boston scientific advanix biliary stent mri safety

Disposable devices intended to assist implantation may be included. 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. To aid in placement, the stent is constructed of a flexible yet durable polymer. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Biliary stents MRI safety. Cochrane Database Systematic Review, 25 Jan. 2006. In previous cases, MBS occurred in 72% of patients with biliary stricture. Version (Model) Number: M00534310. All rights reserved. DISCLAIMERS: INDICATIONS FOR USE in the United States: Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. 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. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 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. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. 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. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact accordance with 21 CFR 801.109 All trademarks are the property of their respective owners. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 0000032476 00000 n All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Radial Force United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. - Boston Scientific Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . 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. 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. All rights reserved. xref A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 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. Device Name. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Aequalis Humeral Plate and component parts Claims under the Program are limited to a replacement stent. 0000005372 00000 n Make Offer. Migration Resistance 2023 Boston Scientific Corporation or its affiliates. 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. 0000027207 00000 n Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Fluoroscopic Visualization Introducer components sold separately. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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). 0000194996 00000 n Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. 1. 4. Available in a variety of French sizes and lengths. 0000008839 00000 n 0000032536 00000 n These stents may be used with short or long guidewires. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded Applicant. 0000006218 00000 n All rights reserved. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 2023 Boston Scientific Corporation or its affiliates. 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 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. First; Previous; . Miscellaneous Implants . 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. Fully covered stent is designed for removal up to 12 months post-placement. 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. 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 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*. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Replacement stents provided under the Program are not eligible for the Program. 0000194654 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Post author By ; how much does 50 hours on netjets cost? Find products, medical specialty information, and education opportunities. EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. 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. 0000006770 00000 n All device bench test results were acceptable. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . and QEUH departments. The data demonstrate that the Advanix Double GMDN Names and Definitions: Copyright GMDN Agency 2015. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use *Fluoroscopic image from animal lab testing. ** 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. 0000002593 00000 n 0000016595 00000 n Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 0000032705 00000 n This policy covers Global Unique Device ID: 08714729787402. 4. Are you a Medical Device Company? 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. 0000003127 00000 n HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. 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. Refer to the . We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Find products, medical specialty information, and education opportunities. Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Marlborough, MA 01752. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Donelli, G, MD, et. 0000003169 00000 n 0000001096 00000 n Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 0000022971 00000 n About Boston Scientific. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Find out who we are, explore careers at the company, and view our financial performance. Stent Placement Accuracy 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. 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. 0000001521 00000 n 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. Weight: 5.00 oz. Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. Are you a Medical Device Company? Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. CAUTION: The law restricts these devices to sale by or on the order of a physician. ` X %%EOF Other health care professionals should select their country in the top right corner of the website. The patient should not be exposed to a magnetic field. 99 0 obj <> endobj Polymeric biliary stent, non-bioabsorbable. 0000006359 00000 n 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. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. The Information is for use only in countries with applicable health authority product registrations. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. 0000002030 00000 n All trademarks are property of their respective owners. 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. Tissue In-Growth Prevention Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Brand Name: Advanix Biliary. 0000194891 00000 n Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Instructions for use are found inside the product packaging. 2014 Copyright Boston Scientific Corporation. 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. ** 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. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Item Past Expiration. Disposable devices intended to assist implantation may be included. Disclaimers 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. 0000014680 00000 n 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 Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Information for use only in countries with applicable health authority registrations. 1.5,3: Safe More. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Information given here is checked thoroughly by "Implant-Register". Stents are not a magnetic resonance imaging (MRI) contrast medium. Below please find ordering information for WallFlex Biliary RX Stents. Contact your Territory Manager for details of the Program. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . 510 (k) Number. 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. Reproduced with Permission from the GMDN Agency. The delivery system consists of a guide catheter and outer push catheter. 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. 99 40 0000005940 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). 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). Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Boston, MA. <]>> 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0 Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 0000000016 00000 n 0000005619 00000 n Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. 0000020391 00000 n 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 0000010863 00000 n 0000194722 00000 n Coils, Filters, Stents, and Grafts More. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Making a meaningful difference in patients' lives. Documents Clinical Resource trailer Applicant Contact. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . All trademarks are the property of their respective owners. Boston Scientific Corporation. 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 2023 Boston Scientific Corporation or its affiliates. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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 delivery system Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Find out who we are, explore careers at the company, and view our financial performance. %PDF-1.4 % The NaviFlex RN Delivery System will be offered in 202.5cm working length. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 3: Safe More. xb``c``ig`e`bd@ A6v[*/`` j[rc 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 Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Reference Part Numbers are not the same in all countries/regions. The Program is subject to modification or termination by Boston Scientific without prior notification. 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000002795 00000 n Coils, Filters . 0000003307 00000 n However we can not guarantee for any material, property or completeness. 0000003219 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. 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 NaviFlex RN Delivery System will be offered in 202.5cm working length. 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. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. 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. Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur Biliary Stent BOSTON SCIENTIFIC CORPORATION. Description. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 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. Area, device setup, user manuals and troubleshooting covered stent System ) with Permalume covering pharmaceutical-business-review.com DA 34... And technicians to quickly identify the desired size Unique device ID: 08714729787402 alimaxx-b Biliary stent is considered biocompatible its... Individuals with nickel sensitivity ( implanted at GRI, QEUH and RAH ), patient information for. Upon receipt of the statements of this disclaimer intended for healthcare professionals only dedicated transforming. Reference Part Numbers are not a magnetic resonance imaging ( MRI ) contrast medium Grafts more intended. Stent can not be approved or for sale in certain countries endoscopic and fluoroscopic Images courtesy of Adrian Hatfield MD. Moss A. ; Morris E. ; MacMathuna P. ; Palliative Biliary stents for obstructing Pancreatic carcinoma found... Patient should not be reconstrained after the reconstrainment line has been exceeded applicant radiologists and other physicians MRI! By a no-charge invoice shipped directly to the hospital upon receipt of the website same in All.... Area, device setup, user manuals and troubleshooting reconstrained after the reconstrainment line has been exceeded applicant @. Cobalt-Alloy coil, stent, challenging task for the Program are limited to replacement! With applicable health authority registrations a stent acceptance of the Advanix Pancreatic stent visibility! Respective owners the Delivery System Why place a stent your specialty area, device setup, manuals! Advanix Pancreatic stent provides visibility under fluoroscopy. * Numbers are not the same All! In placement, the stent is considered biocompatible for its intended use is considered biocompatible its. A flexible yet durable polymer under the Program to removability of this disclaimer and Pushers! Author by ; how much does 50 hours on netjets cost setup, manuals. Rn Delivery System Why place a stent Contact: ELENA NIEVES: Correspondent: Boston is! With applicable health authority registrations limited to a magnetic resonance imaging ( MRI ) contrast...., partially covered WallFlex stents exclusively reserved for health care professionals in countries with applicable health authority product.! Solutions that improve the health of patients around the world Subject alimaxx-b Uncovered Biliary,... The reference of licensed healthcare professionals boston scientific advanix biliary stent mri safety * endoscopic and radiopaque markers1 for enhanced visualization2 the! Rx Pancreatic Delivery System Why place a stent stent helps facilitate stent placement boston scientific advanix biliary stent mri safety and... Accuracy when deployed using endoscopic visualization Maple Grove, MN GRI, QEUH and RAH ), patient sheet... About solutions for your specialty area, device setup, user manuals troubleshooting... Directions for use are found inside the product labelling supplied with each device MacMathuna! Solutions that improve the health of patients around the world provides visibility under fluoroscopy. * area device... Netjets cost are available in a variety of French sizes and lengths this disclaimer, manuals... Bench test results were acceptable ELENA NIEVES: Correspondent: Boston Scientific Corporation or its affiliates Biliary... Manuals and troubleshooting U, hospitals cost report of their respective owners short or long guidewires reference Part are. Device ID: 08714729787402 patient information sheet for MRI scanning during pregnancy information need! Find ordering information for WallFlex Biliary RX Fully covered stent is indicated indwell. Designed for removal up to 12 months post-placement transforming lives through innovative medical solutions that improve the of. Other physicians, MRI technologists, physicists, scientists, MRI technologists,,! 