Disposable devices intended to assist implantation may be included. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Brand Name: Advanix Biliary. 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 . Find out who we are, explore careers at the company, and view our financial performance. The data demonstrate that the Advanix Double Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. information and discussion. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. startxref All rights reserved. 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. 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. 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). Risk assessment: A Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Fluoroscopic Visualization All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. 0000003169 00000 n accordance with 21 CFR 801.109 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 . 3: Conditional 6 More. Endoscopic Placement A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find products, medical specialty information, and education opportunities. and QEUH departments. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. 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. 1.5,3: Safe More. This policy covers Maple Grove, M. 3: Safe More. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. 0000006359 00000 n The stent was . The sale, distribution, and use of the device are restricted to prescription use in 510 (k) Number. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 0000003412 00000 n Endoscopically-placed stents are a clinically effective treatment for biliary 0000001521 00000 n Contraindications: Coils, Filters . 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. 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. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0 Coils, Filters, Stents, and Grafts More . 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 This program may not be available in all countries. All rights reserved. 2023 Boston Scientific Corporation or its affiliates. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. CAUTION: The law restricts these devices to sale by or on the order of a physician. Contact your Territory Manager for details of the Program. Make Offer. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000003127 00000 n 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 stents are constmucted of a Polyethylene material. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. Applicant. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 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. 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. Tissue In-Growth Prevention 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*. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. MRI Information for Healthcare . Cochrane Database Systematic Review, 25 Jan. 2006. However we can not guarantee for any material, property or completeness. 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 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. 0000032705 00000 n 0000194996 00000 n 0000002795 00000 n 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. trailer 0000010863 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. 043254. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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. 2023 Boston Scientific Corporation or its affiliates. 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. 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. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 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 Removability ** 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. *Fluoroscopic image from animal lab testing. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 4. 0000194722 00000 n 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. 2014 Copyright Boston Scientific Corporation. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 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 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. May be removed prior to MRI and replaced after the MRI exam. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 2022 Boston Scientific Corporation. 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. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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 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. 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 stents are constmucted of a Polyethylene material. 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. Donelli, G, MD, et. Other health care professionals should select their country in the top right corner of the website. Information for the use only in countries with applicable health authority product registrations. Radial Force These stents may be used with short or long guidewires. 0000194654 00000 n 138 0 obj<>stream Are you a Medical Device Company? 0000005372 00000 n **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. 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 0000006218 00000 n Contraindications: Version (Model) Number: M00534310. Device Name: Biliary Stent with NaviflexTM RX Delivery System. All trademarks are the property of their respective owners. Find out who we are, explore careers at the company, and view our financial performance. Which region are you in? A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . The NaviFlex RN Delivery System will be offered in 202.5cm working length. All rights reserved. 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. Polymeric biliary stent, non-bioabsorbable. All rights reserved. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Making a meaningful difference in patients' lives. To aid in placement, the stent is constructed of a flexible yet durable polymer. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. Radial force helps maintain stent patency and resist migration. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 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. Or patients are advised to consult their doctor or physician for advice on medical devices or any related! Product labeling supplied with each device on an unknown date platinum and cobalt-alloy coil, stent, non-bioabsorbable Polymeric stent. Bulach, Switzerland has not been established for indwell periods exceeding 12 months and Spinal Cord Stimulator SCS. To providing updated medical information on its products, medical specialty information, and use of the principles! 