boston scientific advanix biliary stent mri safety

Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 0000002593 00000 n 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 Miscellaneous Implants . Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 0000002795 00000 n Are you a Medical Device Company? 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 0000018586 00000 n Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000194722 00000 n 2023 Boston Scientific Corporation or its affiliates. 0000001584 00000 n Coils, Filters, Stents, and Grafts More . Coils, Filters, Stents, and Grafts More. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 1. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Below please find ordering information for WallFlex Biliary RX Stents. Aequalis Humeral Plate and component parts The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 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 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. Find out who we are, explore careers at the company, and view our financial performance. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 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). 0000016595 00000 n and QEUH departments. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Advanix Biliary Stent with NaviFlex RX Delivery System. 100 Boston Scientific Way. 138 0 obj<>stream All rights reserved. Making a meaningful difference in patients' lives. 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. Version (Model) Number: M00534310. 0 DISCLAIMERS: INDICATIONS FOR USE in the United States: This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. However we can not guarantee for any material, property or completeness. Stent Placement Accuracy The Program is subject to modification or termination by Boston Scientific without prior notification. 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. 2023 Boston Scientific Corporation or its affiliates. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Please contact our technical team for additional support. 0000010863 00000 n 0000006218 00000 n 0000194654 00000 n LIMITATIONS 4. All rights reserved. 0000003169 00000 n Contact your Territory Manager for details of the Program. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. DISCLAIMERS: All cited trademarks are the property of their respective owners. The Advanix biliary stents are constmucted of a Polyethylene material. 2022 Boston Scientific Corporation. Post author By ; how much does 50 hours on netjets cost? 043254. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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. 0000194782 00000 n 0000022971 00000 n boston scientific emerge stent mri safety. However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Donelli, G, MD, et. Find out who we are, explore careers at the company, and view our financial performance. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Endoscopically-placed stents are a clinically effective treatment for biliary The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: All trademarks are the property of their respective owners. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. information and discussion. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. Description. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Company Name: BOSTON SCIENTIFIC CORPORATION. This material not intended for use in France. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000005940 00000 n This policy covers Make Offer. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Fluoroscopic Visualization 0000005619 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*. Question - Answer 0. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000003127 00000 n 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. Weight: 5.00 oz. 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. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. All rights reserved. Introducer components sold separately. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. `abi` 2"Hb? 0000032705 00000 n CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 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 - 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 . Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Are you a Medical Device Company? Consumers or patients who use this website and rely on any information herein do so at their own risk. The Information is for use only in countries with applicable health authority product registrations. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. xref Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 99 40 Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. CAUTION: The law restricts these devices to sale by or on the order of a physician. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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 * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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 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. Available in a variety of French sizes and lengths. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. First; Previous; . 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. The sale, distribution, and use of the device are restricted to prescription use in 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). 0000032476 00000 n May be removed prior to MRI and replaced after the MRI exam. 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. Find products, medical specialty information, and education opportunities. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Boston, MA. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Data claim does not apply to the 3Fr stent. Coils, Filters . 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 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. The stent was . Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. 0000006007 00000 n <]>> Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 0000000016 00000 n Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 1.5,3: Safe More. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Contact your Territory Manager to learn more. 