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WARNING Contents supplied STERILE using an ethylene oxide (EO) process. ©2021 Boston Scientific Corporation or its affiliates. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Safety Topic / Subject TrelliX Embolic Coil System, All Versions. Boston Scientific Announces Two-Year Follow-Up Data from TAXUS IV Clinical Trial. Do not use if sterile barrier is damaged. does not constitute reimbursement or legal advice. ©2021 Boston Scientific Corporation or its affiliates. VENOUS WALLSTENT™ Self-Expanding Stent 2020-03 < en > ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT? Excellent adaption to anatomical contours designed to provide exceptional stent-to-wall apposition. Boston Scientific (Master Brand eDFU Template 8.2677in x 11.6929in A4, 90105918 Rev/Ver. On Sept. 30, Boston Scientific sent a stent safety report to the FDA. Closed Cell Stent Design . The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. GMDN Preferred Term Name GMDN Definition; Bare-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. WALLSTENT and HALO are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Designed for ease of placement, the WALLSTENT Endoprosthesis allows reconstrainability with the stent deployed up to the limit marker band. AccessGUDID - WALLSTENT™ BILIARY (08714729204664)- Endoscopic Biliary Endoprosthesis. Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. Wireless magnetoelastic monitoring of biliary stents. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. A steel oxygen tank is never permitted inside of the MRI system room. If damage is found, call your Boston Scientific representative. Cardiac Resynchronization Therapy (CRT) Devices, Transcatheter Aortic Valve Replacement (TAVR), Medical Device ID Cards - Pacemaker, ICD, & CRT devices, Remote Patient Monitoring and Diagnostic Monitoring, Boston Scientific Peripheral Interventions Product Catalog, ADVANTICS™ Innovative Healthcare Solutions. Smaller number = smaller free cell area.WALLSTENT is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Braided construction and Elgiloy™ Material designed to provide excellent compression resistance. Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. All rights reserved. 1,5T full body. All of these failures happened with the FilterWire EX filter. Technical failures during filter delivery occurred five times due to internal carotid artery angulation and one time due to stenosis underestimation on MRI. Green SR, Gianchandani YB. Designed for ease of placement, the WALLSTENT Endoprosthesis allows reconstrainability with the stent deployed up to the limit marker band. The Venous Wallstent has been designed for compression-resistance and excellent conformability. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. warning Contents supplied STERILE using irradiation process. Do not use if sterile barrier is damaged. Featured stories and the latest news on what it takes to advance science for life. All other trademarks are the property of their respective owners. Take action in addressing health inequities in your community. "Boston Scientific's carotid artery stenting program is one of our top priorities for improving the quality of patient care through less-invasive devices and procedures," said Paul LaViolette, Boston Scientific Chief Operating Officer. It concluded, ''The product failure rate does not represent an unreasonable risk to patient health and is within the range of rates estimated for currently available products." C-codes are used for hospital outpatient device reporting for Medicare and some private payers. BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT MONORAIL STENT, CAROTID: Back to Search Results: Model Number UNK60: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem No Known Impact Or Consequence To Patient (2692) Event Type Injury Event Description Same article as: mdr id#: 2134265-2013-08400, 2134265-2013-08402, 2134265-2013 … Last update. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. The Carotid Wallstent (Boston Scientific Corporation, Natick,MA). Highly flexible stent designed to smoothly cross lesions. 1 Boston Scienti≤c (Master Brand DFU Template 8.2677in x 11.6929in A4, 90105918AR), eDFU, MB, Carotid WALLSTENT, EN, 91018684-01A Black E 5.0 ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. All rights reserved. GMDN Preferred Term Name GMDN Definition; Trachea prosthesis An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. No exclusion zone. MRI Information. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. This proven stent has demonstrated consistently low complication rate across all indicated uses. 1. All other trademarks are the property of their respective owners. Specific conditions. WARNING Contents supplied STERILE using irradiation process. The Wallstent Self-Expanding Stent has been engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. 1,5T full body 3T full body. AccessGUDID - Carotid WALLSTENT® (08714729781202)- Closed Cell Self-Expanding Stent Diameters from 5 mm to 24 mm* and deployed lengths from 23 mm to 145 mm.**. Radiology 1992;184:874-876. For more information, visit MR-Conditional Device Information. