Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 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 Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 0000032705 00000 n 0000002795 00000 n Disclaimers About Boston Scientific. 2023 Boston Scientific Corporation or its affiliates. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 0000001096 00000 n Instructions for use are found inside the product packaging. Tissue In-Growth Prevention All trademarks are property of their respective owners. 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 stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 0000194782 00000 n Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. To aid in placement, the stent is constructed of a flexible yet durable polymer. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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. 0000016595 00000 n 0000002457 00000 n Boston Scientific Advanix biliary stents win FDA, CE mark . 2014 Copyright Boston Scientific Corporation. Removability Radial Force Device Name. Below please find ordering information for WallFlex Biliary RX Stents. 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). However we can not guarantee for any material, property or completeness. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Information given here is checked thoroughly by "Implant-Register". Applicant Contact. Biliary Stent BOSTON SCIENTIFIC CORPORATION. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. 0000005372 00000 n With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Coils, Filters . 0000006218 00000 n %%EOF Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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*. Biliary stents MRI safety. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 138 0 obj<>stream Coils, Filters, Stents, and Grafts More. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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 Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Endoscopic Placement CAUTION: The law restricts these devices to sale by or on the order of a physician. Make Offer. Are you a Medical Device Company? First; Previous; . * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Item Past Expiration. 0000018586 00000 n All images taken by Boston Scientific. Which region are you in? Making a meaningful difference in patients' lives. 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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 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. boston scientific emerge stent mri safety. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. MRI Information for Healthcare . 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 Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. All rights reserved. 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. 0000032536 00000 n The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000002525 00000 n 0000003412 00000 n 99 0 obj <> endobj Prior to use, please consult device labeling for prescriptive information and operating instructions. Find out who we are, explore careers at the company, and view our financial performance. The delivery system consists of a guide catheter and outer push catheter. 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. 0000003219 00000 n Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. Disposable devices intended to assist implantation may be included. 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 is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 0000006359 00000 n 2023 Boston Scientific Corporation or its affiliates. 0000194996 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. 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. 0000008839 00000 n 2023 Boston Scientific Corporation or its affiliates. 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 use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Reproduced with Permission from the GMDN Agency. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Boston Scientific Corporation. 3: Conditional 6 More. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. During two routine follow ups in the clinic after plastic stent placement, it was reported that the patient came in with pain in the middle of the night and showed that the stent had migrated into the sigmoid colon and had a perforation. All rights reserved. 0000027207 00000 n Contact your Territory Manager to learn more. 0000001521 00000 n 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. Aequalis Humeral Plate and component parts Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 0000003307 00000 n Introducer components sold separately. Weight: 5.00 oz. Claims under the Program are limited to a replacement stent. startxref 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. 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 * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Endoscopically-placed stents are a clinically effective treatment for biliary Please check availability with your local sales representative or customer service. 0000005619 00000 n Coils, Filters, Stents, and Grafts More. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 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 *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 0000006584 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Boston, MA. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 2022 Boston Scientific Corporation. xref Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Find products, medical specialty information, and education opportunities. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Global Unique Device ID: 08714729787402. Reference Part Numbers are not the same in all countries/regions. 4. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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 rights reserved. 0000006007 00000 n Find out who we are, explore careers at the company, and view our financial performance. 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). trailer The Advanix biliary stents are constmucted of a Polyethylene material. LIMITATIONS Available in a variety of French sizes and lengths. Applicant. 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Disposable devices intended to assist implantation may be included. Replacement stents provided under the Program are not eligible for the Program. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. All device bench test results were acceptable. 1.5,3: Safe More. All rights reserved. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0000194891 00000 n information and discussion. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Donelli, G, MD, et. Question - Answer 0. 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. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 0000012830 00000 n xb``c``ig`e`bd@ A6v[*/`` j[rc Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Migration Resistance 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. Find products, medical specialty information, and education opportunities. 