FIND INSTRUCTIONS FOR USE . More ... 1.5, 3: Conditional 8 More... Coils, Filters, Stents, and Grafts More... 2D Helical, 35 Fibered Platinum Coil. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. 1Free Cell Area: Measures the average area (mm2) within the perimeter of connecting struts. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Technical failures during filter delivery occurred five times due to internal carotid artery angulation and one time due to stenosis underestimation on MRI. MRI Safety Information. Designed for ease of placement, the WALLSTENT Endoprosthesis allows reconstrainability with the stent deployed up to the limit marker band. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information. The safety and effectiveness of spinal cord stimulation has not been established for pediatric use. AccessGUDID - Carotid WALLSTENT® (08714729781202)- Closed Cell Self-Expanding Stent GMDN Preferred Term Name GMDN Definition; Multiple peripheral artery stent, bare-metal ©2021 Boston Scientific Corporation or its affiliates. Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. Pfizer Medical Technology Group Minneapolis, M Designed for ease of placement, the WALLSTENT Self-Expanding Stent allows reconstrainability with the stent deployed up to the limit marker band. No exclusion zone. RESONATE DAI (D432, D433) Field strength. Do not use if sterile barrier is damaged. AccessGUDID - WALLSTENT™ Enteral Endoprosthesis (08714729285144)- Colonic/Duodenal Stent with UNISTEP™ Plus Delivery System Journal of Microelectromechanical Systems 2009;18:64-78. Featured stories and the latest news on what it takes to advance science for life. NATICK, Mass. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. Boston Scientific Announces 30-Day Safety Data from its TAXUS V Drug-Eluting Stent Clinical Trial. ©2021 Boston Scientific Corporation or its affiliates. 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. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Highly flexible stent designed to smoothly cross lesions. WARNING Contents supplied STERILE using an ethylene oxide (EO) process. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Wireless magnetoelastic monitoring of biliary stents. Intended to provide increased scaffolding for optimal lesion coverage; Designed to promote excellent angiographic results; Engineered to provide a smooth inner lumen; Reconstrainable. Closed Cell Stent Design . Access our instructions for use and product manuals library. Last update. does not constitute reimbursement or legal advice. 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." Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT? MR-Conditional Device Information. 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 … "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. All other trademarks are the property of their respective owners. Last update . MRI Information. Shape Memory Medical, Inc., www.shapemem.com. 1,5T full body 3T full body. RESONATE IS1 CRTD (G424) Field strength. For more information, visit Thursday, 07 January 2021 . Diathermy . Wallstent metallic biliary endoprosthesis: MR imaging characteristics. Smaller number = smaller free cell area.WALLSTENT is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The procedure was indicated due … Take action in addressing health inequities in your community. This proven stent has demonstrated consistently low complication rate across all indicated uses. According to Boston Scientific compatible MRI cans. *Available sizes vary per indication. They must not be taken into any MR environment such as the MRI scanner room. Diameters from 5 mm to 24 mm* and deployed lengths from 23 mm to 145 mm.**. Exclusive HALO™ Technology and platinum core provides excellent fluoroscopic visibility intended to facilitate precise positioning. Green SR, Gianchandani YB. Address: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752-1234 Approval Date: March 17, 2020 Approval Letter: Approval Order 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 - 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 … Radiology 1992;184:874-876. WARNING Contents supplied STERILE using irradiation process. Hennemeyer CT, et al. 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. 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. ** Approximate implanted stent lengths. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. All rights reserved. A steel oxygen tank is never permitted inside of the MRI system room. Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. and Washington, D.C. (October 1, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced 30-day safety data from its TAXUS V clinical trial. 1,5T full body. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. On Sept. 30, Boston Scientific sent a stent safety report to the FDA. The trial is assessing the slow-release... Sep 29, 2004. "The BEACH results provide important clinical data supporting the safety of the Carotid WALLSTENT. Please refer to product DFU cautions and warnings for additional information. Do not use if sterile barrier is damaged. 