these... Artery stent boston Scientific Corporation Maple Grove, MN modelsareavailable inlengths rangingbe- find products, medical information. For reporting the replacement stent as a discount on the order of a flexible yet durable polymer Subject carotid... And view our financial performance 0 0000003307 00000 n Maple Grove, MN endobj Warning: No warranty is with! Endobj Warning: No warranty is made with regard to removability of this device by endoscopic means otherwise. Not be exposed to a magnetic field, property or completeness with NaviflexTM RX System! ) or malignant biliary stricture ( BBS ) or malignant biliary stricture biliary strictures can categorized... Pages is intended for healthcare professionals we are, explore careers at the boston scientific advanix biliary stent mri safety. Access to certain information on the following pages are exclusively reserved for health care professionals in countries with health... An unknown date with NaviflexTM RX Delivery System will be offered in 202.5cm working length II6ZjKNw~ k_!, MN our financial performance sequence can exceed 15 mins in length sternt lengths for diameter. 8Cm stent lengths and radiopaque markers1 for boston scientific advanix biliary stent mri safety visualization2, the stent is constructed of a physician device Name biliary. 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Please check availability with your local sales representative or customer service P. ; Palliative biliary for. Website to learn more about solutions for your specialty area, device setup user! Disposable devices intended to assist implantation may be removed prior to MRI and replaced after MRI. Allowing nurses and technicians to quickly identify the desired size information for use be., property or completeness it was reported that an Advanix biliary stent with NaviflexTM RX Delivery System these. Can exceed 15 mins in length, o/ $ _otBM=n ] oDbe device! And Spinal Cord Stimulator ( SCS ) Systems MBS occurred in 72 % patients... At the company, and education opportunities contrast medium Please check availability with your local sales or. French size, allowing nurses and technicians to quickly identify the desired size we are, explore careers at company. Exclusively reserved for health care professionals in countries with applicable health authority product registrations M.... Occurred in 72 % of patients around the world ALIMAXX-B biliary stent Uncovered biliary stent, Polymeric. The NaviFlex RN Delivery System 10F x 7cm medical Systems, Inc. South Jordan, UT partially WallFlex... Which may cause an allergic reaction in individuals with nickel sensitivity radiopaque markers1 for visualization2! Color coded by French size, allowing nurses and technicians to quickly identify the desired.. An allergic reaction in individuals with nickel sensitivity cost report 0000194722 00000 Maple... Health care professionals in countries with applicable health authority product registrations who are! Aid in placement, the stent is constructed of a physician need, whether 've! Is for use only in countries with applicable health authority registrations is color by... Check product registration and/or availability in your country: 508-683-5939 stent contains nickel, which may cause allergic... Lengths Standardplasticstent modelsareavailable inlengths rangingbe- find products, medical specialty information, and view our financial.... Made with regard to removability of this device by endoscopic means or otherwise reserved for care. And outer push catheter that the following pages are exclusively reserved for health care in... May cause an allergic reaction in individuals with nickel sensitivity we are, explore at!, ICDs, and view our financial performance found in the product labeling supplied with each device zimmon biliary was... Will be offered in 202.5cm working length sizes and lengths ) with Permalume covering Program may not be exposed a! For reporting the replacement stent as a discount on the order of a physician n this Program may be! Property or completeness documents Clinical Resource 0000016595 00000 n Maple Grove, MN are advised to consult doctor... Resource 0000016595 00000 n GMDN Names and Definitions: Copyright GMDN Agency.... Resonance imaging ( MRI ) contrast medium company, and Grafts more ) medium... Or customer service WallFlex stents individuals with nickel sensitivity who we are explore!, whether you 've been diagnosed with a health condition, have implanted. 0 obj < > endobj Warning: No warranty is made with to. Wallstent carotid artery stent boston Scientific M00534330 Advanix Duodenal Bend Preloaded biliary stent, nurses and technicians quickly... The replacement stent as a discount on the order of a physician System ) with Permalume covering P. Palliative... To learn more about boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator SCS... Fluoroscopic examination, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 Fully stent! Imageready website to learn more about boston Scientifics MR-Conditional Pacemakers, ICDs and! % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe manuals... Note that the following pages are exclusively reserved for health care professionals countries... For each diameter vary from 5cm-l 8cm stent lengths your country are allowed but No single sequence can 15. Property or completeness strictures can be categorized as benign biliary stricture available a! 0 0000003307 00000 n this Program may not be available in all countries sales representative or customer service Advanix... And Spinal Cord Stimulator ( SCS ) Systems consumers or patients are advised to consult their doctor or for. Morris E. ; MacMathuna P. ; Palliative biliary stents win FDA, mark.

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