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ATS Open Pivot® Mechanical Heart Valves

Open Pivot Design
The ATS Open Pivot® Heart Valve is literally in a class of its own. Instead of cavities in the hinge area, the valve has open pivots, enabling the leaflets to pivot on smooth spheres that project gently into the bloodstream. The unique pivot design and leaflet placement provide continuous passive washing for gentle treatment of red blood cells and low levels of hemolysis and thromboembolic events.^1,2,3 All other bileaflet mechanical heart valves have cavities in the pivot area, which provide logical areas for thrombus formation.

When choosing a mechanical valve for either aortic valve replacement or mitral valve replacement, you can be confident in the unique design of the ATS Open Pivot Valve and its outstanding performance for your patients.

15-Year, Single-Surgeon Experience

Implantation of the ATS Open Pivot AP360 Heart Valve

Aortic Valve Replacement Through a Mini-thoracotomy

Exceptional Performance

Excellent Hemodynamics

Low in-vivo mean pressure gradients ^4,5,6,7
Large in-vivo effective orifice areas ^4,5,6,7
Significant reduction of left ventricular (LV) mass ^8,9

Enhanced Thromboresistance

No recesses or cavities for potential thrombus formation ^1,2
Continuous passive washing creates minimal damage to red blood cells ^1,3
Consistently low rates of hemolysis and thromboembolic events ^10,11

Outstanding Durability

Solid pyrolytic carbon design provides exceptional wear characteristics
Zero structural failures in more than 130,000 implants ⁴
Titanium strengthening band prevents orifice distortion, leaflet immobilization or escape⁴

Exceptional Implantability

Single-plane orifice facilitates easy implantation regardless of suture techniques
Orifice design prevents distortion and provides easy rotation ⁴
Minimal subannular exposure reduces likelihood of subaortic inflammation

Quality of Life

Shown to be considerably quieter than traditional cavity pivot designs ^3,12,13
Excellent hemodynamic performance minimizes likelihood of patient-prosthesis mismatch in most patients

Design Brochure

Clinical Summary

Product Guide

Available Heart Valve Replacement Products

ATS Open Pivot® Standard Mechanical Heart Valve
The proven performance of an intra-annular valve with generous, compliant cuff for exceptional implantability. Available in both aortic and mitral configurations.

BI1-1_astd
ATS Open Pivot® Standard
Aortic Heart Valve

ATS Open Pivot® Standard Heart Valve
ATS Open Pivot® Standard
Mitral Heart Valve

ATS Open Pivot® AP360™ Product Brochure

Effective Orifice Area Index (EOAI) Calculator - ATS Standard

ATS Open Pivot® AP™ Series Mechanical Heart Valves
Exceptional hemodynamic performance, providing a three-size improvement in Geometric Orifice Area (GOA) as compared to the ATS Open Pivot Standard. Available in two cuff configurations to meet surgeon preference. The ATS Open Pivot® AP™ Heart Valve provides excellent suturability and conformability with a traditional compact cuff. The ATS Open Pivot® APex™ Heart Valve provides improved suturabiity and conformability with a modified cuff.

ATS Open Pivot® AP™ Heart Valve
ATS Open Pivot®
AP™ Heart Valve

ATS Open Pivot® ApexTM Heart Valve
ATS Open Pivot®
Apex™ Heart Valve

ATS Open Pivot®
AP360™ Heart Valve

Effective Orifice Area Index (EOAI) Calculator - ATS AP/AP360

ATS Open Pivot® Aortic Valved Graft (AVG)
Unites the distinct advantages of the ATS Open Pivot Heart Valve with leading graft technology for exceptional implantability and proven performance.

ATS Open Pivot® AVG

Indications for Use
The ATS Open Pivot Heart Valve is intended for the replacement of diseased, damaged or malfunctioning heart valves. ATS Open Pivot Heart Valves must be prescribed and ordered by a licensed physician.

Contraindications
There are no known contraindications to heart valve replacement with an ATS Open Pivot Heart Valve for patients who have been determined to be a candidate for mechanical heart valve replacement.

References
1. Kelly S, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Int J Artif Organs 1999; 22:754-763.
2. Emery R, et al. The Initial United States Experience With the ATS Mechanical Cardiac Valve Prosthesis. The Heart Surgery Forum. 2001; 4(4):346-353.
3. Emery R, et al. Five-Year Follow Up of the ATS Mechanical Heart Valve. J Heart Valve Dis. 2004; 13(2):231-8.
4. ATS Medical Inc., Pre-market Approval Application – Summary of Safety and Effectiveness: 2000. Washington, D.C.; U.S. Food and Drug Administration. 2000. P990046.
5. Echevarria J, et al. Clinical and Hemodynamic Performance of the ATS Heart Vavle Prosthesis (AP Series) in the Small Aortic Root. Abstract presented at: 15th World Congress of the World Society of Cardiothoracic Surgeons, 1999.
6. Jazayeri S, et al. Clinical Experience and Doppler Echocardiographic Assessment of the First One Hundred ATS AP (Advanced Perfomance) Prosthetic Valve in the Aortic Position. J Heart Valve Disease. 2003; 12(2):628-634.
7. Karpuz H, et al. Doppler Echocardiographic Assessment of the New ATS Medical Prosthetic Valve in the Aortic Position. Am J Card Imaging. 1996; 10(4):254-60.
8. Thomson H, et al. Haemodynamics and left ventricular mass regression: a comparison of the stentless, stented, and mechanical aortic valve replacement. Eur J Cardio-thorac Surg. 1998; 13(5):572-575.
9. Autschbach R, et al. Prospectively Randomized Comparison of Different Mechanical Aortic Valves. Circulation 2000; 102[suppl III]lIII-1-III-4.
10. Shiono M, et al. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Ann Thorac Cardiovasc Surg. 1996; 2(1):51-8.
11. Krian A. Clinical results of a large series of ATS valve implants. In: Krian A, Matloff JM, Nicoloff DM, eds. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71.
12. Sezai A, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Ann Thorac Surg. 2000; 69:507-512.
13. Hata M, et al. Mid-term results of ATS Open Pivot Bileaflet mechanical prosthetic heart valve. Ann Thorac Cardiovasc Surg. 2000; 6(1):34-38.

Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. The ATS Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The ATS Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. 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.

Manufactured under licensed U.S. Patent 4,692,165. United States Patent Number No. 5,354,330, European Patent Number 0541215 and German Patent No. P69214597.4. ATS Medical and ATS Open Pivot are registered trademarks of ATS Medical, Inc. All rights reserved. ©2006 ATS Medical, Inc.

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