Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Open Pivot valves are remarkably quiet.7,10. P 844-SUTURES (788-8737) P 888.416.2409. Healthcare Professionals Healthcare Professionals Accessed April 20, 2021. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. You just clicked a link to go to another website. Open Pivot Mechanical Heart Valves Ann Thorac Surg. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 2004 Mar;13(2):231-238. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 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. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 to 26 mm for aortic valve replacement, Intra-annular valve with generous, compliant cuff for exceptional implantability, Medtronic Open Pivot Sizer Kit includes AP Series and Standard heart valve sizers, a bendable holder handle, and a sterilization tray, Mitral Hex End Rotators and Holder provide additional length and flexibility when needed for rotation of mitral valves. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Medtronic Open Pivot Heart Valves Product Specifications medtronic open pivot Standard Heart valve Aortic Standard Tissue Annulus Orifice Inner Geometric Valve Size Model Diameter (B) Diameter (A) Orifice Area (mm) Number (mm) (mm) (cm2) 19 500FA19 19.5 14.8 1.55 21 500FA21 21.5 16.8 2.02 23 500FA23 23.5 18.8 2.56 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. Please review applicable product labeling for your country for indications and instructions prior to use. Five-year follow up of the ATS mechanical heart valve. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. Safety Topic / Subject Hancock MO Model 250 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. Even very old stainless steel valves are likewise considered of no danger in MRI. The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. U.S. Food & Drug Administration. Products on x prosthetic heart valve ascending aortic proth. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. A recent publication from a single center in Belgium followed all patients with an Open Pivot valve im-planted over a 20 year period.81 In total, 1520 Open Pivot valves were implanted in 1382 consecutive patients with a 99% rate of follow-up. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. MEDTRONIC ATS MEDICAL . All information that you provide in connection with such registration must be complete, accurate, and truthful. 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. 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. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Five-year follow up of the ATS mechanical heart valve. Home Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. Early results. Home This site is Exclusively Sponsored by BRACCO. Your Acknowledgements. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Medtronic MiniMed 2007 Implantable Insulin Pump System Medtronic, Inc., www.medtronicdiabetes.com Your Personal Information. With an updated browser, you will have a better Medtronic website experience. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. With an updated browser, you will have a better Medtronic website experience. Emery RW, Petersen RJ, Kersten TE, et al. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. Potential Adverse Events: Certain complications may occur with heart valve procedures. Home 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. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. perceval sutureless heart valve: CORCYM Canada Corp. P150011 S026: 11/21/2022: exoseal vascular closure device: Cordis US Corporation: P100013 S026: 10/28/2022: vibrant soundbridge system: Med-el Elektromedizinische Ger: P990052 S026: 10/11/2022: r3 delta ceramic acetabular system: Smith & Nephew, Inc. P150030 S026: 09/21/2022: relayplus . Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Note: Manuals can be viewed using a current version of any major internet browser. With an updated browser, you will have a better Medtronic website experience. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 2,3 . Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. If not approved, please exit this site. 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. Five-year follow up of the ATS mechanical heart valve. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS 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 ]. Safety Topic / Subject Article Text 179: . 2001;4(4):346-352. Emery RW, Van Nooten GJ, Tesar PJ. 3: Conditional 5 More. J Heart Valve Dis. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. 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 Miscellaneous. 2006; 33: 154-159. Heart Surg Forum. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. 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 Heart Valves: Springer Verlag; 1998:53-71. 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 2000;69:507-512. More R and Haubold A. Healthcare Professionals 1996;6: 273-79. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. March 2004;13(2):231-238. Note: Manuals can be viewed using a current version of any major internet browser. 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). Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Emery RW, Van Nooten GJ, Tesar PJ. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. 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. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Accessed April 20, 2021. Cardiovascular 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). Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. 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. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) With an updated browser, you will have a better Medtronic website experience. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Home Cardiovascular Patients View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement, Medtronic Open Pivot Aortic Valved Graft, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. For a Remote Viewer to view information displayed on a Programmer, the Remote Viewer needs to install or access the Bomgar Representative Console software (Licensed Software). Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. 1996; 2(1):51-58. 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. 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. 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. More than 140,000 valves have been implanted worldwide. In: Krian A, Matloff JM, Nicoloff DM, eds. September 1993;106(3):427-433. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Emery RW, Krogh CC, Jones DJ, et al. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. MeSH terms Adolescent Adult Aged Aorta / surgery* 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. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. 2001; 4(4):346-353. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. 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%. Certain complications may occur with heart valve procedures. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. The Medtronic Open Pivot aortic valved graft is intended for use secondary to a diseased, damaged, ormalfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Cardiovascular You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America. ) You shall at all times use the Licensed Software in compliance with all applicable laws. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Products Ann Thorac Cardiovasc Surg. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. MRI safe in all MR environments without conditions Designed to achieve 100% coaptation and minimize central regurgitation. The content may not be approved for use in your specific region or country. 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). Tex Heart Inst J. 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). Open Pivot Aortic Valved Graft. Home Medtronic Open Pivot Heart Valve Instructions for Use. Emery RW, Petersen RJ, Kersten TE, et al. Heart Valves Surgical Premarket Approval (PMA). Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Indications, Safety, and Warnings. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Van Nooten GJ, Caes F, Francois K, et al.