NATICK, Mass. Boston Scientific develops, manufactures and distributes a wide array of products to meet the needs of a health care professionals and patients globally. Boston Scientific. RESONATE IS1 CRTD (G424) Field strength. BOSTON SCIENTIFIC - GALWAY WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC: Back to Search Results: Model Number UNK479: Device Problem Occlusion Within Device (1423) Patient Problem Reocclusion (1985) Event Date 01/29/2013: Event Type Injury Event Description Same case as mdr id# 2134265-2013-00966, 2134265-2013 … The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and … ** Approximate implanted stent lengths. 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. 880 MRI 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. It was reported to boston scientific corporation that two wallstent biliary endoprostheses were implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2010 as part of a post market study. This advanced delivery system allows the endoscopist to resheath a partially deployed %PDF-1.7 %���� 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. Designed to provide excellent compression resistance, WALLSTENT™ Endoprosthesis Stent provides increased scaffolding for optimal lesion coverage. Last update . tИ�@q��0��!�\�����M�Nk [�X�Rz;��S� dc�>@< Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. AccessGUDID - WALLSTENT™ BILIARY (08714729204664)- Endoscopic Biliary Endoprosthesis. October 6, 2009 - Boston Scientific Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. Four radiopaque marker bands on the Unistep Plus delivery … Below is an excerpt of Section 6.12 from the Directions for Use detailing the safety of performing MRI following the placement of a Promus ELITE™ Stent. AccessGUDID - WALLSTENT™ BILIARY (08714729229872)- Endoscopic Biliary Endoprosthesis. WALLSTENT and HALO are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Brand Name: WALLSTENT BILIARY Version or Model: H965430800 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION What MRI safety information Section 6.11 Magnetic Resonance Imaging (MRI) Safety Information . MRI Safe: The Wallstent Venous Endoprosthesis has shown no deflection or torque in the area of maximum spatial gradient (450 gauss centimeter) of a 1.5 tesla MRI system under conditions that produced a Specific Absorption Rate (SAR) of 1.3 W/kg. BOSTON SCIENTIFIC - GALWAY PLACEHIT¿ BILIARY WALLSTENT¿ STENT, CAROTID Back to Search Results Model Number H965SCH650750 Device Problems Stent … The Boston Scientific Launches Sentinol Self-Expanding Nitinol Biliary Stent System (April 8, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced the U.S. launch of its Sentinol™ Self-Expanding Nitinol Biliary Stent System (Sentinol), which has been cleared by the U.S. Food and Drug Administration for the treatment of malignant biliary obstruction. Trade name WALLSTENT 7F PLACEHIT, SELF-EXPANDABLE METAL STENT FOR BILIARY Product Code H965SCH6507X0 Manufacturer of the medical device BOSTON SCIENTIFIC CORPORATION Category Name The covered Wallstent was inserted after unresectability was confirmed. Listing a study does not mean it has been evaluated by the … To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid) stents using magnetic resonance angiography in vitro. Indications:  1 = Tracheobronchial, 2 = Transjugular Intrahepatic Portosystemic Shunt (TIPS), 3 = Transhepatic Biliary, 4 = Iliac, 5 = Venous, Fully open dimensions:  to determine implanted length, refer to Box Label. Purpose . Disease stages were based on the findings of CT and EUS. Boston Scientific Boston Scientific’s products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. Specific conditions. Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA … About Boston Scientific Boston Scientific is a worldwide developer, manufacturer and marketer of 1,5T full body 3T full body. 1.5: Safe More... Orthopedic Implants, Materials, and Devices More... corVCD (implant for vessel coupling) corLife GBR, www.corlife.eu. Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA … Safety Topic / Subject Cortical bone screw small (titanium alloy) orthopedic implant Zimmer Warsaw, I. Non‐clinical testing has demonstrated that WALLSTENT Transhepatic Biliary is MR Conditional for single and overlapping lengths up to 94 mm. Boston Scientific. Please email info@medicalmaterials.com or call us at … Model #: 7233 Epic Biliary Endoscopic Stent Systems - 10mm x 80mm. 9. $40.00. Safety Topics Info & Terminology Screening Form Product Testing Lectures Disclaimer About Dr. Shellock Priority Email Accidents An office chair was in the wrong place - at ANY time! 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. $150.00) OEM: Boston Scientific; Model #: 6981; Year: 2016 Size: 10mm x 100mm Current Stock: This item is out of stock. The Wallstent Endoprosthesis Stent has been engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. In 46 patients, a covered Wallstent was preceded by a plastic biliary stent (N = 21) or by a Boston Scientific Corporation and Stryker Neurovascular, www.stryker.com . Boston Scientific Placehit Biliary Wallstent - Independent Reviews by Clinicians for Clinicians. Designed for ease of placement, the WALLSTENT™ Endoprosthesis Stent allows reconstrainability with the stent deployed up to the limit marker band. Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. TrelliX Embolic Coil System, All Versions Shape Memory Medical, Inc., www.shapemem.com MRI Safety Information Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. They continue to innovate in these areas and are extending their innovations into new geographies and high-growth adjacency markets. Migration Resistance Looped and flared stent ends Materials and Methods . 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. Brand Name: WALLSTENT® Endoprosthesis Version or Model: H965403330 Commercial Distribution Status: In Commercial Distribution Catalog Number: H965403330 What MRI safety information does the labeling BOSTON SCIENTIFIC - GALWAY WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC Back to Search Results Model Number H965403320 Device … The delivery system is braided and offers excellent trackability and pushability Boston Scientific Scimed has not marketed the Wallstent Venous Endoprosthesis for the central vein indication. 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