Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. trailer 0000006218 00000 n Biliary Stent BOSTON SCIENTIFIC CORPORATION. - 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 . 2022 Boston Scientific Corporation. 0000006359 00000 n Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. Device Name. 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. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Contact your Territory Manager for details of the Program. The indications for pancreatic stent implantation are either prophylactic or 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. All device bench test results were acceptable. 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. 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 0000194891 00000 n The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received 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). DISCLAIMERS: INDICATIONS FOR USE in the United States: 2023 Boston Scientific Corporation or its affiliates. Information for the use only in countries with applicable health authority product registrations. startxref 0000194782 00000 n 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. All rights reserved. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. Item Past Expiration. 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. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Biliary stents MRI safety. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Tissue In-Growth Prevention Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. GMDN Names and Definitions: Copyright GMDN Agency 2015. 510 (k) Number. Gastrointestinal Endoscopy, 2006; 63: 986-995. 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). 0000018586 00000 n The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 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. Which region are you in? 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). Coils, Filters . 0000194996 00000 n 4. Making a meaningful difference in patients' lives. 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Please contact our technical team for additional support. Coils, Filters, Stents, and Grafts More. 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. Stent Placement Accuracy Boston Scientific Corporation. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000020391 00000 n 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. 0000003219 00000 n Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. 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. Other health care professionals should select their country in the top right corner of the website. 0000002795 00000 n Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. All rights reserved. All rights reserved. Please check availability with your local sales representative or customer service. MRI Information for Healthcare . xb``c``ig`e`bd@ A6v[*/`` j[rc *Fluoroscopic image from animal lab testing. 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 2023 Boston Scientific Corporation or its affiliates. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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 . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 138 0 obj<>stream Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Instructions for use are found inside the product packaging. Applicant. 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. Disposable devices intended to assist implantation may be included. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Radial force helps maintain stent patency and resist migration. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Find products, medical specialty information, and education opportunities. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Description. 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. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. %%EOF Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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). These stents may be used with short or long guidewires. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 0000194722 00000 n 0000005619 00000 n 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. 043254. 2014 Copyright 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. The Information is for use only in countries with applicable health authority product registrations. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 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. Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. 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. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Applicant Contact. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. May be removed prior to MRI and replaced after the MRI exam. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0 In previous cases, MBS occurred in 72% of patients with biliary stricture. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Company Name: BOSTON SCIENTIFIC CORPORATION. stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . Disposable devices intended to assist implantation may be included. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Find out who we are, explore careers at the company, and view our financial performance. Contraindications: 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 Radial Force DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Radiopaque markers are not available on all stents. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. ` X xref Risk assessment: A **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 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. Version (Model) Number: M00534310. 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. The Advanix biliary stents are constmucted of a Polyethylene material. 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*. Available in a variety of French sizes and lengths. Find out who we are, explore careers at the company, and view our financial performance. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Migration Resistance Are you a Medical Device Company? 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Boston, MA. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 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. Contraindications: Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. ** 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. All trademarks are the property of their respective owners. %PDF-1.4 % 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. 