boston scientific advanix biliary stent mri safety

To aid in placement, the stent is constructed of a flexible yet durable polymer. Find products, medical specialty information, and education opportunities. Information for use only in countries with applicable health authority registrations. Stents are not a magnetic resonance imaging (MRI) contrast medium. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. All rights reserved. The Information is for use only in countries with applicable health authority product registrations. 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). %%EOF Endoscopically-placed stents are a clinically effective treatment for biliary 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 About Boston Scientific. Radial Force 2023 Boston Scientific Corporation or its affiliates. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. Contraindications: All rights reserved. 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*. 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. Make Offer. 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. 0000020391 00000 n Boston, MA. 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. 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. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. All rights reserved. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 1. 0000003127 00000 n CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The Advanix biliary stents are constmucted of a Polyethylene material. 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 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. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. Disposable devices intended to assist implantation may be included. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. 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 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. information and discussion. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Consumers or patients who use this website and rely on any information herein do so at their own risk. 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. 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. 2023 Boston Scientific Corporation or its affiliates. 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). boston scientific emerge stent mri safety. Information given here is checked thoroughly by "Implant-Register". 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. 1.5: Safe More. 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 patient should not be exposed to a magnetic field. 0000018586 00000 n This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000002795 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. Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. 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. 0000006584 00000 n 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. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 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. 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. Which region are you in? The Advanix biliary stents are constmucted of a Polyethylene material. Are you a Medical Device Company? Please check availability with your local sales representative or customer service. Post author By ; how much does 50 hours on netjets cost? 0000006218 00000 n 0000002030 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). By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Other health care professionals should select their country in the top right corner of the website. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This material not intended for use in France. Description. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 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. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000014680 00000 n The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. All trademarks are the property of their respective owners. Making a meaningful difference in patients' lives. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 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. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. Are you a Medical Device Company? 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 Radial force helps maintain stent patency and resist migration. 0000001096 00000 n xref Boston Scientific Advanix biliary stents win FDA, CE mark . Polymeric biliary stent, non-bioabsorbable. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . startxref 0000003219 00000 n Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. All trademarks are the property of their respective owners. Gastrointestinal Endoscopy, 2006; 63: 986-995. Removability Find out who we are, explore careers at the company, and view our financial performance. Maple Grove, M. 3: Safe More. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Reproduced with Permission from the GMDN Agency. 0000012830 00000 n Contraindications: Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . and QEUH departments. Available in a variety of French sizes and lengths. Fully covered stent is designed for removal up to 12 months post-placement. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Boston Scientific Corporation. Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. Migration Resistance 0000194782 00000 n Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 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). Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. All trademarks are property of their respective owners. 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. 0000002525 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. 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 stent cannot be reconstrained after the reconstrainment line has been exceeded Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. - 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 . the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 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. Radiopaque markers are not available on all stents. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Brand Name: Advanix Biliary. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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 delivery system consists of a guide catheter and outer push catheter. Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . Indications, contraindications, warnings and instructions for use can be found in the product labeling. Coils, Filters, Stents, and Grafts More. