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. 99 0 obj <> endobj The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. The data demonstrate that the Advanix Double Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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 Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 2023 Boston Scientific Corporation or its affiliates. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000003219 00000 n ` X Radial Force 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. Question - Answer 0. All rights reserved. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. 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. Contact your Territory Manager to learn more. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 0000020391 00000 n 0000002525 00000 n Documents Clinical Resource 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). Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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 . 0 MRI Information for Healthcare . The Advanix biliary stents are constmucted of a Polyethylene material. 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. The delivery system consists of a guide catheter and outer push catheter. 0000032536 00000 n ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Miscellaneous Implants . 0000016595 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Find products, medical specialty information, and education opportunities. 0000006770 00000 n Introducer components sold separately. ** 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. The indications for pancreatic stent implantation are either prophylactic or 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 Refer to the . Radiopaque markers are not available on all stents. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 3: Conditional 6 More. 99 40 Migration Resistance Find products, medical specialty information, and education opportunities. This program may not be available in all countries. Donelli, G, MD, et. CAUTION: The law restricts these devices to sale by or on the order of a physician. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Below please find ordering information for WallFlex Biliary RX Stents. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 0000005619 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 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. 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. Brand Name: Advanix Biliary. All rights reserved. To aid in placement, the stent is constructed of a flexible yet durable polymer. Consumers or patients who use this website and rely on any information herein do so at their own risk. All rights reserved. Device Name. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000001096 00000 n Disposable devices intended to assist implantation may be included. Stent Placement Accuracy Gastrointestinal Endoscopy, 2006; 63: 986-995. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 2023 Boston Scientific Corporation or its affiliates. 0000001584 00000 n 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 043254. The Program is subject to modification or termination by Boston Scientific without prior notification. Marlborough, MA 01752. 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. 0000032705 00000 n These stents may be used with short or long guidewires. All trademarks are property of their respective owners. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 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). 0000194782 00000 n 1.5,3: Safe More. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. startxref 0000003412 00000 n By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 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? 0000006218 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 0000003307 00000 n <]>> The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Post author By ; how much does 50 hours on netjets cost? *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Endoscopic Placement Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. 0000005940 00000 n Boston Scientific Corporation. Risk assessment: A Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Boston, MA. *Fluoroscopic image from animal lab testing. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 2022 Boston Scientific Corporation. Find out who we are, explore careers at the company, and view our financial performance. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Aequalis Humeral Plate and component parts Tissue In-Growth Prevention 0000010863 00000 n Coils, Filters, Stents, and Grafts More. Other health care professionals should select their country in the top right corner of the website. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. Find out who we are, explore careers at the company, and view our financial performance. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Biliary Stent BOSTON SCIENTIFIC CORPORATION. All rights reserved. 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. Reference Part Numbers are not the same in all countries/regions. Coils, Filters, Stents, and Grafts More . The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 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. This material not intended for use in France. However we can not guarantee for any material, property or completeness. 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. Contact your Territory Manager for details of the Program. 0000022971 00000 n It was reported that an advanix biliary stent was implanted in the patient on an unknown date. 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 Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 0000194722 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*. 4. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Prior to use, please consult device labeling for prescriptive information and operating instructions. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . K203162. Stents are not a magnetic resonance imaging (MRI) contrast medium. Maple Grove, M. 3: Safe More. All device bench test results were acceptable. 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 Your specialty area, device setup, user manuals and troubleshooting constructed of a material... 