boston scientific epic stent mri safety

0.3. 0 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The results found that the stent was MRI . We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 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. 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 [?] Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. H7YPnf'Sq-. Instructions for Downloading Viewers and Players. 59 0 obj <> endobj By using this site, you consent to the placement of our cookies. 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. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Overview of the ELUVIA Drug- Eluting Stent (DES) III. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Boston Scientific Corporation . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 1.5,3: Conditional 5 More . Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. An inner shaft, with two radiopaque markers, aids in the placement of the stent. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Can I undergo MRI or scanner testing with a stent? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. For more information, please visit: www.bostonscientific.com. Marlborough, MA 01752-1566 . Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. This includes continuous monitoring of the patient's hemodynamic function. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. endstream endobj startxref Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . This press release contains forward-looking statements. Boston Scientific 2 Agenda I. If a device is not shown in the list, it is not MR Conditional. Before sharing sensitive information, make sure you're on a federal government site. 2022 Boston Scientific Corporation or its affiliates. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 5-year data for. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. No deaths have been reported. 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. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. 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 default MRI parameter settings are automatically stored in the Abbott MR Conditional device. 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.". Search for coronary and peripheral disease and valve disease IFUS. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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. "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. 38948-8607. 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 stent delivery system for a balloon expandable stent consists Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. 3: Conditional 6 . 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. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Use this database for coronary intervention, peripheral intervention and valve repair products. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 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. Orthopedic Implants, Materials, and Devices More. The MRI parameter settings are selected at the physician's discretion. The product, pouch label and carton label are all correct and the correct DFU is in the package. The site is secure. Proper patient monitoring must be provided during the MRI scan. 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. Reproduced with Permission from the GMDN Agency. 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. The stent is constrained within a 6F delivery system. All rights reserved. 2*Uax?t} The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. 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-1.5 % The FDA has identified this as a Class I recall, the most serious type of recall. All other trademarks are the property of their respective owners. You can search by model number or product category. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. hbbd``b` C9E tk`/@PHA,HyM! Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. %%EOF "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 is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. 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: Catalog No. 1.5 . Boston Scientific, www.bostonscientific.com . 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. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Epic Stent Boston Scientific, www.bostonscientific.com. For more information, please visit: www.bostonscientific.com. It is required to program the device to MRI Settings as part of the MRI scan workflow. 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. If the stent migrates to the heart, it could cause life-threatening injury. f@ 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. 1) Confirm MRI readiness. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Safe More. VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018 to April 9, 2021 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. 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).