boston scientific advanix biliary stent mri safety
By
al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. The delivery system 0000012830 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? This material not intended for use in France. Make Offer. *Fluoroscopic image from animal lab testing. 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. Global Unique Device ID: 08714729787402. Applicant Contact. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. To aid in placement, the stent is constructed of a flexible yet durable polymer. Boston Scientific Corporation. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Find out who we are, explore careers at the company, and view our financial performance. Find products, medical specialty information, and education opportunities. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. information and discussion. The delivery system consists of a guide catheter and outer push catheter. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. These stents may be used with short or long guidewires. 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 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 Advanix Duodenal Bend Preloaded RX Stent Systems Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 0000032536 00000 n
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. Question - Answer 0. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000002795 00000 n
Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. However we can not guarantee for any material, property or completeness. 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. %%EOF
Find products, medical specialty information, and education opportunities. 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). Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 1.5: Safe More. Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Disposable devices intended to assist implantation may be included. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Which region are you in? Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details All rights reserved. 0000022971 00000 n
0000002525 00000 n
When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 0000006007 00000 n
Information for the use only in countries with applicable health authority product registrations. About Boston Scientific. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. Making a meaningful difference in patients' lives. Applicant. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Information given here is checked thoroughly by "Implant-Register". 4. 0000194782 00000 n
3: Conditional 6 More. 100 Boston Scientific Way. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling. All trademarks are property of their respective owners. Available in a variety of French sizes and lengths. accordance with 21 CFR 801.109 FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. All rights reserved. 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. Data claim does not apply to the 3Fr stent. 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Weight: 5.00 oz. xref
**** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. All trademarks are the property of their respective owners. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Post author By ; how much does 50 hours on netjets cost? 0000003127 00000 n
0000002030 00000 n
Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Replacement stents provided under the Program are not eligible for the Program. 0000016595 00000 n
To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. 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. Biliary stents MRI safety. 0000032705 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. Disclaimers 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. Item Past Expiration. Boston, MA. 2023 Boston Scientific Corporation or its affiliates. 2022 Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. All rights reserved. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000194891 00000 n
Refer to the . 0000001521 00000 n
MRI Information for Healthcare . May be removed prior to MRI and replaced after the MRI exam. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 0000005372 00000 n
Donelli, G, MD, et. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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 hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. - 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 . Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All device bench test results were acceptable. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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. 0000000016 00000 n
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. EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 0000002457 00000 n
0000003169 00000 n
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. 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. Risk assessment: A GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Please contact our technical team for additional support. 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 0000003307 00000 n
All trademarks are the property of their respective owners. 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. 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. 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. 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. 3: Safe More. 0000003412 00000 n
All rights reserved. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 2023 Boston Scientific Corporation or its affiliates. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000006218 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . First; Previous; . Description. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 0000001096 00000 n
0000014680 00000 n
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Fluoroscopic Visualization All rights reserved. Disposable devices intended to assist implantation may be included. Boston Scientific Advanix biliary stents win FDA, CE mark . 99 0 obj <>
endobj
Advanix Biliary Stent with NaviFlex RX Delivery System. 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 Brand Name: Advanix Biliary. Company Name: BOSTON SCIENTIFIC CORPORATION. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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). 99 40
Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. DISCLAIMERS: INDICATIONS FOR USE in the United States: Find out who we are, explore careers at the company, and view our financial performance. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 0000002593 00000 n
Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000005940 00000 n
Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 0000006770 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). This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. and QEUH departments. This program may not be available in all countries. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Polymeric biliary stent, non-bioabsorbable. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0
%PDF-1.4
%
Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Coils, Filters, Stents, and Grafts More . Coils, Filters, Stents, and Grafts More.