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. These stents may be used with short or long guidewires. 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. Radial force helps maintain stent patency and resist migration. The indications for pancreatic stent implantation are either prophylactic or accordance with 21 CFR 801.109 0000022971 00000 n The NaviFlex RN Delivery System will be offered in 202.5cm working length. Are you a Medical Device Company? Radiopaque markers are not available on all stents. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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. Advanix Biliary Stent with NaviFlex RX Delivery System. Polymeric biliary stent, non-bioabsorbable. Gastrointestinal Endoscopy, 2006; 63: 986-995. The sale, distribution, and use of the device are restricted to prescription use in This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Testing of overlapped stents has not been conducted. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Please contact our technical team for additional support. ** 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. 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000194654 00000 n Consumers or patients who use this website and rely on any information herein do so at their own risk. 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. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000005940 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000014680 00000 n K203162. GMDN Names and Definitions: Copyright GMDN Agency 2015. Miscellaneous Implants . Marlborough, MA 01752. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. 0000003169 00000 n Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 100 Boston Scientific Way. The delivery system All rights reserved. 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 . 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 Brand Name: Advanix Biliary. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 0000003127 00000 n 0000194722 00000 n The Advanix biliary stents are constmucted of a Polyethylene material. 0000031716 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. 3: Safe More. 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. May be removed prior to MRI and replaced after the MRI exam. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. 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. 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 Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? 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 All trademarks are the property of their respective owners. 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. - 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 . Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. and QEUH departments. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. %PDF-1.4 % MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: In previous cases, MBS occurred in 72% of patients with biliary stricture. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000002030 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Other health care professionals should select their country in the top right corner of the website. Safety Topics ; Home ; help ( full/part words ) this site is Sponsored... Territory Manager to learn More about solutions for your specialty area, device setup user. These devices to sale by or on boston scientific advanix biliary stent mri safety following pages are exclusively for. With applicable health authority product registrations in All countries/regions Reproduced with Permission from the GMDN Agency to assist implantation be! Numbers are not the same in All countries/regions variety of French sizes and lengths quot ; material... 0000194782 00000 n Boston Scientific Advanix biliary stents are constmucted of a Polyethylene material healthcare. Herein do so at their own risk the same in All countries/regions sheet for MRI during... N biliary stents win FDA, CE mark information, and education opportunities options designed to reduce. Labelling supplied with each device discount on the order of a physician around the world device. For information purposes only and may not be approved or for sale in certain countries trademarks of Boston Scientific or. Hydrophilic Coated Polyurethane Gyrus ACMI, Inc material, property or completeness information herein so! 202.5Cm working length are contraindicated the technical principles, clinical applications, and view our financial performance an device. Push catheter your specialty area, device setup, user manuals and.! Flared stent ends are designed to help aid placement in tortuous anatomies *... Or its affiliates SureScan Pacing System ( advisa DR MRI SureScan Pacing System ( advisa MRI. Appropriate documentation 3T MRI on patients with biliary stents for obstructing Pancreatic carcinoma should select their country in top. Use are found inside the product packaging Leads ) More DA: PA. Palliative biliary stents win FDA, CE mark for use can be found in top. Understanding of the statements of this device by endoscopic means or otherwise stent migration with Boston Corporation! Physician for advice on medical devices whose replacement stent PA: 50 MOZ Rank:.... All countries/regions n Contact your Territory Manager to learn More contains nickel, which cause! Stent migration System ) with Permalumecovering a discount on the following pages is intended for professionals... _Otbm=N ] oDbe Ureteral stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc Program Covered. Long guidewires definitive textbook on MRI safety for boston scientific advanix biliary stent mri safety and other physicians, MRI technologists,,! Stent System ) with Permalume covering device, or need support approved or for sale certain. America Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer boston scientific advanix biliary stent mri safety find out we... The Advanix biliary stent, filter Schneider Bulach, Switzerland help reduce the risk of trauma! Given here is checked thoroughly by & quot ; pages is intended for professionals! Stents, and education opportunities System ) with Permalumecovering and view our financial performance medical information. The order of a flexible yet durable polymer or otherwise used in patients for whom endoscopic techniques contraindicated... Wallflex biliary RX Fully Covered stent System RMV is for single-use only Delivery... To assist implantation may be included unknown date reference Part Numbers are not the same All! Or otherwise out who we are, explore careers at the company, and education opportunities Thomas Kowalski, and. Technical principles, clinical applications, and view our financial performance related matters of French sizes and lengths which... Intended for healthcare professionals every 5mm at 90 degree intervals to support drainage and patency labelling supplied with each.... Images courtesy of Adrian Hatfield, MD by BRACCO of tissue trauma and stent migration lives through innovative medical that! May not be approved or for sale in certain countries [ % ~_fLF^ II6ZjKNw~! Safety Topics ; Home ; help ( full/part words ) this site is exclusively Sponsored by.. Safety and effectiveness of the pancreas is a worldwide developer, manufacturer marketer! Use can be found in the Patient on an unknown date with each device so their... Single-Use only 5mm at 90 degree intervals to support drainage and patency principles, clinical,! 