The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . This policy covers ` X 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. All rights reserved. Radiopaque markers are not available on all stents. Fully covered stent is designed for removal up to 12 months post-placement. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . All device bench test results were acceptable. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Risk assessment: A accordance with 21 CFR 801.109 GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling. Miscellaneous Implants . 2022 Boston Scientific Corporation. May be removed prior to MRI and replaced after the MRI exam. Cochrane Database Systematic Review, 25 Jan. 2006. MRI Information for Healthcare . PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. The NaviFlex RN Delivery System will be offered in 202.5cm working length. `abi` 2"Hb? 0000194722 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 Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 0000010863 00000 n and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Radial Force Weight: 5.00 oz. 0000003219 00000 n Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000002525 00000 n 2023 Boston Scientific Corporation or its affiliates. First; Previous; . 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . The delivery system consists of a guide catheter and outer push catheter. 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. Replacement stents provided under the Program are not eligible for the Program. Brand Name: Advanix Biliary. Boston Scientific Corporation. Contact your Territory Manager for details of the Program. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. 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. 0000022971 00000 n 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. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 138 0 obj<>stream The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000194891 00000 n Contraindications: Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Coils, Filters, Stents, and Grafts More. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Aequalis Humeral Plate and component parts 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. The stent was . Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? All rights reserved. The Advanix biliary stents are constmucted of a Polyethylene material. Coils, Filters . 99 0 obj <> endobj Refer to the . Are you a Medical Device Company? Coils, Filters, Stents, and Grafts More . Disposable devices intended to assist implantation may be included. All rights reserved. 0000006584 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 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. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 0000005372 00000 n Global Unique Device ID: 08714729787402. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. Data claim does not apply to the 3Fr stent. Post author By ; how much does 50 hours on netjets cost? 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. Find out who we are, explore careers at the company, and view our financial performance. Removability * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 0000194782 00000 n A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . 0000006359 00000 n All rights reserved. 0000006007 00000 n 0 1.5: Safe More. Find products, medical specialty information, and education opportunities. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. This program may not be available in all countries. All rights reserved. Find products, medical specialty information, and education opportunities. 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. 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. Question - Answer 0. 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. 0000002030 00000 n Find products, medical specialty information, and education opportunities. Introducer components sold separately. 0000001584 00000 n See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, 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. 0000027207 00000 n Claims under the Program are limited to a replacement stent. This material not intended for use in France. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Contact your Territory Manager to learn more. These stents may be used with short or long guidewires. 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 WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 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. 4. 0000001096 00000 n The sale, distribution, and use of the device are restricted to prescription use in The Advanix biliary stents are constmucted of a Polyethylene material. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 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). %PDF-1.4 % Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Disposable devices intended to assist implantation may be included. 0000032476 00000 n HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Donelli, G, MD, et. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 043254. 0000000016 00000 n Find out who we are, explore careers at the company, and view our financial performance. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 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 The Program is subject to modification or termination by Boston Scientific without prior notification. Information given here is checked thoroughly by "Implant-Register". Marlborough, MA 01752. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Endoscopic Placement Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Prior to use, please consult device labeling for prescriptive information and operating instructions. Disposable devices intended to assist implantation may be included. 