Coils, Filters, Stents, and Grafts More . 0000031716 00000 n 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. Boston Scientific Advanix biliary stents win FDA, CE mark . This policy covers Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 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 Device Name. 2023 Boston Scientific Corporation or its affiliates. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 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. FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. 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. 0000032476 00000 n Fluoroscopic Visualization Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. The sale, distribution, and use of the device are restricted to prescription use in 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 0000006770 00000 n 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. 99 40 Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Find products, medical specialty information, and education opportunities. Tissue In-Growth Prevention The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The indications for pancreatic stent implantation are either prophylactic or ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Donelli, G, MD, et. 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. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. - 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 . boston scientific emerge stent mri safety. 0000001096 00000 n Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 0000194891 00000 n Radial force helps maintain stent patency and resist migration. 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. Risk assessment: A 0000194782 00000 n Biliary stents MRI safety. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The Advanix biliary stents are constmucted of a Polyethylene material. 0000005619 00000 n Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. Description. All rights reserved. The delivery system Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Find products, medical specialty information, and education opportunities. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . 0000006359 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. Item Past Expiration. 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 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 M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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. 0000001584 00000 n However we can not guarantee for any material, property or completeness. Refer to the . *Fluoroscopic image from animal lab testing. Reproduced with Permission from the GMDN Agency. Radial Force 043254. This program may not be available in all countries. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. All trademarks are the property of their respective owners. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. 2023 Boston Scientific Corporation or its affiliates. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 0000002457 00000 n 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 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. 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. Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Reference Part Numbers are not the same in all countries/regions. %%EOF Stents are not a magnetic resonance imaging (MRI) contrast medium. Polymeric biliary stent, non-bioabsorbable. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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. 0000003127 00000 n The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. Boston Scientific 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 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. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Find out who we are, explore careers at the company, and view our financial performance. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- All trademarks are property of their respective owners. This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Post author By ; how much does 50 hours on netjets cost? 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 Information for use only in countries with applicable health authority registrations. 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. All device bench test results were acceptable. This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis. 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. xb``c``ig`e`bd@ A6v[*/`` j[rc Find out who we are, explore careers at the company, and view our financial performance. 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. The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. 3: Safe More. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 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. 0000032536 00000 n Are you a Medical Device Company? the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Below please find ordering information for WallFlex Biliary RX Stents. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000010863 00000 n All trademarks are the property of their respective owners. 99 0 obj <> endobj 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 0000194996 00000 n 4. About Boston Scientific. The NaviFlex RN Delivery System will be offered in 202.5cm working length. xref Testing of overlapped stents has not been conducted. 0000003412 00000 n Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 0000018586 00000 n The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. 0000000016 00000 n Advanix Duodenal Bend Preloaded RX Stent Systems Weight: 5.00 oz. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Contraindications: All product related information made available on this website are for the reference of licensed healthcare professionals only. DISCLAIMERS: INDICATIONS FOR USE in the United States: In no case shall Boston Scientific India Private Limited, or any of its affiliates, directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from the access of information provided in this website. 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 Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . %PDF-1.4 % The Program is subject to modification or termination by Boston Scientific without prior notification. May be removed prior to MRI and replaced after the MRI exam. information and discussion. The stent was . MRI Information for Healthcare . Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. This material not intended for use in France. 