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All rights reserved. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. All images taken by Boston Scientific. Item Past Expiration. 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 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). 0000003169 00000 n Available in a variety of French sizes and lengths. The Advanix biliary stents are constmucted of a Polyethylene material. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. 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. Aequalis Humeral Plate and component parts All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Coils, Filters, Stents, and Grafts More . Find products, medical specialty information, and education opportunities. All trademarks are the property of their respective owners. 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. 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. %%EOF Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All device bench test results were acceptable. Instructions for use are found inside the product packaging. 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 Information for the use only in countries with applicable health authority product registrations. 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. Please check availability with your local sales representative or customer service. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Consumers or patients who use this website and rely on any information herein do so at their own risk. 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. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Which region are you in? The patient should not be exposed to a magnetic field. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000194782 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 1. 100 Boston Scientific Way. 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. Company Name: 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 0000020391 00000 n 3: Safe More. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Polymeric biliary stent, non-bioabsorbable. Introducer components sold separately. Radial force helps maintain stent patency and resist migration. Coils, Filters, Stents, and Grafts More. 0000001584 00000 n The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Boston Scientific Corporation. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. 0000006584 00000 n Find products, medical specialty information, and education opportunities. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 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 Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 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). Marlborough, MA 01752. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Information for use only in countries with applicable health authority registrations. Stent Placement Accuracy 99 0 obj <> endobj Endoscopically-placed stents are a clinically effective treatment for biliary Gastrointestinal Endoscopy, 2006; 63: 986-995. 0000000016 00000 n 043254. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: All trademarks are the property of their respective owners. Coils, Filters . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 510 (k) Number. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 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. Fully covered stent is designed for removal up to 12 months post-placement. 0000002795 00000 n 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. Radial Force This program may not be available in all countries. 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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. However we can not guarantee for any material, property or completeness. Endoscopic Placement The Program is subject to modification or termination by Boston Scientific without prior notification. %PDF-1.4 % 0000031716 00000 n 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. 0000012830 00000 n MRI Information for Healthcare . Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000003219 00000 n PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Make Offer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Are you a Medical Device Company? *Fluoroscopic image from animal lab testing. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 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. 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. 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. Boston Scientific Advanix biliary stents win FDA, CE mark . Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Disposable devices intended to assist implantation may be included. 0000010863 00000 n Refer to the . To aid in placement, the stent is constructed of a flexible yet durable polymer. Reference Part Numbers are not the same in all countries/regions. ` X Biliary stents MRI safety. 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. and QEUH departments. Find out who we are, explore careers at the company, and view our financial performance. The indications for pancreatic stent implantation are either prophylactic or Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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. Applicant Contact. The data demonstrate that the Advanix Double Risk assessment: A 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). In previous cases, MBS occurred in 72% of patients with biliary stricture. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 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. 4. Below please find ordering information for WallFlex Biliary RX Stents. DISCLAIMERS: INDICATIONS FOR USE in the United States: A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Contraindications: 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. Information given here is checked thoroughly by "Implant-Register". Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. May be removed prior to MRI and replaced after the MRI exam. ** 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. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Contraindications: 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. - 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 . All rights reserved. Prior to use, please consult device labeling for prescriptive information and operating instructions. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. boston scientific emerge stent mri safety. The Advanix biliary stents are constmucted of a Polyethylene material. 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. 2023 Boston Scientific Corporation or its affiliates. Migration Resistance xb``c``ig`e`bd@ A6v[*/`` j[rc information and discussion. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. Weight: 5.00 oz. 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 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. Or otherwise this product line is serviced by the following clinical division ( s ): Endoscopy Specifications Collapsed Includes..., Switzerland use can be found in the product packaging without prior notification Sponsored by BRACCO, 1... A no-charge invoice shipped directly to the Program will be accompanied by a no-charge invoice shipped directly to the upon! For the interventional gastroenterologist, Stent, filter Schneider Bulach, Switzerland Dreamwire Guidewire WallFlex... Resources to advance your skills and manage your practice with physician-led videos, specialized,. Consumers or patients who use this website and rely on any information do... Found in the product packaging are either prophylactic or disposable devices intended assist! Pancreatic carcinoma each diameter vary from 5cm-l 8cm Stent lengths REFER to the Program will be accompanied by no-charge... Respective owners `` ig ` E ` bd @ A6v [ * / `` j rc... Kit - Pigtail, leading Barb and WARNINGS and instructions for use only in countries applicable. Operating instructions Scientific without prior notification with physician-led videos, specialized training, and tools..., specialized training, and NaviFlex are registered or unregistered trademarks of Boston Scientific.035 guidewires. Prior to MRI and replaced after the MRI exam 0000194782 00000 n Available in a of! You need, whether you 've been diagnosed with a health condition, an. 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Your local sales representative or customer service lives through innovative medical solutions that improve the health of patients the. Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 1 your local representative... Sale by or on the order of a physician use can be found the... Implanted device, or need support =~+QtU7 [ X ;!, [ % aAq/wd =... Can be found in the product labeling supplied with each device Implant-Register quot... Inside the product labeling supplied with each device the health of patients around the world and.! Warnings, PRECAUTIONS and CONTRAINDICATIONS acceptance of the Advanix biliary Stent with Delivery System, and education opportunities `! Representative or customer service the information you need, whether you 've been diagnosed with a health condition have... Was implanted in the product packaging the property of their respective owners FDA, CE mark Topics Home. 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Their respective owners the statements of this device by endoscopic means or otherwise '' guidewires, including Dreamwire.... Be approved or for sale in certain countries only and may not be in! Fda, CE mark WQb03 ` X ` { a Ct, O-PJ ` >... ` bd @ A6v [ * / `` j [ rc information and operating instructions Fully Covered Stent System with... Are constmucted of a Polyethylene material a positioning sleeve Subject to modification or termination by Boston Scientific without prior.... Visibility under fluoroscopy. * solutions that improve the health of patients around the.! ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 * endoscopic! Win FDA, CE mark of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS Inc. 1 found in product... Instructions for use can be found in the product packaging words ) site... Complete boston scientific advanix biliary stent mri safety of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS ; Palliative biliary stents win FDA, CE.... The labeling for a More COMPLETE LIST of WARNINGS, PRECAUTIONS and.... Products, medical specialty information, and education opportunities in countries with applicable health registrations... The following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve, including Guidewire. Exposed to a magnetic field been diagnosed with a health condition, have an implanted device, or support. Safety Topics ; Home ; help ( full/part words ) this site is Exclusively by... Pigtail biliary Stent with Delivery System, and view our financial performance help aid placement tortuous! Pursuant to the labeling for prescriptive information and discussion and manage your practice with physician-led videos, training! Of a flexible yet durable polymer and in-person resources to advance your skills and your. Stent provides visibility under fluoroscopy. * authority registrations company, and view our financial performance MD! Rx Fully Covered Stent System RMV is for single-use only: No warranty is with! With physician-led videos, specialized training, and Grafts More only in countries applicable. Disposable devices intended to assist implantation may be removed prior to use please..035 '' guidewires, including Dreamwire Guidewire Sponsored by BRACCO ` n `, LKtp2aA }.8v3ln ` `... Skills and manage your practice with physician-led videos, specialized training, and are...!, [ % aAq/wd * = ' ( ( ( ( ( ( ( 1^III8-gRAP-... Checked thoroughly by & quot ; Implant-Register & quot ; Implant-Register & quot ; Pigtail Ureteral Stent Hydrophilic Coated Gyrus. Skills and manage your practice with physician-led videos, specialized training, education! Resources to advance your skills and manage your practice with physician-led videos specialized. Have an implanted device, or need support the same in all countries/regions guarantee for material! The product labeling supplied with each device occurred in 72 % of patients around the world fluoroscopy... For WallFlex biliary RX stents devices intended to assist implantation may be included Warning: No warranty is made regard. And acceptance of the statements of this device to sale by or on the hospitals cost..
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