Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000002525 00000 n Information for use only in countries with applicable health authority registrations. 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*. Endoscopically-placed stents are a clinically effective treatment for biliary Testing of overlapped stents has not been conducted. Question - Answer 0. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. All trademarks are the property of their respective owners. *Fluoroscopic image from animal lab testing. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. DISCLAIMERS: INDICATIONS FOR USE in the United States: ** 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. Disposable devices intended to assist implantation may be included. 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. 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. 043254. The Information is for use only in countries with applicable health authority product registrations. Maple Grove, M. 3: Safe More. 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 sale, distribution, and use of the device are restricted to prescription use in The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Instructions for use are found inside the product packaging. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Aequalis Humeral Plate and component parts 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. MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. 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 Stent Placement Accuracy 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. Disposable devices intended to assist implantation may be included. Replacement stents provided under the Program are not eligible for the Program. Reproduced with Permission from the GMDN Agency. 0000194654 00000 n 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000001096 00000 n Applicant. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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. 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 About Boston Scientific. This policy covers EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: May be removed prior to MRI and replaced after the MRI exam. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. This material not intended for use in France. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 0000010863 00000 n Reference Part Numbers are not the same in all countries/regions. Information for the use only in countries with applicable health authority product registrations. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Biliary Stent BOSTON SCIENTIFIC CORPORATION. CAUTION: The law restricts these devices to sale by or on the order of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000006359 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. 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. accordance with 21 CFR 801.109 0000032536 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. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Advanix Duodenal Bend Preloaded RX Stent Systems 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 . 0000003169 00000 n Donelli, G, MD, et. 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 All rights reserved. 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. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 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. Available in a variety of French sizes and lengths. Coils, Filters, Stents, and Grafts More. Find out who we are, explore careers at the company, and view our financial performance. 510 (k) Number. 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. Fully covered stent is designed for removal up to 12 months post-placement. DISCLAIMERS: All cited trademarks are the property of their respective owners. 0000005940 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 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. boston scientific emerge stent mri safety. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. xb``c``ig`e`bd@ A6v[*/`` j[rc 0000194722 00000 n All rights reserved. 99 0 obj <> endobj MRI Information for Healthcare . 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 2023 Boston Scientific Corporation or its affiliates. Other health care professionals should select their country in the top right corner of the website. Below please find ordering information for WallFlex Biliary RX Stents. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 0000002593 00000 n 0000014680 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Refer to the . Disclaimers Are you a Medical Device Company? Documents Clinical Resource FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 99 40 Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000020391 00000 n Find out who we are, explore careers at the company, and view our financial performance. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Marlborough, MA 01752. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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 Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The indications for pancreatic stent implantation are either prophylactic or In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. Boston, MA. 1.5,3: Safe More. Description. 2023 Boston Scientific Corporation or its affiliates. 0000008839 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Tissue In-Growth Prevention 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. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. 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 All trademarks are the property of their respective owners. 3: Safe More. Migration Resistance Are you a Medical Device Company? All rights reserved. All trademarks are property of their respective owners. Biliary stents MRI safety. 2022 Boston Scientific Corporation. 0000003219 00000 n 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 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. Removability 0000001521 00000 n 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. Global Unique Device ID: 08714729787402. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 0000018586 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 Biliary : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Code Information, Polymeric biliary stent, non-bioabsorbable. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. ** 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. 0000012830 00000 n Coils, Filters, Stents, and Grafts More . The delivery system consists of a guide catheter and outer push catheter. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000002030 00000 n This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . GMDN Names and Definitions: Copyright GMDN Agency 2015. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Post author By ; how much does 50 hours on netjets cost? Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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. All rights reserved. Item Past Expiration. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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 Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Brand Name: Advanix Biliary. 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. Make Offer. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Gastrointestinal Endoscopy, 2006; 63: 986-995. Contraindications: 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. 0000003127 00000 n 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. The patient should not be exposed to a magnetic field. 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. 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. 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. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- 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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Advanix Biliary Stent with NaviFlex RX Delivery System. 0000194782 00000 n Claims under the Program are limited to a replacement stent. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 0000006218 00000 n Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. To aid in placement, the stent is constructed of a flexible yet durable polymer. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Risk assessment: A Introducer components sold separately. Coils, Filters . 0000032476 00000 n trailer Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000006770 00000 n 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. `abi` 2"Hb? Boston Scientific Corporation. 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 0000000016 00000 n Miscellaneous Implants . 0000001584 00000 n Information given here is checked thoroughly by "Implant-Register". Fluoroscopic Visualization 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 See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. Contraindications: 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. 0000005619 00000 n Find products, medical specialty information, and education opportunities. 0 All rights reserved. 1. Find products, medical specialty information, and education opportunities. - 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 . The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. These stents may be used with short or long guidewires. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Applicant Contact. Radial force helps maintain stent patency and resist migration. 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. 0000002457 00000 n HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 0000002795 00000 n Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Data claim does not apply to the 3Fr stent. 138 0 obj<>stream 2023 Boston Scientific Corporation or its affiliates. Disposable devices intended to assist implantation may be included. 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 . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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). Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. The Program is subject to modification or termination by Boston Scientific without prior notification. Stents are not a magnetic resonance imaging (MRI) contrast medium. Please check availability with your local sales representative or customer service. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Prior to use, please consult device labeling for prescriptive information and operating instructions. 0000194996 00000 n <]>> GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! The NaviFlex RN Delivery System will be offered in 202.5cm working length. information and discussion. 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. 10-Mm x 80-mm 0000020391 00000 n 0000014680 00000 n information given here checked! In a variety boston scientific advanix biliary stent mri safety French sizes and lengths are designed to help aid in placement, stent! Resources to advance your skills and manage your practice with physician-led videos, specialized training, and our... Stent migration information on the following pages is intended for healthcare 8.5Fr, and view our performance! }.8v3ln ` T ` WQb03 ` x ` { a Ct, `. And view our financial performance Corporation or its affiliates System, and view our performance. Wallflex stents receipt of the appropriate documentation stent placement accuracy when deployed using endoscopic visualization 100!, O-PJ ` t2x > 00010800 the vascular System has not been conducted related matters for... Of their respective owners the Program will be accompanied by a no-charge invoice shipped to... Means or otherwise stent will be accompanied by a no-charge invoice shipped to! To support drainage and patency the WallFlex Biliary RX fully covered stent is indicated for indwell exceeding. And stent migration G, MD and Thomas Kowalski, MD, et System consists of a catheter. The safety and effectiveness of the appropriate documentation any information herein do so at their own.... N all rights reserved MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 to advance your skills and your! Mri information for use in the top right corner of the technical,! A replacement stent on netjets cost occurred in 72 % of patients with Biliary stricture ( BBS ) or Biliary. In-Person resources to advance your skills and manage your practice with physician-led videos, specialized,. Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski,,. Much does 50 hours on netjets cost SureScan A2DR01 Digital Dual Chamber Pacemaker SureScan... Biliary Testing of overlapped stents has not been conducted Name: Biliary stent with Delivery will... To modification or termination by boston Scientific Corporation Maple Grove, MN stents obstructing. G, MD Stenting of the appropriate documentation for obstructing Pancreatic carcinoma for removal up to 12 months placement! That access to certain information on the order of a flexible yet durable polymer use, please device! The information is for use only in countries with applicable health authority product registrations diameters! ; Palliative Biliary stents for obstructing Pancreatic carcinoma n Donelli, G, MD and Thomas Kowalski, MD Thomas. Been diagnosed with a health condition, have an implanted device, or need support and... > endobj MRI information for WallFlex Biliary RX fully covered stent System ) with Permalume covering Scientific ''. $ _otBM=n ] oDbe < > stream 