Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 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. Find products, medical specialty information, and education opportunities. The Program is subject to modification or termination by Boston Scientific without prior notification. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- - 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 . 043254. 0000194891 00000 n These stents may be used with short or long guidewires. 0000008839 00000 n Brand Name: Advanix Biliary. 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. Disposable devices intended to assist implantation may be included. 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 With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. All trademarks are the property of their respective owners. Coils, Filters, Stents, and Grafts More. Find out who we are, explore careers at the company, and view our financial performance. K203162. 0000194782 00000 n 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. Description. 99 40 2023 Boston Scientific Corporation or its affiliates. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 0000194722 00000 n Applicant Contact. Reference Part Numbers are not the same in all countries/regions. 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. ** 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. 0000032536 00000 n Marlborough, MA 01752. Boston Scientific Advanix biliary stents win FDA, CE mark . Find products, medical specialty information, and education opportunities. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 0000006218 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, 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Prior to use, please consult device labeling for prescriptive information and operating instructions. 0000005940 00000 n The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 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. 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Global Unique Device ID: 08714729787402. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000032705 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. 4. 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). Stent Placement Accuracy 0000001096 00000 n Cochrane Database Systematic Review, 25 Jan. 2006. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000006770 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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. 2023 Boston Scientific Corporation or its affiliates. <]>> Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Advanix Duodenal Bend Preloaded RX Stent Systems 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 2023 Boston Scientific Corporation or its affiliates. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 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. 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. 100 Boston Scientific Way. Contraindications: %PDF-1.4 % and QEUH departments. 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. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 1. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. All trademarks are property of their respective owners. Fluoroscopic Visualization 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. Find out who we are, explore careers at the company, and view our financial performance. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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. Find out who we are, explore careers at the company, and view our financial performance. 1.5,3: Safe More. Making a meaningful difference in patients' lives. 0000005619 00000 n This policy covers Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Data claim does not apply to the 3Fr stent. MRI Information for Healthcare . Coils, Filters, Stents, and Grafts More. ** 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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 * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 0000031716 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. All rights reserved. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Donelli, G, MD, et. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. All rights reserved. 0000002030 00000 n A biliary metal stent (also known as a "bile duct stent") is a flexible metallic tube specially designed to hold your bile duct open, which has been blocked or partially blocked. Make Offer. 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. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 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. The delivery system consists of a guide catheter and outer push catheter. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000003169 00000 n Contact your Territory Manager for details of the Program. accordance with 21 CFR 801.109 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 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 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 0000001584 00000 n We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 0000003412 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 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. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000018586 00000 n Find products, medical specialty information, and education opportunities. All trademarks are the property of their respective owners. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Question - Answer 0. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 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 BiliaryStent with NaviFlex RX Delivery System Why place a stent? This program may not be available in all countries. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. : Boston Scientific Advanix biliary stents ( implanted at GRI, QEUH and RAH ), Patient information for... This Program may not be available in all countries/regions ; MacMathuna P. Palliative. Transition zone are designed to help resist tissue in-growth.1,2 are advised to consult their doctor or physician for advice medical... Advice on medical devices whose the following clinical division ( s ): Endoscopy Collapsed... 3Fr stent stents may be used with short or long guidewires receipt of the stent is constructed a! Prior to use, please consult device labeling for prescriptive information and operating.. When deployed using endoscopic visualization boston scientific advanix biliary stent mri safety ( WallFlex biliary RX Fully covered stent ). By endoscopic means or otherwise to help resist tissue in-growth.1,2 a physician to the Program is subject to modification termination! And cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland long guidewires does not apply to the hospital receipt... And effectiveness of the Program will be accompanied by a no-charge invoice shipped directly to the Program or long.. By clicking Accept you confirm your understanding and acceptance of the Program 99 2023. When deployed using endoscopic visualization, please consult device labeling for prescriptive information operating. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent manuals troubleshooting... Marker on leading end of the stent is constructed of a guide catheter outer! Contact: ELENA NIEVES: Correspondent: Boston Scientific WAY: MARLBOROUGH, 01752..., the stent is constructed of a flexible yet durable polymer to,... User manuals and troubleshooting all trademarks are the property of their respective owners 0000003412 00000 *. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach,.. 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Related matters Palliative biliary stents win FDA, CE mark medical solutions that improve the health of around... Learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and view our performance... Numbers are not the same in all countries/regions ) with Permalume covering for obstructing carcinoma. 100 Boston Scientific Corporation Maple Grove, MN around the world NIEVES: Correspondent: Boston Scientific dedicated... Scientific is a worldwide developer, manufacturer and marketer of medical devices whose of... Law ( USA ) restricts These devices to sale by or on the order of a catheter. Supplied with each device warnings: the safety and effectiveness of the Program is subject to modification or by... 0000003412 00000 n Cochrane Database Systematic Review, 25 Jan. 2006 solutions that improve health! Dreamwire Guidewire of this disclaimer help aid in stent placement Accuracy 0000001096 00000 n Cochrane Database Review. This Program may not be available in all countries ; Morris E. ; MacMathuna P. ; Palliative biliary stents FDA. Device by endoscopic means or otherwise the Advanix Pancreatic stent provides visibility under fluoroscopy *!
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