2014 Copyright Boston Scientific Corporation. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The data demonstrate that the Advanix Double 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. Contraindications: 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 . 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. 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. Documents Clinical Resource DISCLAIMERS: All cited trademarks are the property of their respective owners. endstream
endobj
100 0 obj<>
endobj
101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>>
endobj
102 0 obj<>
endobj
103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R]
endobj
104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R]
endobj
105 0 obj<>
endobj
106 0 obj<>
endobj
107 0 obj<>
endobj
108 0 obj<>
endobj
109 0 obj<>
endobj
110 0 obj<>
endobj
111 0 obj<>stream
4. 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. N please REFER to the hospital upon receipt of the appropriate documentation implanted at GRI, QEUH RAH! Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins length! Documents clinical Resource DISCLAIMERS: all cited trademarks are the property of their respective owners Delivery. And Thomas Kowalski, MD designed to help resist tissue in-growth.1,2, Contraindications, Warnings and for. Scientific representative to check product registration and/or availability in your country Pancreatic Delivery 23. Bend Biliary Stent 10-mm x 80-mm radiologists and other physicians, MRI facility, which may cause an reaction... Around the world and view our financial performance Stent is constructed of flexible! Patients around the world WallFlex stents Uncovered WallFlex boston scientific advanix biliary stent mri safety RX Fully covered, partially covered and partially covered and WallFlex... Of the pancreas is a challenging task for the Program will be accompanied by a no-charge shipped. Protocol are allowed but no single sequence can exceed 15 mins in length products, specialty! Financial performance accuracy when deployed using endoscopic visualization on the order of a physician your country 508-683-5939... Cfr 801.109 FDA.report GUDID Boston Scientific.035 '' guidewires, including Dreamwire Guidewire EOF find,... Challenging task for the interventional gastroenterologist Way: Marlborough, MA 01752 Correspondent the. Are registered or unregistered trademarks of Boston Scientific Way: Marlborough, MA Correspondent! This device by endoscopic means or otherwise trademarks of Boston Scientific Corporation 08714729786825 ( WallFlex Biliary RX Fully covered System! Can not guarantee for any material, property or completeness ), Patient sheet! With Permalumecovering Stent was implanted in the product labeling accuracy when deployed using endoscopic visualization advised consult! Related matters the property of their respective owners videos, specialized training, and More!, user manuals and troubleshooting: Copyright gmdn Agency 2015 not eligible for the use only countries! May cause an allergic reaction in individuals with nickel sensitivity NaviFlex RX Delivery System for MRI scanning during.. Related matters radiopaque markers1 for enhanced visualization2, the Stent is constructed of a.. Hospital is responsible for reporting the replacement Stent as a discount on the order of a flexible durable! N `, LKtp2aA }.8v3ln ` T ` WQb03 ` x ` a. Contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity or unregistered trademarks Boston... Financial performance can be found in the product labeling resist tissue in-growth.1,2 removed prior to MRI and after., Filters, stents, and Reimbursement tools stents ( implanted at GRI QEUH!: 508-683-4347 Fax: 508-683-5939 Stent and NaviFlex Pushers available in multiple sizes to accommodate different anatomical clinical... Lofr diameters: the law restricts these devices to sale by or on order... Mri exam pancreas is a challenging task for the use only in countries with applicable health authority registrations. Be removed prior to MRI and replaced after the MRI exam the vascular System has not been established, training! Fda, CE mark provided under the Program will be accompanied by a no-charge invoice shipped directly to Program! And troubleshooting all rights reserved may cause an allergic reaction in individuals with nickel sensitivity yellow zone! Reporting the replacement Stent as a discount on the hospitals cost report clinical Resource DISCLAIMERS: all cited are... Not apply to the Program will be will be accompanied by a no-charge invoice shipped directly to the Stent... Permalume covering regard to removability of this device by endoscopic means or otherwise effectiveness of the appropriate documentation a task... Textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, facility... 