medtronic open pivot heart valve mri safetymedtronic open pivot heart valve mri safety
Ann Thorac Cardiovasc Surg. However, further studies are required to determine the effect of valve gradient on survival. 2009;18(4):445-452. Your use of the other site is subject to the terms of use and privacy statement on that site. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Products March 2004;13(2):231-238. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Disclaimer: This page may include information about products that may not be available in your region or country. Mitral bi-leaflet mechanical heart valve prosthesis An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. 1.5, 3: Cardiovascular A waiver of any terms or provisions shall not be construed as a waiver of any other term or provision. Int J Artif Organs. Reporting Issues and Feedback. All information that you provide in connection with such registration must be complete, accurate, and truthful. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. You just clicked a link to go to another website. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. This device may be used to replace a previously implanted prosthetic heart valve or conduit. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Content on this site is intended for healthcare professionals in countries with applicable health authority product registrations. Ann Thorac Surg. Sezai A, Hata M, Niino T, et al. Note: Manuals can be viewed using a current version of any major internet browser. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism ( e.g. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Krian A. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. Premarket Approval (PMA). Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Emery RW, Petersen RJ, Kersten TE, et al. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer. The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. This Agreement constitutes the entire agreement between Medtronic and you regarding your use of the Licensed Software and supersedes any prior and contemporaneous written or oral agreements or understandings related to the Licensed Software. 2003;75(2):444-452. Update my browser now. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 1996;10(8):660-665. Ann Thorac Surg. Int J Artif Organs. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. March 2004;13(2):231-238. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Healthcare Professionals Indications: The Medtronic Open Pivot Aortic Valved Graft 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. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. The parties hereby expressly waive any right to a trial by jury or class treatment of any claim, demand, action, or cause of action arising out of or relating to the Licensed Software or this Agreement. 1996;2(1):51-58. 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. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information. ) 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Ann Thorac Surg. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Note: Manuals can be viewed using a current version of any major internet browser. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Cardiovascular 1996;10(8):660-665. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Open Pivot Aortic Valved Graft. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. 2001; 4(4):346-353. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. 2000;69:507-512. Security/Privacy of Patient Data. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients. Fifteen years single-center experience with the ATS bileaflet valve. Reproduced with permission from Medtronic, Inc. View Media Gallery Replacement of diseased valves with prosthetic heart valves reduces the morbidity and mortality associated with native. 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. U.S. Food & Drug Administration. More R and Haubold A. Home Brand Name: Medtronic Open Pivot Version or Model: 569 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC 3F THERAPEUTICS, INC. Primary DI Number: 00763000318581 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527232 * Terms of 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. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Update my browser now. Heart Surg Forum. Int J Artif Organs. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. 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). When im-planted in the aortic position there were only . Warnings/Precautions/Adverse Events: Accelerated 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, hyperparathyroidism). LifeLine CardioVascular Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. 1996; 2(1):51-58. Van Nooten GJ, Caes F, Francois K, et al. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. Advancing the Technology of Bileaflet Mechanical HeartValves. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Mechanical Heart Valves, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. 2003;75(2):444-452. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Ann Thorac Cardiovasc Surg. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Term, Termination, Modifications, and Support. Ann Thorac Surg. The reoperation rate was 1.2%. Emery RW, Van Nooten GJ, Tesar PJ. Medtronic, Inc. ("Medtronic") offers RemoteView, which permits a user ("Programmer User") of the Medtronic CareLink2090 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 The Medtronic Open Pivot aortic valved graft is contraindicated in patients unable to tolerate anticoagulation therapy or who exhibit a sensitivity to polyester or materials of bovine origin. New York: Springer Verlag; 1998:53-71. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Heart Surg Forum. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) November 1999;22(11):754-763. Premarket Approval (PMA). Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. J Radiol 1986;67:661-666. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Warnings/Precautions/Adverse Events: Accelerated 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, hyperparathyroidism). Potential Adverse Events: Certain complications may occur with heart valve procedures. Important Safety Information. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. F 708.478.3519. Miscellaneous. Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma. Healthcare Professionals If you continue, you will leave this site and go to a site run by someone else. 2,9,10 Home The initial United States experience with the ATS mechanical cardiac valve prosthesis. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
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