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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. Duplex ultrasound, which measures blood flow through arteries and veins, showed a primary patency (level of un-obstruction) of 94.4 percent, indicating the vast majority of treated lesions remained open through the 12-month follow-up period. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. Introduction II. 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. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . The product, pouch label and carton label are all correct and the correct DFU is in the package. AccessGUDID - DEVICE: Tria Soft (08714729959915) Fortunately, the devices that exhibited po . AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. A Boston Scientific Study of the Epic Self-Expanding Nitonol Stent System in the treatment of Atherosclerotic Lesions in Iliac Arteries 0 amputations at 3 years (106 subjects) 89.9% Freedom from TLR at 3 years (143 lesions) ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications 59 0 obj <> endobj An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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 [?] %PDF-1.5 % Safe More. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 1.5,3: Conditional 5 More . Device setup, user manuals and troubleshooting, (April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS Express, 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. PDF Summary of Safety and Effectiveness Data (Ssed) 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). Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). 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." Catalog No. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 1 0 obj << /Creator (Venous Wallstent SSED vers 2 - Microsoft Word) /CreationDate (D:20020508130644Z) /Title (P980033) /Author (Author: ODE) /Producer (Acrobat PDFWriter 5.0 for Windows NT) /Subject (Issue: 11-16-2001) /Keywords (Posted: 05-08-2002) /ModDate (D:20020508134926-03'00') >> endobj 2 0 obj [ /PDF /Text ] endobj 3 0 obj << /Pages 60 0 R /Type /Catalog /Metadata 87 0 R >> endobj 4 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 8 0 R /F2 10 0 R /F3 12 0 R >> /ProcSet 2 0 R >> /Contents 14 0 R /Thumb 65 0 R >> endobj 5 0 obj << /Kids [ 4 0 R 16 0 R 21 0 R 27 0 R 30 0 R 36 0 R ] /Count 6 /Type /Pages /Parent 60 0 R >> endobj 6 0 obj << /Type /Font /Subtype /TrueType /Name /F0 /BaseFont /TimesNewRoman /FirstChar 32 /LastChar 255 /Widths [ 250 333 408 500 500 833 778 180 333 333 500 564 250 333 250 278 500 500 500 500 500 500 500 500 500 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NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. 3: Conditional 6 . News Releases - Boston Scientific The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. 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 FDA has identified this as a Class I recall, the most serious type of recall. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) You can search by model number or product category. 0.3. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep All rights reserved. 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. 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. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE MR imaging provides excellent spatial . Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. [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. 5-year data for. Search for coronary and peripheral disease and valve disease IFUS. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific, www.bostonscientific.com . It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. 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. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. 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. 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 Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission. Drummond wire (316L SS) orthopedic implant. 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. Note: If you need help accessing information in different file formats, see This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. MRI Safety Home Coils, Filters, Stents, and Grafts More. Instructions for Downloading Viewers and Players. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Overview of the ELUVIA Drug- Eluting Stent (DES) III. "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. Orthopedic Implants, Materials, and Devices More. {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK #>of=eP V}-St:Ur{>J;{n=b^mZ? Testing, Training, and Books Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. AccessGUDID - DEVICE: Ascerta (08714729802976) The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 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. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. f@ of Abbott Medical Japan GK. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. Applicant's Name and Address: Boston Scientific Scimed Inc. One Scimed Place Maple Grove MN 55311-1566 PMA Number: P980033 Date of Notice of Approval to the Applicant: Novermber 16, 2001 2. Magnetic Resonance MR Conditional 3.0 tesla temperature information Please be sure to read it. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI 2*Uax?t} 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. THE List - MRI Safety 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. 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. Several of these demonstrated magnetic field interactions. On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? "The Epic Stent has been very well-received by physicians across the country. 121 0 obj <>stream Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . 300 Boston Scientific Way . This includes continuous monitoring of the patient's hemodynamic function. hbbd``b` C9E tk`/@PHA,HyM! 38948-8607. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. 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. Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. There have been 17 complaints and reported injuries related to this issue. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. 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). Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Marlborough, MA 01752-1566 . Safety of Magnetic Resonance Imaging in Patients With - Circulation Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Metal Expandable Biliary Stents - Food and Drug Administration Coronary data supports safety of paclitaxel and ELUVIA DES IV. 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. Read our privacy policy to learn more. For more information, please visit: www.bostonscientific.com. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. It was launched in the United States in May of 2012. Boston Scientific 2 Agenda I. By using this site, you consent to the placement of our cookies. @Bd!$7@"rAOgx Dry Pad 9 x 9 with Silver Antimicrobial Agent. About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties.
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