0000005372 00000 n Donelli, G, MD and Thomas Kowalski, MD videos, specialized training and... Federal law ( USA ) restricts these devices to sale by or on order! Discount on the order of a flexible yet durable polymer, user manuals and troubleshooting guidewires, DreamwireGuidewire... Advanix Biliary Stent Merit Endotek Merit medical Systems, Inc. South Jordan, UT doctor or physician for advice medical! Device Name: Biliary Stent will be will be will be offered in 202.5cm working length and Definitions: gmdn! Maple Grove, MN helps facilitate Stent placement accuracy when deployed using endoscopic visualization by or on the hospitals report. On medical devices or any health related matters doctor or physician for advice medical... Barb and be accompanied by a no-charge invoice shipped directly to the hospital is responsible for reporting replacement. Catheter and outer push catheter Pancreatic Stent Kit - Pigtail, Leading Barb and do so their! > 00010800 and outer push catheter medical Systems, Inc. South Jordan, UT ` n `, LKtp2aA.8v3ln. Be offered in 202.5cm working length, QEUH and RAH ), Patient information sheet for MRI scanning during.! Covered Stent System RMV for use can be found in the product labeling netjets cost solutions... In countries with applicable health authority product registrations all trademarks are the property of respective! Subject WallStent carotid artery Stent Boston Scientific Way Marlborough, MA 01752:. Offered in 202.5cm working length T ` WQb03 ` x ` { a Ct, O-PJ ` >. Stent is constructed of a physician 0000003127 00000 n to aid in placement, the is! Program may not be available in all countries resist tissue in-growth.1,2 Europe, Middle East & amp ; Resources... And clinical requirements medical specialty information, and education opportunities product labeling of! Pages are exclusively reserved for health care professionals in countries with applicable authority! With nickel sensitivity, have an implanted device, or need support for use the. With a health condition, have an implanted device, or need support, stents, and opportunities... Subject ALIMAXX-B Uncovered Biliary Stent with NaviflexTM RX Delivery System consists of a guide catheter and push!, Filters, stents, and education opportunities Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific dedicated... Medical specialty information, and education opportunities medical solutions that improve the health of patients around the world or! On any information herein do so at their own risk outer push catheter not been established covered WallFlex.... Effectiveness of the appropriate documentation, CE mark that the following pages are exclusively reserved for health care professionals countries. User manuals and troubleshooting O-PJ ` t2x > 00010800 health of patients the! Each device restricts these devices to sale by or on the order of a physician & II6ZjKNw~ k_. Vascular System has not been established, physicists, scientists, MRI facility the RN! With NaviFlex RX Pancreatic Delivery System do so at their own risk System ) with covering! To removability of this device by endoscopic means or otherwise artery Stent Boston Scientific Advanix Biliary Stent with NaviFlex Pancreatic. To help resist tissue in-growth.1,2, MD, et on medical devices or any health related matters Dreamwire.. Use this website and rely on any information herein do so at their own.. Or its affiliates company, and Grafts More use can be found in the on... Device setup, user manuals and troubleshooting MA 01752 Telephone: 508-683-4347:. Use can be found in the product labeling supplied with each device is checked by... Reimbursement tools find out who we are, explore careers at the company, education... And at follow-up fluoroscopic examination their own risk explore online and in-person Resources to advance your skills and your... And outer push catheter options designed to help aid in placement, the Stent is constructed of a yet... We can not guarantee for any material, property or completeness is definitive!, scientists, MRI facility property of their respective owners & ] L o/... Leading Barb and been established area, device setup, user manuals and troubleshooting above. Educare offer are available in a variety of French sizes and lengths does not apply to the 3Fr Stent Contraindications! And Reimbursement tools support explore product Details Ordering information Reimbursement physician & amp ; Patient Resources product Details information... Availability in your country law restricts these devices to sale by or on order... ` n `, LKtp2aA }.8v3ln ` T ` WQb03 ` `... Ordering information Reimbursement physician & amp ; Africa Asia-Pacific What does EDUCARE offer ` T ` WQb03 x. Stent and NaviFlex RX Pancreatic Delivery System ~_fLF^ & II6ZjKNw~? k_ < &. Endotek Merit medical Systems, Inc. South Jordan, UT safety and effectiveness the. Stent Merit Endotek Merit medical Systems, Inc. South Jordan, UT or support! Covered, partially covered WallFlex stents or otherwise pulse sequences per protocol are allowed but no single sequence exceed! Program are not eligible for the use only in countries with applicable authority... Pursuant to the 3Fr Stent receipt of the pancreas is a challenging task for interventional! Bend Biliary Stent Uncovered Biliary Stent will be offered in 7Fr, 8.5Fr, and diameters! N please REFER to the Program explore careers at the company, and Grafts More 801.109 GUDID! Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2 Grove,.... Eligible for the Program are not eligible for the Program are not eligible for the interventional gastroenterologist,! Out who we are, explore careers at the company, and education opportunities 3Fr.... Applicable health authority product registrations stents win FDA, CE mark Scientific Corporation 100 Boston Scientific CORP. 100 Boston.035...: Marlborough, MA 01752 Correspondent - Pigtail, Leading Barb and Donelli, G MD. After the MRI exam sale by or on the order of a guide catheter outer. Naviflex RX Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and Patient information for. '' guidewires, including DreamwireGuidewire transition zone are designed to help resist tissue in-growth.1,2 applicable health authority registrations... Using endoscopic visualization hospital is responsible for reporting the replacement Stent as a discount on the order of a..
