*** A stent cannot be reconstrained after the reconstrainment line has been exceeded Replacement stents provided under the Program are not eligible for the Program. The indications for pancreatic stent implantation are either prophylactic or Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. DISCLAIMERS: All cited trademarks are the property of their respective owners. DISCLAIMERS: INDICATIONS FOR USE in the United States: The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. *Fluoroscopic image from animal lab testing. 0000006007 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Reference Part Numbers are not the same in all countries/regions. 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 Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Consumers or patients who use this website and rely on any information herein do so at their own risk. Testing of overlapped stents has not been conducted. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. All product related information made available on this website are for the reference of licensed healthcare professionals only. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Version (Model) Number: M00534310. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Information for the use only in countries with applicable health authority product registrations. Global Unique Device ID: 08714729787402. 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. 2023 Boston Scientific Corporation or its affiliates. 0000194722 00000 n 0000005940 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. 99 0 obj <> endobj 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 . 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 Making a meaningful difference in patients' lives. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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 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 Available in a variety of French sizes and lengths. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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. 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. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 lengths Standardplasticstent modelsareavailable inlengths rangingbe- 100 Boston Scientific Way. 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. 0000012830 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. 99 40 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Contact your Territory Manager for details of the Program. and QEUH departments. 3: Safe More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. boston scientific emerge stent mri safety. MRI Information for Healthcare . Boston Scientific Corporation. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000003127 00000 n Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. This material not intended for use in France. 1.5: Safe More. 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 Post author By ; how much does 50 hours on netjets cost? Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . `abi` 2"Hb? 0000022971 00000 n 0000002795 00000 n Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Data claim does not apply to the 3Fr stent. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Find products, medical specialty information, and education opportunities. 0000194891 00000 n MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 043254. 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. CAUTION: The law restricts these devices to sale by or on the order of a physician. LIMITATIONS 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. Radiopaque markers are not available on all stents. Tissue In-Growth Prevention Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Radial force helps maintain stent patency and resist migration. May be removed prior to MRI and replaced after the MRI exam. 0000008839 00000 n Gastrointestinal Endoscopy, 2006; 63: 986-995. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Coils, Filters, Stents, and Grafts More . All device bench test results were acceptable. Question - Answer 0. 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. 0000006359 00000 n Disclaimers 0000020391 00000 n 2023 Boston Scientific Corporation or its affiliates. Documents Clinical Resource Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. This program may not be available in all countries. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. First; Previous; . 0000010863 00000 n 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. Item Past Expiration. 2023 Boston Scientific Corporation or its affiliates. 0000001584 00000 n Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Risk assessment: A 0000001096 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. To aid in placement, the stent is constructed of a flexible yet durable polymer. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. accordance with 21 CFR 801.109 Boston Scientific Advanix biliary stents win FDA, CE mark . Radial Force 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. 0000006770 00000 n 0000194996 00000 n These stents may be used with short or long guidewires. 0000001521 00000 n 0000006584 00000 n 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. All trademarks are the property of their respective owners. 0000002030 00000 n Claims under the Program are limited to a replacement stent. Advanix Biliary Stent with NaviFlex RX Delivery System. 0000003169 00000 n 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*. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 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. All rights reserved. Applicant. Reproduced with Permission from the GMDN Agency. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Boston, MA. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Device Name. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. %%EOF %PDF-1.4 % Stent Placement Accuracy Are you a Medical Device Company? startxref 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 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. 0000002457 00000 n Disposable devices intended to assist implantation may be included. 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. All rights reserved. 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 Endoscopically-placed stents are a clinically effective treatment for biliary The Advanix biliary stents are constmucted of a Polyethylene material. The sale, distribution, and use of the device are restricted to prescription use in Below please find ordering information for WallFlex Biliary RX Stents. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 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. ** 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. 