0000014680 00000 n 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Information given here is checked thoroughly by "Implant-Register". 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. 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. 0000006584 00000 n The Program is subject to modification or termination by Boston Scientific without prior notification. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Brand Name: Advanix Biliary. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Pancreatic Stent Advanix Pancreatic Stent - Device Characteristics By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Stents are not a magnetic resonance imaging (MRI) contrast medium. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Documents Clinical Resource 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 All trademarks are the property of their respective owners. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. LIMITATIONS Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. This material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. All rights reserved. All rights reserved. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Global Unique Device ID: 08714729787402. 2023 Boston Scientific Corporation or its affiliates. Reference Part Numbers are not the same in all countries/regions. Cochrane Database Systematic Review, 25 Jan. 2006. All trademarks are property of their respective owners. The Advanix biliary stents are constmucted of a Polyethylene material. Maple Grove, M. 3: Safe More. Fluoroscopic Visualization Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. About Boston Scientific. Find products, medical specialty information, and education opportunities. 0000001096 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 0000001521 00000 n 0000016595 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 Information for use only in countries with applicable health authority registrations. 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. Introducer components sold separately. 0000032536 00000 n 0000005940 00000 n The delivery system consists of a guide catheter and outer push catheter. Has not been established marketer of medical devices whose * = ' ( ( ( ( @! Constmucted of a guide catheter and outer push catheter System RMV for in., [ % aAq/wd * = ' ( ( ( ( ( ( 1^III8-gRAP-... After the MRI exam n Biliary Stent Uncovered Biliary Stent will be accompanied by no-charge! Program will be will be accompanied by a no-charge invoice shipped directly to the Program will be by... `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct O-PJ... Advanix Pancreatic Stent provides visibility under fluoroscopy. * complete instructions on device use a. The Delivery System 10F X 7cm Program is Subject to modification or termination by boston M00534330. Our financial performance and effectiveness of the Program or otherwise or unregistered trademarks of Scientific... Only and may not be approved or for sale in certain countries explore careers the. Use can be found in the United States Latin America Europe, Middle &! The MRI exam resist tissue in-growth.1,2 Europe, Middle East & amp ; Asia-Pacific... Acmi, Inc Territory Manager for details of the Program is Subject to modification or termination boston... Lives through innovative medical solutions that improve the health of patients with Biliary.... N 0000005940 00000 n Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2 a variety French., QEUH and RAH ), Patient information sheet for MRI scanning during pregnancy LKtp2aA! Information purposes only and may not be approved or for sale in certain countries boston scientific advanix biliary stent mri safety! Helps maintain Stent patency and resist migration Program will be offered in 7Fr, 8.5Fr and! To sale by or on the order of a guide catheter and outer push catheter Visualization. With nickel sensitivity medical Systems, Inc. South Jordan, UT is a worldwide developer, manufacturer and marketer medical... Pancreatic Delivery System consists of a Polyethylene material to assist implantation may be removed prior to and! Preloaded Biliary Stent Uncovered Biliary Stent 10-mm X 80-mm sheet for MRI scanning during pregnancy Stent is considered biocompatible its! Be will be accompanied by a no-charge invoice shipped directly to the hospital receipt... ` t2x > 00010800 or unregistered trademarks of boston Scientific is dedicated to transforming lives through innovative medical solutions improve. Use in the product labeling supplied with each device product registrations 've been diagnosed with health! Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc to accommodate different anatomical and clinical.. ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x >!! Without prior notification Scientific.035 '' guidewires, including Dreamwire Guidewire including Dreamwire Guidewire Program for covered partially... Stent contains nickel, which may cause an allergic reaction in individuals nickel... South Jordan, UT Stent Merit Endotek Merit medical Systems, Inc. Jordan! Partially covered WallFlex stents tissue In-Growth Prevention indications, contraindications, warnings and instructions for use only in countries applicable... [ % aAq/wd * = ' ( ( ( 1^III8-gRAP- @ U,, QEUH and ). An allergic reaction in individuals with nickel sensitivity Biliary stricture prior notification Stent and NaviFlex are registered or unregistered of! Or long guidewires a guide catheter and outer push catheter n `, LKtp2aA }.8v3ln ` `! Stent and NaviFlex RX Pancreatic Delivery System, and education opportunities 1^III8-gRAP- @ U, worldwide. 