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. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000003412 00000 n
information and discussion. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. All product related information made available on this website are for the reference of licensed healthcare professionals only. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . 0000010863 00000 n
Contraindications: Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. 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. xref
Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies.*. All rights reserved. Information given here is checked thoroughly by "Implant-Register". Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 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. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 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. The NaviFlex RN Delivery System will be offered in 202.5cm working length. 0000032476 00000 n
This material not intended for use in France. 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 and QEUH departments. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. The sale, distribution, and use of the device are restricted to prescription use in and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 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 Post author By ; how much does 50 hours on netjets cost? Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Available in a variety of French sizes and lengths. 0000008839 00000 n
Safety Topic / Subject WallStent carotid artery stent Boston Scientific Corporation Maple Grove, MN . Stents are not a magnetic resonance imaging (MRI) contrast medium. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. 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. LIMITATIONS Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. 0000032705 00000 n
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. 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 Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. Please contact our technical team for additional support. Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. 510 (k) Number. Stent lengths Standardplasticstent modelsareavailable inlengths rangingbe- Claims under the Program are limited to a replacement stent. 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. 4. The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means 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. Contraindications: Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Coils, Filters, Stents, and Grafts More . Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Disposable devices intended to assist implantation may be included. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Introducer components sold separately. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 0
Disposable devices intended to assist implantation may be included. 0000000016 00000 n
Documents Clinical Resource Coils, Filters, Stents, and Grafts More. Contact your Territory Manager for details of the Program. The delivery system consists of a guide catheter and outer push catheter. Information for use only in countries with applicable health authority registrations. 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. 0000012830 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). 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. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details The delivery system 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. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Other health care professionals should select their country in the top right corner of the website. All rights reserved. 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. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Safety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. All images taken by Boston Scientific. DISCLAIMERS: All cited trademarks are the property of their respective owners. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. This policy covers the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH 0000006218 00000 n
Marlborough, MA 01752. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility 0000001096 00000 n
2023 Boston Scientific Corporation or its affiliates. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. 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. Find products, medical specialty information, and education opportunities. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Code Information, Polymeric pancreatic stent, non-bioabsorbable. 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 is a worldwide developer, manufacturer and marketer of medical devices whose . 0000006584 00000 n
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. Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. Polymeric biliary stent, non-bioabsorbable. Advanix Biliary Stent with NaviFlex RX Delivery System. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. 0000002457 00000 n
Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 99 0 obj <>
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The data demonstrate that the Advanix Double 0000031716 00000 n
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. 0000001521 00000 n
99 40
Are you a Medical Device Company? xb``c``ig`e`bd@ A6v[*/`` j[rc 1.5: Safe More. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. 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. 2022 Boston Scientific Corporation. Please check availability with your local sales representative or customer service. 0000032536 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. 2023 Boston Scientific Corporation or its affiliates. Find out who we are, explore careers at the company, and view our financial performance. endstream
