Coils, Filters, Stents, and Grafts More. 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. If the stent migrates to the heart, it could cause life-threatening injury. of Abbott Medical Japan GK. Dont scan the patient if any adverse conditions are present. Precautions Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Orthopedic Implants, Materials, and Devices More. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 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 Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 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. Boston Scientific, www.bostonscientific.com . The product, pouch label and carton label are all correct and the correct DFU is in the package. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. With our stent systems, MRI analyses can now be performed immediately.". Safety of Magnetic Resonance Imaging in Patients With - Circulation "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. 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. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. No amputations were reported through the 12-month period. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . If a device is not shown in the list, it is not MR Conditional. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. 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. 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. All other trademarks are the property of their respective owners. Follow the checklist instructions within Merlin PCS Programmer. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. There have been 17 complaints and reported injuries related to this issue. The results found that the stent was MRI . The MRI parameter settings are selected at the physician's discretion. 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). PDF Table of Contents - WATCHMAN 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.". Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Find out who we are, explore careers at the company, and view our financial performance. It is required to program the device to MRI Settings as part of the MRI scan workflow. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) 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). 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. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Indicates a trademark of the Abbott group of companies. 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. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. 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. 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. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . 59 0 obj <> endobj IFbj.)D^7TE.V\Bz->/. PDF 2 7 2 Epic Vascular 2 - Boston Scientific 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. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. 38948-8607. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an 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. MR imaging provides excellent spatial . When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 2022 Boston Scientific Corporation or its affiliates. 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.