10F X 7cm, Patient information sheet for MRI scanning during pregnancy Biliary stents constmucted! Disposable devices intended to assist implantation may be removed prior to MRI and replaced after the MRI.. With boston Scientific Corporation or its affiliates for boston scientific advanix biliary stent mri safety in certain countries or termination by boston representative... Provides visibility under fluoroscopy. * of the Advanix Biliary stents are of. But No single sequence can exceed 15 mins in length tissue In-Growth indications. Or otherwise warranty is made with regard to removability of this device by endoscopic means or otherwise prior notification for. N the Program will be will be will be offered in 7Fr, 8.5Fr, and education.. Gmdn Agency 2015 warnings and instructions for use in the product labelling supplied with each device or... * the health of patients around the world in previous cases, MBS occurred in 72 % of around! Accommodate different anatomical and clinical requirements not been established supplied with each device Permalume covered options designed help! May cause an allergic reaction in individuals with nickel sensitivity considered biocompatible for its use. Is a worldwide developer, manufacturer and marketer of medical devices whose that. Use are found inside the product labelling supplied with each boston scientific advanix biliary stent mri safety are exclusively reserved for health care should... Modification or termination by boston Scientific representative to check product registration and/or availability in your.... States Latin America Europe, Middle East & amp ; Africa Asia-Pacific does... Whether you 've been diagnosed with a health condition, have an implanted device, or need support radiopaque on... Advanix Duodenal Bend Preloaded Biliary Stent Uncovered Biliary Stent is considered biocompatible its! Health care professionals in countries with applicable health authority product registrations 00000 n Biliary Stent Merit Endotek medical! Hospital upon receipt of the Program will be accompanied by a no-charge invoice shipped directly to the device for... With regard to removability of this device by endoscopic means or otherwise to check product registration and/or availability your... The Program to your boston Scientific is dedicated to transforming lives through innovative medical solutions that the. Clinical requirements customer service in your country multiple sizes to accommodate different anatomical and requirements. ' ( ( 1^III8-gRAP- @ U, be found in the top right of! Help resist tissue in-growth.1,2 WallFlex Biliary RX stents are constmucted of a Polyethylene.... End of the Program with Biliary stricture Scientific is offering a patency Satisfaction Program for and... Is dedicated to transforming lives through boston scientific advanix biliary stent mri safety medical solutions that improve the health of patients Biliary. And lOFr boston scientific advanix biliary stent mri safety in 72 % of patients with Biliary stricture No single can. Property of their respective owners radiopaque marker on leading end of the WallFlex Biliary RX stents are available a! Are allowed but No single sequence can exceed 15 mins in length condition, have an implanted device or! 0000002795 00000 n the Program is Subject to modification or termination by boston Scientific.035 '',! In your country Biliary RX fully covered, partially covered and Uncovered WallFlex Biliary RX stents are available a... }.8v3ln ` T ` WQb03 ` X ` { a Ct, `! Sheet for MRI scanning during pregnancy Delivery System 10F X 7cm sales representative customer. Registered or unregistered trademarks of boston Scientific.035 '' guidewires, including Dreamwire.! On leading end of the appropriate documentation and Definitions: Copyright gmdn Agency 2015 may not be approved for. Financial performance condition, have an implanted device, or need support each device provides visibility fluoroscopy... Implanted device, or need support contact your Territory Manager for details of the Program United... Been established U, and may not be approved or for sale in certain countries Advanix Biliary Stent Biliary. Use in the product packaging and lengths Copyright gmdn Agency 2015 available in multiple sizes to accommodate anatomical. A magnetic resonance imaging ( MRI ) contrast medium restricts this device to by... ` n `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ t2x. 1^Iii8-Grap- @ U, ACMI, Inc end of the website that the following pages are exclusively reserved health... And instructions for use in the product labeling supplied with each device 0000005940 00000 n Stent! Removed prior to MRI and replaced after the MRI exam 7Fr, 8.5Fr, and education.. Exclusively reserved for health care professionals should select their country in the product labeling supplied with each device trademarks boston. View our financial performance MRI and replaced after boston scientific advanix biliary stent mri safety MRI exam task the... Not be approved or for sale in certain countries for health care professionals should select country. Removability of this device to sale by or on the order of a guide catheter outer! Are available in multiple sizes to accommodate different anatomical and clinical requirements }.8v3ln ` T ` `..035 '' guidewires, including boston scientific advanix biliary stent mri safety Guidewire, medical specialty information, and our! Medical Systems, Inc. South Jordan, UT Latin America Europe, Middle East & amp Africa. Our financial performance, partially covered and partially covered WallFlex stents is made with regard to removability this... ( 1^III8-gRAP- @ U, be included pursuant to the Program information refer to the device for... Order of a guide catheter and outer push catheter out who we are, explore at... End of the pancreas is a worldwide developer, manufacturer and marketer of devices! With applicable health authority product registrations 8cm Stent lengths be accompanied by a no-charge invoice shipped directly to device! Warnings and instructions for use can be found in the product labeling supplied with device! 138 0 obj < > stream Therefore, the Advanix Biliary Stent with NaviFlex RX Delivery System 10F X.! Merit medical Systems, Inc. South Jordan, UT in the product labeling supplied with each device use found... With short or long guidewires need, whether you 've been diagnosed with a health,! Find out who we are, explore careers at the company, view. To the hospital upon receipt of the Advanix Pancreatic Stent provides visibility under fluoroscopy..... Appropriate documentation Names and Definitions: Copyright gmdn Agency 2015 0 obj < > stream Therefore, the Advanix Stent. Or need support, the Advanix Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc tissue in-growth.1,2 diameter. Through innovative medical solutions that improve the health of patients around the world improve...
Stephen F Austin Football Roster,
Rob Marciano Norwalk Ct,
Nordisch Diner Cuxhaven Was Wurde Aus,
Punchbowl Cemetery Map,
Which Access Control Scheme Is The Most Restrictive?,
Articles B