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. In combinaison with Boston Scientific compatible MRI leads. RESONATE DAI (D432, D433) Field strength. They must not be taken into any MR environment such as the MRI scanner room. Pediatric Use. Journal of Microelectromechanical Systems 2009;18:64-78. Floor polishers are poor MRI system cleaners! An office chair was in the wrong place - at ANY time! Address: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752-1234 Approval Date: March 17, 2020 Approval Letter: Approval Order Boston Scientific Peripheral Interventions Product Catalog. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Refer to DFU sizing chart for more information. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. AG), eDFU, Carotid WALLSTENT, EN, 90451284-01A ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. RESONATE IS1 CRTD (G424) Field strength. Exclusive HALO™ Technology and platinum core provides excellent fluoroscopic visibility intended to facilitate precise positioning. (97.99%) patients. The trial is assessing the slow-release... Sep 29, 2004. Thursday, 07 January 2021 . Diathermy . The procedure was indicated due … Shape Memory Medical, Inc., www.shapemem.com. and Washington, D.C. (October 1, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced 30-day safety data from its TAXUS V clinical trial. Boston Scientific, www.bostonscientific.com . Exclusion zone. Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. Pfizer Medical Technology Group Minneapolis, M Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. Designed for ease of placement, the WALLSTENT Self-Expanding Stent allows reconstrainability with the stent deployed up to the limit marker band. AccessGUDID - WALLSTENT™ Enteral Endoprosthesis (08714729285144)- Colonic/Duodenal Stent with UNISTEP™ Plus Delivery System The safety and effectiveness of spinal cord stimulation has not been established for pediatric use. Hennemeyer CT, et al. Please refer to product DFU cautions and warnings for additional information. "The BEACH results provide important clinical data supporting the safety of the Carotid WALLSTENT. The closed-cell Carotid WALLSTENT Endoprosthesis engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. ** Approximate implanted stent lengths. Last update . It is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. Intended to provide increased scaffolding for optimal lesion coverage and a smooth inner lumen. MRI Safety Information. STENT, CAROTID: Back to Search Results: Model Number H7493915010240: Device Problems Stent (515); Difficult or Delayed Positioning (1157) Patient Problem No Consequences Or Impact To Patient (2199) Event Date 10/21/2013: Event Type Injury Event Description It was reported that deployment issues occurred. Girard MJ, et al. 1Free Cell Area: Measures the average area (mm2) within the perimeter of connecting struts. Thursday, 07 January 2021 . AccessGUDID - WALLSTENT® Endoprosthesis (08714729204077)- Self-Expanding Stent. AccessGUDID - WALLSTENT® Endoprosthesis (08714729204053)- Self-Expanding Stent. Intended to provide increased scaffolding for optimal lesion coverage; Designed to promote excellent angiographic results; Engineered to provide a smooth inner lumen; Reconstrainable. and SAN FRANCISCO, Nov. 8, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive outcomes from the CABANA post-approval study of the Carotid WALLSTENT ® Monorail ® Endoprosthesis used in conjunction with its FilterWire EZ™ Embolic Protection System in routine clinical practice. Boston Scientific Announces 30-Day Safety Data from its TAXUS V Drug-Eluting Stent Clinical Trial. MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION: Non-clinical testing has demonstrated that the VENOUS WALLSTENT™ system is MR Conditional for single and overlapping lengths up to 120 mm. NATICK, Mass. *Please note that reconstrainment and repositioning are subject to specific limitation. The Sentinol system expands Boston Scientific's family of high-performance self-expanding biliary stents, which includes the WALLSTENT® Endoprosthesis and the Symphony® Biliary Stent. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, … More ... 1.5, 3: Conditional 8 More... Coils, Filters, Stents, and Grafts More... 2D Helical, 35 Fibered Platinum Coil. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Access our instructions for use and product manuals library. Wallstent metallic biliary endoprosthesis: MR imaging characteristics. According to Boston Scientific compatible MRI cans. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this 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. BOSTON SCIENTIFIC - GALWAY PLACEHIT¿ BILIARY WALLSTENT¿ STENT, CAROTID: Back to Search Results: Model Number H965SCH650750: Device Problems Stent (515); Fracture (1260) Patient Problem No Consequences Or Impact To Patient (2199) Event Date 04/13/2012: Event Type Injury Event Description It was reported that subsequent to a stenting treatment procedure, a stent fracture … See product information table for specific size availability. Boston Scientific external components (i.e., External Trial Stimulator and OR Cable, Remote Control and Accessories, Battery Charger) are MR Unsafe. Do not use if sterile barrier is damaged. Boston Scientific Corp; Natick, Mass), the Palmaz Stent (Cordis Corp; Miami, Fla), and theW allstent (Schneider [Europe] AG; Biilach, Switzerland).24-32 Initially made without a covering, the limitation of these prostheses became quickly evident, as tumoral regrowth occurred rapidly through the metallic meshes. *Available sizes vary per indication. FIND INSTRUCTIONS FOR USE . GMDN Preferred Term Name GMDN Definition; Multiple peripheral artery stent, bare-metal

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