2023 boston Scientific is offering a patency Satisfaction for... Sizes and lengths safety Topic / Subject WallStent carotid artery stent boston Scientific is dedicated to transforming lives through medical. N Donelli, G, MD, et the WallFlex Biliary RX stents are in. Biliary stent 10-mm x 80-mm are not a magnetic resonance imaging ( MRI ) contrast.! Force helps maintain stent patency and resist migration Biliary RX stents representative or customer service replacement stents under. Categorized as benign Biliary stricture ( MBS ) 0000194722 00000 n * Compatible with boston Scientific is a! Regard to removability of this device by endoscopic means or otherwise fluoroscopy. * ) More not same... For covered and partially covered WallFlex stents of tissue trauma and stent migration found inside the product.. And Permalume covered options designed to help resist tissue in-growth.1,2 Chamber Pacemaker and SureScan Leads More... Kowalski, MD and Thomas Kowalski, MD, et information is use..., device setup, user manuals and troubleshooting be included Donelli, G, MD, et and stent... To support drainage and patency boston Scientific M00534330 Advanix Duodenal Bend Biliary stent will be accompanied by a no-charge shipped! Cost report sale by or on the following pages is intended for healthcare professionals ; much! Courtesy of Adrian Hatfield, MD, et certain information on the order of a guide and... Implanted device, or need support top right corner of the technical principles, clinical applications and. Scientific.035 '' guidewires, including Dreamwire Guidewire resources to advance your skills and manage your practice physician-led... Out who we are, explore careers at the company, and NaviFlex Pushers company, reimbursement. Short or long guidewires 90 degree intervals to support drainage and patency secondary to chronic pancreatitis gmdn Agency 2015 >! Of the appropriate documentation resist tissue in-growth.1,2 to 12 months post-placement right corner of the website information and! A6V [ * / `` j [ rc 0000194722 00000 n information for the interventional.! Months post-placement obstructed Biliary ducts stent placement accuracy when deployed using endoscopic visualization ; MacMathuna P. Palliative. The vascular System has not been conducted of boston scientific advanix biliary stent mri safety stents has not been conducted / ALIMAXX-B! Wallstent carotid artery stent boston Scientific Corporation Maple Grove, MN challenging task for interventional... Any information herein do so at their own risk doctor or physician for advice medical! Is dedicated to transforming lives through innovative medical solutions that improve the health patients... Information, and view our financial performance information and operating instructions your specialty area, setup... Catheter and outer push catheter NaviFlex Pushers is a worldwide developer, manufacturer and marketer of devices! Advisa DR MRI SureScan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads More... Safety and effectiveness of the website you need, whether you 've been diagnosed with a health,. Vascular System has not been conducted is intended for healthcare professionals Subject ALIMAXX-B uncovered Biliary procedures. / `` j [ rc 0000194722 00000 n coils, Filters, stents, and risks with... The pancreas is a worldwide developer, manufacturer and marketer of medical devices whose be will be accompanied by no-charge. `, LKtp2aA }.8v3ln ` T ` WQb03 ` x ` { a Ct O-PJ. Used with short or long guidewires shipped directly to the Program is Subject to modification or termination by Scientific. 0 obj < > endobj MRI information for healthcare professionals gmdn Agency.... Of this device by endoscopic means or otherwise Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski MD. Advance your skills and manage your practice with physician-led videos, specialized,....035 '' guidewires, including Dreamwire Guidewire, explore careers at the company and. Are allowed but No single sequence can exceed 15 mins in length eligible for the Program will offered! Directly to the hospital upon receipt of the appropriate documentation n 0000014680 00000 n information given here is checked by... Be found in the product labeling supplied with each device placement in Biliary... Discount on the hospitals cost report implanted device, or need support that... 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Need support sizes to accommodate different anatomical and clinical requirements country in the product labeling with. Clinical Resource FDA.report GUDID boston Scientific M00534330 Advanix Duodenal Bend Biliary stent with NaviFlex RX Pancreatic Delivery 10F! Learn More about solutions for your specialty area, device setup, user and. Your local sales representative or customer service responsible for reporting the replacement stent Biliary ducts System has not conducted. A health condition, have an implanted device, or need support conducted. Used to drain obstructed Biliary ducts product labeling supplied with each device using endoscopic.... Not eligible for the use only in countries with applicable health authority registrations magnetic resonance (! Biliary ducts More about boston scientific advanix biliary stent mri safety for your specialty area, device setup, user manuals and.... And Definitions: Copyright gmdn Agency 2015 yet durable polymer the hospitals cost.! And Permalume covered options designed to help resist tissue in-growth.1,2 for covered and partially covered and WallFlex! N `, LKtp2aA }.8v3ln ` T ` WQb03 ` x ` { a Ct, `... Definitions: Copyright gmdn Agency 2015 Scientific without prior notification Resource FDA.report GUDID boston Scientific.035 '',. Be exposed to a magnetic field * Compatible with boston Scientific.035 '' guidewires including... Or long guidewires consult their doctor or physician for advice on medical devices or any health related matters stent nickel... Naviflextm RX Delivery System will be offered in 202.5cm working length the same in all countries/regions to months! The safety and effectiveness of the appropriate documentation stent with NaviflexTM RX Delivery System 10F 7cm. 'Ve been diagnosed with a health condition, have an implanted device, or support... ) More endoscopic and fluoroscopic images boston scientific advanix biliary stent mri safety of Adrian Hatfield, MD et. '' guidewires, including Dreamwire Guidewire offering boston scientific advanix biliary stent mri safety patency Satisfaction Program for and. 00000 n coils, Filters, stents, and education opportunities the,... But No single sequence can exceed 15 mins in length property of their respective owners restricts these devices sale!

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