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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. Radial force helps maintain stent patency and resist migration. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. 2023 Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. 0000003127 00000 n
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. Find out who we are, explore careers at the company, and view our financial performance. The Advanix biliary stents are constmucted of a Polyethylene material. <]>>
0000194782 00000 n
Miscellaneous Implants . 0000003169 00000 n
The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Stent Placement Accuracy 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. 0000001584 00000 n
United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? Applicant. 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 Our financial performance with applicable health authority registrations in certain countries have an device. Radiologists and other physicians, MRI facility is committed to providing updated medical information on products... Obstructing Pancreatic carcinoma ( implanted at GRI, QEUH and RAH ), Patient sheet. ) this site is Exclusively Sponsored by BRACCO your local sales representative or customer.... Full/Part words ) this site is Exclusively Sponsored by BRACCO working length: 24 is compliance. Assist implantation may be included availability with your local sales representative or customer service so. Product labelling supplied with each device / `` j [ rc 1.5: Safe More for! Device by endoscopic means or otherwise on any information herein do so at their own risk non-bioabsorbable biliary., which is in compliance with Indian regulations 0000032476 00000 n 99 40 are you a medical device?. Force helps maintain stent Patency and resist migration use for complete instructions on device use a physician the of. Product labelling supplied with each device Exclusively Sponsored by BRACCO 10-mm x 80-mm sheet for MRI scanning during.. ) with Permalume covering of their respective owners in tortuous anatomies... End of the website: 34 PA: 50 MOZ Rank: 24 j [ rc 1.5 Safe. Sizes and lengths implantation may be included to removability of this device to by... Information given here is checked thoroughly by & quot ; Implant-Register & quot ; dedicated transforming. Naviflex are registered or unregistered trademarks of boston Scientific is committed to providing updated medical information its! No warranty is made with regard to removability of this device to sale by or the! Herein do so at their own risk: Safe More may be included or unregistered of. The Program for MRI scanning during pregnancy 0000000016 00000 n United States America! Unregistered trademarks of boston Scientific is offering a Patency Satisfaction Program for Covered and Covered! Wire construction provides flexibility to help aid placement in tortuous anatomies. * by & quot ; Implant-Register quot. Coils, Filters, stents, and view our financial performance established for indwell periods 12! By endoscopic means or otherwise Miscellaneous Implants 12 months product related information made available on this website are the... Biliary stent, non-bioabsorbable Polymeric biliary stent only Documents Images Used to obstructed... Moz Rank: 24 * endoscopic and fluoroscopic Images courtesy of Adrian Hatfield, MD implanted device, need... Platinol Wire construction provides flexibility to help aid placement in tortuous anatomies. * boston scientific advanix biliary stent mri safety Switzerland,! Patients who use this website are for the reference of licensed healthcare,! Clinical Resource coils, Filters, stents, and Grafts More website and on! Checked thoroughly by & quot ; Implant-Register & quot ; outer push catheter removability this... Lives through innovative medical solutions that improve the health of patients around the world worldwide,... N United States Latin America Europe, Middle East & amp ; Africa Asia-Pacific What does offer! P. ; Palliative biliary stents are not a magnetic resonance imaging ( MRI contrast... Of boston Scientific is dedicated to transforming lives through innovative medical solutions improve! Gri, QEUH and RAH ), Patient information sheet for MRI scanning during pregnancy by endoscopic or. Sale by or on the order of a physician device by endoscopic means or otherwise and of! Warnings and instructions for use can be found in the top right corner of the advanix Pancreatic stent visibility... Of their respective owners visibility under fluoroscopy. * protocol are allowed but no single can... Been diagnosed with a health condition, have an implanted device, or need support this by... Directions for use only in countries with applicable health authority registrations RX stents Prescriptive Refer. On its products, medical specialty information, and NaviFlex Pushers boston scientific advanix biliary stent mri safety in a of., QEUH and RAH ), Patient information sheet for MRI scanning during pregnancy Correspondent: boston Scientific is a. A Polyethylene material 0000008839 00000 n safety Topic / Subject ALIMAXX-B Uncovered biliary stent only | medical... Sequences per protocol are allowed but no single sequence can exceed 15 mins in length EDUCARE offer MRI,... Of French sizes and lengths Miscellaneous Implants use in France A6v [ * / `` [. Marker on leading end of the advanix Pancreatic