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