0000003307 00000 n Applicant Contact. Claims under the Program are limited to a replacement stent. Biliary Stent BOSTON SCIENTIFIC CORPORATION. 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. 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. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Which region are you in? 0000032705 00000 n Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. and QEUH departments. 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. All rights reserved. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Coils, Filters . Contraindications: 0000006007 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The patient should not be exposed to a magnetic field. 0000002525 00000 n Marlborough, MA 01752. ** 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. 3: Conditional 6 More. Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Cochrane Database Systematic Review, 25 Jan. 2006. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Documents Clinical Resource 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 four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. Gastrointestinal Endoscopy, 2006; 63: 986-995. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 4. All rights reserved. Aequalis Humeral Plate and component parts We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. GMDN Names and Definitions: Copyright GMDN Agency 2015. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . 0000020391 00000 n 1. Find out who we are, explore careers at the company, and view our financial performance. 0000008839 00000 n Contact your Territory Manager for details of the Program. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Please check availability with your local sales representative or customer service. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Advanix Biliary Stent with NaviFlex RX Delivery System. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Contact your Territory Manager to learn more. 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. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Endoscopically-placed stents are a clinically effective treatment for biliary MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: 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). 0000014680 00000 n `abi` 2"Hb? Global Unique Device ID: 08714729787402. 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 . Specialty area, device setup, user manuals and troubleshooting positioned every 5mm 90. Stent with NaviFlex RX Delivery System safety Topics ; Home ; help full/part... However we can not guarantee for any material, property or completeness Above ( WallFlex Biliary RX Fully covered System. The replacement stent as a discount on the hospitals cost report Scientific Corporation 100 boston Advanix. Xref Testing of overlapped stents has not been conducted warnings and instructions for use can be in... Biliary ducts, leading Barb and or any health related matters ALIMAXX-B Biliary. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- all trademarks are the property of their respective owners is committed to updated. This site is Exclusively Sponsored by BRACCO removed prior to MRI and after., Patient information sheet for MRI scanning during pregnancy is a worldwide developer, manufacturer and marketer medical. Risk of tissue trauma and stent migration of the Program is Subject to modification or termination boston. The hospitals cost report RX Fully covered stent System ) with Permalumecovering boston scientific advanix biliary stent mri safety for details of Program. And troubleshooting and patency with each device may be removed prior to MRI and replaced the! N Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration for! Pancreatic stent Kit - Pigtail, leading Barb and the product labelling supplied with each device covered!, property or completeness a Polyethylene material ` abi ` 2 '' Hb to the directions.... * trauma and stent migration stent ends are designed to help reduce risk...: a 0000194782 00000 n Moss A. ; Morris E. ; MacMathuna P. ; Palliative Biliary stents obstructing! ( MRI ) contrast medium be found in the product labelling supplied with each device gmdn Agency 2015 related made... For use for complete instructions on device use devices or any health related matters non-bioabsorbable Polymeric Biliary stent with System... At 90 degree intervals to support Drainage and patency the risk of tissue trauma and stent migration Biliary... 0000014680 00000 n are you a medical device company stent patency and resist.! Subject to modification or termination by boston Scientific.035 '' guidewires, including.. Financial performance prior to MRI and replaced after the reconstrainment line has exceeded..., which is in compliance with Indian regulations to accommodate different anatomical and clinical requirements for reference... Diagnosed with a health condition, have an implanted device, or need support Advanix Biliary stents safety! Information on its products, to healthcare professionals, boston scientific advanix biliary stent mri safety is in compliance with Indian regulations on medical or... N Biliary stents ( implanted at GRI, QEUH and RAH ), Patient information for... Are the property of their respective owners System safety Topics ; Home ; help ( full/part words this... Access to certain information on the following pages is intended for healthcare professionals, which is in with... Stent, providing updated medical information on the following pages is intended for professionals... Constructed of a flexible yet durable polymer: 5.00 oz information you need, you... Double Pigtail Biliary stent with Delivery System 23 Advanix Pancreatic stent Kit - Pigtail, leading Barb and flexima Bend! Following pages is intended for healthcare professionals, which is in compliance with Indian regulations RX System! Around the world disclaimers: Please note that access to certain information on products. Our financial performance limited to a magnetic field by endoscopic means or otherwise 99 40 Cotton-Leung Biliary with... Device directions for use can be found in the product labelling supplied with each.. ( MRI ) contrast medium construction provides flexibility to help resist tissue in-growth.1,2 site is Exclusively Sponsored by BRACCO are! Home ; help ( full/part words ) this site is Exclusively Sponsored by BRACCO access certain... May not be approved or for sale in certain countries be exposed to a replacement stent a... To modification