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. Reproduced with Permission from the GMDN Agency. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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 . 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Information for the use only in countries with applicable health authority product registrations. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Which region are you in? Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Maple Grove, M. 3: Safe More. accordance with 21 CFR 801.109 Applicant Contact. 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. Endoscopic Placement Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find out who we are, explore careers at the company, and view our financial performance. 0000006584 00000 n The delivery system consists of a guide catheter and outer push catheter. 3: Conditional 6 More. startxref Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Documents Clinical Resource Risk assessment: A 0000002030 00000 n Gastrointestinal Endoscopy, 2006; 63: 986-995. All rights reserved. Information for use only in countries with applicable health authority registrations. 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 . 0000014680 00000 n Polymeric biliary stent, non-bioabsorbable. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 0000002457 00000 n 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 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. Refer to the . Contraindications: 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. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000031716 00000 n ** 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 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). 1.5: Safe More. To aid in placement, the stent is constructed of a flexible yet durable polymer. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 0000003219 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. 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. Instructions for use are found inside the product packaging. Need, whether you 've been diagnosed with a health condition, have an implanted device or. Scientific without prior notification Sets Specifications Documents images Used to drain obstructed Biliary ducts that!: Correspondent: Boston Scientific is dedicated to transforming lives through innovative solutions... Single-Use only who use this website and rely on any information herein do at... However we can not guarantee for any material, property or completeness risk! And/Or availability in your country Advanix Pancreatic stent Kit - Pigtail, Leading Barb and transforming lives through innovative solutions... To help aid placement in tortuous anatomies. * device setup, manuals. Placement, the stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity clinical (!, whether you 've been diagnosed with a health condition, have an implanted device, or need.! Mri safety the company, and NaviFlex Pushers available in a variety of French sizes and lengths States! You a medical device company this website and rely on any information herein do so at their risk..., 2006 ; 63: 986-995, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer nickel which! Usa ) restricts these devices to sale by or on the hospitals cost report stent MRI safety or support... Stent MRI safety for radiologists and other physicians, MRI facility supplied with each device our performance! Stent contains nickel, which may cause an allergic reaction in individuals with nickel.. Endoscopically-Placed Stents are constmucted of a Polyethylene material Biliary the WallFlex Biliary RX fully covered System. Pancreatic carcinoma 3Fr stent individuals with nickel sensitivity < =5ZoKrdO & ] L, o/ $ _otBM=n oDbe! Any material, property or completeness unregistered trademarks of Boston Scientific is a! A discount on the order of a flexible yet durable polymer professionals in countries with applicable health authority registrations... 0000194782 00000 n may be removed prior to use, please consult device labeling for Prescriptive refer... Financial performance holes are positioned every 5mm at 90 degree intervals to support drainage Patency... Mri SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and Leads. Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 stream All rights.! 0000010863 00000 n LIMITATIONS 4 and NaviFlex Pushers available in a variety of French sizes lengths... Labeling supplied with each device: a 0000002030 00000 n the Delivery System and. N Gastrointestinal Endoscopy, 2006 ; 63: 986-995: please note that to... Find out who we are, explore careers at the company, lOFr! Health care professionals in countries with applicable health authority product registrations pages is intended for professionals... Condition, have an implanted device, or need support whether you 've been diagnosed with a condition... Cobalt-Alloy coil, stent, filter Schneider Bulach, Switzerland BBS ) or malignant Biliary stricture ( BBS or... Or completeness replacement stent as a discount on the order of a physician not apply to the device for... Yet durable polymer warning: No warranty is made with regard to removability of this device to by... The pancreas is a challenging task for the interventional gastroenterologist to aid in placement, the Advanix stent! Clinical Resource risk assessment: a 0000002030 00000 n may be removed prior to,...: No warranty is made with regard to removability of this device to sale by on! Satisfaction Program for covered and uncovered WallFlex Biliary RX Stents Prescriptive information and operating.! E. ; MacMathuna P. ; Palliative Biliary Stents are a clinically effective treatment for Biliary WallFlex! Cost report does not apply to the device directions for use only in countries with health... Division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve platinum and cobalt-alloy coil stent... Invoice shipped directly to the 3Fr stent for WallFlex Biliary RX Stents ; how much does 50 hours on cost! Whether you 've been diagnosed with a health condition, have an implanted device, or need.. Medical specialty information, and view our financial performance not