From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). Use of these devices may cause serious injuries or death. 59 0 obj
<>
endobj
The stent is constrained within a 6F delivery system.
MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Conditional 6 More. For more information, please visit: www.bostonscientific.com. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. BSC began marketing the product internationally following approval in September 2001. Follow the checklist instructions within Merlin PCS Programmer.
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI 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.". 2022 Boston Scientific Corporation or its affiliates. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan.
Fortunately, the devices that exhibited po . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Orthopedic Implants, Materials, and Devices More. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . No amputations were reported through the 12-month period. 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. IFbj.)D^7TE.V\Bz->/. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. 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." 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. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook A stent delivery system for a balloon expandable stent consists Can I undergo MRI or scanner testing with a stent? The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins.
PDF Table of Contents - WATCHMAN "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Boston Scientific, www.bostonscientific.com . Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 3: Conditional 6 . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Marlborough, MA 01752-1566 . The results found that the stent was MRI . "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. 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 MRI parameter settings are selected at the physician's discretion. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP.
Class 3 Device Recall Sentinol Nitinol Biliary Stent System The Epic Stent should not migrate in this MRI environment. 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 [?] Search for arrhythmia, heart failure and structural heart IFUs. The revised Express2 bare-metal stent DFU will be available shortly. 5-year data for. }7MWJ!%c. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 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. This includes continuous monitoring of the patient's hemodynamic function. About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to check the MRI scan parameter tables for the applicable scan and identify the settings for RF Transmit Conditions and scan regions. 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. 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. All other trademarks are the property of their respective owners. "The Epic Stent has been very well-received by physicians across the country. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. Drummond wire (316L SS) orthopedic implant. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. You can search by model number or product category.
Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent Introduction II. Disposable devices associated with implantation may be included. The delivery system is compatible with 0.035 in.
AccessGUDID - DEVICE: Epic Vascular (08714729805014) The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. If needed, perform capture and sense and lead impedance tests. MR imaging provides excellent spatial . Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. 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). If the stent migrates to the heart, it could cause life-threatening injury. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t
We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 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: As the stent is exposed to body temperature it expands to appose the duct wall. Epic Stent Boston Scientific, www.bostonscientific.com. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Use this database for arrhythmia, heart failure and structural heart products. 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. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. All rights reserved. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires.
MRI Safety Home 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. 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. 1.5,3: Conditional 5 More . Are you a healthcare professional? All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Precautions
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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The Sentinol Nitinol Stent System is comprised of two components: the implantable . CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). 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. 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. 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. Search for coronary and peripheral disease and valve disease IFUS. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Before sharing sensitive information, make sure you're on a federal government site. (0.89mm) guidewires. :V
m_C.4c9M/:4"Pp^8r_h_(2KDz]H4{T["y&7xPWe8Iw]rp%c2D|t-++@n 6j.#C\Ks
_R]O%[D8Y}[1HshY$7\.
38948-8607. Note: If you need help accessing information in different file formats, see
Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Indicates a third party trademark, which is property of its respective owner.
PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA.
PDF 2 7 2 Epic Vascular 2 - Boston Scientific The Boston Scientific ELUVIA Drug-Eluting Vascular Stent System is a medical device containing an ancillary medicinal substance, which provides a mechanical scaffold for vascular lumen support (the stent component) and a pharmacological agent (paclitaxel) targeted towards reducing the injury response that leads to restenosis after
THE List - MRI Safety 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 [?] Catalog No. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Newmatic Medical, www.newmaticmedical.com. 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. "The performance of the Epic Stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic Stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.". 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. 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. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. %PDF-1.5
%
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2022 Boston Scientific Corporation or its affiliates.
PDF Summary of Safety and Effectiveness Data (Ssed) Overview of the ELUVIA Drug- Eluting Stent (DES) III. 1.5 .
You can search by product, model number, category or family. %PDF-1.4
%
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 121 0 obj
<>stream
Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . 38948-8607.
MRI Safety for Cardiovascular Products I Abbott AccessGUDID - DEVICE: Ascerta Firm (08714729861720) {}(;]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? May be removed prior to MRI and replaced after the MRI exam. 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. Instructions for Downloading Viewers and Players. 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. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 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 The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 [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. 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).