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Carpentier-Edwards PERIMOUNT
Theon Aortic Heart Valve

Putting Performance Out Front



Carpentier-Edwards PERIMOUNT Theon heart valves balance ease of implantation with a 20-year PERIMOUNT tissue valve legacy of proven long-term durability. Now, by adding the Carpentier-Edwards ThermaFix process*—the only tissue treatment to confront both major causes of calcification—PERIMOUNT Theon pericardial bioprostheses put long-term performance and confidence in a whole new light.1,2

Dual-action performance—the ThermaFix process*
Calcification can result when calcium in the circulatory system is attracted to phospholipids and glutaraldehyde residuals in the bioprosthetic tissue.1  Confronting each of these potential calcium binding sites is critical to achieving long-term performance for tissue valves.1  The ThermaFix process is the only dual-action tissue treatment designed to confront calcific structural valve deterioration resulting from residual glutaraldehydes and phospholipids.3
  • Proven to reduce the risk of calcification uptake by up to 81% over glutaraldehyde-fixed controls.3
  • Not a reversible or degenerative bonding like other tissue treatments.4
Lasting performance
The PERIMOUNT platform of pericardial tissue valves delivers robust performance with a proven track record of uncompromised durability
up to 20 years.5

Proven performance

To provide confidence in sustained hemodynamics, PERIMOUNT Theon bioprostheses are based on a tissue valve design with proven long-term hemodynamic stability, and reliable function as late as 17 years after implantation.6

Streamlined performance
PERIMOUNT THEON bioprostheses optimize annular conformity and suturability. Their low aortic protrusion provides sinotubular junction clearance,7,8 while a low cusp height maximizes coronary ostia clearance.


*No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients.


References
1. Schoen FJ, Levy RJ. Calcification of tissue heart valve substitutes: Progress toward understanding and prevention. Ann Thorac Surg 2005; 79:1072-80.
2. Data on file. Edwards Lifesciences. RD 127, RD 128, RD 784, RD 795.
3. Data of file. Edwards Lifesciences. RD 795.
4. Chen W, et al. Mechanism of efficacy of 2-amino oleic acid for inhibition of calcification of glutaraldehyde pre-treated porcine bioprosthetic heart valves. Circulation 1994;90(1):323-29.
5. Carpentier-Edwards PERIMOUNT aortic pericardial bioprosthesis 20-year results. Data on file at Edwards Lifesciences, 2003.
6. Banbury, et al. Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis. Ann Thorac Surg 2002; 73:1460-5.
7. Data on File. Edwards Lifesciences. RD 1089.
8. Carpentier-Edwards PERIMOUNT Theon pericardial bioprostheses, models 2700TFX, 2800TFX, and 6900PTFX product inserts– Directions for use– 2006. 2007.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.