medtronic open pivot heart valve mri safety

by on April 8, 2023

2009;18(4):445-452. Thus, a patient with any heart valve prosthesis listed in Table 1 undergoing an MRI procedure using an MR system operating at 1.5 T or less would not be at risk with regard to movement or dislodgement of the implant. 2001;4(4):346-352. At any time upon Medtronics request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. Click OK to confirm you are a Healthcare Professional. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. The Medtronic Open Pivot AP360, AP, and Standard valves provide exceptional implantability, performance, and durability.1-3, Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Session Key as used herein means a unique token active for a limited period of time generated by the Remote Viewer. November 1999;22(11):754-763. These improvements led to low thromboembolic rates of 1.25% per patient year and encouraged a reduction in anticoagulation treatment to an INR of 1.5 to 2.5 in isolated aortic valve replacement cases [ 179 ]. Healthcare Professionals You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Accelerated structural deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, or hyperparathyroidism). Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for Aortic Valve and Ascending Aorta Replacement, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Cardiac Surgery Education, Innovation, and Evidence, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Note: Manuals can be viewed using a current version of any major internet browser. Healthcare Professionals MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. Int J Artif Organs. This Agreement shall be governed by and interpreted, construed, and enforced in accordance with the laws of the State of Minnesota (exclusive of the choice of law rules thereof). Cardiovascular Home CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Home Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User: ) Registration. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Single-plane orifice facilitates valve seating and implant regardless of suture technique. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 2009;18(4):445-452. With an updated browser, you will have a better Medtronic website experience. Advanced Discussion (show/hide) References Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Brand Name: Open Pivot Version or Model: 500FA23 Commercial Distribution Status: Not in Commercial Distribution Catalog Number: Company Name: MEDTRONIC, INC. Primary DI Number: 00613994960412 Issuing Agency: GS1 Commercial Distribution End Date: October 21, 2019 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Eur J Cardio-thorac Surg. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Products March 2004;13(2):231-238. Your use of the other site is subject to the terms of use and privacy statement on that site. Low target-INR anticoagulation is safe in selected aortic valve patients with the Medtronic Open Pivot mechanical prosthesis: Long-term results of a propensity-matched comparison with standard. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU OR YOUR ASSOCIATED HOSPITAL, CLINIC, OR PRACTICE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE, SESSIONS KEYS, OR THESE TERMS OF USE (WHETHER IN WARRANTY, CONTRACT, TORT, OR OTHERWISE, INCLUDING NEGLIGENCE, AND EVEN IF MEDTRONIC HAS BEEN ADVISED OF THE POSSIBILITY THEREOF), INCLUDING WITHOUT LIMITATION MEDICAL EXPENSES, LOSS OF REVENUE OR PROFITS, OR DAMAGES RESULTING FROM LOSS, MISAPPROPRIATION, OR UNAUTHORIZED OR MALICIOUS ACCESS TO OR MODIFICATION OF DEVICE DATA, OR FROM MISTAKES, OMISSIONS, OR DELAYS IN TRANSMISSION OF INFORMATION, OR FROM INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS, VIRUSES OR FAILURES OF PERFORMANCE, OR FROM THE IMPACT OF THE USE ON YOUR SYSTEM. Krian A. Cardiovascular Products Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required. A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Clinical results of a large series of ATS valve implants. Healthcare Professionals Heart Valves Surgical Logging of Session Activity. 2001;4(4):346-352. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Heart Valve Replacement - Surgical 1996; 2(1):51-58. Premarket Approval (PMA). More than 140,000 valves have been implanted worldwide. Ann Thorac Cardiovasc Surg. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Open Pivot Mechanical Heart Valve. 2,3 . This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS Open Pivot Mechanical Heart Valves AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Int J Artif Organs. Ann Thorac Cardiovasc Surg. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. Five-year follow up of the ATS mechanical heart valve. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America. ) Medtronic, Inc. (Medtronic) offers RemoteView, which permits a user (Programmer User) of the Medtronic CareLink 2090 Programmer (Programmer) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (Remote Viewer), including remote health care professionals or Medtronic representatives. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. Five-year follow up of the ATS mechanical heart valve. J Heart Valve Dis. Permissions. (4) Hassler M, et al. Accessed April 20, 2021. Advancing the Technology of Bileaflet Mechanical HeartValves. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M MEDTRONIC ATS MEDICAL, INC. P990046 S065: 10/21/2022: open pivot heart valve, open pivot aortic valved g. MEDTRONIC ATS MEDICAL, INC. P990046 S064: 03/10/2022: medtronic open pivot heart valve, medtronic open p. MEDTRONIC ATS MEDICAL, INC. P990046 S063: 03/11/2022: open pivot mechanical valve (ophv), open pivot aor. Proven Graft Material The Suture Superstore that provides surgical disposables, sutures & more. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. March 2004;13(2):231-238. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Ann Thorac Surg. Indications for Use The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, or malfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Technical Support. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Ann Thorac Surg. J Heart Valve Dis. Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. U.S. Food & Drug Administration. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. Home 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. Accessed April 20, 2021. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. In: Krian A, Matloff JM, Nicoloff DM, eds. However, further studies are required to determine the effect of valve gradient on survival. Email: Corporate.UDI@medtronic.com CLOSE . Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. With an updated browser, you will have a better Medtronic website experience. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis.

Section 8 Raleigh, Nc Houses, Articles M

Previous post: