Treatment for Calcification of Heart Valve Leaflets

The treatment has been cleared by the U.S. Food and Drug Administration (FDA).

Called ThermaFix, the process is designed for the tissue heart valves of Edwards Lifesciences Corp. (Irvine, CA, USA; www.edwards.com). The process was co-developed with Edwards by Prof. Alain Carpentier, chairman of the department of cardiovascular surgery at the European Hospital Georges Pompidou in Paris (France) and inventor of Edwards' line of Perimount tissue replacement heart valves. Gradual aggregation of calcium on a tissue heart valve's leaflets is the leading cause of valve degeneration or failure. ThermaFix is designed to reduce the potential for this type of failure.

"While we are confident in the excellent performance of our existing tissue processes, the addition of the ThermaFix process has been shown in laboratory studies to reduce calcification up to 44% beyond Edward's current tissue treatment alone,” said Anita B. Bessler, vice president, global franchise management, Edwards Lifesciences. She noted that data released in 2003 indicated that patients 60 and over will have a greater-than- 90% chance of not needing a new valve for 20 years.

One of the first valves to feature the process will be Edwards Perimount Magna valve, which Edwards states is based on 20 years of clinical experience and the most advanced tissue engineering technologies. Edwards is the world's leading heart valve company.





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