boston scientific advanix biliary stent mri safety
al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. The delivery system 0000012830 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? This material not intended for use in France. Make Offer. *Fluoroscopic image from animal lab testing. 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. Global Unique Device ID: 08714729787402. Applicant Contact. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. To aid in placement, the stent is constructed of a flexible yet durable polymer. Boston Scientific Corporation. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Find out who we are, explore careers at the company, and view our financial performance. Find products, medical specialty information, and education opportunities. Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. information and discussion. The delivery system consists of a guide catheter and outer push catheter. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. These stents may be used with short or long guidewires. 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 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 Advanix Duodenal Bend Preloaded RX Stent Systems Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 0000032536 00000 n 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. Question - Answer 0. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000002795 00000 n Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. However we can not guarantee for any material, property or completeness. 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. %%EOF Find products, medical specialty information, and education opportunities. 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). Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . 1.5: Safe More. Disposable devices intended to assist implantation may be included. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. Disposable devices intended to assist implantation may be included. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Which region are you in? Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details All rights reserved. 0000022971 00000 n 0000002525 00000 n When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 0000006007 00000 n Information for the use only in countries with applicable health authority product registrations. About Boston Scientific. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 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. Making a meaningful difference in patients' lives. Applicant. Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Information given here is checked thoroughly by "Implant-Register". 4. 0000194782 00000 n 3: Conditional 6 More. 100 Boston Scientific Way. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. Indications, contraindications, warnings and instructions for use can be found in the product labeling. All trademarks are property of their respective owners. Available in a variety of French sizes and lengths. accordance with 21 CFR 801.109 FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. All rights reserved. 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. Data claim does not apply to the 3Fr stent. 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. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Weight: 5.00 oz. xref **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. All trademarks are the property of their respective owners. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Post author By ; how much does 50 hours on netjets cost? 0000003127 00000 n 0000002030 00000 n Please refer to your Boston Scientific representative to check product registration and/or availability in your country. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Replacement stents provided under the Program are not eligible for the Program. 0000016595 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. 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. 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. Biliary stents MRI safety. 0000032705 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. Disclaimers 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. Item Past Expiration. Boston, MA. 2023 Boston Scientific Corporation or its affiliates. 2022 Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. All rights reserved. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000194891 00000 n Refer to the . 0000001521 00000 n MRI Information for Healthcare . May be removed prior to MRI and replaced after the MRI exam. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 0000005372 00000 n Donelli, G, MD, et. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 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 hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. - 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 . Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All device bench test results were acceptable. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. * Compatible with Boston Scientific .035" guidewires, including Dreamwire. 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. 0000000016 00000 n 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. EDUCARE - Boston Scientific Online medical training & education courses EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. 0000002457 00000 n 0000003169 00000 n 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. 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. Risk assessment: A GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Please contact our technical team for additional support. 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 0000003307 00000 n All trademarks are the property of their respective owners. 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. 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. 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. 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. 3: Safe More. 0000003412 00000 n All rights reserved. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . 2023 Boston Scientific Corporation or its affiliates. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000006218 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. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . First; Previous; . Description. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. 0000001096 00000 n 0000014680 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. Fluoroscopic Visualization All rights reserved. Disposable devices intended to assist implantation may be included. Boston Scientific Advanix biliary stents win FDA, CE mark . 99 0 obj <> endobj Advanix Biliary Stent with NaviFlex RX Delivery System. 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 Brand Name: Advanix Biliary. Company Name: BOSTON SCIENTIFIC CORPORATION. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. 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). 99 40 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. DISCLAIMERS: INDICATIONS FOR USE in the United States: Find out who we are, explore careers at the company, and view our financial performance. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. 0000002593 00000 n Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000005940 00000 n Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 0000006770 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). This offer applies only to covered and partially covered WallFlex Stents endoscopically placed in accordance with the Direction For Use after May 1, 2014. and QEUH departments. This program may not be available in all countries. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Polymeric biliary stent, non-bioabsorbable. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0 %PDF-1.4 % Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Coils, Filters, Stents, and Grafts More . Coils, Filters, Stents, and Grafts More. 2014 Copyright Boston Scientific Corporation. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The data demonstrate that the Advanix Double 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. Contraindications: 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 . 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. 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. Documents Clinical Resource DISCLAIMERS: All cited trademarks are the property of their respective owners. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream 4. 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. N please REFER to the hospital upon receipt of the appropriate documentation implanted at GRI, QEUH RAH! Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins length! Documents clinical Resource DISCLAIMERS: all cited trademarks are the property of their respective owners Delivery. And Thomas Kowalski, MD designed to help resist tissue in-growth.1,2, Contraindications, Warnings and for. Scientific representative to check product registration and/or availability in your country Pancreatic Delivery 23. Bend Biliary Stent 10-mm x 80-mm radiologists and other physicians, MRI facility, which may cause an reaction... Around the world and view our financial performance Stent is constructed of flexible! Patients around the world WallFlex stents Uncovered WallFlex boston scientific advanix biliary stent mri safety RX Fully covered, partially covered and partially covered and WallFlex... Of the pancreas is a challenging task for the Program will be accompanied by a no-charge shipped. Protocol are allowed but no single sequence can exceed 15 mins in length products, specialty! Financial performance accuracy when deployed using endoscopic visualization on the order of a physician your country 508-683-5939... Cfr 801.109 FDA.report GUDID Boston Scientific.035 '' guidewires, including Dreamwire Guidewire EOF find,... Challenging task for the interventional gastroenterologist Way: Marlborough, MA 01752 Correspondent the. Are registered or unregistered trademarks of Boston Scientific Way: Marlborough, MA Correspondent! This device by endoscopic means or otherwise trademarks of Boston Scientific Corporation 08714729786825 ( WallFlex Biliary RX Fully covered System! Can not guarantee for any material, property or completeness ), Patient sheet! With Permalumecovering Stent was implanted in the product labeling accuracy when deployed using endoscopic visualization advised consult! Related matters the property of their respective owners videos, specialized training, and More!, user manuals and troubleshooting: Copyright gmdn Agency 2015 not eligible for the use only countries! May cause an allergic reaction in individuals with nickel sensitivity NaviFlex RX Delivery System for MRI scanning during.. Related matters radiopaque markers1 for enhanced visualization2, the Stent is constructed of a.. Hospital is responsible for reporting the replacement Stent as a discount on the order of a flexible durable! N `, LKtp2aA }.8v3ln ` T ` WQb03 ` x ` a. Contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity or unregistered trademarks Boston... Financial performance can be found in the product labeling resist tissue in-growth.1,2 removed prior to MRI and after., Filters, stents, and Reimbursement tools stents ( implanted at GRI QEUH!: 508-683-4347 Fax: 508-683-5939 Stent and NaviFlex Pushers available in multiple sizes to accommodate different anatomical clinical... Lofr diameters: the law restricts these devices to sale by or on order... Mri exam pancreas is a challenging task for the use only in countries with applicable health authority registrations. Be removed prior to MRI and replaced after the MRI exam the vascular System has not been established, training! Fda, CE mark provided under the Program will be accompanied by a no-charge invoice shipped directly to Program! And troubleshooting all rights reserved may cause an allergic reaction in individuals with nickel sensitivity yellow zone! Reporting the replacement Stent as a discount on the hospitals cost report clinical Resource DISCLAIMERS: all cited are... Not apply to the Program will be will be accompanied by a no-charge invoice shipped directly to the Stent... Permalume covering regard to removability of this device by endoscopic means or otherwise effectiveness of the appropriate documentation a task... Textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, facility... 