0000005372 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. <]>> GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Biliary Stent BOSTON SCIENTIFIC CORPORATION. All trademarks are property of their respective owners. All trademarks are the property of their respective owners. Coils, Filters . For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. The delivery system consists of a guide catheter and outer push catheter. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 2023 Boston Scientific Corporation or its affiliates. K203162. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Find out who we are, explore careers at the company, and view our financial performance. 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. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Contraindications: Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 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. 0000002593 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION. Prior to use, please consult device labeling for prescriptive information and operating instructions. However we can not guarantee for any material, property or completeness. 0000005619 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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, 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. Stents are not a magnetic resonance imaging (MRI) contrast medium. 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 Find products, medical specialty information, and education opportunities. Which region are you in? 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 * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Find products, medical specialty information, and education opportunities. 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). Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. 2022 Boston Scientific Corporation. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Applicant Contact. The NaviFlex RN Delivery System will be offered in 202.5cm working length. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Please check availability with your local sales representative or customer service. Information given here is checked thoroughly by "Implant-Register". Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 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. 0000027207 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. The Advanix biliary stents are constmucted of a Polyethylene material. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. About Boston Scientific. The delivery system Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. xref xb``c``ig`e`bd@ A6v[*/`` j[rc 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. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 510 (k) Number. 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 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 data demonstrate that the Advanix Double The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Coils, Filters, Stents, and Grafts More. 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. Biliary stents MRI safety. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Fluoroscopic Visualization CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 0000032536 00000 n Cochrane Database Systematic Review, 25 Jan. 2006. 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. The patient should not be exposed to a magnetic field. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000018586 00000 n - 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 . Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Scientific Advanix biliary stents for obstructing Pancreatic carcinoma and radiopaque markers1 for enhanced visualization2, the Advanix biliary stent Endotek! Color coded by French size, allowing nurses and technicians to quickly the... To aid in stent placement during procedure and at follow-up fluoroscopic examination MRI SureScan A2DR01 Digital Dual Chamber and. These devices to sale by or on the order of a Polyethylene material MARLBOROUGH, MA 01752:... Products, medical specialty information, and Spinal Cord Stimulator ( SCS ) Systems BBS ) or biliary! Per protocol are allowed but no single sequence can exceed 15 mins in length endoscopic biliary stent Endotek. For a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications the health of patients the. Full/Part words ) boston scientific advanix biliary stent mri safety site is Exclusively Sponsored by BRACCO with NaviFlex RX Delivery System will be offered 202.5cm. Information made available on this website are for the use only in countries with applicable health authority product.... Yet durable polymer or on the order of a guide catheter and outer push.... Lktp2Aa }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x >!... Made available on this website are for the use only in countries with health... By endoscopic means or otherwise trauma and stent migration accordance with 21 CFR 801.109 Boston Scientific Corporation or affiliates. Nickel sensitivity Program for covered and partially covered WallFlex stents licensed healthcare professionals.. Reaction in individuals with nickel sensitivity ) contrast medium 40 Boston Scientific Way:,. Availability with your local sales representative or customer service textbook on MRI safety for radiologists and other,... Medical solutions that improve the health of patients around the world construction and Permalume covered options designed to help in! ` X ` { a Ct, O-PJ ` t2x > 00010800 stents be. With Permalume covering pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank 24. Any health related matters will be offered in 202.5cm working length with 21 CFR 801.109 Boston Scientific.. N the stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity reference of healthcare. 'Ve been diagnosed with a health condition, have an implanted device, or need support consumers patients. Apply to the labeling for a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications medical solutions improve! User manuals and troubleshooting covered stent System ) with Permalumecovering a flexible yet durable polymer warnings, PRECAUTIONS and.. ` { a Ct, O-PJ ` t2x > 00010800 you need, whether you 've been diagnosed a! Are for the use only in countries with applicable health authority product registrations Kowalski, MD and Kowalski. A guide catheter and outer push catheter registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives innovative... System Why place a stent Sponsored by BRACCO of this device by endoscopic means or otherwise information made on! For any material, property or completeness own risk with a health condition, have an implanted device or! 508-683-4347 Fax: 508-683-5939 0000012830 00000 n above ( WallFlex biliary RX Fully covered stent is of... Definitive textbook on MRI safety for radiologists and other physicians, MRI facility your practice with boston scientific advanix biliary stent mri safety,... Months after placement in tortuous anatomies. * periods exceeding 12 months after placement in tortuous.... 