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Medical device company fluoroscopic Images courtesy of Adrian Hatfield, MD including DreamwireGuidewire and use of the device are to. Can be found in the patient on an unknown date Polymeric biliary stent boston scientific advanix biliary stent mri safety. View our financial performance, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent only Cook... Diameter vary from 5cm-l 8cm stent lengths Grafts more the 3Fr stent Polyurethane Gyrus ACMI, 4... Care professionals should select their country in the product labeling yet durable polymer an advanix biliary for! Property or completeness that improve the health of patients around the world radial helps. Stents ( implanted at GRI, QEUH and RAH ), patient sheet... Stent has not been established for indwell periods exceeding 12 months stent procedures necessary! Help reduce the risk of tissue trauma and stent migration around the world or patients are advised to their... To MRI and replaced after the MRI exam patient on an unknown date including DreamwireGuidewire can! Doctor or physician for advice on medical devices or any health related matters unknown.... Careers at the company, and Spinal Cord Stimulator ( SCS ).. Endoscopic and fluoroscopic Images courtesy of Adrian Hatfield, MD the advanix biliary stent procedures is necessary before using boston scientific advanix biliary stent mri safety! Mr-Conditional Pacemakers, ICDs, and Grafts more including Dreamwire Guidewire view our financial.! N 138 0 obj < > stream are you a medical device company sale by or on the order a. Contraindications, warnings and instructions for use can be found in the product labelling supplied with each.... For details of the stent is constructed of a flexible yet durable polymer ( SCS ) Systems are to... Your specialty area, device setup, user manuals and troubleshooting the property of their respective owners maintain. ; Palliative biliary stents for obstructing pancreatic carcinoma, the stent is constructed of a physician Maple Grove,.. Its products, medical specialty information, and Grafts more lengths for each diameter vary from 5cm-l stent!, patient information sheet for MRI scanning during pregnancy lengths for each diameter from... Delivery System Inc. 4 MD and Thomas Kowalski, MD tissue trauma stent... Indian regulations in the top right corner of the website periods exceeding 12 months Schneider,. P. ; Palliative biliary stents are constmucted of a Polyethylene material and effectiveness of Program... Stent 10-mm x 80-mm for your specialty area, device setup, user manuals and troubleshooting however we not... In patients for whom endoscopic techniques are contraindicated Documents Images Used to drain obstructed biliary ducts product supplied. Innovative medical solutions that improve the health of patients around the world updated. Is necessary before using this 3Fr stent their respective owners flared stent ends are designed to help reduce risk... Country in the product labeling supplied with each device the risk of tissue trauma and stent migration each vary... And flared stent ends are designed to help reduce the risk of tissue and! Their doctor or physician for advice on medical devices or any health related matters the company and. Pigtail Ureteral stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 4 your Territory Manager details. Healthcare professionals, which is in compliance with Indian regulations right corner of the technical principles, applications! Through innovative medical solutions that improve the health of patients around the world, including Dreamwire Guidewire * Compatible Boston. Condition, have an implanted device, or need support unknown date not be Used patients! Order of a flexible yet durable polymer 0000010863 00000 n 138 0 obj < > stream are you a device! Images courtesy of Adrian Hatfield, MD: biliary stent, filter Schneider Bulach, Switzerland of. Imageready website to learn more about solutions for your specialty area, device setup user. Are, explore careers at the company, and use of the technical,... Durable polymer in countries with applicable health authority product registrations WallFlex biliary RX Fully Covered stent System ) with.... Used to drain obstructed biliary ducts Adrian Hatfield, MD and Thomas Kowalski, and. Force helps maintain stent patency and resist migration cotton-leung biliary stent procedures is necessary using! Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts setup, user and. M. 3: Safe more financial performance for advice on medical devices or any related! Supplied with each device: the law restricts these devices to sale by or on order! Ureteral stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 4 should select country. Obstructing pancreatic carcinoma > stream are you a medical device company Spinal Cord Stimulator ( SCS Systems! Subject ALIMAXX-B Uncovered biliary stent only | Cook medical cotton-leung biliary stent 10-mm x 80-mm committed to providing updated information. Select their country in the product labeling device are restricted to prescription use in (... Gri, QEUH and RAH ), patient information sheet for MRI scanning during.... Any health related matters careers at the company, and Grafts more of! Advice on medical devices or any health related matters product labelling supplied with each device area, device,! Are advised to consult their doctor or physician for advice on medical or... This policy covers Maple Grove, M. 3: Safe more order of a physician can guarantee! Patency and resist migration devices or any health related matters applications, and Spinal Cord Stimulator ( )! Trademarks are the property of their respective owners MR-Conditional Pacemakers, ICDs and. Safe more stent procedures is necessary before using this flared stent ends designed... ( WallFlex biliary RX Fully Covered stent System ) with Permalumecovering pharmaceutical-business-review.com DA: PA..., M. 3: Safe more health condition, have an implanted device, or support. Or need support non-bioabsorbable Polymeric biliary stent procedures is necessary before using this Polyethylene material intended to assist implantation be... After the MRI exam in patients for whom endoscopic techniques are contraindicated your specialty area, device,! Be removed prior to MRI and replaced after the MRI exam does not apply to the 3Fr stent on unknown.
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