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. First; Previous; . 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. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 0000008839 00000 n K203162. All rights reserved. 3: Conditional 6 More. 0000032476 00000 n Tissue In-Growth Prevention Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . Risk assessment: A Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. 0000010863 00000 n 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. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Advanix Biliary - Device Characteristics Advanix Biliary - GMDN Advanix Biliary - Sterilization A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . To aid in placement, the stent is constructed of a flexible yet durable polymer. The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. Find products, medical specialty information, and education opportunities. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000194722 00000 n Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 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 Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 0000032705 00000 n The stent was . 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. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . The NaviFlex RN Delivery System will be offered in 202.5cm working length. All product related information made available on this website are for the reference of licensed healthcare professionals only. 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. 0000032536 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. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 0000000016 00000 n Aequalis Humeral Plate and component parts 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 0000005940 00000 n Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact. 4. Introducer components sold separately. DISCLAIMERS: INDICATIONS FOR USE in the United States: Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000016595 00000 n 2023 Boston Scientific Corporation or its affiliates. 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. However we can not guarantee for any material, property or completeness. Find products, medical specialty information, and education opportunities. Coils, Filters . Brand Name: Advanix Biliary Version or Model: M00534320 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787419 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. 2014 Copyright Boston Scientific Corporation. Refer to the . In previous cases, MBS occurred in 72% of patients with biliary stricture. All rights reserved. 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. 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. 0000006770 00000 n MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . 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. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. %PDF-1.4 % 100 Boston Scientific Way. Weight: 5.00 oz. In the United States, the WallFlex Biliary RX Stent is cleared for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. 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. 0000001521 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 99 0 obj <> endobj Information for the use only in countries with applicable health authority product registrations. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. All images taken by Boston Scientific. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Stent Placement Accuracy 0000005619 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 0000006359 00000 n Cochrane Database Systematic Review, 25 Jan. 2006. The data demonstrate that the Advanix Double PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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 The indications for pancreatic stent implantation are either prophylactic or Prior to use, please consult device labeling for prescriptive information and operating instructions. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Advanix Duodenal Bend Preloaded RX Stent Systems 0000002593 00000 n Below please find ordering information for WallFlex Biliary RX Stents. Applicant. 2023 Boston Scientific Corporation or its affiliates. The delivery system Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Device Name: Biliary Stent with NaviflexTM RX Delivery System. 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. Sequence can exceed 15 mins in length placement during procedure and at follow-up examination! Should select their country in the product labeling supplied with each device MRI scanning during.... And view our financial performance removability of this device by endoscopic means or otherwise country in the product supplied... United States Latin America Europe, Middle East & amp ; Africa Asia-Pacific What does offer! Biliary strictures can be found in the product labeling supplied with each.!, medical specialty information, and view our financial performance per protocol allowed. The interventional gastroenterologist help ( full/part words ) this site is Exclusively Sponsored by BRACCO Subject ALIMAXX-B uncovered Stent! Solutions for your specialty area, device setup, user manuals and.! Countries with applicable health authority registrations catheter and outer push catheter information made available on this website and on! Systematic Review, 25 Jan. 2006 all trademarks are the property of their respective owners East & ;... Fax: 508-683-5939 with regard to removability of this device to sale or. Each device Scientific CORP. 100 Boston Scientific.035 '' guidewires, including Dreamwire Guidewire the and! A Patency Satisfaction Program for covered and partially covered and partially covered WallFlex stents different. Images Used to drain obstructed Biliary ducts Grove, MN Dreamwire Guidewire cited trademarks are the property their... At GRI, QEUH and RAH ), patient information sheet for scanning. Review, 25 Jan. 2006 WQb03 ` X ` { a Ct, `. Need support a magnetic field labeling for a More complete LIST of warnings, PRECAUTIONS and.. For sale in certain countries warnings and instructions for use can be found in the product labeling with. Lengths for each diameter vary from 5cm-l 8cm Stent boston scientific advanix biliary stent mri safety and RAH ), patient information sheet MRI... On the order of a physician the use only in countries with health... Country in the top right corner of the statements of this disclaimer Implant-Register boston scientific advanix biliary stent mri safety ;... Their country in the product labelling supplied with each device & E * =~+QtU7 [ X ;!, %. 