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. Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. For more information, please visit: www.bostonscientific.com. PDF Summary of Safety and Effectiveness
Following is some high-level information about preparing for and administering an MRI with patients with a leadless pacemaker, traditional pacemaker, ICD, CRT-D or CRT-P. The site is secure. Catalog No. AccessGUDID - DEVICE: Epic Vascular (08714729805014) 1.5,3: Conditional 5 More . The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. All rights reserved. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The MRI parameter settings are selected at the physician's discretion. 38948-8607. Fortunately, the devices that exhibited po . All other trademarks are the property of their respective owners. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep If needed, perform capture and sense and lead impedance tests. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. "The Epic Stent has been very well-received by physicians across the country. A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). 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. hbbd``b` C9E tk`/@PHA,HyM! Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. 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. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) Epic Stent Boston Scientific, www.bostonscientific.com. BSC began marketing the product internationally following approval in September 2001. Dry Pad 9 x 9 with Silver Antimicrobial Agent. PDF Table of Contents - WATCHMAN %PDF-1.4
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Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI It was launched in the United States in May of 2012. The Epic Stent should not migrate in this MRI environment. Magnetic Resonance MR Conditional 3.0 tesla temperature information MR imaging provides excellent spatial . Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." GMDN Names and Definitions: Copyright GMDN Agency 2015. No amputations were reported through the 12-month period. Dont scan the patient if any adverse conditions are present. HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? Proper patient monitoring must be provided during the MRI scan. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Reproduced with Permission from the GMDN Agency. To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to see examples of checklist screens and get additional details about the checklist. Search for coronary and peripheral disease and valve disease IFUS. The delivery system is compatible with 0.035 in. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 121 0 obj
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. May be removed prior to MRI and replaced after the MRI exam. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. The Sentinol Nitinol Stent System is comprised of two components: the implantable . 2022 Boston Scientific Corporation or its affiliates. Follow the checklist instructions within Merlin PCS Programmer. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . They appreciate the radial force of the stent, which helps allow the artery to stay open, and the flexibility in its design, which helps in deliverability. endstream
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Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. MRI Safety for Cardiovascular Products I Abbott Coronary data supports safety of paclitaxel and ELUVIA DES IV. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Use this database for arrhythmia, heart failure and structural heart products. A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery (ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Find products, medical specialty information, and education opportunities. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] AccessGUDID - DEVICE: Ascerta (08714729802976)
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. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. THE List - MRI Safety Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. "The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. Read our privacy policy to learn more. No deaths have been reported. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Are you a healthcare professional? Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details on default settings and how to save modified settings for scanning. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. By using this site, you consent to the placement of our cookies. 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. THE List - MRI Safety Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel CAUTION: These products are intended for use by or under the direction of a physician. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 0
The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4 percent for the Epic Stent compared to a pre-specified performance goal. Premarket Approval (PMA) %%EOF
Several of these demonstrated magnetic field interactions. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details about checking the MRI Settings status with and without the MRI Activator handheld device. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. If the stent migrates to the heart, it could cause life-threatening injury. [N-'u,uDQOUyUInFl
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1) Confirm MRI readiness. Ideal for the Iliac: The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE THE List - MRI Safety
Boston Scientific Corporation . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Please be sure to read it. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Instructions for Downloading Viewers and Players. Refer to the . All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. A stent delivery system for a balloon expandable stent consists Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. MRI Safety Home Several of these demonstrated magnetic field interactions. Metal Expandable Biliary Stents - Food and Drug Administration No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Newmatic Medical, www.newmaticmedical.com. Device setup, user manuals and troubleshooting, The Boston Scientific Epic Stent Continues to Demonstrate Positive Clinical Outcomes for Patients with Iliac Artery Disease, Twelve-Month Data Presented at TCT 2012 Support Safety and Efficacy of Epic Stent in Iliac Stenting, 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, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 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. This site uses cookies. News Releases - Boston Scientific PDF Summary of Safety and Effectivness (SSED)Template Boston Scientific 2 Agenda I. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. 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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at www.taxus-stent.com. Safety of Magnetic Resonance Imaging in Patients With - Circulation 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. of Abbott Medical Japan GK. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. [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. THE List - MRI Safety 38948-8607. "The positive 12-month data from the ORION trial complement our early launch success and market share gains," said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. There have been 17 complaints and reported injuries related to this issue. An official website of the United States government, : Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. PDF Summary of Safety and Effectiveness Data (Ssed) Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 0.3. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Stents, Drains And Dilators For The Biliary Ducts, Code of Federal Regulations (CFR) Title 21 7.55. Enterra II Model 37800Gastric Electrical Stimulation (GES) SystemEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Enterra TherapyGastric Electrical Stimulation (GES) SystemModels 3116 and 7425 GEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Entovis ProMRI Cardiac Pacing SystemWhich consists of the Entovis pulse generator and the Setrox S and Safio S leadsBIOTRONIK, Inc., http://www.biotronikusa.com/manuals/index.cfmNote that the MR Condi, ENTRI-FLEXEntriFlexNasogastric (NG) Feeding TubeCOVIDIENHazelwood, MO, ENTRISTARJejunum Feeding Tube/Gastric Depression TubeCOVIDIENHazelwood, MO, EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)Expanding Orthopedics Inc.Israel, EOS (Endoluminal Occlusion System) ImplantMedical Murray, Inc., medicalmurray.com, Epic StentBoston Scientific, www.bostonscientific.com, EpicageAlphatec Spine Inc., www.alphatecspine.com, Episealer Knee CondyleEpisurf Medical AB, www.episurf.com, Equi-Flow Valve System(s)15174, SLRKL, SLSKLL, 15175, SLRKLL,SLSKLM, 15179, SLRKLM, SLSKM, 15185,SLRKM, SLSL, 15549, SLRL, SLSLL,15551, SLRLL, SLSLM, 15552, SLRLM,SLSM, 15554, SLRM, 15181, 15555,SLSKL, Equine Pericardial Patch, Model XAGEdwards Lifesciences, www.edwards.com, EquipLite bladeTruphatek International LTD., www.truphatek.com, ES-830 MicroCutter Green StapleCardica, Inc. and Dextera Surgical, www.dexterasurgical.com, EsophaCoil-SRnitinolcoil, stent, filterIntratherapeutics, Inc.St. 2*Uax?t} GMDN Preferred Term Name GMDN Definition; Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Coils, Filters, Stents, and Grafts More. If you are not using the MRI Activator, MRI Settings must be disabled by the patient's device management physician or clinician using the Merlin PCS Programmer and Aveir Link Module (if applicable). The Boston Scientific Epic Stent Continues to Demonstrate Positive 1 0 obj
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