Patients with congenital heart disease that have abnormal blood flow in the right side of their heart traditionally have had to have repeated cardiac surgeries to fix their abnormal heart valves.
The new type of valves were placed in patients that had a narrowed pulmonary valve associated with their congenital heart disease. The new artificial heart valve can be compressed onto a balloon to the approximate diameter of a pencil was passed into the heart from a leg blood vessel and then expanded with a balloon to position it in the position previously occupied by the diseased pulmonary valve.
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of thirty patients at three hospitals is in progress to collect safety and effectiveness data, to gain FDA approval.
Edwards Lifesciences Corporation of Irvine, Calif., makes the Edwards SAPIEN transcatheter valve that was implanted. The company also makes similar valves for the mitral and aotic valves. For more information on non invasive heart surgery please visit:
http://healthblaster.com/2008/04/heart-valves-replaced-without-surgery/
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