2001; 4(4):346-353. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. It is possible that some of the products on the other site are not approved in your country. 1996;6: 273-79.
You shall at all times use the Licensed Software in compliance with all applicable laws. The initial United States experience with the ATS mechanical cardiac valve prosthesis.
Potential Adverse Events: 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.
2001;4(4):346-352. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. In: Krian A, Matloff JM, Nicoloff DM, eds.
Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Home Open Pivot Mechanical Heart Valves Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection.
Ann Thorac Cardiovasc Surg.
U.S. Food & Drug Administration. . Surgical Heart Valve Repair and Replacement
Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. Products Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement.
F 708.478.3519.
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.
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. 2000;69:507-512. 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. Van Nooten GJ, Caes F, Francois K, et al.
Five-year follow up of the ATS mechanical heart valve.
Proven Graft Material Ann Thorac Cardiovasc Surg.
September 1993;106(3):427-433. Cardiovascular Ann Thorac Surg.
The valve itself was correctly labeled as Mitral. The content may not be approved for use in your specific region or country. Krian A. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design.
Shiono M, Sezai Y, Sezai A, et al. Technical Support. Shiono M, Sezai Y, Sezai A, et al. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) 2003;75(2):444-452. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 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). Availability.
Van Nooten GJ, Caes F, Francois K, et al. Ann Thorac Surg. Krian A. 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. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Heart Valves Surgical
Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. 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.
Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
1.5, 3: 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. Healthcare Professionals
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.
Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. You just clicked a link to go to another website. This device may also be used to replace a previously implanted prosthetic heart valve CONTRAINDICATIONS 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 .
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). Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 2001;4(4):346-352. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 Accessed April 20, 2021.
Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. data, and the Medtronic valves are no exception.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Products
3: Conditional 5 More. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party.
Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992.
Five-year follow up of the ATS mechanical heart valve. Products Email:
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You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. 2003;75(2):444-452. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Logging of Session Activity.
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Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, 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. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com.
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. 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.
Home 2000;69:507-512.
Open Pivot Mechanical Heart Valves. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Please review applicable product labeling for your country for indications and instructions prior to use. Your Acknowledgements.
Heart Valve Replacement - Surgical
Contraindications: None known .
Open Pivot Aortic Valved Graft. Sezai A, Shiono M, Orime Y, et al. The adverse events potentially associated with the use ofprosthetic aortic 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. Premarket Approval (PMA). 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.
With an updated browser, you will have a better Medtronic website experience. The reoperation rate was 1.2%.
MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE. More than 140,000 valves have been implanted worldwide. Eur J Cardio-thorac Surg.
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. Indications, Safety, & Warnings.
If you continue, you may go to a site run by someone else.
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV.
Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin.
1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. With regard to any purported agreement or terms of use between you and Bomgar Corporation in connection with the Licensed Software (Bomgar EULA): (a) any Bomgar EULA shall be solely between you and Bomgar Corporation; (b) Medtronic shall not be a party to any Bomgar EULA; (c) any Bomgar EULA shall not necessarily reflect the contents of any agreement between Bomgar Corporation and Medtronic; (d) any Bomgar EULA shall not modify or take precedence over this Agreement; and (e) nothing in this Agreement shall be construed to suggest the enforceability or unenforceability of any Bomgar EULA.
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Int J Artif Organs.
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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. November 1999;22(11):754-763.
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. If you continue, you will leave this site and go to a site run by someone else. FDA Determined Cause 2: Labeling mix-ups .
Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. Emery RW, Van Nooten GJ, Tesar PJ.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
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Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Van Nooten GJ, Caes F, Francois K, et al. Update my browser now.
With an updated browser, you will have a better Medtronic website experience. 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. Active Remote Users. Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy.
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Fifteen years single-center experience with the ATS bileaflet valve. ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Sezai A, Shiono M, Orime Y, et al. Shellock R & D Services, Inc. email:
[email protected].
Update my browser now. 2010;139:1494-1500. View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve When im-planted in the aortic position there were only . This Agreement shall be in effect from the date when you first install or use the Licensed Software. Healthcare Professionals Heart Valves Surgical The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Heart Surg Forum. Ann Thorac Surg.
georgia ad valorem tax family member | | absorbed crossword clue 7 letters. Open Pivot Mechanical Heart Valve.
With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. 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.
Cardiovascular Flexible support frame with firm base designed to maintain circularity and consistent hemodynamic performance.
Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV.
Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: 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 Open Pivot Heart Valve Instructions for Use. Heart Surg Forum. 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. 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.
Emery RW, Petersen RJ, Kersten TE, et al.
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. 2006; 33: 154-159. 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. Heart Valves Surgical J Heart Valve Dis. Note: Manuals can be viewed using a current version of any major internet browser.
Ann Thorac Surg.
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.
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 You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Medtronic Open Pivot Aortic Valved Graft (AVG) 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. With an updated browser, you will have a better Medtronic website experience.
These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.
November 1999;22(11):754-763.
Technical Support.
Miscellaneous.
A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Emery RW, Petersen RJ, Kersten TE, et al. With an updated browser, you will have a better Medtronic website experience.
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. Healthcare Professionals Patients In addition, upon Medtronics request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG.
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 Accessed April 20, 2021. March 2004;13(2):231-238. 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). Term, Termination, Modifications, and Support. 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. On-X Life Technologies, Inc. P000037 S059: 03/24/2022: 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.
Tex Heart Inst J. Update my browser now.
Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life.
Clinical results of a large series of ATS valve implants. Reporting Issues and Feedback.
The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Healthcare Professionals
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. Products
The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. March 2004;13(2):231-238. 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. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Unique axis of suspension results in leaflet movement responsive to physiological demands; Gentle, passive washing ensures complete washing of the pivot in both open and closed positions; Most patients cannot hear the sound of their valve after implantation; Low levels of hemolysis and thromboembolic events Note: Manuals can be viewed using a current version of any major internet browser. Limitations of Liability. Advancing the Technology of Bileaflet Mechanical HeartValves.
Technical Support. 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%. 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). Note: Manuals can be viewed using a current version of any major internet browser. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . 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. Ann Thorac Cardiovasc Surg.
Potential Adverse Events: Certain complications may occur with heart valve procedures. Products 2000;69:507-512.
You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software.
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). J Vasc Surg.
1996; 2(1):51-58.
2003;75(2):444-452. Krian A.
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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. The Medtronic Open Pivot heart valve is contraindicated in patients unable to tolerate anticoagulation therapy. Cardiovascular Int J Artif Organs. LifeLine CardioVascular
Update my browser now. Healthcare Professionals In: Krian A, Matloff JM, Nicoloff DM, eds.