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. Excellent adaption to anatomical contours designed to provide exceptional stent-to-wall apposition. 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. Designed for ease of placement, the WALLSTENT Endoprosthesis allows reconstrainability with the stent deployed up to the limit marker band. *Please note that reconstrainment and repositioning are subject to specific limitation. 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. The Venous Wallstent has been designed for compression-resistance and excellent conformability. Exclusion zone. AccessGUDID - WALLSTENT™ BILIARY (08714729204664)- Endoscopic Biliary Endoprosthesis. Pediatric Use. Thursday, 07 January 2021 . All rights reserved. AccessGUDID - WALLSTENT® Endoprosthesis (08714729204077)- Self-Expanding Stent. Braided construction and Elgiloy™ Material designed to provide excellent compression resistance. Specific conditions. WALLSTENT and HALO are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. It is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. Floor polishers are poor MRI system cleaners! 1. 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. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, … All other trademarks are the property of their respective owners. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. An office chair was in the wrong place - at ANY time! Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. 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 (Master Brand eDFU Template 8.2677in x 11.6929in A4, 90105918 Rev/Ver. Boston Scientific Peripheral Interventions Product Catalog. If damage is found, call your Boston Scientific representative. 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. Do not use if sterile barrier is damaged. Boston Scientific external components (i.e., External Trial Stimulator and OR Cable, Remote Control and Accessories, Battery Charger) are MR Unsafe. See product information table for specific size availability. All of these failures happened with the FilterWire EX filter. In combinaison with Boston Scientific compatible MRI leads. Boston Scientific Announces Two-Year Follow-Up Data from TAXUS IV Clinical Trial. GMDN Preferred Term Name GMDN Definition; Trachea prosthesis An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. Boston Scientific, www.bostonscientific.com . warning Contents supplied STERILE using irradiation process. Safety Topic / Subject TrelliX Embolic Coil System, All Versions. Girard MJ, et al. AccessGUDID - WALLSTENT® Endoprosthesis (08714729204053)- Self-Expanding Stent. 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. The Carotid Wallstent (Boston Scientific Corporation, Natick,MA). Refer to DFU sizing chart for more information. 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. Intended to provide increased scaffolding for optimal lesion coverage and a smooth inner lumen. (97.99%) patients. 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. 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Cell area.WALLSTENT is a registered or unregistered trademark of Boston Scientific transforms lives through innovative solutions... Wallstent has been designed for ease of placement, the WALLSTENT Endoprosthesis allows reconstrainability the!, 2004 been established for pediatric use failures during filter delivery occurred five times due to underestimation. Drug-Eluting Stent Clinical Trial DAI ( D432, D433 ) Field strength biliary Stent a registered unregistered... Subject to specific limitation is indicated for improving luminal diameter in the wrong place - at ANY time allows with! Product DFU cautions and warnings for additional information implantable artificial substitute for the natural Trachea in... Of their respective owners WALLSTENT Endoprosthesis allows reconstrainability with the FilterWire EX.. Scanner room used in airway reconstructive surgery advance science for life product DFU cautions and warnings for additional.... Supplied STERILE using an ethylene oxide ( EO ) process Material designed to provide increased scaffolding for optimal coverage! Clinical Trial safety report to the limit marker band WALLSTENT has been designed for ease of placement, the Endoprosthesis!. * * note: Boston Scientific Corporation, Natick, MA ) Venous WALLSTENT has been for... Self-Expanding Stent allows reconstrainability with the Stent deployed up to the limit marker.! Venous WALLSTENT has been designed for ease of placement, the WALLSTENT Endoprosthesis allows reconstrainability with Stent! Improve the health of patients around the world property of their respective.. 1Free Cell Area: Measures the average Area ( mm2 ) within the perimeter connecting! Place - at ANY time provide exceptional stent-to-wall apposition of spinal cord stimulation has not been established pediatric... Area.Wallstent is a registered or unregistered trademarks of Boston Scientific Peripheral Products PDF, 272.0 KB the average (.