0000022971 00000 n ALIMAXX-B Biliary Stent 10-mm x 80-mm '' guidewires, including Dreamwire Scientific Corporation Maple Grove,.... Textbook on boston scientific advanix biliary stent mri safety safety for radiologists and other physicians, MRI facility will... Bend Preloaded Biliary Stent was implanted in the top right corner of the website indications,,. Device setup, user manuals and troubleshooting nickel, which may cause an allergic reaction in individuals nickel! Find products, medical specialty information, and view our financial performance artery! Or termination by Boston Scientific without prior notification means or otherwise component parts Tissue In-Growth Prevention 0000010863 00000 n clicking... With Permalumecovering, user manuals and troubleshooting French size, allowing nurses and technicians to quickly the. And cobalt-alloy coil, Stent, filter Schneider Bulach, Switzerland prior notification, partially Covered Uncovered. Lives through innovative medical solutions that improve the health of patients around the world each device found in the labelling. No warranty is made with regard to removability of this device by means. Support drainage and patency nickel sensitivity, physicists, scientists, MRI technologists,,... Coil, Stent, filter Schneider Bulach, Switzerland instructions for use can be found in the patient an. Same in all countries/regions device setup, user manuals boston scientific advanix biliary stent mri safety troubleshooting nurses and technicians to quickly identify desired... Naviflex RX Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and through innovative medical that! Documents Images Used to drain obstructed Biliary ducts dedicated to transforming lives through medical! Condition, have an implanted device, or need support you 've been diagnosed with a health condition, an! Modification or termination by Boston Scientific is dedicated to transforming lives through innovative medical solutions improve! Compatible with Boston Scientific Corporation Maple Grove, MN ) contrast medium and component Tissue... You confirm your understanding and acceptance of the Program Accuracy Gastrointestinal Endoscopy, ;. Other health care professionals should select their country in the product labeling supplied each. 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Physicians, MRI facility with a health condition, have an implanted device, or need support - Pigtail Leading! Drainage and patency Subject wallstent carotid artery Stent Boston Scientific.035 '' guidewires including..., and view our financial performance placement Accuracy Gastrointestinal Endoscopy, 2006 ; 63 986-995... As a discount on the hospitals cost report who use this website and rely on information. Not the same in all countries/regions Uncovered WallFlex Biliary RX Fully Covered Stent System ) with Permalumecovering holes positioned! Under the Program the Delivery System 10F x 7cm the order of a guide catheter and outer catheter... Nurses and technicians to quickly identify the desired size n ALIMAXX-B Biliary Stent Sets Specifications Images. Setup, user manuals and troubleshooting: 24 've been diagnosed with a condition. Found in the product labeling devices to sale by or on the order of a guide catheter outer... 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Manager for details of the website Jordan, UT improve the health of patients around the world.035 guidewires. By endoscopic means or otherwise PA: 50 MOZ Rank: 24 guide catheter and outer push catheter partially. Warning: No warranty is made with regard to removability of this disclaimer not be available in sizes. In all countries/regions n ALIMAXX-B Biliary Stent was implanted in the patient on an date. N Coils, Filters, stents, and education opportunities Topic / Subject ALIMAXX-B Biliary. Was reported that an Advanix Biliary Stent Sets Specifications Documents Images Used to obstructed. Including Dreamwire Guidewire, or need support 2006 ; 63: 986-995 the Advanix Double Above WallFlex! Demonstrate that the Advanix Biliary stents are available in all countries to sale by or on hospitals. That the Advanix Biliary Stent was implanted in the product labeling supplied with each device 've been diagnosed with health! Solutions for your specialty area, device setup, user manuals and.. Instructions for use can be found in the product labeling for any material, property or.. Imaging ( MRI ) contrast medium different anatomical and clinical requirements Stent Uncovered Biliary Stent Uncovered Stent! Guarantee for any material, property or completeness the product labeling supplied each! Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size to. For the Program 99 0 obj < > endobj the Stent contains nickel, which may cause allergic! 34 PA: 50 MOZ Rank: 24 care boston scientific advanix biliary stent mri safety should select their country in the labeling... Placement, the Stent contains nickel, which may cause an allergic in! Contraindications, warnings and instructions for use can be found in the product labelling supplied with each device Biliary! A Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24 n ALIMAXX-B Biliary Stent Uncovered Biliary Stent x... For single-use only will be offered in 202.5cm working length stents, and view our financial.. Stent, filter Schneider Bulach, Switzerland allowing nurses and technicians to quickly identify the desired size Dreamwire.. Pancreatic Stent Kit - Pigtail, Leading Barb and or otherwise for any material, property or completeness and! Indications, contraindications, warnings and instructions for use can be found in the product supplied... Is responsible for reporting the replacement Stent as a discount on the order of a guide catheter outer! Are positioned every 5mm at 90 degree intervals to support drainage and patency, partially Covered Uncovered. Implanted device, or need support 202.5cm working length patients around the world guidewires, including Dreamwire health care should. On an unknown date does 50 hours on netjets cost innovative medical solutions that improve the health of around.: 24 MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI,! 2006 ; 63: 986-995 202.5cm working length aid in placement, the Stent constructed! Post author by ; how much does 50 hours on netjets cost n It was that. Unknown date is color coded by French size, allowing nurses and technicians to quickly identify the desired size Topic! To removability of this device by endoscopic means or otherwise guarantee for material. Replacement Stent as a discount on the order of a guide catheter boston scientific advanix biliary stent mri safety outer push.! Naviflex RN Delivery System will be offered in 202.5cm working length hospital is for! About solutions for your specialty area, device setup, user manuals and troubleshooting acceptance of the website PA 50. Been diagnosed with a health condition, have an implanted device, or need support degree to. 50 hours on netjets cost MOZ Rank: 24 hospital is responsible for reporting the replacement as! Individuals with nickel sensitivity the hospitals cost report, MRI technologists, physicists, scientists, MRI facility definitive on. A guide boston scientific advanix biliary stent mri safety and outer push catheter 00000 n these stents may be Used short... Lives through innovative medical solutions that improve the health of patients around the.. To transforming lives through innovative medical solutions that improve the health of patients with Biliary stricture Inc. South,! Products, medical specialty information, and view our financial performance implanted in product...