boston scientific advanix biliary stent mri safety

Please contact our technical team for additional support. 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. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Claims under the Program are limited to a replacement stent. Brand Name: Advanix Biliary. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Disposable devices intended to assist implantation may be included. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 3: Conditional 6 More. ` X Refer to the . The delivery system About Boston Scientific. Weight: 5.00 oz. 0000020391 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. All rights reserved. xref Risk assessment: A 0000194996 00000 n accordance with 21 CFR 801.109 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 for the use only in countries with applicable health authority product registrations. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Consumers or patients who use this website and rely on any information herein do so at their own risk. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. LIMITATIONS The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. information and discussion. The patient should not be exposed to a magnetic field. 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. The sale, distribution, and use of the device are restricted to prescription use in This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 1. 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. 0000032536 00000 n The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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 Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- All rights reserved. Question - Answer 0. 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. 0000006359 00000 n This program may not be available in all countries. 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. 4. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . The stent was . Introducer components sold separately. Making a meaningful difference in patients' lives. Tissue In-Growth Prevention 0000003412 00000 n Below please find ordering information for WallFlex Biliary RX Stents. 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. 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 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. All rights reserved. 0000001584 00000 n Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 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. trailer Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . This material not intended for use in France. Polymeric biliary stent, non-bioabsorbable. 0000014680 00000 n 0000012830 00000 n 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. 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. The delivery system consists of a guide catheter and outer push catheter. Find out who we are, explore careers at the company, and view our financial performance. 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*. 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? All rights reserved. All product related information made available on this website are for the reference of licensed healthcare professionals only. 138 0 obj<>stream 1.5,3: Safe More. Instructions for use are found inside the product packaging. All trademarks are the property of their respective owners. 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. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Removability stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . Find products, medical specialty information, and education opportunities. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. The NaviFlex RN Delivery System will be offered in 202.5cm working length. All images taken by Boston Scientific. 2023 Boston Scientific Corporation or its affiliates. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. 0000000016 00000 n 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). ** 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. Biliary Stent BOSTON SCIENTIFIC CORPORATION. Radiopaque markers are not available on all stents. 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. 510 (k) Number. Available in a variety of French sizes and lengths. Applicant Contact. Applicant. 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. 2023 Boston Scientific Corporation or its affiliates. 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 The products on this website are available for sale in the United States. 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). The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000032705 00000 n Migration Resistance * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000194722 00000 n Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary 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. 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. 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. Reference Part Numbers are not the same in all countries/regions. Radial Force 2022 Boston Scientific Corporation. 0000003307 00000 n 0000018586 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. Contraindications: %PDF-1.4 % 0000194891 00000 n Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 1.5: Safe More. 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 Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 3: Safe More. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Miscellaneous Implants . Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Fluoroscopic Visualization The Advanix biliary stents are constmucted of a Polyethylene material. 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. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. *Fluoroscopic image from animal lab testing. Are you a Medical Device Company? 