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1A [10L(02)] Printspec k - 5.25 x 9.875 inches. THE List - MRI Safety Heart Surgery Forum. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Safety Topic/Article: You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. PDF Emerging Trends in Heart Valve Engineering: Part II - eScholarship We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. 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 Single-plane orifice facilitates valve seating and implant regardless of suture technique. 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. Cardiovascular Indications, Safety, & Warnings. Cardiovascular Five-year follow up of the ATS mechanical heart valve. 2001; 4(4):346-353. Treatments & Therapies LifeLine CardioVascular Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Ann Thorac Surg. NayaMed International Srl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Srl. 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. Shiono M, Sezai Y, Sezai A, et al. on x prosthetic heart valve ascending aortic proth. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. The content may not be approved for use in your specific region or country. Update my browser now. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Ann Thorac Surg. 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. 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. With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. The Suture Superstore that provides surgical disposables, sutures & more. 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. When im-planted in the aortic position there were only . Cardiovascular You may not assign any of your rights or responsibilities under this Agreement without the prior written consent of Medtronic. March 1993;17(3):538-545. 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. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 You just clicked a link to go to another website. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Note: Manuals can be viewed using a current version of any major internet browser. Ann Thorac Cardiovasc 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. Please review applicable product labeling for your country for indications and instructions prior to use. Ann Thorac Cardiovasc Surg. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. Permissions. 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. More R and Haubold A. This site is Exclusively Sponsored by BRACCO. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. The HemashieldWoven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Healthcare Professionals 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. With an updated browser, you will have a better Medtronic website experience. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Technical Support. Your Personal Information. what happened in 1906 in europe The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. 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. ) 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. ) The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. F 708.478.3519. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information. Healthcare Professionals In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Update my browser now. Eur J Cardiothorac Surg. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. 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. 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. Long-term outcomes following Medtronic Open Pivot valved conduit MEDTRONIC ATS MEDICAL . 2003;75(2):444-452. 3: Conditional 5 More. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Valve Design & Features - CryoLife, Inc. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. THE List - MRI Safety Home If you continue, you will leave this site and go to a site run by someone else. Open Pivot Mechanical Heart Valves - Surgical Heart Valves - Medtronic Open Pivot Mechanical Heart Valves. With an updated browser, you will have a better Medtronic website experience. If you continue, you may go to a site run by someone else. More than 140,000 valves have been implanted worldwide. Five-year follow up of the ATS mechanical heart valve. Heart Valves - Surgical | Medtronic 1996;10(8):660-665. Van Nooten GJ, Caes F, Francois K, et al. Heart Valves and Annuloplasty Rings More. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Sezai A, Hata M, Niino T, et al. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Open Pivot Mechanical Heart Valves 2010;139:1494-1500. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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. Cardiovascular CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. New York: Springer Verlag; 1998:53-71. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Advanced Discussion (show/hide) References Heart Valves Surgical Products Krian A. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions. 2004 Mar;13(2):231-238. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. medtronic open pivot - Cor-Medical Premarket Approval (PMA) - Food and Drug Administration Aortic and Mitral Valve Replacement Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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. 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). For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Ats Medical Heart Valve Mri Safety | Day of Difference Update my browser now. With an updated browser, you will have a better Medtronic website experience. . 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. Product Specifications and Ordering Information Avalus Valve Ordering and Specifications Avalus Valve Accessories Open Pivot Mechanical Heart Valves - Surgical Heart Valves | Medtronic . 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 Potential Adverse Events: Certain complications may occur with heart valve procedures. Heart Surg Forum. Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. 2003;75(2):444-452. With an updated browser, you will have a better Medtronic website experience. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. Ann Thorac Surg. Medtronic Open Pivot Heart Valve Instructions for Use. Cell Mater. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. March 2004;13(2):231-238. 3: . 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. 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. Warnings/Precautions/Adverse Events 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. 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. Click OK to confirm you are a Healthcare Professional. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Your Acknowledgements. On-X Aortic Heart Valve Hemodynamics - CryoLife, Inc. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Important Labeling Information for United States. LifeLine CardioVascular Is the St. Jude Heart Valve MRI Safe? - Reference.com 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). For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Int J Artif Organs. Update my browser now. 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. Therapies & Procedures Object Info: - MRI Safety Even very old stainless steel valves are likewise considered of no danger in MRI. Your use of the other site is subject to the terms of use and privacy statement on that site. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. 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 Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Thus at present, most centers consider all implanted heart valves and annuloplasty rings conditionally safe for MR imaging up to 3.0T, and do not require any waiting period after surgery before they can be scanned. Open Pivot Mechanical Heart Valves. 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. data, and the Medtronic valves are no exception. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. Atriasept Closure DeviceCardia, Inc.Eagan, MN, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., Lake Forrest, CA, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., www.navigatecsi.com, Atrix-C Cervical Allograft Interbody SpacerXtant Medical, www.xtantmedical.com, Atrostim Phrenic Nerve StimulatorASTROTECH OYTampere, Finland, ATS 3f Enable Aortic BioprosthesisModel 6000ATS Medical, Inc.Lake Forest, CA, ATS Medical Open PivotAortic Valved GraftModel # XX denotes size502AGxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAortic, Model 501DA18Advanced Performance (AP)pyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 AorticModel # XX denotes size505DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 MitralModel # XX denotes size505DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP AorticModel # XX denotes size501DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP MitralModel # XX denotes size501DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex AorticModel # XX denotes size503DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex MitralModel # XX denotes size503DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveMitral, Model 500DM29Standard Valvepyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard AorticModel # XX denotes size500FAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard MitralModel # XX denotes size500DMxxATS MedicalMinneapolis, M, ATTRACTOR Screw17-4 SSPorex Surgical, Newnan, GA, Attune Flexible Annuloplasty RingSt. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. 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). The initial United States experience with the ATS mechanical cardiac valve prosthesis. 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. Update my browser now. Van Nooten GJ, Caes F, Francois K, et al. Fifteen years of experience with ATS mechanical heart valve prostheses. 1996;2(1):51-58. Accessed April 20, 2021. 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. 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. Accessed April 20, 2021. 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. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. 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. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. You shall at all times use the Licensed Software in compliance with all applicable laws. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Healthcare Professionals Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, infection other than endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Heart Valves Surgical For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Early results. Home Eur J Cardiothorac Surg. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. 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. Home Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Technical Support. March 2004;13(2):231-238. With an updated browser, you will have a better Medtronic website experience. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. J Heart Valve Dis. Open Pivot valves are remarkably quiet.7,10. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. J Heart Valve Dis. 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. Fifteen years of experience with ATS mechanical heart valve - PubMed J Radiol 1986;67:661-666. 2,9,10 Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Tex Heart Inst J. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card 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. 2000;69:507-512. Heart Surg Forum. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While 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.7,8.