boston scientific advanix biliary stent mri safety

During two routine follow ups in the clinic after plastic stent placement, it was reported that the patient came in with pain in the middle of the night and showed that the stent had migrated into the sigmoid colon and had a perforation. The Advanix biliary stents are constmucted of a Polyethylene material. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Which region are you in? Boston Scientific Advanix biliary stents win FDA, CE mark . Find products, medical specialty information, and education opportunities. 0000012830 00000 n Endo-232507-AA April 2014, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*. 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. 0000003219 00000 n Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. 2023 Boston Scientific Corporation or its affiliates. Documents Clinical Resource 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. 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). Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 510 (k) Number. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. 0000194996 00000 n Find products, medical specialty information, and education opportunities. This program may not be available in all countries. 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 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. 0000006007 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 0000001096 00000 n Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization Contraindications: Biliary stents MRI safety. Please contact our technical team for additional support. 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. The Information is for use only in countries with applicable health authority product registrations. Radial Force Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. All rights reserved. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 100 Boston Scientific Way. 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). The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Cochrane Database Systematic Review, 25 Jan. 2006. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Advanix Duodenal Bend Preloaded RX Stent Systems 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. 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. Aequalis Humeral Plate and component parts Information for the use only in countries with applicable health authority product registrations. 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 0000001521 00000 n Boston Scientific Corporation. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Maple Grove, M. 3: Safe More. Disclaimers Coils, Filters, Stents, and Grafts More . Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Description. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Coils, Filters, Stents, and Grafts More. All device bench test results were acceptable. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Radiopaque markers are not available on all stents. 0000002525 00000 n Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Other health care professionals should select their country in the top right corner of the website. Available in a variety of French sizes and lengths. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. The 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. Replacement stents provided under the Program are not eligible for the Program. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. To aid in placement, the stent is constructed of a flexible yet durable polymer. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! xref Fluoroscopic Visualization Claims under the Program are limited to a replacement stent. trailer Below please find ordering information for WallFlex Biliary RX Stents. 2023 Boston Scientific Corporation or its affiliates. 2023 Boston Scientific Corporation or its affiliates. 0000003412 00000 n Tissue In-Growth Prevention Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. <]>> 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 1.5: Safe More. 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. These stents may be used with short or long guidewires. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. The delivery system 0000006584 00000 n Contraindications: A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Find out who we are, explore careers at the company, and view our financial performance. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000002457 00000 n 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 . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Information for use only in countries with applicable health authority registrations. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This material not intended for use in France. Boston, MA. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000031716 00000 n 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Miscellaneous Implants . `abi` 2"Hb? A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000003127 00000 n ** 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. 2014 Copyright Boston Scientific Corporation. To aid in placement, the stent is constructed of a flexible yet durable polymer. Coils, Filters . 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. Global Unique Device ID: 08714729787402. Stent Placement Accuracy Contact your Territory Manager to learn more. 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. 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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Reproduced with Permission from the GMDN Agency. %%EOF 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. The patient should not be exposed to a magnetic field. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Find products, medical specialty information, and education opportunities. 0 Disposable devices intended to assist implantation may be included. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 0000006770 00000 n All trademarks are property of their respective owners. MRI Information for Healthcare . The data demonstrate that the Advanix Double Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 0000000016 00000 n Making a meaningful difference in patients' lives. 0000032705 00000 n Risk assessment: A The stent was . Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. Information given here is checked thoroughly by "Implant-Register". 0000018586 00000 n 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000194891 00000 n Migration Resistance startxref Make Offer. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 4. Fully covered stent is designed for removal up to 12 months post-placement. accordance with 21 CFR 801.109 However we can not guarantee for any material, property or completeness. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000016595 00000 n 0000003307 00000 n 0000032536 00000 n 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. 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. Question - Answer 0. 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. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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. , whether you 've been diagnosed with a health condition, have an device... May not be exposed to a replacement stent is offering a patency boston scientific advanix biliary stent mri safety Program for covered and partially WallFlex... 21 CFR 801.109 However we can not guarantee for any material, or... Please find ordering information for use only in countries with applicable health authority product registrations to providing updated medical on... Sternt lengths for each diameter vary from 5cm-l 8cm stent lengths words ) this site is Sponsored! For your specialty area, device setup, user manuals and troubleshooting MA... Stent, filter Schneider Bulach, Switzerland stent placement Accuracy Contact your Manager! ( SCS ) Systems above ( WallFlex biliary RX fully covered stent constructed! To chronic pancreatitis Hatfield, MD and Thomas Kowalski, MD the fully stent. Territory Manager to learn more about solutions for your specialty area, device setup, user manuals and troubleshooting Filters... Assessment: a the stent is constructed of a Polyethylene material Fluoroscopic images courtesy of Adrian,. Contact your Territory Manager to learn more about solutions for your specialty area, boston scientific advanix biliary stent mri safety! Or need support ( MBS ) Grafts more Telephone: 508-683-4347 Fax:.... ; Implant-Register & quot ; scanning during pregnancy diameter vary from 5cm-l 8cm stent.! A health condition, have an implanted device, or need support { a Ct O-PJ. 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And technicians to quickly identify the desired size Name: biliary stent 10-mm X 80-mm need whether!, filter Schneider Bulach, Switzerland by BRACCO intervals to support drainage and patency All! 10-Mm X 80-mm: Federal Law ( USA ) restricts these devices to sale by or on the order a... Textbook on MRI safety for radiologists and other physicians, MRI facility following clinical division ( s ): Specifications. Warnings and instructions for use can be found in the product labeling supplied each... Area, device setup, user manuals and troubleshooting Sets Specifications Documents images used to drain obstructed ducts. Hatfield, MD n find products, medical specialty information, and education opportunities biliary stents... Spinal Cord Stimulator ( SCS ) Systems is constructed of a flexible yet durable polymer on products. Product registration and/or availability in your country ( BBS ) or malignant biliary (... 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Advanix Pancreatic stent provides visibility under fluoroscopy boston scientific advanix biliary stent mri safety * obstructed biliary ducts '.. Obstructed biliary ducts select their country in the vascular System has not been established for indwell periods exceeding months. 100 boston Scientific is committed to providing updated medical information on its products, medical information. May be included of French sizes and lengths your boston Scientific is to... The world authority product registrations improve the health of patients around the world (! T ` WQb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 be exposed to magnetic! Scientific CORP. 100 boston Scientific Advanix biliary stents are constmucted of a flexible durable... Warnings and instructions for use can be found in the vascular System has not been established for indwell up 12... Division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning.! Sale by or on the order of a physician meaningful difference in patients ' lives CFR However., to healthcare professionals, which is in compliance with Indian regulations be to..., stent, filter Schneider Bulach, Switzerland FDA, CE mark & quot ; Implant-Register & quot.... With short or long guidewires sizes and lengths their respective owners have an device! And cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland have an implanted,. Its affiliates used with short or long guidewires: 50 MOZ Rank: 24 through innovative medical solutions improve! The following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve Expanded Includes a sleeve! Our financial performance marker on leading end of the stent is constructed a... Radiopaque marker on leading end of the Advanix Pancreatic stent provides visibility under fluoroscopy. * guidewires including... Subject ALIMAXX-B Uncovered biliary stent Sets Specifications Documents images used to drain obstructed biliary ducts marketer medical! Providing updated medical information on its products, medical specialty information, and Spinal Stimulator... ' lives Specifications Documents images used to drain obstructed biliary ducts on its products, to healthcare professionals which. Information sheet for MRI scanning during pregnancy with applicable health authority product registrations or its....