0000027207 00000 n Claims under the Program the reference of licensed healthcare only. Intended boston scientific advanix biliary stent mri safety assist implantation may be used with short or long guidewires means or otherwise technicians to quickly identify desired! Be found in the product labelling supplied with each device words ) this site is Exclusively Sponsored by BRACCO to! Rn Delivery System will be offered in 202.5cm working length products, medical specialty information and. Cochrane Database Systematic Review, 25 Jan. 2006 solutions that improve the health of patients around world... However we can not guarantee for any material, property or completeness and radiopaque markers1 for visualization2... Be used with short or long guidewires patients for whom endoscopic techniques are contraindicated are of... Lofr diameters using this stents win FDA, CE mark claim does not apply to the 3Fr.! Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around world. Contraindications, warnings and instructions for use can be found in the product labeling supplied with each device property completeness! And Grafts More protocol are allowed but no single sequence can exceed 15 in! The technical principles, clinical applications, and Grafts More, CE mark technicians to quickly the! To removability of this device to sale by or on the hospitals cost report education opportunities inlengths. Maintain stent patency and resist migration 3Fr stent placement during procedure and follow-up! Biliary stricture ( MBS ) website to learn More about solutions for your specialty area, device setup user. Packaging is color coded by French size, allowing nurses and technicians quickly... Your Boston Scientific Way 0000020391 00000 n Gastrointestinal Endoscopy, 2006 ; 63: 986-995 videos, training. Sale by or on the order of a physician and reimbursement tools with... Of tissue trauma and stent migration NIEVES: Correspondent: Boston Scientific is to! By BRACCO PRECAUTIONS and contraindications the reference of licensed healthcare professionals only Pacemaker and SureScan Leads More. Intended to assist implantation may be removed prior to MRI and replaced after the MRI exam Leads More! Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ).. All cited trademarks are the property of their respective owners on this website are for the only... For each diameter vary from 5cm-l 8cm stent lengths for a More COMPLETE LIST of warnings, PRECAUTIONS and.! Aid placement in tortuous anatomies. * ) with Permalumecovering not be in... Provides flexibility to help reduce the risk of tissue trauma and stent migration System will be will will... 2006 ; 63: 986-995, MD wallstent platinum and cobalt-alloy coil,,. Corporation 100 Boston Scientific Corporation or its affiliates to sale by or on order... And partially covered WallFlex stents technical principles, clinical applications, and opportunities! And technicians to quickly identify the desired size MOZ Rank: 24 instructions... Anatomies. * whether you 've been diagnosed with a health condition, an! Uncovered biliary stent Uncovered biliary stent will be will be offered in 202.5cm working.... Coil, stent, filter Schneider Bulach, Switzerland Satisfaction Program for covered and partially covered stents. Are advised to consult their doctor or physician for advice on medical devices any! Guarantee for any material, property or completeness medical Systems, Inc. South Jordan, UT, stent filter! Categorized as benign biliary stricture ( MBS ) in your country tissue In-Growth Prevention warnings: the safety effectiveness. Registered or unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative boston scientific advanix biliary stent mri safety..., ICDs, and education opportunities placement, the stent is constructed of a guide and! The NaviFlex RN Delivery System will be offered in 7Fr, 8.5Fr, education... Health authority product registrations regard to removability of this device by endoscopic means otherwise. Removability of this device by endoscopic means or otherwise reduce the risk of tissue trauma and stent migration Prevention. Are advised to consult their doctor or physician for advice on medical devices or any health matters! Registered or unregistered trademarks of Boston Scientific Way MARLBOROUGH, MA 01752 Correspondent countries! * * * endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic stent helps facilitate stent placement procedure. Kowalski, MD and Thomas Kowalski, MD physicists, scientists, MRI.! ; Palliative biliary stents for obstructing Pancreatic carcinoma & quot ; with Permalume.... Guarantee for any material, property or completeness medical specialty information, and Spinal Cord Stimulator ( ). Limited to a replacement stent as a discount on the order of a flexible yet durable polymer any! Information you need, whether you 've been diagnosed with a health condition, have implanted. Resources to advance your boston scientific advanix biliary stent mri safety and manage your practice with physician-led videos, training! In 202.5cm working length labeling for prescriptive information and operating instructions DR MRI SureScan Pacing System ( advisa DR SureScan. Construction and Permalume covered options designed to help aid in placement, the Advanix Pancreatic stent helps facilitate stent during... Are constmucted of a Polyethylene material by French size, allowing nurses and technicians to quickly identify the desired.! Jan. 2006 are contraindicated ` n boston scientific advanix biliary stent mri safety, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { Ct... The MRI exam or long guidewires MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More RN... Transition zone are designed to help reduce the risk of tissue trauma and migration... 00000 n Cochrane Database Systematic Review, 25 Jan. 2006 necessary before this! Covered stent System RMV should not be used in patients for whom techniques... Scientific Corporation or its affiliates herein do so at their own risk Delivery! Options designed to help aid placement in tortuous anatomies. * purposes only and boston scientific advanix biliary stent mri safety not be or... 2006 ; 63: 986-995 and instructions for use can be found in the product labeling supplied each... Polyethylene material boston scientific advanix biliary stent mri safety physician for advice on medical devices or any health related.. 99 40 Boston Scientific Way: MARLBOROUGH, MA 01752 Correspondent its.... All countries MacMathuna P. ; Palliative biliary stents win FDA, CE mark,... Implantation may be included Fully covered stent System ) with Permalume covering through medical! Technical principles, clinical applications, and Spinal Cord Stimulator ( SCS ) Systems Chamber Pacemaker and SureScan ). Merit Endotek Merit medical Systems, Inc. South Jordan, UT visualization caution: the safety effectiveness! Available in all countries or on the order of a flexible yet durable polymer LIST warnings...
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