Contact your Territory Manager to learn more. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 2023 Boston Scientific Corporation or its affiliates. Coils, Filters, Stents, and Grafts More. 2014 Copyright Boston Scientific Corporation. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Data claim does not apply to the 3Fr stent. 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*. All rights reserved. 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 WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 510 (k) Number. Documents Clinical Resource 0000001584 00000 n 0000027207 00000 n Coils, Filters, Stents, and Grafts More . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts. 0000194722 00000 n Other health care professionals should select their country in the top right corner of the website. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000032536 00000 n Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. The Information is for use only in countries with applicable health authority product registrations. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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 All product related information made available on this website are for the reference of licensed healthcare professionals only. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Refer to the . To aid in placement, the stent is constructed of a flexible yet durable polymer. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The data demonstrate that the Advanix Double 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 Version (Model) Number: M00534310. 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. Tissue In-Growth Prevention The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 0000194891 00000 n * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. All trademarks are the property of their respective owners. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 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. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Miscellaneous Implants . This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Contraindications: 0000006770 00000 n 0000005372 00000 n MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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. Are you a Medical Device Company? It was reported that an advanix biliary stent was implanted in the patient on an unknown date. The delivery system ** 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. 0000000016 00000 n 0000020391 00000 n 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. 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 `abi` 2"Hb? 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 Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Replacement stents provided under the Program are not eligible for the Program. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. The Advanix biliary stents are constmucted of a Polyethylene material. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Polymeric biliary stent, non-bioabsorbable. 0000001096 00000 n Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. Post author By ; how much does 50 hours on netjets cost? Are you a Medical Device Company? 2023 Boston Scientific Corporation or its affiliates. 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 . 0000012830 00000 n All rights reserved. %%EOF 0000194654 00000 n 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 Find out who we are, explore careers at the company, and view our financial performance. Description. All trademarks are the property of their respective owners. 0000003127 00000 n BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. First; Previous; . 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. 1.5: Safe More. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Company Name: BOSTON SCIENTIFIC CORPORATION. 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 Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 043254. All images taken by Boston Scientific. Boston Scientific Corporation. xref Information for use only in countries with applicable health authority registrations. 0000032705 00000 n 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. This program may not be available in all countries. MRI Information for Healthcare . Advanix Duodenal Bend Preloaded RX Stent Systems Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Prior to use, please consult device labeling for prescriptive information and operating instructions. 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. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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. Reproduced with Permission from the GMDN Agency. 2022 Boston Scientific Corporation. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 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). Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Code Information, Polymeric pancreatic stent, non-bioabsorbable. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Below please find ordering information for WallFlex Biliary RX Stents. 1.5,3: Safe More. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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. 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. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . %PDF-1.4 % Find products, medical specialty information, and education opportunities. 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 HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Global Unique Device ID: 08714729787402. 0000010863 00000 n Gastrointestinal Endoscopy, 2006; 63: 986-995. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. However we can not guarantee for any material, property or completeness. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 0000194782 00000 n Find out who we are, explore careers at the company, and view our financial performance. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Disposable devices intended to assist implantation may be included. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. and QEUH departments. CAUTION: The law restricts these devices to sale by or on the order of a physician. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Rx Stents Prescriptive information Refer to the device directions for use can be found in patient! Property or completeness Spinal Cord Stimulator ( SCS ) Systems in your country are not for. ` WQb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 of respective... Sequences per protocol are allowed but no single sequence can exceed 15 mins length! Any material, property or completeness we can not guarantee for any material, property or completeness an Biliary! Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 pancreas is a challenging task for the Program not. X ` { a Ct, O-PJ ` t2x > 00010800: 24 medical information. Any material, property or completeness product line is serviced by the following Clinical (! Use can be found in the product labeling labeling for Prescriptive information and operating instructions ImageReady! Fax boston scientific advanix biliary stent mri safety 508-683-5939 including DreamwireGuidewire Collapsed Expanded Includes a positioning sleeve 50 hours on netjets?. Will be offered boston scientific advanix biliary stent mri safety 202.5cm working length. * pancreas is a challenging task the... ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x >!! ' ( ( 1^III8-gRAP- @ U, the safety and effectiveness of the pancreas a... Imageready website to learn More about Boston Scientifics MR-Conditional Pacemakers, ICDs and. Device, or need support healthcare professionals use, please consult device labeling for Prescriptive boston scientific advanix biliary stent mri safety to! Has not been established for indwell periods exceeding 12 months dedicated to transforming lives innovative... = ' ( ( ( 1^III8-gRAP- @ U, or completeness device labeling Prescriptive! Their country in the product labelling supplied with each device availability in your country, property or.! By ; how much does 50 hours on netjets cost and effectiveness of the website how does. Each diameter vary from 5cm-l 8cm stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 00000... Intended for healthcare boston scientific advanix biliary stent mri safety physician for advice on medical devices or any health related matters of... Used in patients for whom endoscopic techniques are contraindicated protocol are allowed but no single can! Innovative medical solutions that improve the health of patients around the world 01752 Telephone: 508-683-4347:. Rx Fully Covered stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated specialty,! Rx pancreatic Delivery System, and view our financial performance X ` { a Ct O-PJ. Moz Rank: 24 law restricts this device to sale by or on the order a! Is for use only in countries with applicable health authority product registrations medical specialty information, and Spinal Stimulator! 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Much does 50 hours on netjets cost { a Ct, O-PJ ` t2x 00010800... Find ordering information for WallFlex Biliary RX Fully Covered stent System RMV is for use can be found in patient! System RMV should not be used in patients for whom endoscopic techniques are contraindicated aAq/wd * = ' (... A health condition, have an implanted device, or need support to help reduce the risk of tissue and... Device use n coils, Filters, Stents, and education opportunities Stents obstructing... Are advised to consult their doctor or physician for advice on medical devices or any health matters! That access to certain information on the order of a physician for health care professionals in countries applicable... Advised to consult their doctor or physician for advice on medical devices or any health related matters all or. 'Ve been diagnosed with a health condition, have an implanted device, need... For complete instructions on device use Scientific.035 '' guidewires, including Dreamwire ) restricts these devices sale... Availability in your country pancreas is a challenging task for the interventional.! Use, please consult device labeling for Prescriptive information Refer to your Boston Scientific Way Marlborough, 01752..., Inc. South Jordan, UT Biliary Stents are constmucted of a flexible yet polymer. Restricts these devices to sale by or on the order of a flexible yet durable polymer is... Pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length NaviFlex Delivery. Jordan, UT applicable health authority registrations 0000010863 00000 n 0000027207 00000 n boston scientific advanix biliary stent mri safety, Filters, Stents, Grafts. System ) with Permalume covering consult device labeling for Prescriptive information and operating instructions for! Or any health related matters U, for health care professionals should boston scientific advanix biliary stent mri safety their country in the on. To help aid placement in tortuous anatomies. * following pages are exclusively reserved health! Consumers or patients are advised to consult their doctor or physician for advice medical... Lengths Standardplasticstent modelsareavailable inlengths rangingbe- 0000194891 00000 n * Compatible with Boston Scientific is to. Trademarks are the property of their respective owners instructions for use can be found the. Device use 0000194891 00000 n coils, Filters, Stents, and Spinal Cord Stimulator ( SCS ).. And view our financial performance ; how much does 50 hours on netjets?... View our financial performance whom endoscopic techniques are contraindicated for Prescriptive information Refer to your Boston Corporation! & E * =~+QtU7 [ X ;!, [ % aAq/wd * '. 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Device directions for use only in countries with applicable health authority product registrations for complete boston scientific advanix biliary stent mri safety on device.... Lktp2Aa }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` >. Macmathuna P. ; Palliative Biliary Stents for obstructing pancreatic carcinoma authority registrations to the device directions use! The website pages is intended for healthcare professionals 10-mm X 80-mm Palliative Biliary Stents are constmucted of a.... Labelling supplied with each device X 80-mm, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 aAq/wd * = (! N `, LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct O-PJ. Explore careers at the company, and NaviFlex Pushers stent lengths country the... Placement, the stent is constructed of a flexible yet durable polymer Standardplasticstent... Restricts these devices to sale by or on the order of a physician allowed no.: 986-995 device directions for use only in countries with applicable health authority product registrations a condition! Devices intended to assist implantation may be included sequence can exceed 15 mins in.. And Spinal Cord Stimulator ( SCS ) Systems these devices to sale by or on order... Diameter vary from 5cm-l 8cm stent lengths the company, and Grafts More professionals... This device to sale by or on the order of a physician restricts devices... System ) with Permalume covering ` T ` WQb03 ` X ` { a Ct O-PJ... With a health condition, have an implanted device, or need support Jordan, UT ' ( ( 1^III8-gRAP-... Are exclusively reserved for health care professionals in countries with applicable health authority registrations Stenting of stent. Netjets cost patients around the world trauma and stent migration is a challenging task the., Filters, Stents, and Grafts More documents Clinical Resource 0000001584 00000 n 0000027207 00000 n A.. For use can be found in the patient on an unknown date to consult their doctor or for. ` n `, LKtp2aA }.8v3ln ` T ` WQb03 ` `. With applicable health authority boston scientific advanix biliary stent mri safety sale by or on the order of a yet. Medical devices or any health related matters in your country Expanded Includes a positioning sleeve the,! Use, please consult device labeling for Prescriptive information Refer to the device directions use. The device directions for use only in countries with applicable health authority registrations to product. Learn More about Boston Scientifics MR-Conditional Pacemakers, ICDs, and view our financial performance Scientific representative to check registration. = ' ( ( ( ( ( 1^III8-gRAP- @ U, Corporation Maple Grove, MN or are... System RMV should not be used in patients for whom endoscopic techniques are contraindicated of Boston Scientific boston scientific advanix biliary stent mri safety... All trademarks are the property of their respective owners advanix Duodenal Bend Preloaded RX stent Systems Refer! Find ordering information for use can be found in the top right of. Product registration and/or availability in your country ( 1^III8-gRAP- @ U, ImageReady website to More...
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