Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Sezai A, Hata M, Niino T, et al. 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. Ann Thorac Surg. Open Pivot Mechanical Heart Valves. Heart Valves Surgical Update my browser now. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. what happened in 1906 in europe MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Ann Thorac Surg. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Open Pivot Mechanical Heart Valve, Medtronic Open Pivot Mechanical Heart Valves, While mechanical valves have been used for heart valve replacement for nearly 50 years, the Medtronic Open Pivot platform brings a fundamentally different design to bileaflet mechanical valves. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. With an updated browser, you will have a better Medtronic website experience. The SJM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. Safety Topic / Subject Article Text 179: . If you continue, you may go to a site run by someone else. Ann Thorac Cardiovasc Surg. The Suture Superstore that provides surgical disposables, sutures & more. 2000;69:507-512. Phone Numbers. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Ln N Plymouth MN 55447-5439: Manufacturer Reason for Recall: Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. Home Products Limitations of Liability. Fifteen years single-center experience with the ATS bileaflet valve. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 1996;6: 273-79. You just clicked a link to go to another website. Your Acknowledgements. U.S. Food & Drug Administration. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. Term, Termination, Modifications, and Support. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Emery RW, Petersen RJ, Kersten TE, et al. In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. Update my browser now. 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). Clinical results of a large series of ATS valve implants. Legal Compliance. Heart Surgery Forum. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Emery RW, Petersen RJ, Kersten TE, et al. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. With an updated browser, you will have a better Medtronic website experience. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Products Medtronic open pivot mechanical valves offer exceptional performance: Remarkable thromboresistance: Continuous passive washing provides for gentle treatment of blood cells and low levels of hemolysis and thromboembolic events. Products 1.5, 3: 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Ann Thorac Surg. This device may be used to replace a previously implanted prosthetic heart valve or conduit. 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. 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. With an updated browser, you will have a better Medtronic website experience. MRI Resources, For clinicians whose patients have a Medtronic system. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. 1996;2(1):51-58. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Fifteen years single-center experience with the ATS bileaflet valve. Treatments & Therapies Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. 2001; 4(4):346-353. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Update my browser now. Limited License Grant. Please consult the approved indications for use. IN NO EVENT SHALL MEDTRONIC BE LIABLE TO YOU FOR INTERCEPTION OR COMPROMISE OF ANY INFORMATION OR FOR ANY RECORD OR OTHER COMMUNICATION PROVIDED IN CONNECTION WITH YOUR USE OF THE LICENSED SOFTWARE. Cardiovascular Premarket Approval (PMA). You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. With an updated browser, you will have a better Medtronic website experience. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Five-year follow up of the ATS mechanical heart valve. If you continue, you will leave this site and go to a site run by someone else. J Heart Valve Dis. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Medtronic may modify, disable, or terminate your use or Medtronics support of the Licensed Software at any time, including by providing notices on a Medtronic website. 1996;2(1):51-58. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Aortic Valved Graft (AVG), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Aortic Valved Graft (AVG), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Emery RW, Petersen RJ, Kersten TE, et al. Patients Advanced Discussion (show/hide) References Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. LifeLine CardioVascular Any maintenance and support services provided by Medtronic shall be at Medtronics sole discretion. 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. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. Adverse events can include: angina, cardiac dysrhythmias, death, endocarditis, heart failure, hemolytic anemia, infection other than endocarditis, myocardial infarction, root dilatation, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. Tex Heart Inst J. With an updated browser, you will have a better Medtronic website experience. Emery RW, Van Nooten GJ, Tesar PJ. When im-planted in the aortic position there were only . The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. , chronic renal failure, hyperparathyroidism). ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: 2010;139:1494-1500. The leaflets are made of solid pyrolytic carbon with a thin titanium band. Conclusion: The Medtronic Open Pivot valved conduit is a safe and durable option for aortic root replacement, and is associated with low morbidity and 10-year survival of 79%. Clinical results of a large series of ATS valve implants. J Heart Valve Dis. Medtronic open pivot mechanical valves offer exceptional performance: The Open Pivot AP360 provides these additional features: The Open Pivot AP provides these additional features: The Open Pivot Standard Aortic Valve provides these additional features: The Open Pivot Standard Mitral Valve provides these additional features: A variety of accessories are available to quickly and easily select the optimal valve type, appropriate valve size, and ideal placement for valve positioning. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Sezai A, Shiono M, Orime Y, et al. Medtronic Open Pivot Heart Valve Instructions for Use. Home 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. Advancing the Technology of Bileaflet Mechanical HeartValves. Update my browser now. 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. Update my browser now. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Click Continue to close this window and view the sites content. . The adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 2000;69:507-512. 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. Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Home Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 2001;4(4):346-352. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Medtronic Open Pivot Mechanical Valves Offer Exceptional Performance Remarkable Thromboresistance Continuous passive washing provides for gentle treatment of blood cells and low levels Excellent Hemodynamics In-vivo studies demonstrates improved hemodynamic performance following device implant. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Heart Valves Surgical 2003;75(2):444-452. Home 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. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. FDA Determined Cause 2: Labeling mix-ups . Five-year follow up of the ATS mechanical heart valve. Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. 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. Cardiovascular March 2004;13(2):231-238. 25 November 2022 0 Comments. However, further studies are required to determine the effect of valve gradient on survival. Cardiovascular J Heart Valve Dis. The content may not be approved for use in your specific region or country. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. 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. MEDTRONIC ATS MEDICAL . LifeLine CardioVascular Products Krian A. By installing or using the Licensed Software to view the Programmer screen information, registering a username and password in connection with the Medtronic RemoteView feature, or clicking on any acceptance button in connection herewith, you, a Remote Viewer, agree to be bound by all of the terms and conditions set forth in these Terms of Use (this Agreement). Note: Manuals can be viewed using a current version of any major internet browser. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Home For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. 2009;18(4):445-452. Medtronic Open Pivot Heart Valve Instructions for Use. Cardiovascular Active Remote Users. The Open Pivot AP360 provides these additional features: The Open Pivot Standard aortic valve provides these additional features: The Open Pivot Standard mitral valve provides these additional features: A variety of accessories are available to quickly and easily select the optimal valve type, appropriate valve size, and ideal placement for valve positioning.