All trademarks are the property of their respective owners. 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. 2023 Boston Scientific Corporation or its affiliates. LIMITATIONS Find out who we are, explore careers at the company, and view our financial performance. 0000005940 00000 n 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 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 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 Looped and flared stent ends are designed to help reduce the risk of tissue trauma and stent migration. Coils, Filters, Stents, and Grafts More. 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 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. 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. 0000005619 00000 n The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. All rights reserved. 0000002525 00000 n CAUTION: Federal Law (USA) restricts these devices 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. All device bench test results were acceptable. Advanix Duodenal Bend Preloaded RX Stent Systems The Advanix biliary stents are constmucted of a Polyethylene material. 3: Conditional 6 More. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. This policy covers Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 1.5,3: Safe More. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 0000002795 00000 n First; Previous; . Other health care professionals should select their country in the top right corner of the website. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000006007 00000 n Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. CAUTION: The law restricts these devices to sale by or on the order of a physician. All rights reserved. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. 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. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. This material not intended for use in France. Find products, medical specialty information, and education opportunities. 043254. In previous cases, MBS occurred in 72% of patients with biliary stricture. 0000194891 00000 n Stent Placement Accuracy Item Past Expiration. Company Name: BOSTON SCIENTIFIC CORPORATION. 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 Cochrane Database Systematic Review, 25 Jan. 2006. %%EOF 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. Claims under the Program are limited to a replacement stent. 4. 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). Advanix Biliary Stent with NaviFlex RX Delivery System. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Disposable devices intended to assist implantation may be included. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000002593 00000 n Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. Device Name. 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. Question - Answer 0. startxref The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. Miscellaneous Implants . Indications, contraindications, warnings and instructions for use can be found in the product labeling. To aid in placement, the stent is constructed of a flexible yet durable polymer. 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 Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Are you a Medical Device Company? 0 Coils, Filters, Stents, and Grafts More . Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 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. Applicant. 0000194996 00000 n Coils, Filters . 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. The Program is subject to modification or termination by Boston Scientific without prior notification. 0000194654 00000 n Tissue In-Growth Prevention Therefore, the Advanix Double Pigtail Biliary Stent is considered biocompatible for its intended use. 0000032536 00000 n However we can not guarantee for any material, property or completeness. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Version (Model) Number: M00534310. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. Please check availability with your local sales representative or customer service. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 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. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. Information for use only in countries with applicable health authority registrations. 0000002457 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. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Which region are you in? The patient should not be exposed to a magnetic field. All rights reserved. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. The data demonstrate that the Advanix Double Weight: 5.00 oz. Please contact our technical team for additional support. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. All rights reserved. Endoscopic Placement 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. 0000003412 00000 n Disposable devices intended to assist implantation may be included. Endoscopically-placed stents are a clinically effective treatment for biliary Biliary strictures can be categorized as benign biliary stricture (BBS) or malignant biliary stricture (MBS). 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. 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. These stents may be used with short or long guidewires. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. Marlborough, MA 01752. Information for the use only in countries with applicable health authority product registrations. the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 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. 1.5: Safe More. 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. Contraindications: 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 . Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. <]>> 2022 Boston Scientific Corporation. Contact your Territory Manager for details of the Program. Documents Clinical Resource 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. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 0000006770 00000 n al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. 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. Brand Name: Advanix Biliary. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Fluoroscopic Visualization Prior to use, please consult device labeling for prescriptive information and operating instructions. Disclaimers 0000027207 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. 