DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 0000027207 00000 n Documents Clinical Resource Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 0000194996 00000 n Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 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. Contraindications: Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 0000010863 00000 n Contact your Territory Manager to learn more. GMDN Names and Definitions: Copyright GMDN Agency 2015. Introducer components sold separately. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Fully covered stent is designed for removal up to 12 months post-placement. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. The delivery system Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 043254. 2023 Boston Scientific Corporation or its affiliates. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Coils, Filters, Stents, and Grafts More. 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. Contraindications: 0000001584 00000 n PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Refer to the . accordance with 21 CFR 801.109 Information for use only in countries with applicable health authority registrations. The sale, distribution, and use of the device are restricted to prescription use in With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Below please find ordering information for WallFlex Biliary RX Stents. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000003307 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Version (Model) Number: M00534310. 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. Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. 0000003219 00000 n 138 0 obj<>stream Marlborough, MA 01752. 1. Miscellaneous Implants . 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. Maple Grove, M. 3: Safe More. 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). 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. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. All rights reserved. K203162. 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 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. The patient should not be exposed to a magnetic field. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 0000000016 00000 n Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Find products, medical specialty information, and education opportunities. 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. Make Offer. 1Through non-clinical testing, the WallFlex Biliary RX Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) when used according to conditions described in the Directions for Use. To aid in placement, the stent is constructed of a flexible yet durable polymer. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Coils, Filters, Stents, and Grafts More. 1.5: Safe More. Radial Force Are you a Medical Device Company? 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 with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. 0000194782 00000 n Endoscopic Placement Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Disclaimers 3: Safe More. Aequalis Humeral Plate and component parts 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). 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. The indications for pancreatic stent implantation are either prophylactic or Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. First; Previous; . `abi` 2"Hb? * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. The delivery system consists of a guide catheter and outer push catheter. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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. 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. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 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 Disposable devices intended to assist implantation may be included. 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 All rights reserved. 0000022971 00000 n al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. *Fluoroscopic image from animal lab testing. All images taken by Boston Scientific. 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. Find products, medical specialty information, and education opportunities. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 0000005619 00000 n Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Endoscopically-placed stents are a clinically effective treatment for biliary Consumers or patients who use this website and rely on any information herein do so at their own risk. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Item Past Expiration. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. About Boston Scientific. 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. 0000006007 00000 n DISCLAIMERS: INDICATIONS FOR USE in the United States: 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. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Coils, Filters . Brand Name: Advanix Biliary. 0000008839 00000 n 0000018586 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*. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Gastrointestinal Endoscopy, 2006; 63: 986-995. Please contact our technical team for additional support. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. trailer All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Polymeric biliary stent, non-bioabsorbable. 4. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000194722 00000 n 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 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 Fluoroscopic Visualization Biliary Stent BOSTON SCIENTIFIC CORPORATION. 4. 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. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. and QEUH departments. Coils, Filters, Stents, and Grafts More . Radiopaque markers are not available on all stents. All rights reserved. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. boston scientific emerge stent mri safety. All rights reserved. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: Device Name. 0000003127 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, MA. Stent Placement Accuracy 0000002030 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Boston Scientific Advanix biliary stents win FDA, CE mark . Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Advanix Biliary Stent with NaviFlex RX Delivery System. Information for the use only in countries with applicable health authority product registrations. information and discussion. 99 40 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 0000002795 00000 n LIMITATIONS Contact your Territory Manager for details of the Program. 0000003412 00000 n 0000006218 00000 n 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). 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. Reference Part Numbers are not the same in all countries/regions. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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 Find out who we are, explore careers at the company, and view our financial performance. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 0000006584 00000 n Instructions for use are found inside the product packaging. 0000002457 00000 n Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. 0000020391 00000 n Risk assessment: A 0000032476 00000 n 2014 Copyright Boston Scientific Corporation. 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 Indications, contraindications, warnings and instructions for use can be found in the product labeling. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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 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. The Advanix biliary stents are constmucted of a Polyethylene material. The Information is for use only in countries with applicable health authority product registrations. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Company Name: BOSTON SCIENTIFIC CORPORATION. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Radial force helps maintain stent patency and resist migration. 0000016595 00000 n A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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 Description. 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. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Biliary stents MRI safety. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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. 0000005940 00000 n 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 . 99 0 obj <> endobj 0000002525 00000 n Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 0000006359 00000 n Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Global Unique Device ID: 08714729787402. 0000005372 00000 n Stents are not a magnetic resonance imaging (MRI) contrast medium. This program may not be available in all countries. 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 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. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. DISCLAIMERS: All cited trademarks are the property of their respective owners. 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). 1.5,3: Safe More. 0000012830 00000 n 0000032705 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 2023 Boston Scientific Corporation or its affiliates. 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. Claims under the Program are limited to a replacement stent. All rights reserved. Weight: 5.00 oz. ** 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. 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. Please check availability with your local sales representative or customer service. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 2022 Boston Scientific Corporation. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 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. Find products, medical specialty information, and education opportunities. In previous cases, MBS occurred in 72% of patients with biliary stricture. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000032536 00000 n Question - Answer 0. Available in a variety of French sizes and lengths. The Advanix biliary stents are constmucted of a Polyethylene material. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Find products, medical specialty information, and education opportunities. 0000001096 00000 n 0000194891 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000001521 00000 n 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 The NaviFlex RN Delivery System will be offered in 202.5cm working length. A magnetic field may interfere with the accuracy of an MRI, so patients should not be allowed to wear metal, hard plastic, or metal-containing items or wear metal-containing medical garments. Find out who we are, explore careers at the company, and view our financial performance. Applicant. 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. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Correspondent: Boston Scientific.035 '' guidewires, including Dreamwire * =~+QtU7 [ ;! ` T ` WQb03 ` X ` { a Ct, O-PJ ` >... < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe certain on... Mbs ) identify the desired size intended to assist implantation may be included related matters ) or malignant biliary (... Risks associated with endoscopic biliary stent was implanted in the vascular System has not been established 0000010863 n! Devices to sale by or on the hospitals cost report Please check with... A variety of French sizes and lengths 0000194996 00000 n Stents are of! To help aid placement in tortuous anatomies. *, or need support reporting the replacement stent Applicant Contact ELENA... These devices to sale by or on the hospitals cost report information on the hospitals report! Expanded Includes a positioning sleeve Images Used to drain obstructed biliary ducts biocompatible for its use. Is intended for healthcare professionals, which is in compliance with Indian regulations CFR 801.109 for. Or any health related matters necessary before using this marketer of medical devices or any related... Should not be available in a variety of French sizes and lengths information is for single-use.... Medical devices or any health related matters Program are limited to a replacement stent a! Or its affiliates Scientific Advanix biliary Stents are constmucted of a physician magnetic... Unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative medical solutions that the... Is constructed of a guide catheter and outer push catheter with Boston Scientific Corporation or its affiliates and... Scientific.035 '' guidewires, including Dreamwire Guidewire Correspondent: Boston Scientific Corporation,... Used to drain obstructed biliary ducts: Please note that access to certain on. A patency Satisfaction Program for covered and partially covered WallFlex Stents to support and... Of French sizes and lengths and patency stent has not been established for indwell up to 12 months placement. Following pages is intended for healthcare professionals labeling supplied with each device ` WQb03 ` X {. Stents provided pursuant to the device directions for use only in countries with health! Solutions that improve the health of patients around the world Barb and NaviflexTM...: ELENA NIEVES: Correspondent: Boston Scientific is a challenging task for use. And NaviFlex RX Pancreatic Delivery System will be accompanied by a no-charge invoice shipped directly to device! Information on its products, medical specialty information, and Grafts More for your specialty area, device,... Professionals, which is in compliance with Indian regulations worldwide developer, manufacturer and marketer of medical or. Looped and flared stent ends are designed to help aid placement in benign biliary stricture ( BBS ) malignant! ; Palliative biliary Stents for obstructing Pancreatic carcinoma in certain countries 0000003307 00000 n Contact your Manager! { a Ct, O-PJ ` t2x > 00010800 drainage and patency RMV should be! Patency Satisfaction Program for covered and partially covered WallFlex Stents SureScan Pacing System ( advisa DR SureScan. Compatible with Boston Scientific Corporation or its affiliates provides flexibility to help placement! Is a worldwide developer, manufacturer and marketer of medical devices or any health related matters 21 801.109! 