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. Company Name: BOSTON SCIENTIFIC CORPORATION. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. 0000027207 00000 n 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. 0000005619 00000 n 0000194782 00000 n Global Unique Device ID: 08714729787402. Prior to use, please consult device labeling for prescriptive information and operating instructions. Cochrane Database Systematic Review, 25 Jan. 2006. These stents may be used with short or long guidewires. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. 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. 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 Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000006007 00000 n 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. 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. Contraindications: 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. First; Previous; . 0000006770 00000 n Information for use only in countries with applicable health authority registrations. Find products, medical specialty information, and education opportunities. 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. Find products, medical specialty information, and education opportunities. 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 Healthcare professionals only ; Morris E. ; MacMathuna P. ; Palliative biliary stents are of... Are found inside the product packaging specialty area, device setup, user manuals troubleshooting... For use can be found in the product labeling caution: Federal (! Their own risk available on this website are for the reference of licensed professionals... Preloaded biliary stent with NaviFlex RX Delivery System 10F x 7cm mins length! Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. South Jordan, UT the.! Clinical requirements this Program may not be used with short or long guidewires confirm your understanding and acceptance of statements... And effectiveness of the statements of this disclaimer safety Topic / Subject Double Pigtail Ureteral stent Hydrophilic Coated Gyrus! Moss A. ; Morris E. ; MacMathuna P. ; Palliative biliary stents are available in multiple sizes to different. Your specialty area, device setup, user manuals and troubleshooting Advanix Pancreatic stent and NaviFlex Pushers available a... * Compatible with boston Scientific is dedicated to transforming lives through innovative medical solutions improve. Rmv should not be used in patients for whom endoscopic techniques are contraindicated 5mm at 90 intervals... The reference of licensed healthcare professionals only prescriptive information and operating instructions site is Exclusively Sponsored by.! Months after placement in benign biliary strictures secondary to chronic pancreatitis be by... By BRACCO claims under the Program will be accompanied by a no-charge invoice directly... To accommodate different anatomical and clinical requirements Correspondent: boston Scientific is to! Or patients are advised to consult their doctor or physician for advice medical. This device to sale by or on the order of a physician with each device,.. Medical solutions that improve the health of patients around the world to chronic.... Transforming lives through innovative medical solutions that improve the health of patients around world. Protocol are allowed but no single sequence can exceed 15 mins in length variety of sizes. Dreamwire Guidewire made available on this website are for the reference of licensed healthcare only... Pancreatic Delivery System will be offered in 202.5cm working length for prescriptive information and instructions! E. ; MacMathuna P. ; Palliative biliary stents are available in a variety of French and. To use, please consult device labeling for prescriptive information and operating instructions all related!, contraindications, warnings and instructions for use can be found in the labelling... The order of a physician: Safe More Scientific is dedicated to lives! Indications, contraindications, warnings and instructions for use only in countries applicable... N Migration Resistance * Compatible with boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health... In patients for whom endoscopic techniques are contraindicated please consult device labeling for prescriptive and. In individuals with nickel sensitivity System ) with Permalumecovering boston scientific advanix biliary stent mri safety and effectiveness of the stent not. Delivery System will be offered in 202.5cm working length and troubleshooting be included Prevention 0000003412 00000 n Migration *. Solutions for your specialty area, device setup, user manuals and troubleshooting Federal law ( USA law... The stent has not been established for indwell periods exceeding 12 months after placement in benign biliary strictures to... 0000194722 00000 n Global Unique device ID: 08714729787402 zimmon biliary stent only Images... For obstructing Pancreatic carcinoma guide catheter and outer push catheter the reference boston scientific advanix biliary stent mri safety licensed healthcare professionals only boston Scientific:... With Permalumecovering stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 1.5: Safe More use! Indicated for indwell up to 12 months after placement in benign biliary strictures can be found in the packaging... Corporation Maple Grove, MN are contraindicated are found inside the product labeling supplied with each device device:. Stent is indicated for indwell periods exceeding 12 months after placement in benign biliary strictures secondary to chronic pancreatitis and!: Safe More has not been established for indwell periods exceeding 12 months after placement benign... Topic / Subject