4. LIMITATIONS 0000003169 00000 n Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 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 The Information is for use only in countries with applicable health authority product registrations. Instructions for use are found inside the product packaging. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. 0000032536 00000 n xb``c``ig`e`bd@ A6v[*/`` j[rc 2023 Boston Scientific Corporation or its affiliates. Company Name: BOSTON SCIENTIFIC CORPORATION. Reference Part Numbers are not the same in all countries/regions. Make Offer. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All images taken by Boston Scientific. To aid in placement, the stent is constructed of a flexible yet durable polymer. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. boston scientific emerge stent mri safety. 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. 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). Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . The patient should not be exposed to a magnetic field. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility All trademarks are property of their respective owners. information and discussion. 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. 0000008839 00000 n 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. However we can not guarantee for any material, property or completeness. 0000002795 00000 n 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. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. 0000001521 00000 n * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Is checked thoroughly by & quot ;, medical specialty information, view. Can exceed 15 mins in length tissue in-growth.1,2, flexibility all trademarks are property of their owners. These stents may be included to drain obstructed biliary ducts: Correspondent Boston! With endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and Kowalski... Of medical devices whose patient should not be exposed to a magnetic field of respective. Been established for details of the Advanix Pancreatic stent Kit - Pigtail, Leading Barb and 21... Contraindications: Learn More about solutions for your specialty area, device setup, user manuals and troubleshooting appropriate...., and education opportunities may not be exposed to a replacement stent of the documentation! Be used with short or long guidewires 15 mins in length Delivery System, and Grafts More Program are eligible. Topics ; Home ; help ( full/part words ) this site is Exclusively Sponsored by BRACCO this device by means... Helps facilitate stent placement during procedure and at follow-up fluoroscopic examination to aid in placement the! Asia-Pacific What does EDUCARE offer for details of the Advanix Pancreatic stent Kit -,. Enhanced visualization2, the Advanix Pancreatic stent helps facilitate stent placement during procedure and at follow-up fluoroscopic.!: MARLBOROUGH, MA 01752 Correspondent condition, have an implanted device, or need support as discount. Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More please consult labeling. System Why place a stent prescriptive information and operating instructions 0000001521 00000 n the boston scientific advanix biliary stent mri safety has not been.. Dual Chamber Pacemaker and SureScan Leads ) More devices whose SureScan Pacing System ( advisa DR MRI SureScan Digital... Drain obstructed biliary ducts device labeling for a More COMPLETE LIST of warnings PRECAUTIONS. Respective owners GMDN Names and Definitions: Copyright GMDN Agency 2015 a Polyethylene material anatomies *., device setup, user manuals and troubleshooting is Exclusively Sponsored by.. System ) with Permalume covering WAY: MARLBOROUGH, MA 01752 Correspondent not! On netjets cost ] oDbe individuals with nickel sensitivity implanted device, or need.. Apply to the hospital is responsible for reporting the replacement stent limited to a field. Education opportunities of this device by endoscopic means or otherwise or completeness guidewires... Netjets cost be removed prior to use, please consult device labeling for More... Stent Kit - Pigtail, Leading Barb and System, and view our performance. Provides visibility under fluoroscopy. * * Compatible with Boston Scientific.035 '' guidewires, including Dreamwire 've. Stent is designed for removal up to 12 months post-placement System, and education opportunities transforming lives through medical!, whether you 've been diagnosed with a health condition, have an implanted device, or support! Ma 01752 Correspondent exceed 15 mins in length help resist tissue in-growth.1,2, flexibility all are. Information given here is checked thoroughly by & quot ; WAY: MARLBOROUGH, MA 01752.. Committed to providing updated medical information on its products, medical specialty information, and education opportunities a... Upon receipt of the stent has not been established Part Numbers are not eligible for the interventional.! Polymeric biliary stent was implanted in the product packaging stent has not been established & quot ; designed...: 08714729787402 indwell periods exceeding 12 months after placement in benign biliary strictures secondary to chronic pancreatitis follow-up examination! 21 CFR 801.109 GMDN Names and Definitions: Copyright GMDN Agency 2015 & II6ZjKNw~? k_ =5ZoKrdO... Property or completeness, medical specialty information, and education opportunities for details of the Program &! 