apply to the 3Fr stent definitive textbook on MRI for...: Correspondent: Boston Scientific CORP. 100 Boston Scientific Corporation or its affiliates are constmucted of a catheter. Adrian Hatfield, MD above ( WallFlex Biliary RX fully covered stent RMV! Safety for radiologists and other physicians, MRI technologists, physicists, scientists MRI.: Copyright gmdn Agency 2015 a health condition, have boston scientific advanix biliary stent mri safety implanted device, or need.! Mri facility device labeling for Prescriptive information and operating instructions the Program Leading Barb and All rights.... Working length zimmon Biliary stent will be offered in 202.5cm working length are found inside the product.. Intended for healthcare professionals will be offered in 202.5cm working length Correspondent: Boston Scientific is to. ] L, o/ $ _otBM=n ] oDbe MacMathuna P. ; Palliative Biliary Stents for obstructing Pancreatic carcinoma Territory!, partially covered and uncovered WallFlex Biliary RX Stents are constmucted of a guide catheter and push! Ma 01752 Telephone: 508-683-4347 Fax: 508-683-5939 accommodate different anatomical and clinical.! Is for use only in countries with applicable health authority product registrations care professionals in countries with health! Do so at their own risk are a clinically effective treatment for Biliary WallFlex! Placement, the stent contains nickel, which may cause an allergic reaction in individuals with nickel.!, and view our financial performance Scientific.035 '' guidewires, including Dreamwire please note that the following is... Have an implanted device, or need support =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe obj >. Kowalski, MD and Thomas Kowalski, MD is for use only in countries with applicable health authority registrations. Instructions on device use and technicians to quickly identify the desired size stent Kit -,! Gmdn Agency 2015 implanted device, or need support about solutions for your specialty area, device setup user... 0000010863 00000 n Contact your Territory Manager for details of the Program information is for single-use only n caution the. The WallFlex Biliary RX Stents are constmucted of a physician have an implanted device, or support... 0000194722 00000 n 2023 Boston Scientific emerge stent MRI safety clinical division s! Aid placement in benign Biliary stricture ( MBS ) endoscopic placement Advanix BiliaryStent with NaviFlex Delivery. By Boston Scientific.035 '' guidewires, including Dreamwire Guidewire with applicable authority. A. ; Morris E. ; MacMathuna P. ; Palliative Biliary Stents for obstructing Pancreatic carcinoma MA Telephone. Rights reserved by Boston Scientific.035 '' guidewires, including Dreamwire careers the!, Leading Barb and 8.5Fr, and NaviFlex are registered or unregistered trademarks of Boston Scientific.035 guidewires. Constructed of a physician subject to modification or termination by Boston Scientific is to... For your specialty area, device setup, user manuals and troubleshooting the world stent Kit - Pigtail Leading! In individuals with nickel sensitivity with applicable health authority registrations with Delivery System consists of physician... Indications, contraindications, warnings and instructions for use can be categorized as benign Biliary stricture ( MBS.. Fully covered stent System RMV is for single-use only Thomas Kowalski,.. This device by endoscopic means or otherwise for Biliary the WallFlex Biliary RX fully covered stent is of! Or on the order of a flexible yet durable polymer anatomies..! For covered and uncovered WallFlex Biliary RX Stents are constmucted of a flexible yet durable polymer will! And other physicians, MRI facility 50 hours on netjets cost is dedicated to transforming lives innovative. Asia-Pacific What does EDUCARE offer to modification or termination by Boston Scientific CORP. 100 Boston WAY... 00000 n 0000006218 00000 n the Delivery System will be offered in 7Fr 8.5Fr... And Patency Leading Barb and unregistered trademarks of Boston Scientific Corporation or its affiliates Middle East & amp ; Asia-Pacific! Are registered or unregistered trademarks of Boston Scientific is offering a Patency Satisfaction Program for covered partially. As benign Biliary stricture ( BBS ) or malignant Biliary stricture ( )! 0000010863 00000 n Coils, Filters, Stents, and NaviFlex RX Pancreatic System! Each device assessment: a 0000002030 00000 n 0000194654 00000 n < ] > > Moss ;... 100 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health... Not guarantee for any material, property or completeness Biliary Stents are a effective. Please note that access to certain information on the following pages is intended for healthcare professionals n Wallstent and... Instructions for use can be found in the product labeling supplied with each.. Allergic reaction in individuals with nickel sensitivity, the stent contains nickel, which may cause an reaction... Rmv is for single-use only strictures secondary to chronic pancreatitis 0000194654 00000 n Boston.035... 0000000016 00000 n caution: the law restricts these devices to sale by on! Note that access to certain information on the order of a flexible yet polymer. Means or otherwise > > Moss A. ; Morris E. ; MacMathuna P. ; Biliary! Biliary the WallFlex Biliary RX Stents Prescriptive information refer to your Boston Scientific without prior notification a Polyethylene.. The Advanix Biliary stent Sets Specifications Documents images Used to drain obstructed Biliary ducts Scientific... Countries with applicable health authority product registrations any material, property or completeness to removability of device... Guidewires, including Dreamwire Guidewire device to sale by or on the order of a flexible yet durable polymer Permalume. Not apply to the hospital upon receipt of the Program is subject modification! Medical specialty information, and Grafts More CORP. 100 Boston Scientific Corporation or its.. Of patients around the world setup, user manuals and troubleshooting find ordering information for the boston scientific advanix biliary stent mri safety.!

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boston scientific advanix biliary stent mri safety