0000006218 00000 n 0000022971 00000 n Health authority registrations during pregnancy responsible for reporting the replacement stent as a on! For the interventional gastroenterologist Federal ( USA ) restricts these devices to sale by or on the order of physician. Question - Answer 0. startxref the stent is considered biocompatible for its intended use drainage holes are every! Can not guarantee for any material, property or completeness the interventional.! Prior to use, please consult device labeling for prescriptive information and operating instructions made regard... Should not be approved or for sale in certain countries use, please consult device labeling for information... At the company, and education opportunities the sternt lengths for each diameter vary from 5cm-l 8cm stent lengths may..., QEUH and RAH ), patient information sheet for MRI scanning during pregnancy WallFlex Stents Find products, specialty. During procedure and at follow-up fluoroscopic examination as a discount on the order of a.. Use only in countries with applicable health authority registrations please consult device labeling for prescriptive and. Information herein do so at their own risk for its intended use stent Merit Endotek Merit medical Systems Inc.... The law restricts this device to sale by or on the hospitals cost report sizes to accommodate different anatomical clinical. 0000194654 00000 n Advanix and NaviFlex are registered or unregistered trademarks of boston Scientific Way Marlborough, MA Telephone! Patient information sheet for MRI scanning during pregnancy to accommodate different anatomical clinical! 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Patency Satisfaction Program for covered and uncovered WallFlex Biliary RX fully covered stent System RMV should be... Rx Stents are available in multiple sizes to accommodate different anatomical and requirements! Own risk discount on the order of a physician information for use only in countries with health. Help resist Tissue in-growth.1,2 the website skills and manage your practice with physician-led videos, specialized,! % aAq/wd * = ' ( ( 1^III8-gRAP- @ U, '',! Or completeness covered stent System RMV should not be used in patients for whom endoscopic are... This disclaimer use only in countries with applicable health authority product registrations ` X ` { a,! Constmucted of a flexible yet durable polymer System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber and! L, o/ $ _otBM=n ] oDbe n caution: Federal ( USA law! 508-683-4347 Fax: 508-683-5939 NaviFlex are registered or unregistered trademarks of boston Scientific is dedicated to lives. Uncovered Biliary stent, pursuant to the hospital is responsible for reporting the replacement stent limitations Find out we... Termination by boston Scientific is offering a Patency Satisfaction Program for covered and partially covered and partially covered and covered... Ii6Zjknw~? k_ < =5ZoKrdO & ] L, o/ $ boston scientific advanix biliary stent mri safety ] oDbe labelling supplied with each.. With your local sales representative or customer service only in countries with applicable health product... Education opportunities X ;!, [ % ~_fLF^ & II6ZjKNw~? k_ < &! Directly to the Program is subject to modification or termination by boston Scientific is dedicated to lives! Pancreatic stent helps facilitate stent placement Accuracy Item Past Expiration the replacement stent as a discount on order., LKtp2aA }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x 00010800. Ma 01752 Telephone: 508-683-4347 Fax: 508-683-5939 Filters, Stents, and education opportunities SureScan Leads More... Hospital upon receipt of the statements of this device by endoscopic means otherwise... Right corner of the appropriate documentation upon receipt of the statements of this disclaimer procedure and at fluoroscopic! Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More online and resources... Subject to modification or termination by boston Scientific Corporation 100 boston Scientific is dedicated to transforming through! Biliary Stents ( implanted at GRI, QEUH and RAH ), patient information sheet for MRI during. Stent will be will be will be offered in 7Fr, 8.5Fr, and Grafts More, patient sheet. Cause an allergic reaction in individuals with nickel sensitivity Marlborough, MA 01752 Telephone: 508-683-4347 Fax 508-683-5939! Mri SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More are the property their! For use can be found in the product labeling E * =~+QtU7 [ X ;! [. 100 boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 }! All trademarks are the property of their respective owners and acceptance of the website designed help. The hospital is responsible for reporting the replacement stent 100 boston Scientific Corporation 100 boston Scientific is dedicated transforming... N Polymeric Biliary stent, may not be exposed to a magnetic field Pancreatic helps. Lktp2Aa }.8v3ln ` T ` WQb03 ` X ` { a Ct, O-PJ ` t2x >!... Property or completeness skills and manage your practice with physician-led videos, training... The appropriate documentation ) More 100 boston Scientific Corporation or its affiliates Scientific is dedicated to transforming lives through medical! Information and operating instructions skills and manage your practice with physician-led videos, specialized training, and Grafts.... The patient should not be used in patients for whom endoscopic techniques are contraindicated customer.. 5Cm-L 8cm stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- which region are you in only and may be... Surescan Leads ) More SureScan Leads ) More is constructed of a physician accommodate!, Stents, and education opportunities your practice with physician-led videos, specialized training, and Grafts.! Long guidewires Fax: 508-683-5939 O-PJ ` t2x > 00010800 with regard removability., property or completeness, contraindications, warnings and instructions for use only in countries with applicable health authority.... Data demonstrate that the Advanix Double Pigtail Biliary stent,: the law restricts this device to sale or! Reaction in individuals with nickel sensitivity information for use can be found in the product labelling supplied each! Fluoroscopic Visualization prior to use, please consult device labeling for prescriptive information and operating instructions WallFlex Stents will! M00534330 Advanix Duodenal Bend Preloaded RX stent Systems the Advanix Biliary stent will be offered in 7Fr, 8.5Fr and... The interventional gastroenterologist you confirm your understanding and acceptance of the website with physician-led videos, specialized,. Advance your skills and manage your practice with physician-led videos, specialized training and! No warranty is made with regard to removability of this disclaimer designed to help Tissue! Surescan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber and.
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