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ATS Open Pivot® APTM Series Heart Valves
ATS MEDICAL, INC.
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3905 Annapolis Lane, Suite 105 |
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Identical open pivot design in a supra-annular configuration providing a three-size improvement in Geometric Orifice Area (GOA) compared to the ATS Open Pivot® Standard Heart Valve. With ATS Open Pivot AP Series, best-in-class hemodynamic performance comes in two cuff configurations for implant preference. 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 suturability and conformability with a modified cuff.
Open Pivot Design
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 performance.4
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.
Exceptional Performance
Open Pivot Design
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 performance.4
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.
Exceptional Performance
- Excellent hemodynamics5
- Enhanced thromboresistance5
- Outstanding durability6
- Quiet valve function7
- Exceptional implantability6
PRODUCT FEATURES
- ATS Open Pivot AP Heart Valve
- Aortic sizes 16mm to 26mm
- Mitral sizes 24mm to 28mm
- ATS Open Pivot APex Heart Valve
- Aortic sizes 16mm to 28mm
Indications for Use
The ATS Open Pivot Heart Valve is intended for the replacement of diseased, damaged, 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. 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.
The ATS Open Pivot Heart Valve is intended for the replacement of diseased, damaged, 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. 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.