Evalve, Inc. First United Kingdom Patients Treated With Percutaneous MitraClip(R) System Use of MitraClip(R)

MENLO PARK, Calif., Nov. 26 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today that the first three patients have been successfully treated with the MitraClip(R) system at the University of Hull, Castle Hill Hospital in the United Kingdom. The MitraClip(R) system is the first commercially available medical device which provides a non-surgical mitral valve repair option for patients suffering from the effects of mitral regurgitation (MR).

Mitral regurgitation is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. In the vast majority of patients, the MR is untreated, requiring the heart to work harder and ultimately leading to heart failure.

The first patients in the United Kingdom were treated by the team led by Farqad Alamgir, M.D., consultant cardiologist for the Trust; Simon Thackray, M.D., consultant cardiologist; Raj Nair, M.D., cardiology registrar and Andrew L. Clark, M.D., reader and honorary consultant in cardiology.

“This technology is cutting edge and may transform the way many of our patients receive heart surgery,” said Dr. Alamgir. “The MitraClip(R) therapy reduces many of the risks and trauma currently associated with open heart surgery. Currently, patients with MR only have one option. Now they have a second option which may not require them to have surgery. I believe the MitraClip(R) system will not only play a key role for non-surgical MR patients, but should also be considered as a therapy for select surgical candidates.”

Evalve received CE Mark approval for the MitraClip(R) system this year and began commercial sales in Europe in September, 2008. The company has worked with hospitals across Europe to establish training programs in support of the European roll out.

“Suitable patients now have a less invasive therapeutic alternative to surgery for repairing the mitral valve,” said Ferolyn Powell, president and chief executive officer of Evalve. “The announcement of treatment of the first series of patients in the United Kingdom marks another notable milestone for those suffering from MR. We are pleased with the early acceptance and results of the MitraClip(R) therapy and will continue to work diligently to make the therapy available throughout the European Union.”

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 http://www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (http://www.thefoundry.com).

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

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

CONTACT: Heather Harper of Edelman, 1-415-486-3233,
Heather.Harper@edelman.com, for Evalve, Inc.

Web site: http://www.evalveinc.com/
http://www.thefoundry.com/

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