ThermaFix Process Overview


	Pericardial Heart Valves

Magna Ease Aortic Valve

Magna Mitral Ease Valve

Magna Aortic Valve

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.2

Proven to reduce the risk of calcification uptake by up to 81% over glutaraldehyde-fixed controls.2
Not a reversible or degenerative bonding like other tissue treatments.3

*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 795.
3. 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.

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.

ThermaFix Process

Description

Animation

Important Risk Information