MitraClip(R) Therapy Introduced ...( MENLO PARK Calif. S...),Health

MENLO PARK, Calif., Sept. 9 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, today announced treatment of the first group of patients with the MitraClip((R)) system at the Elisabethinen Krankenhaus, Linz, Austria. The MitraClip((R)) system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for patients suffering from the effects of functional and degenerative mitral regurgitation (MR).

MR is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe, the majority of which have FMR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the US; however, only 20 percent of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

The first patients in Austria were successfully treated by a team led by Wolfgang Tkalec, M.D., assisted by Josef Aichinger, M.D., and Christian Ebner, M.D.

"I have been very encouraged by the support and cooperation across specialties in establishing the MitraClip((R)) therapy as a new therapeutic option for our patients for whom surgery is not a good option," said Dr. Aichinger. "What we've seen is that this procedure appears to be a good option for functional MR patients as there has been a dramatic improvement in mitral regurgitation in most patients immediately following the procedure."

Evalve initiated commercial sales of the MitraClip((R)) system in Europe under the CE Mark in late 2008. The company is employing a dir
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