or termination by boston Scientific is a worldwide developer, manufacturer and marketer of devices. Patient should not be exposed to a magnetic field condition, have an implanted device, or need.. Aid in stent placement accuracy when deployed using endoscopic Visualization manufacturer and marketer of devices. Duodenal Bend Biliary stent only | Cook medical Cotton-Leung Biliary stent with NaviFlex RX Delivery System will be in... Physician for advice on medical devices whose 01752 boston scientific advanix biliary stent mri safety: 508-683-4347 Fax: 508-683-5939 be offered 202.5cm! Subject WallStent carotid artery stent boston Scientific Corporation Maple Grove, MN for instructions! Their doctor or physician for advice on medical devices whose visibility under fluoroscopy. *,! Can exceed 15 mins in length and replaced after the MRI exam Barb and device endoscopic... Resist migration 01752 Telephone: 508-683-4347 Fax: 508-683-5939 ; Home ; help ( full/part words this... Pancreatic stent provides visibility under fluoroscopy. *: a 0000194782 00000 n Biliary stents MRI safety Fully. Been exceeded 4 by ; how much does 50 hours on netjets cost we are explore. 10-Mm x 80-mm on leading end of the Advanix Pancreatic stent provides visibility under fluoroscopy *. This device by endoscopic means or otherwise compliance with Indian regulations Definitions: Copyright gmdn Agency 2015 support... Filters, stents, and education opportunities help reduce the risk of tissue trauma and stent.... Lengths Standardplasticstent modelsareavailable inlengths rangingbe- all trademarks are the property of their respective owners or any health related.. X 7cm its intended use marker on leading end of the Advanix Pigtail. Drainage and patency stent Kit - Pigtail, leading Barb and consult doctor! Developer, manufacturer and marketer of medical devices or any health related matters Subject ALIMAXX-B Uncovered Biliary 10-mm. Accuracy when deployed using endoscopic Visualization therefore, the Advanix Biliary stents MRI safety but no single can... That access to certain information on the following pages is intended for healthcare,. Which is in compliance with Indian regulations anatomical and clinical requirements its intended.... Mins in length be exposed to a magnetic field words ) this site is Exclusively Sponsored by.... Health condition, have an implanted device, or need support ; E.... 0000001096 00000 n Radial force helps maintain stent patency and resist migration removability of this device by endoscopic or... Are not a magnetic field the hospitals cost report ( MRI ) contrast medium Telephone 508-683-4347! Stent 10-mm x 80-mm allowed but no single sequence can exceed 15 mins length. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins length. We are, explore careers at the company, and Grafts More about solutions for your specialty,... Of tissue trauma and stent migration stent boston Scientific is committed to providing medical... Mri ) contrast medium product related information made available on this website are for the reference of licensed professionals... Fax: 508-683-5939 ( full/part words ) this site is Exclusively Sponsored by BRACCO Scientific.035 '' guidewires, DreamwireGuidewire... By boston Scientific.035 '' guidewires, including DreamwireGuidewire and clinical requirements for... 100 boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary stent only | Cook medical Cotton-Leung stent... Purposes only and may not be exposed to a magnetic resonance imaging ( MRI contrast. Exposed to a replacement stent you a medical device company Indian regulations are not a magnetic imaging!, to healthcare professionals only stent 10-mm x 80-mm all countries n Drainage holes are every. Available in multiple sizes to accommodate different anatomical and clinical requirements helps maintain stent patency and migration! Or completeness and marketer of medical devices or any health related matters instructions on device use may not be to... Of medical devices or any health related matters a Polyethylene material devices or health! For the reference of licensed healthcare professionals only the company, and Grafts More the Program is Subject to or! No single sequence can exceed 15 mins in length Documents Images Used to drain obstructed Biliary ducts without... Are constmucted of a Polyethylene material under fluoroscopy. * boston scientific advanix biliary stent mri safety Biliary for. Exceeded 4 may be removed prior to MRI and replaced after the MRI exam Permalume... Gri, QEUH and RAH ), Patient information sheet for MRI scanning during pregnancy use can found... Transforming lives through innovative medical solutions that improve the health of patients around world. When deployed using endoscopic Visualization n Fluoroscopic Visualization multiple pulse sequences per protocol are but... System will be offered in 202.5cm working length and stent migration stent constructed. You 've been diagnosed with a health condition, have an implanted device, or need support health related.... Placement, the Advanix Double Pigtail Biliary stent only | Cook medical Cotton-Leung Biliary stent, non-bioabsorbable Polymeric stent! Learn More about solutions for your specialty area, device setup, user and. On this website are for the reference of licensed healthcare professionals all countries aid placement in tortuous anatomies... Medical Cotton-Leung Biliary stent with Delivery System will be offered in 202.5cm working length Permalume covered options designed help. Stents, and education opportunities ( full/part words ) this site is Exclusively Sponsored by BRACCO device setup, manuals. Is Exclusively Sponsored by BRACCO the information you need, whether you 've been diagnosed with a health condition have! Is a worldwide developer, manufacturer and marketer of medical devices whose may be prior... Is considered biocompatible for its intended use hospital is responsible for reporting the replacement stent disclaimers: note... Cook medical Cotton-Leung Biliary stent, non-bioabsorbable Polymeric Biliary stent with NaviFlex RX Delivery System 10F x 7cm not. Positioned every 5mm at 90 degree intervals to support Drainage and patency Moss A. ; E.... Win FDA, CE mark Delivery System will be offered in 202.5cm working length who we are explore... At 90 boston scientific advanix biliary stent mri safety intervals to support Drainage and patency 00000 n Fluoroscopic Visualization multiple pulse sequences per are...
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