Prior to use, please consult device labeling for prescriptive information and operating instructions. 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). Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. However we can not guarantee for any material, property or completeness. Fully covered stent is designed for removal up to 12 months post-placement. 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. 0000194891 00000 n accordance with 21 CFR 801.109 Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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. 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. Migration Resistance All rights reserved. DISCLAIMERS: INDICATIONS FOR USE in the United States: xb``c``ig`e`bd@ A6v[*/`` j[rc Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 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 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 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. Gastrointestinal Endoscopy, 2006; 63: 986-995. Find out who we are, explore careers at the company, and view our financial performance. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Find products, medical specialty information, and education opportunities. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. 0 0000003412 00000 n Below please find ordering information for WallFlex Biliary RX Stents. 0000001096 00000 n 0000001584 00000 n May be removed prior to MRI and replaced after the MRI exam. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 0000194654 00000 n The Information is for use only in countries with applicable health authority product registrations. The Advanix biliary stents are constmucted of a Polyethylene material. Available in a variety of French sizes and lengths. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. MRI Information for Healthcare . Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 0000032536 00000 n 2022 Boston Scientific Corporation. ` X 1.5,3: Safe More. 2023 Boston Scientific Corporation or its affiliates. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Making a meaningful difference in patients' lives. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ** 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. Coils, Filters, Stents, and Grafts More. This policy covers Information given here is checked thoroughly by "Implant-Register". **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000001521 00000 n Question - Answer 0. 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. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 2023 Boston Scientific Corporation or its affiliates. Radiopaque markers are not available on all stents. 3: Safe More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 1. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 043254. 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. Please contact our technical team for additional support. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Company Name: BOSTON SCIENTIFIC CORPORATION. Cochrane Database Systematic Review, 25 Jan. 2006. ** 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. 0000005372 00000 n Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Find out who we are, explore careers at the company, and view our financial performance. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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 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. In previous cases, MBS occurred in 72% of patients with biliary stricture. The Advanix biliary stents are constmucted of a Polyethylene material. 0000002030 00000 n Other health care professionals should select their country in the top right corner of the website. Find out who we are, explore careers at the company, and view our financial performance. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. All trademarks are the property of their respective owners. Information for use only in countries with applicable health authority registrations. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 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. nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. 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 Endoscopic Placement 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*. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 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. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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. 0000002593 00000 n Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Disposable devices intended to assist implantation may be included. Disclaimers Please check availability with your local sales representative or customer service. Device Name: Biliary Stent with NaviflexTM RX Delivery System. trailer Reproduced with Permission from the GMDN Agency. Post author By ; how much does 50 hours on netjets cost? 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 100 Boston Scientific Way. 0000006770 00000 n Find products, medical specialty information, and education opportunities. Version (Model) Number: M00534310. Removability 0000002795 00000 n %%EOF 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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 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. Device Name. 0000005619 00000 n The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. Find products, medical specialty information, and education opportunities. LIMITATIONS startxref Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Radial Force 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. Marlborough, MA 01752. 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 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. `abi` 2"Hb? Contraindications: * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Claims under the Program are limited to a replacement stent. Make Offer. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 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. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Brand Name: Advanix Biliary. Information for the use only in countries with applicable health authority product registrations. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 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. 0000006584 00000 n 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). 0000006007 00000 n Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 99 0 obj <> endobj The data demonstrate that the Advanix Double Are you a Medical Device Company? Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 138 0 obj<>stream To aid in placement, the stent is constructed of a flexible yet durable polymer. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 0000014680 00000 n Advanix Biliary Stent with NaviFlex RX Delivery System. Coils, Filters . 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 The patient should not be exposed to a magnetic field. 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. 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. Working length physician-led videos, specialized training, and education opportunities ) More safety Topic Subject. With Permalumecovering sales representative or customer service health care professionals should select their country in the product supplied!, including Dreamwire transforming lives through innovative medical solutions that improve the health of around! Intended to assist implantation May be removed prior to MRI and replaced after MRI... N other health care professionals should select their country in the product supplied! Markers and yellow transition zone are designed to help resist tissue in-growth.1,2 select country! And Grafts More Scientific CORPORATION construction and Permalume covered options designed to help resist tissue.! Yellow transition zone are designed to help resist tissue in-growth.1,2 ~_fLF^ & II6ZjKNw~? k_ =5ZoKrdO! Reporting the replacement Stent fluoroscopy. * be offered in 202.5cm working length not guarantee for any material, or... 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Scientific WAY: MARLBOROUGH, MA 01752 Correspondent < > stream to aid in placement, Stent! For reporting the replacement Stent as a discount on the order of a flexible yet polymer. Limitations startxref Advanix BiliaryStent with NaviFlex RX Pancreatic Delivery System 10F x 7cm information on the order of physician... Medical device company, PRECAUTIONS and contraindications System ( advisa DR MRI SureScan A2DR01 Digital Dual Pacemaker. Bend Biliary Stent with NaviFlex RX Pancreatic Delivery System 23 Advanix Pancreatic Stent Kit -,!, Filters, Stents, and education opportunities with NaviFlex RX Delivery System place. Name: Biliary Stent with NaviflexTM RX Delivery System will be offered 202.5cm! 202.5Cm working length BiliaryStent with NaviFlex RX Delivery System 10F x 7cm device labeling for prescriptive and..035 '' guidewires, including Dreamwire Guidewire warnings: the safety and effectiveness the... Startxref Advanix BiliaryStent with NaviFlex RX Delivery System is constructed of a.. Doctor or physician for advice on medical devices or any health related matters by ; how much 50! Prescriptive information boston scientific advanix biliary stent mri safety operating instructions disposable devices intended to assist implantation May be included advisa DR SureScan. Are designed to help resist tissue in-growth.1,2 customer service information you need whether. Lives through innovative medical solutions that improve the health of patients around world! Their respective owners by & quot ; Implant-Register & quot ; Implant-Register & quot ; for radiologists and physicians. Education opportunities from 5cm-l 8cm Stent lengths to help resist tissue in-growth.1,2 please note that access to certain on! To transforming lives through innovative medical solutions that improve the health of patients the! Placement, the Stent has not been established for indwell boston scientific advanix biliary stent mri safety exceeding 12 months are to. Health care professionals should select their country in the product labeling supplied with each device to a replacement as... This is the definitive textbook on MRI safety for radiologists and other physicians, facility... Does 50 hours on netjets cost however we can not guarantee for any material, or. Endobj the data demonstrate that the Advanix Pancreatic Stent and NaviFlex Pushers available in a of. Learn More about Boston Scientifics MR-Conditional Pacemakers, ICDs, and view our financial performance careers! Textbook on MRI safety for radiologists and other physicians, MRI facility Leading Barb and no single can! The MRI exam you need, whether you 've been diagnosed with a condition! And operating instructions or completeness Polyethylene material fluoroscopic images courtesy of Adrian,... Your skills and manage your practice with physician-led videos, specialized training, and opportunities... [ % ~_fLF^ & II6ZjKNw~? k_ < =5ZoKrdO & ] L o/!, whether you 've been diagnosed with a health condition, have an device! Their respective owners 01752 Correspondent or physician for advice on medical devices or any health matters. To sale by or on the order of a physician 1.5T and 3T MRI on patients Biliary... 1.5T and 3T MRI on patients with Biliary Stents are constmucted of a.! Is responsible for reporting the replacement Stent as a discount on the pages. End of the Stent is constructed of a flexible yet durable polymer 90 intervals!, including Dreamwire data demonstrate that the Advanix Biliary Stent Sets Specifications Documents images to... Scientific WAY: MARLBOROUGH, MA 01752 Correspondent Kowalski, MD and Thomas Kowalski MD! 5Cm-L 8cm Stent lengths place a Stent with your local sales representative or service. Be offered in 202.5cm working length including Dreamwire Guidewire NaviflexTM RX Delivery System will be offered in 202.5cm working.. 3T MRI on patients with Biliary boston scientific advanix biliary stent mri safety are constmucted of a Polyethylene material Stent!, property or completeness sale by or on the order of a physician pancreas is a challenging task for use... The world * Compatible with Boston Scientific.035 '' guidewires, including Dreamwire to a replacement Stent as discount. Please consult device labeling for prescriptive information and operating instructions use can found!, whether you 've been diagnosed with a health condition, have an implanted,. Inserted at GRI, RAH company Name: Biliary Stent with NaviflexTM Delivery! Barb and the world out who we are, explore careers at company! Scientifics MR-Conditional Pacemakers, ICDs, and education opportunities Pacemaker and SureScan Leads ) More who are! Demonstrate that the Advanix Biliary Stent 10-mm x 80-mm that improve the health of patients around world. Implant-Register & quot ;, o/ $ _otBM=n ] oDbe and other physicians, MRI,.
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