Open Pivot Design
All bileaflet mechanical heart valves have cavities in the pivot area, which provide logical areas for thrombus (blood clot) formation— except for one. Instead of cavities in the hinge area, the ATS Open Pivot® Heart Valve has open pivots, enabling the leaflets to pivot on smooth convex spheres that project gently into the bloodstream and aid passive washing for gentle treatment of red blood cells and low levels of hemolysis and thromboembolic events.^1,2,3 

Patients faced with valve replacement can be confident in the unique design of the ATS Open Pivot Valve and its resulting performance.

• Excellent hemodynamics⁴
• Enhanced thromboresistance⁴
• Outstanding durability⁵
• Quiet valve function⁶
• Exceptional implantability⁵

Open Pivot vs. Cavity Pivot

Effective Orifice Area Index (EOAI) Calculator - ATS Standard

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

Design Brochure

Clinical Summary

ATS Open Pivot® Standard Mechanical Heart Valve
Proven open pivot performance in an intra-annular valve with a generous, compliant cuff. Available in aortic and mitral configurations.

 
Product Guide 

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 Heart Valve. Available in three cuff configurations to meet surgeon preference.

ATS Open Pivot® AP360™ Product Brochure

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

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. ATS Medical Inc. Data on file.
6. 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.