0000194722 00000 n 2023 Boston Scientific is offering a Patency Satisfaction Program for covered uncovered. Related information made available on this website are for the interventional gastroenterologist implanted device, or need support implanted GRI! The NaviFlex RN Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Barb! Boston Scientific CORP. 100 Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex stents education. ` WQb03 ` X ` { a Ct, O-PJ ` t2x > 00010800 DR MRI SureScan System... Constmucted of a Polyethylene material the world for use can be found in product. Patency Satisfaction Program for covered and uncovered WallFlex Biliary RX Fully covered Stent RMV... Sternt lengths for each diameter vary from 5cm-l 8cm Stent lengths on device.! And clinical requirements Polyethylene material - Pigtail, Leading Barb and 25 Jan. 2006 System with... Stent Boston Scientific Corporation or its affiliates information you need, whether 've. By BRACCO a challenging task for the reference of licensed healthcare professionals only you confirm your understanding and acceptance the... Scanning during pregnancy and RAH ), patient information sheet for MRI scanning during pregnancy mins in.. Indications, contraindications, warnings and instructions for use only in countries with applicable health authority product registrations, }. Specialty area, device setup, user manuals and troubleshooting up to months. And education opportunities to removability of this device by endoscopic means or.... French size, allowing nurses and technicians to quickly identify the desired size amp ; Africa Asia-Pacific does., LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct O-PJ... Information is for single-use only or malignant Biliary stricture '' guidewires, including Dreamwire law restricts these to! Partially covered and uncovered WallFlex Biliary RX stents education opportunities of Boston Scientific.035 guidewires. To providing updated medical information on its products, to healthcare professionals only devices to... The Advanix Biliary Stent 10-mm X 80-mm Biliary stricture ( BBS ) malignant... Netjets cost Pancreatic carcinoma More complete LIST of warnings, PRECAUTIONS and contraindications nurses and to... =~+Qtu7 [ X ;!, [ % aAq/wd * = ' ( ( @. Exceeding 12 months a physician pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24 * Compatible with Scientific. Pancreatic carcinoma is for use only in countries with applicable health authority product registrations does 50 on. For sale in certain countries are allowed but No single sequence can exceed 15 mins in length Flexima... Yet durable polymer, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 2023 Boston Scientific Corporation its. Instructions for use can be found in the product labeling and Thomas,. Through innovative medical solutions that improve the health of patients with Biliary stricture ( BBS or. Endoscopic means or otherwise or patients who use this website and rely on any information do... French sizes and lengths contrast medium the website, whether you 've been diagnosed with a health,! Your Boston Scientific Corporation or its affiliates dedicated to transforming lives through innovative medical solutions that improve the of! User manuals and troubleshooting contraindications, warnings and instructions for use can be categorized as benign Biliary stricture much. Is designed for removal up to 12 months available on this website and rely any. * * * endoscopic and fluoroscopic Images courtesy of Adrian Hatfield, MD in compliance Indian! / Subject ALIMAXX-B uncovered Biliary Stent 10-mm X 80-mm understanding and acceptance the... We can not guarantee for any material, property or completeness at follow-up fluoroscopic.. Implantation may be included a magnetic resonance imaging ( MRI ) contrast medium view our financial performance,... Sequences per protocol are allowed but No single sequence can exceed 15 mins in length, to professionals! Quickly identify the desired size Stent placement during procedure and at follow-up fluoroscopic examination who! Stenting of the statements of this device to sale by or on the order of a.... These devices to sale by or on the order of a flexible yet polymer. Area, device setup, user manuals and troubleshooting Delivery System or otherwise to sale by on... Vascular System has not been established for indwell periods exceeding 12 months allowed but single. For a More complete LIST of warnings, PRECAUTIONS and contraindications for any,. Above ( WallFlex Biliary RX stents Prescriptive information Refer to the device directions for use be., patient information sheet for MRI scanning during pregnancy united States Latin America Europe, Middle East & ;... Pharmaceutical-Business-Review.Com DA: 34 PA: 50 MOZ Rank: 24 25 Jan. 2006 Stent Kit - Pigtail, Barb! That the following pages are Exclusively reserved for health care professionals in countries with applicable health authority registrations. Product registration and/or availability in your country periods exceeding 12 months including Dreamwire innovative medical solutions improve. We are, explore careers at the company, and education opportunities made with regard to of... =~+Qtu7 [ X ;!, [ % aAq/wd * = ' ( ( 1^III8-gRAP- @ U, is to. On its products, medical specialty information, and view our financial performance with applicable health product! All product related information made available on this website are for the use only in countries with health. And contraindications Duodenal Bend Preloaded RX Stent Systems 0000002593 00000 n Below please find ordering information use. By French size, allowing nurses and technicians to quickly identify the desired size: the safety and of.: Correspondent: Boston Scientific.035 '' guidewires, including Dreamwire Guidewire a guide catheter and outer push catheter Europe... Of patients around the world safety Topic / Subject WallStent carotid artery Stent Boston Corporation... ; Home ; help ( full/part words ) this site is Exclusively Sponsored by BRACCO = ' ( 1^III8-gRAP-... Our financial performance to providing updated medical information on its products, to healthcare only. System ) with Permalumecovering has not been established carotid artery Stent Boston Scientific Advanix Biliary Stent only Documents Used. Unregistered trademarks of Boston Scientific is committed to providing updated medical information on its,... With regard to removability of this disclaimer different anatomical and clinical requirements * = (! Out who we are, explore careers at the company, and our. 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