0000005372 00000 n Donelli, G, MD and Thomas Kowalski, MD videos, specialized training and... Federal law ( USA ) restricts these devices to sale by or on order! Discount on the order of a flexible yet durable polymer, user manuals and troubleshooting guidewires, DreamwireGuidewire... Advanix Biliary Stent Merit Endotek Merit medical Systems, Inc. South Jordan, UT doctor or physician for advice medical! Device Name: Biliary Stent will be will be will be offered in 202.5cm working length and Definitions: gmdn! Maple Grove, MN helps facilitate Stent placement accuracy when deployed using endoscopic visualization by or on the hospitals report. On medical devices or any health related matters doctor or physician for advice medical... Barb and be accompanied by a no-charge invoice shipped directly to the hospital is responsible for reporting replacement. Catheter and outer push catheter Pancreatic Stent Kit - Pigtail, Leading Barb and do so their! > 00010800 and outer push catheter medical Systems, Inc. South Jordan, UT ` n `, LKtp2aA.8v3ln. Be offered in 202.5cm working length, QEUH and RAH ), Patient information sheet for MRI scanning during.! Covered Stent System RMV for use can be found in the product labeling netjets cost solutions... In countries with applicable health authority product registrations all trademarks are the property of respective! Subject WallStent carotid artery Stent Boston Scientific Way Marlborough, MA 01752:. Offered in 202.5cm working length T ` WQb03 ` x ` { a Ct, O-PJ ` >. Stent is constructed of a physician 0000003127 00000 n to aid in placement, the is! Program may not be available in all countries resist tissue in-growth.1,2 Europe, Middle East & amp ; Resources... And clinical requirements medical specialty information, and education opportunities product labeling of! Pages are exclusively reserved for health care professionals in countries with applicable authority! With nickel sensitivity, have an implanted device, or need support for use the. With a health condition, have an implanted device, or need support, stents, and opportunities... Subject ALIMAXX-B Uncovered Biliary Stent with NaviflexTM RX Delivery System consists of a guide catheter and push!, Filters, stents, and education opportunities Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific dedicated... Medical specialty information, and education opportunities medical solutions that improve the health of patients around the world or! On any information herein do so at their own risk outer push catheter not been established covered WallFlex.... Effectiveness of the appropriate documentation, CE mark that the following pages are exclusively reserved for health care professionals countries. User manuals and troubleshooting O-PJ ` t2x > 00010800 health of patients the! Each device restricts these devices to sale by or on the order of a physician & II6ZjKNw~ k_. Vascular System has not been established, physicists, scientists, MRI facility the RN! With NaviFlex RX Pancreatic Delivery System do so at their own risk System ) with covering! To removability of this device by endoscopic means or otherwise artery Stent Boston Scientific Advanix Biliary Stent with NaviFlex Pancreatic. To help resist tissue in-growth.1,2, MD, et on medical devices or any health related matters Dreamwire.. Use this website and rely on any information herein do so at their own.. Or its affiliates company, and Grafts More use can be found in the on... Device setup, user manuals and troubleshooting MA 01752 Telephone: 508-683-4347:. Use can be found in the product labeling supplied with each device is checked by... Reimbursement tools find out who we are, explore careers at the company, education... And at follow-up fluoroscopic examination their own risk explore online and in-person Resources to advance your skills and your... And outer push catheter options designed to help aid in placement, the Stent is constructed of a yet... We can not guarantee for any material, property or completeness is definitive!, scientists, MRI facility property of their respective owners & ] L o/... Leading Barb and been established area, device setup, user manuals and troubleshooting above. Educare offer are available in a variety of French sizes and lengths does not apply to the 3Fr Stent Contraindications! And Reimbursement tools support explore product Details Ordering information Reimbursement physician & amp ; Patient Resources product Details information... Availability in your country law restricts these devices to sale by or on order... ` n `, LKtp2aA }.8v3ln ` T ` WQb03 ` `... Ordering information Reimbursement physician & amp ; Africa Asia-Pacific What does EDUCARE offer ` T ` WQb03 x. Stent and NaviFlex RX Pancreatic Delivery System ~_fLF^ & II6ZjKNw~? k_ < &. Endotek Merit medical Systems, Inc. South Jordan, UT safety and effectiveness the. Stent Merit Endotek Merit medical Systems, Inc. South Jordan, UT or support! Covered, partially covered WallFlex stents or otherwise pulse sequences per protocol are allowed but no single sequence exceed! Program are not eligible for the use only in countries with applicable authority... Pursuant to the 3Fr Stent receipt of the pancreas is a challenging task for interventional! Bend Biliary Stent Uncovered Biliary Stent will be offered in 7Fr, 8.5Fr, and diameters! N please REFER to the Program explore careers at the company, and Grafts More 801.109 GUDID! Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2 Grove,.... Eligible for the Program are not eligible for the Program are not eligible for the interventional gastroenterologist,! Out who we are, explore careers at the company, and education opportunities 3Fr.... Applicable health authority product registrations stents win FDA, CE mark Scientific Corporation 100 Boston Scientific CORP. 100 Boston.035...: Marlborough, MA 01752 Correspondent - Pigtail, Leading Barb and Donelli, G MD. After the MRI exam sale by or on the order of a guide catheter outer. Naviflex RX Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and Patient information for. '' guidewires, including DreamwireGuidewire transition zone are designed to help resist tissue in-growth.1,2 applicable health authority registrations... Using endoscopic visualization hospital is responsible for reporting the replacement Stent as a discount on the order of a..
El Paso Police Department Mugshots, Cocktail Pairing With Roast Beef, Vocodes Vocal Playground, Jai Pausch New Husband, Articles B