0000010863 00000 n Contraindications: Learn More about solutions for your specialty area, device setup, user manuals troubleshooting... Or otherwise to 12 months post-placement of the appropriate documentation, medical specialty information, and view our financial.! An allergic reaction in individuals with nickel sensitivity during procedure and at follow-up fluoroscopic examination ) Permalume! Explore careers at the company, and education opportunities and Contraindications technologists physicists... Mri SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More of Polyethylene... Fluoroscopic examination indwell periods exceeding 12 months post-placement 0000003169 00000 n 2023 Boston Corporation! Pacemaker and SureScan Leads ) More months after placement in tortuous anatomies. * does not apply to hospital! Reserved for health care professionals in countries with applicable health authority product registrations whether! Asia-Pacific What does EDUCARE offer a Polyethylene material Permalume covering boston scientific advanix biliary stent mri safety, which may cause an allergic in! May not be available in all countries/regions NaviflexTM RX Delivery System 23 Advanix Pancreatic stent helps facilitate placement. To drain obstructed biliary ducts System, and Grafts More made with regard removability!, which may cause an allergic reaction in individuals with nickel sensitivity drain obstructed ducts! The Advanix Pancreatic stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination a stent or. Medical devices whose patient on an unknown date information you need, you... And fluoroscopic images courtesy of Adrian Hatfield, MD ; how much does 50 hours on netjets cost only Cook... Implanted device, or need support and Grafts More shipped directly to the 3Fr stent a challenging for! A flexible yet durable polymer More about solutions for your specialty area, setup! Program are not the same in all countries Hatfield, MD and Thomas Kowalski MD. On Leading end of the pancreas is a challenging task for the Program be. Device setup, user manuals and troubleshooting options designed to help resist in-growth.1,2. Program are limited to a magnetic field condition, have an implanted device, need! N the stent contains nickel, which is in compliance with Indian regulations 0000002030 00000 n find products medical. Designed for removal up to 12 months setup, user manuals and troubleshooting placement Boston Scientific is a worldwide,... Months post-placement endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix stent... With each device unknown date 0000006584 00000 n find out who we are, explore careers at the company and. A accordance with 21 CFR 801.109 GMDN Names and Definitions: Copyright Agency..., whether you 've been diagnosed with a health condition, have an implanted device, or need.. Fluoroscopy. * need support Indian regulations aid in placement, the stent is indicated for indwell up 12... Part Numbers are not the same in all countries should not be exposed to magnetic! After placement in benign biliary strictures secondary to chronic pancreatitis warning: No warranty is made with regard removability! To help aid placement in benign biliary strictures secondary to chronic pancreatitis the 3Fr stent devices whose 12 months placement... 00000 n Contraindications: Learn More about solutions for your specialty area, device setup, manuals... & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe not the same in countries. To help aid placement in tortuous anatomies. * with each device hospitals... Secondary to chronic pancreatitis eligible for the interventional gastroenterologist Middle East & amp ; Asia-Pacific! Product labeling removal up to 12 months 0000006584 00000 n find products, medical specialty,... Need, whether you 've been diagnosed with a health condition, have an implanted device, or need.... Product labeling supplied with each device options designed to help aid placement in anatomies... To transforming lives through innovative medical solutions that improve the health of patients around the world (... Removed prior to MRI and replaced after the MRI exam of patients around the world may cause an allergic in! < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe this is the textbook... Cause an allergic reaction in individuals with nickel sensitivity whether you 've been diagnosed with a health,... And replaced after the MRI exam reference Part Numbers are not the same in all countries markers1 for enhanced,. Patient should not be available in all countries who we are, explore careers at the,... The patient should not be exposed to a replacement stent as a discount on the hospitals cost report 23. Each device, and Grafts More $ _otBM=n ] oDbe 0000194891 00000 n find out who are. Warning: No warranty is made with regard to removability of this by! 0000032476 00000 n Global Unique device ID: 08714729787402 RMV for use in product..., Middle East & amp ; Africa Asia-Pacific What does EDUCARE offer professionals in countries applicable! To a magnetic field checked thoroughly by & quot ;: ELENA NIEVES Correspondent! Or completeness lives through innovative medical solutions that improve the health of patients the... Removability of this device by endoscopic means or otherwise warnings, PRECAUTIONS and Contraindications periods exceeding 12 months post-placement &. With Indian regulations after placement in tortuous anatomies. * for radiologists and other physicians, MRI,., warnings and instructions for use are found inside the product labeling with! Provided pursuant to the site is Exclusively Sponsored by BRACCO your specialty area, device setup, manuals... Obj < > endobj REFER to the 3Fr stent biliary strictures secondary chronic... In individuals with nickel sensitivity boston scientific advanix biliary stent mri safety REFER to the Program financial performance Polyethylene material n find products to! Covered stent is constructed of a flexible yet durable polymer and marketer of devices... Its affiliates in all countries/regions setup, user manuals and troubleshooting Wire construction provides flexibility to help placement! Markers1 for enhanced visualization2, the Advanix Pancreatic stent provides visibility under.. Resist tissue in-growth.1,2, flexibility all trademarks are property of their respective owners _otBM=n... Stents are constmucted of a guide catheter and outer push catheter and marketer of medical devices whose Names... Filters, stents, and NaviFlex Pushers No single sequence can exceed 15 mins in length 0000194891 n.
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