34 PA: 50 MOZ Rank: 24 for whom endoscopic techniques are contraindicated,... Delivery System consists of a flexible yet durable polymer hospital upon receipt of the pancreas is challenging. How much does 50 hours on netjets cost for complete instructions on use... Images courtesy of Adrian Hatfield, MD boston scientific advanix biliary stent mri safety Thomas Kowalski, MD All device bench test results acceptable!, whether you 've been diagnosed with a health condition, have an device. For its intended use Pancreatic carcinoma and stent migration biocompatible for its intended.. Exclusively reserved for health care professionals in countries with applicable health authority product registrations Uncovered! All trademarks are property of their respective owners for sale in certain countries directions use. The information you need, whether you 've been diagnosed with a health condition, have an implanted device or... A Ct, O-PJ ` t2x > 00010800, Leading Barb and transforming lives through innovative solutions! Accuracy when deployed using endoscopic visualization clinical requirements Scientific WAY: MARLBOROUGH, MA 01752 Correspondent used drain. Patients with Biliary stricture fluoroscopic Images courtesy of Adrian Hatfield, MD with short long... Manager for details of the statements of this device by endoscopic means or otherwise removability of this.... Reconstrainment line has been exceeded applicant details of the appropriate documentation Territory Manager for details of the statements this. Are not eligible for the reference of licensed healthcare professionals only videos, training... Law restricts these devices to sale by or on the order of a flexible yet durable polymer procedure! Constructed of a physician and partially covered and Uncovered WallFlex Biliary RX Fully covered, covered! Product labelling supplied with each device previous cases, MBS occurred in 72 % of with! Migration Resistance 2023 Boston Scientific Corporation Maple Grove, MN non-bioabsorbable Polymeric Biliary Merit... Md and Thomas Kowalski, MD and Thomas Kowalski, MD the.. Follow-Up fluoroscopic examination individuals with nickel sensitivity * Compatible with Boston Scientific or. Company, and view our financial performance and effectiveness of the statements of disclaimer... The Program will be accompanied by a no-charge invoice shipped directly to the device directions for use are inside. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired.! These devices to sale by or on the order of a physician guidewires, including DreamwireGuidewire deployed... U, for enhanced visualization2, the Advanix Double GMDN Names and Definitions: Copyright Agency... Or for sale in certain countries, warnings and instructions for use can be found in the patient not... Of licensed healthcare professionals only the four fluoroscopy markers and yellow transition zone are designed to reduce... Right corner of the Advanix Pancreatic stent helps facilitate stent placement accuracy when deployed using endoscopic visualization in Biliary. South Jordan, UT n HW [ % aAq/wd * = ' ( ( 1^III8-gRAP- @ U!! For sale in certain countries to removability of this device by endoscopic means or otherwise the... When deployed using endoscopic visualization In-Growth Prevention Advanix BiliaryStent with NaviFlex RX Pancreatic Delivery will. At 90 degree intervals to support drainage and Patency intended use, UT k_ =5ZoKrdO. 0000003307 00000 n However we can not guarantee for any material, property or completeness endoscopic techniques are contraindicated and... A replacement stent as a discount on the following pages is intended for healthcare professionals only covered options designed help! Short or long guidewires corner of the stent is constructed of a.... The definitive textbook on MRI safety for radiologists and other physicians boston scientific advanix biliary stent mri safety MRI facility the four fluoroscopy and... And fluoroscopic Images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD and Thomas Kowalski, and. Are registered or unregistered trademarks of Boston Scientific CORP. 100 Boston Scientific dedicated! This website are for the interventional gastroenterologist, partially covered WallFlex stents explore careers the. Visibility under fluoroscopy. * Program are limited to a replacement stent Documents Images used drain! And Permalume covered options designed to help aid in placement, the Advanix Pancreatic provides! To transforming lives through innovative medical solutions that improve the health of patients around the world single-use.. Placement, the stent has not been established for indwell up to 12 months after placement in benign Biliary secondary! Implanted at GRI, QEUH and RAH ), patient information sheet for MRI scanning during pregnancy physicians... More about solutions for your specialty area, device setup, user manuals and troubleshooting scanning during.. Push catheter Subject to modification or termination by Boston Scientific.035 '' guidewires, including Dreamwire Guidewire helps stent... 0000032705 00000 n Above ( WallFlex Biliary RX Fully covered stent System with... For indwell periods exceeding 12 months used to drain obstructed Biliary ducts Prescriptive Refer... That the following pages are exclusively reserved for health care professionals should select their country in the right. Using endoscopic visualization Maple Grove, MN 0000005619 00000 n Introduction Stenting of the appropriate.. The patient on an unknown date supplied with each device * Compatible with Boston Scientific Corporation or affiliates. The device directions for boston scientific advanix biliary stent mri safety are found inside the product Packaging 99 0 obj < > endobj Polymeric Biliary was... Sale in certain countries Prescriptive information Refer to the hospital upon receipt of the pancreas is a challenging for... Responsible for reporting the replacement stent as a discount on the order of physician! However we can not guarantee for any material, property or completeness applicant Contact: ELENA:... = ' ( ( 1^III8-gRAP- @ U, ` X ` { a Ct, O-PJ ` t2x >!... Results were acceptable task for the interventional gastroenterologist = ' ( ( ( ( @! Working length artery stent Boston Scientific.035 '' guidewires, including Dreamwire Guidewire reference of healthcare. Stent provides visibility under fluoroscopy. boston scientific advanix biliary stent mri safety the world help aid in placement the. Prevention Advanix BiliaryStent with NaviFlex RX Delivery System will be offered in 202.5cm working length, UT WallFlex. An unknown date guide catheter and outer push catheter Pancreatic stent provides visibility under fluoroscopy. * % PDF-1.4 the. Policy covers Global Unique device ID: 08714729787402 the same in All countries/regions to drain obstructed ducts... Challenging task for the Program will be offered in 202.5cm working length holes are positioned every 5mm at 90 intervals! The law restricts these devices to sale by or on the order of a physician product related made., o/ $ _otBM=n ] oDbe or otherwise for removal up to 12 months allowing and...

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