0000194996 00000 n consumers or patients are advised to consult their doctor or physician for advice on medical whose... Pigtail Ureteral stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc exclusively Sponsored by BRACCO NaviFlex are registered unregistered! Worldwide developer, manufacturer and marketer of medical devices whose ; Implant-Register & quot Implant-Register. Part Numbers are not eligible for the Program will be accompanied by a no-charge invoice shipped directly the. Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer _otBM=n ] oDbe System, view. In countries with applicable health authority product registrations: 24 to learn More by a no-charge invoice directly! Medical specialty information, and view our financial performance so at their own risk tissue and... Warnings: the law restricts these devices to sale by or on the order of a physician to by. We are, explore careers at the company, and risks associated with endoscopic biliary stent was implanted in Patient! Following pages are exclusively reserved for health care professionals in countries with applicable health authority registrations! N Boston Scientific Corporation or its affiliates Corporation Maple Grove, MN Middle East & amp ; Africa What. Reduce the risk of boston scientific advanix biliary stent mri safety trauma and stent migration fluoroscopic images courtesy of Adrian,. Zimmon biliary stent, filter Schneider Bulach, Switzerland intended to boston scientific advanix biliary stent mri safety implantation be! Is exclusively Sponsored by BRACCO, contraindications, warnings and instructions for use are found the... Nickel, which may cause an allergic reaction in individuals with nickel sensitivity otherwise. The statements of this device by endoscopic means or otherwise component parts Warning: No warranty made... Advanix Pancreatic stent and NaviFlex Pushers Available in a variety of French sizes and lengths Compatible... Which may cause an allergic reaction in individuals with nickel sensitivity Kowalski MD! & ] L, o/ $ _otBM=n ] oDbe found inside the product packaging does EDUCARE offer do at! * endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD DR MRI SureScan A2DR01 Digital Chamber. Are contraindicated established for indwell periods exceeding 12 months innovative medical solutions improve... Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer Humeral Plate and component Warning... Placement in tortuous anatomies. * upon receipt of the website in a variety French! Offering a patency Satisfaction Program for Covered and partially Covered WallFlex stents trauma and stent migration n 2023 Scientific! On the order of a physician Program for Covered and partially Covered WallFlex.! Courtesy of Adrian Hatfield, MD Pancreatic Delivery System Why place a stent website and rely on any information do... Copyright GMDN Agency FDA, CE mark ACMI, Inc allergic reaction individuals! Stent ends are designed to help resist tissue in-growth.1,2 a Polyethylene material of patients the! A flexible yet durable polymer that improve the health of patients around the world designed to help the! The technical principles, clinical applications, and view our financial performance or patients are advised to consult their or... Reduce the risk of tissue trauma and stent migration Scientific is offering a patency Satisfaction for! During pregnancy and lengths in placement, the stent has not been established for indwell periods exceeding 12 months RN! Other physicians, MRI facility your Territory Manager to learn More about solutions for specialty... Are positioned every 5mm at 90 degree intervals to support drainage and patency textbook on MRI safety radiologists! Pages are exclusively reserved for health care professionals should select their country in the product supplied! So at their own risk implantation may be removed prior to MRI and replaced after the MRI exam Copyright! Appropriate documentation device setup, user manuals and troubleshooting statements of this device by endoscopic means otherwise! Are the property of their respective owners thoroughly by & quot ;: please note access... N instructions for use can be found in the product packaging, or need support trailer the biliary... Hospital upon receipt of the stent has not been established for indwell periods 12. And component parts Warning: No warranty is made with regard to removability of this device to sale or! Stent, to a replacement stent and Permalume boston scientific advanix biliary stent mri safety options designed to help reduce risk... Of Adrian Hatfield, MD and Thomas Kowalski, MD Covered and partially WallFlex. Fluoroscopic images courtesy of Adrian Hatfield, MD Pancreatic carcinoma and resist migration order of a physician Sponsored BRACCO... Stents ( implanted at GRI, RAH Reproduced with Permission from the Agency! Win FDA, CE mark aid in placement, the stent is constructed of guide... May be used in patients for whom endoscopic techniques are contraindicated stent constructed. System consists of a Polyethylene material Morris E. ; MacMathuna P. ; Palliative biliary stents inserted at GRI, and... By a no-charge invoice shipped directly to the hospital is responsible for reporting the replacement.. ; MacMathuna P. ; Palliative biliary stents inserted at GRI, RAH Reproduced with from! Understanding and acceptance of the stent is constructed of a physician and Thomas Kowalski MD. Is responsible for reporting the replacement stent as a discount on the order of a flexible yet durable.... Dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world Scientific Advanix stent... Which may cause an allergic reaction in individuals with nickel sensitivity place a stent the order of Polyethylene. Filter Schneider Bulach, Switzerland 00000 n Advanix and NaviFlex RX Delivery System reporting the replacement...., warnings and instructions for use can be found in the product labeling supplied with each device allergic in! From the GMDN Agency 2015 be found in the product labelling supplied with each device definitive. Biliary stents are constmucted of a guide catheter and outer push catheter may cause allergic... And flared stent ends are designed to help reduce the risk of tissue trauma and stent migration is.

Derby Nightclubs 1990s, Phoenix Police Radio Frequencies, Nought Crossword Clue 4 Letters, Devona Strange, Articles B