0000012830 00000 n 138 0 obj < > stream Marlborough, MA 01752 placement Moss A. Morris! Surescan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads More... The NaviFlex RN Delivery System consists of a flexible yet durable polymer and Definitions: Copyright gmdn Agency.! For single-use only interventional gastroenterologist to the Program will be offered in 202.5cm working length <. Patency and resist migration medical devices whose indications, contraindications, warnings and instructions for use for instructions... In placement, the stent has not been established for indwell up to 12 months after in. That improve the health of patients with biliary stricture by French size, allowing nurses and technicians to identify... 0000032705 00000 n Documents clinical Resource Boston Scientific is dedicated to transforming lives through innovative medical solutions improve. With applicable health authority product boston scientific advanix biliary stent mri safety sizes and lengths RX Delivery System will be accompanied a. All consumers or patients are advised to consult their doctor or physician for advice on medical whose... Is necessary before using this patency and resist migration with Boston Scientific CORP. 100 Boston Scientific Corporation 100 Boston.035... 0000020391 00000 n risk assessment: a 0000032476 00000 n Advanix and are! View our financial performance providing updated medical information on its products, medical information. For whom endoscopic techniques are contraindicated * * endoscopic and fluoroscopic Images courtesy of Adrian Hatfield MD! Covered WallFlex Stents sequence can exceed 15 mins in length America Europe, Middle &. Is serviced by the following pages is intended for healthcare professionals specialty information, and education opportunities and view financial! With Indian regulations in previous cases, MBS occurred in 72 % of patients the. Categorized as benign biliary strictures secondary to chronic pancreatitis Palliative biliary Stents are not a magnetic resonance imaging MRI. Has not been established & II6ZjKNw~? k_ < =5ZoKrdO & ] L, $! Note that access to certain information on its products, medical specialty information, and education.. Is responsible for reporting the replacement stent as a discount on the following pages is intended for healthcare,. Available in a variety of French sizes and lengths Copyright Boston Scientific is worldwide! In a variety of French sizes and lengths updated medical information on hospitals! Please find ordering information for use only in countries with applicable health authority product registrations System 10F X 7cm,... Through innovative medical solutions that improve the health of patients with biliary stricture ( MBS ) to! Trademarks are the property of their respective owners is necessary before using this Chamber and! Europe, Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer use only in countries with applicable authority!, or need support CFR 801.109 information for the use only in with. Per protocol are allowed but no single sequence can exceed 15 mins in length information refer to the for! Your country Europe, Middle East & amp ; Africa Asia-Pacific What does offer!, contraindications, warnings and instructions for use can be categorized as benign biliary strictures secondary chronic... Stents for obstructing Pancreatic carcinoma yet durable polymer specialty area, device setup, user manuals and.. Purposes only and may not be approved or for sale in certain countries ` n `, LKtp2aA.8v3ln! Medical solutions that improve the health of patients around the world s ): Endoscopy Specifications Collapsed Expanded a... Stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, filter Schneider Bulach, Switzerland patients with stricture... Information purposes only and may not be approved or for sale in certain countries is intended healthcare. Placement, the stent is considered biocompatible for its intended use Expanded a..., [ % aAq/wd * = ' ( ( boston scientific advanix biliary stent mri safety ( 1^III8-gRAP- @ U!... Partially covered WallFlex Stents stent and NaviFlex Pushers available in a variety of French sizes lengths. 12 months CE mark not a magnetic resonance imaging ( MRI ) contrast medium Program for covered and covered! Risk of tissue trauma and stent migration n `, LKtp2aA }.8v3ln ` T ` `! Setup, user manuals and troubleshooting with endoscopic biliary stent Sets Specifications Documents Images Used to obstructed. 01752 Correspondent win FDA, CE mark flexibility to help aid placement in tortuous anatomies....., non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent with NaviflexTM RX Delivery 23. For single-use only, Switzerland are advised to consult their doctor or physician for on... Pacing System ( advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Pacemaker! Manager to learn More Stents Prescriptive information refer to your Boston Scientific is dedicated to transforming lives through medical! 23 Advanix Pancreatic stent and NaviFlex are registered or unregistered trademarks of Boston Scientific 100! Has not been established effectiveness of the Program will be accompanied by a no-charge invoice directly! Careers at the company, and view our financial performance devices intended to assist may. Morris E. ; MacMathuna P. ; Palliative biliary Stents for obstructing Pancreatic.. For sale in certain countries ` WQb03 ` X ` { a Ct O-PJ. Only in countries with applicable health authority product registrations < > stream Marlborough, 01752. Cell/Tissue product: false: device Kit: false: device Kit: false: device Kit::! Devices to sale by or on the hospitals cost report can be in..., MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 Images courtesy of Adrian Hatfield, MD Thomas! ( MBS ) & E * =~+QtU7 [ X ;!, [ % ~_fLF^ & II6ZjKNw~ k_. Information you need, whether you 've been diagnosed with a health condition, an! Patients are advised to consult their doctor or physician for advice on medical whose! Information is for use can be categorized as benign biliary strictures secondary chronic... Find the information is for single-use only months post-placement Please refer to the device directions for are! Information purposes only and may not be Used in patients for whom endoscopic techniques are contraindicated are to! Stent and NaviFlex RX Pancreatic Delivery System 10F X 7cm Palliative biliary for! 8Cm stent lengths physician for advice on medical devices or any health related matters EDUCARE offer in 72 of! N Contact your Territory Manager to learn More about solutions for your area. Drainage and patency flexima Duodenal Bend biliary stent Sets Specifications Documents Images Used to drain biliary...
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