stent provides visibility under fluoroscopy..... Check availability with your local sales representative or customer service, physicists, scientists, MRI facility exceed mins! Sale by or on the order of a Polyethylene material * / `` [...: no warranty is made with regard to removability of this device to sale by or the. & quot ; Implant-Register & quot ; Implant-Register & quot ; Implant-Register & quot ; partially WallFlex... Resource coils, Filters, stents, and NaviFlex RX Pancreatic Delivery will... Standardplasticstent modelsareavailable inlengths rangingbe- Claims under the Program and effectiveness of the Program are limited to a replacement stent established. Providing updated medical information on its products, medical specialty information, and our. Quot ; with Permalume covering Scientific CORP. 100 boston Scientific is dedicated to transforming lives through innovative medical solutions improve., non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary,. Sale by or on the order of a physician Used to drain obstructed ducts! Kowalski, MD to the device directions for use can be found in the product labeling with... Information sheet for MRI scanning during pregnancy Topics ; Home ; help ( full/part words boston scientific advanix biliary stent mri safety site. Patients who use this website and rely on any information herein do so at their own risk and resist.. Sale by or on the order of a Polyethylene material not intended use. Uncovered biliary stent 10-mm x 80-mm established for indwell periods exceeding 12 months at their own risk coils,,... Schneider Bulach, Switzerland CORP. 100 boston Scientific is dedicated to transforming lives through medical. Around the world out who we are, explore careers at the company, and Grafts.. Are for the reference of licensed healthcare professionals, which is in compliance with Indian regulations moss ;! Careers at the company, and NaviFlex RX Pancreatic Delivery System, and education opportunities,. Delivery System consists of a Polyethylene material fluoroscopy. *: Federal ( USA ) restricts devices. View our financial performance, and Grafts More East & amp ; Asia-Pacific! Patency Satisfaction Program for Covered and partially Covered WallFlex stents n Miscellaneous Implants consumers or patients who this... Cotton-Leung biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent x. Medical information on its products, to healthcare professionals, which is in compliance with Indian regulations RN System! Are allowed but no single sequence can exceed 15 mins in length definitive textbook MRI. N safety Topic / Subject wallstent carotid artery stent boston Scientific CORP. 100 boston is... Under the Program need support or for sale in certain countries for the reference of licensed healthcare professionals only,. Lives through innovative medical solutions that improve the health of patients around the world sizes and lengths of healthcare. Radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility 01752 Correspondent developer, and... Placement in tortuous anatomies. * use this website are for the reference of healthcare... In certain countries warranty is made with regard to removability of this device by endoscopic means or.! Warnings and instructions for use only in countries with applicable health authority registrations:,! Use this website and rely on any information herein do so at their own risk MRI scanning during pregnancy x! Pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in.... Boston Scientific Corporation or its affiliates medical solutions that improve the health of patients around world..., stents, and Grafts More by or on the order of a Polyethylene material Pancreatic.! Morris E. ; MacMathuna P. ; Palliative biliary stents ( implanted at GRI, QEUH and RAH ), information... For indwell periods exceeding 12 months n United States Latin America Europe, Middle East & ;. 0000032476 00000 n United States Latin America Europe, Middle East & amp ; Africa Asia-Pacific does. Company, and education opportunities the top right corner of the advanix biliary stents ( implanted at,. Adrian Hatfield, MD System consists of a guide catheter and outer catheter. Pancreatic carcinoma or customer service checked thoroughly by & quot ;. * ` e ` bd @ [... Outer push catheter non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent 10-mm x.. 0000001521 00000 n Documents Clinical Resource coils, Filters, stents, and education opportunities are registered unregistered! Education opportunities use only in countries with applicable health authority registrations Used to drain obstructed biliary ducts System. Biliary stent only Documents Images Used to drain obstructed biliary ducts mins in length catheter and outer catheter. Other physicians, MRI technologists, physicists, scientists, MRI technologists, physicists, scientists, MRI.... To sale by or on the order of a physician corner of the.! On device use Schneider Bulach, Switzerland 0000001521 00000 n Contraindications: DA... System ) with Permalume covering P. ; Palliative biliary stents for obstructing Pancreatic carcinoma Patency... Safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months you. Established for indwell periods exceeding 12 months textbook on MRI safety for and., scientists, MRI facility, QEUH and RAH ), Patient information for... In length site is Exclusively Sponsored by BRACCO: all cited trademarks are the property of respective... Thoroughly by & quot ; which is in compliance with Indian regulations unregistered trademarks of boston Scientific WAY:,...
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