(,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. For more information, please visit: www.bostonscientific.com. The Boston Scientific Epic Stent Continues to Demonstrate Positive It was launched in the United States in May of 2012. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. Search for coronary and peripheral disease and valve disease IFUS. News Releases - Boston Scientific }7MWJ!%c. Before sharing sensitive information, make sure you're on a federal government site. All rights reserved. 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Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Conditional 6 More. Use this database for arrhythmia, heart failure and structural heart products. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. 3: Conditional 6 . Search for arrhythmia, heart failure and structural heart IFUs. PDF Summary of Safety and Effectivness (SSED)Template Safe More. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Introduction II. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug The .gov means its official.Federal government websites often end in .gov or .mil. Sterile. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Newmatic Medical, www.newmaticmedical.com. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent 2022 Boston Scientific Corporation or its affiliates. By using this site, you consent to the placement of our cookies. 2023 Boston Scientific Corporation or its affiliates. Our ability to provide a total iliac solution, with the market-leading Express LD Stent and our expansive balloon catheter portfolio, allows Boston Scientific to offer a complete line of advanced solutions to physicians and patients.". These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Refer to the . Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System, Distribution Dates: September 21, 2018 to April 9, 2021, Health care providers using the VICI VENOUS STENT System and VICI RDS VENOUS STENT System, Patients who have a procedure using the VICI VENOUS STENT System or VICI RDS VENOUS STENT System, Immediately discontinue use of the device, Remove all affected units from inventory and secure them, Complete the company's Verification Form to acknowledge receipt and report products that will be returned, Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. AccessGUDID - DEVICE: Epic Vascular (08714729805014) Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. BSC began marketing the product internationally following approval in September 2001. PDF Summary of Safety and Effectiveness Data (Ssed) An official website of the United States government, : MRI Safety for Cardiovascular Products I Abbott Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. 38948-8607. The TAXUS Express2 and Express2 systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 12-month Primary Patency by TASC Classification, 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, Epic Vascular Self-Expanding Stent System, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, 0 amputations at 3 years (106 subjects), ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications, Tandem Architecture Stent Design features Macro, Medium and Micro Struts, as well as patented connector patternsdesigned to optimize flexibility, Hybrid Architecture Design with open- and closed-cell geometry engineered to provide flexibility and deployment uniformity, Macro and Micro Struts are engineered to work in tandem for balanced forceeven in tortuous vasculature, Ergonomic handle with two convenient deployment options: thumb wheel and pull grip, Radiopaque stent markers and catheter shaft marker band enhance visibility and simplify placement, Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance, Tandem Architecture Stent Design engineered to bend and flex and reduce the risk of fracture, 0% Amputation of index limb at 12-months (0/111). This site is Exclusively Sponsored by BRACCO. 86 0 obj <>/Encrypt 60 0 R/Filter/FlateDecode/ID[<7D8C813C4252734AB79DD3D747A7C1DD><1D49B7B49C69E9479F78B175C988B6B0>]/Index[59 63]/Length 120/Prev 229479/Root 61 0 R/Size 122/Type/XRef/W[1 2 1]>>stream PDF 2 7 2 Epic Vascular 2 - Boston Scientific 2*Uax?t} Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . As the stent is exposed to body temperature it expands to appose the duct wall. 0.3. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. To look up your patient's system, use the Product Search tool to determine whether your patient's device and leads (if applicable) are safe for an MRI. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . Catalog No. If the stent migrates to the heart, it could cause life-threatening injury. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 300 Boston Scientific Way . %%EOF MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. f@ Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the ORION trial and chairman of the Department of Vascular Surgery at The Cleveland Clinic Foundation, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. 1.5,3: May be removed prior to MRI and replaced after the MRI exam. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. You can search by product, model number, category or family. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, MRI Ready Systems Manual or MRI Ready Leadless System Manual, Interrogate the device with the Merlin PCS Programmer. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol).

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