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.