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MitraClip(R) Therapy Introduced in Austria

Thursday, September 17, 2009 General News J E 4
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MENLO PARK, Calif., Sept. 9 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 direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. Evalve has worked closely with hospitals to deliver high quality training programs in preparation for the first series of implants and offers ongoing support. The MitraClip((R)) device is currently being implanted in seven Western European countries, including Germany, Italy, the United Kingdom, the Netherlands, Switzerland, Sweden and now in Austria.

"We are pleased with the successful initial use of the MitraClip((R)) device at this important cardiac center," said Ferolyn Powell, president and chief executive officer of Evalve. "We have been very encouraged by the interest in Europe from both interventional cardiologists and cardiac surgeons. We think that their adoption and the commercial success to date speak to the benefits that the MitraClip therapy can bring to patients."

About the MitraClip((R)) Procedure

Percutaneous mitral repair with Evalve's MitraClip((R)) device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip((R)) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc., headquartered in Menlo Park, Calif., has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the procedure using the MitraClip((R)) device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (www.thefoundry.com).

The MitraClip((R)) system is currently undergoing clinical evaluation in the United States and Canada.

MitraClip((R)) and Evalve((R)) are registered trademarks of Evalve, Inc.

Media Contact: Amy Hytowitz Edelman 1-323-202-1028 Amy.Hytowitz@edelman.com

SOURCE Evalve, Inc.
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