The ATS Open Pivot® Heart Valve utilizes a fundamentally different design intended to offer you unique advantages over traditional cavity pivot valves. Unlike any other heart valve on the market, the ATS Open Pivot Heart Valve was developed to improve thromboresistance by doing what might now seem obvious – eliminate the major cause of the problem, the cavity. The following enhancements put the ATS Open Pivot Heart Valve literally in a class by itself.

• Unlike all other bileaflet valves, ATS Open Pivot Valves have no recesses or cavities in the pivot area which could provide areas for stasis and platelet aggregation.^1,2
• Leaflets pivot smoothly on small convex hinge points which extend into the flow path, minimizing flow disruption and turbulence.³

The open pivot design ensures that the ATS Open Pivot Heart Valve has no cavities where persistent recirculating flow may occur.1 [Watch Video]

Unique Axis of Suspension
With no cavity to contend with, the leaflets are placed to provide a fundamentally unique axis of leverage whereby 92% of the leaflet is distal to the axis of suspension, making the valve extremely responsive to blood flow and gentler on the blood.⁴

A unique axis of leverage results in less force to open and close leaflets, lower pressure drops and leaflet movement more responsive to physiological demands.4,5,6,7

Continuous Passive Washing
Continuous passive washing ensures complete washing of the pivot in both open and closed positions with less force required to open and close leaflets.

The unimpeded flow of blood through the pivot area provides for gentle treatment of red blood cells and low levels of hemolysis.8,9 [Watch Video]

Won’t Compromise Implantability for Improved Flow
Because of the unique leaflet placement, there is no need to manipulate leaflet motion by extending the orifice in any way. This allows for a single-plane orifice, providing ease of implantability. And its orifice of thin yet strong pyrolytic carbon and titanium strengthening band provide excellent orifice-to-annulus ratios without compromising structural integrity.

Single-plane orifice allows for improved seating and suturing. Minimal sub-annular exposure reduces orifice ring stress and possibility for sub-aortic inflammation.

Barely Audible Valve Sound
The ATS Open Pivot Heart Valve has been shown to be considerably quieter than traditional cavity pivot designs. It is suggested that perhaps the efficient opening and closing of the leaflets and cushioning effects of continuous passive washings contributes to all the non-noise. Further, patients have reported they cannot hear the valve during normal daily activity.^10,11,12

The Open Pivot Design in Multiple Product Configurations
ATS Open Pivot® Standard Heart Valve – Aortic and Mitral
ATS Open Pivot® AP™ Heart Valve – Aortic and Mitral
ATS Open Pivot® Apex™ Heart Valve – Aortic
ATS Open Pivot® Aortic Valved Graft (AVG)

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. Westaby S, et al. Valve Replacement with the ATS Open Pivot Bileaflet Prosthesis. Eur J Cardio-thorac Surg. 1996; 10(8):660-5.
4. Feng Z, et al. In Vitro Hydrodynamic Characteristics Among Three Bileaflet Valves in the Mitral Position. Artif Organs. 2000; 24(5):346-53.
5. Feng Z, et al. In vitro investigation of opening behavior and hydrodynamics of bileaflet valves in the mitral position. Artif Organs. 2002; 26(1):32-9.
6. Verdonck P, et al. Pulse duplicator hydrodynamics of four different bileaflet valves in the mitral position. Cardiovasc Surg. 1997; 5(6):593-603.
7. Hasegawa M. Clinical evaluation of ATS Prosthetic Valve by Doppler Echocardiography Comparison with St. Jude Medical (SJM) valve. Ann Thorac Cardiovasc Surg. 2000; 6(4):247-251.
8. 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.
9. 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.
10. Emery R, et al. Five-Year Follow Up of the ATS Mechanical Heart Valve. J Heart Valve Dis. 2004; 13(2):231-8.
11. 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.
12. 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.
13. Tayama E, Feng Z, Oda T, et al. ATS prosthetic valve motion: an in vitro analysis. J Heart Valve Dis. 2000; 9(3):408-414.

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