Intra-annular heart valve with generous, compliant cuff for exceptional implantability.

• No recesses or cavities in the pivot area where thrombus can form^1,2
• Continuous passive washing provides for gentle treatment of red blood cells, low levels of hemolysis and thromboembolic events^1,3
• Unique axis of suspension provides an exceptionally efficient design resulting in leaflet movement responsive to physiological demands and improved hemodynamic performance⁴
• Solid pyrolytic carbon orifice and strengthening band for thin yet strong orifice and large Geometric Orifice Areas (GOAs)
• Single plane orifice facilitates valve seating and implant regardless of suture technique
• Soft, pliable sewing ring of double-velour polyester facilitates optimal valve positioning and suturing to the annulus

ATS Open Pivot® Standard Mitral Heart Valve

ATS Open Pivot® Standard Aortic Heart Valve

• Excellent hemodynamics⁵
• Enhanced thromboresistance⁵
• Outstanding durability⁶
• Quiet valve function⁷
• Exceptional implantability⁶

Product Specifications

• Aortic valve sizes 19mm to 29mm
• Mitral valve sizes 27mm to 33mm

Contact ATS Medical at 1-866-287-6331 for more specific product specifications.

Indications for Use
The ATS Open Pivot Heart Valve is a prosthetic heart valve indicated for use in aortic and mitral valve replacement surgery and 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. Feng Z, et al. In Vitro Hydrodynamic Characteristics Among Three Bileaflet Valves in the Mitral Position. Artif Organs 2000; 24(5):346-53.
5. ATS Medical Inc., Pre-market Approval Application – Summary of Safety and Effectiveness: 2000. Washington, D.C.; U.S. Food and Drug Administration. 2000. P990046.
6. ATS Medical Inc. Data on file.
7. 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.

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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