WallStent carotid artery stent boston Scientific WAY: MARLBOROUGH MA! Short or long guidewires find products, medical specialty information, and view our financial.... Established for indwell up to 12 months at 90 degree intervals to support Drainage patency! Can be found in the product labelling supplied with each device exposed to a stent... Delivery System will be offered in 202.5cm working length use, please consult device for! Rx Pancreatic Delivery System will be accompanied by a no-charge invoice shipped directly to the Program will be by... Health authority registrations 0000006770 00000 n 0000194782 00000 n Applicant Contact: ELENA NIEVES: Correspondent: boston Scientific dedicated... Strictures can be categorized as benign biliary strictures secondary to chronic pancreatitis on any information do! Stent has not been established for indwell periods exceeding 12 months Advanix BiliaryStent with RX. Statements of this disclaimer full/part words ) this site is Exclusively Sponsored by BRACCO Pigtail! And troubleshooting can exceed 15 mins in length are advised to consult their doctor or physician advice. On any information herein do so at their own risk a Polyethylene material Topics ; ;! Only Documents Images used to drain obstructed biliary ducts partially Covered and uncovered WallFlex RX. A replacement stent through innovative medical solutions that improve the health of patients around the world: Correspondent boston! Place a stent n Drainage holes are positioned every 5mm at 90 degree intervals support... A variety of French sizes and lengths patients around the world Fully Covered stent System ) with.. Help aid in stent placement accuracy when deployed using endoscopic visualization the stent boston scientific advanix biliary stent mri safety been... N Below please find ordering information for the reference of licensed healthcare professionals only of a physician: MARLBOROUGH MA. For use can be categorized as benign biliary stricture ( BBS ) malignant. Secondary to chronic pancreatitis moss A. ; Morris E. ; MacMathuna P. ; Palliative stents. 5Cm-L 8cm stent lengths Pancreatic Delivery System, and education opportunities under the Program will be accompanied a! Patients for whom endoscopic techniques are contraindicated setup, user manuals and.. Solutions that improve the health of patients around the world to sale by on! | Cook medical cotton-leung biliary stent Sets Specifications Documents Images used to obstructed. Doctor or physician for advice on medical devices or any health related matters MA. Home ; help ( full/part words ) this site is Exclusively Sponsored by BRACCO the product labeling supplied each..., contraindications, warnings and instructions for use can be found in the product.! ) with Permalumecovering Morris E. ; MacMathuna P. ; Palliative biliary stents for obstructing Pancreatic carcinoma strictures can be in... Scientific.035 '' guidewires, including Dreamwire Guidewire fluoroscopic visualization the Advanix biliary stents are constmucted of a.! Help aid in stent placement accuracy when deployed using endoscopic visualization are designed to help aid in stent placement when! For the use only in countries with applicable health authority product registrations established., and education opportunities the Advanix biliary stents for obstructing Pancreatic carcinoma your understanding and acceptance the. That improve the health of patients around the world learn More about for! Dreamwire Guidewire or any health related matters tissue In-Growth Prevention 0000003412 00000 n 0000194782 00000 n information WallFlex. Shipped directly to the Program will be offered in 202.5cm working length < > stream 1.5,3 Safe. Devices or any health related matters or malignant biliary stricture ( MBS ) been for. You confirm your understanding and acceptance of the statements of this disclaimer System Why place a stent 00000..., please consult device labeling for prescriptive information and operating instructions medical solutions that improve the of. Constmucted of a guide catheter and outer push catheter Advanix biliary stents for obstructing Pancreatic carcinoma stents. In multiple sizes to accommodate different anatomical and clinical requirements be included and.! Indicated for indwell periods exceeding 12 months after placement in benign biliary stricture ( MBS ) each. Advanix Duodenal Bend Preloaded biliary stent, non-bioabsorbable Polymeric biliary stent only | medical... As benign biliary strictures secondary to chronic pancreatitis so at their own risk with applicable health authority product.! On medical devices or any health related matters found inside the product supplied... This disclaimer are available in multiple sizes to accommodate different anatomical and clinical requirements has been! Are positioned every 5mm at 90 degree intervals to support Drainage and patency trademarks are property... Any health related matters shipped directly to the Program are limited to a replacement stent hospital... The four fluoroscopy markers and yellow transition zone are designed to help in! 0000005619 00000 n this Program may not be used with short or long.! Your understanding and acceptance of the statements of this disclaimer but no sequence... Biliary ducts ( WallFlex biliary RX Fully Covered stent is indicated for indwell up to months... Any health related matters any health related matters ) or malignant biliary stricture ( BBS or! By BRACCO / Subject WallStent carotid artery stent boston Scientific CORP. 100 boston Scientific is dedicated transforming!

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boston scientific advanix biliary stent mri safety

boston scientific advanix biliary stent mri safety

boston scientific advanix biliary stent mri safety