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First Swiss Patients Treated with the Percutaneous MitraClip(R) System
Date:3/10/2009

Use of the MitraClip(R) System Continues to Expand in the European Union

MENLO PARK, Calif., March 10 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today that the first series of patients have been successfully treated with the MitraClip(R) system at the Cardiocentro Ticino in Lugano, Switzerland. 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).

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 Switzerland were treated by the team led by Prof. T. Moccetti, M.D., assisted by G.B. Pedrazzini, M.D.; E. Pasotti, M.D.; F.F. Faletra, M.D.; and A. Auricchio, M.D., Ph.D.

"Until now, many heart failure patients with associated functional MR had no therapeutic options except medical management when surgery was not possible either because they have already had heart surgery, or presented with important renal insufficiency or lung disease, all of which significantly increase the risk of a second or a third operation," said Prof. Moccetti, Head of Cardiology Division and Medical Director of Cardiocentro Ticino. He added "The MitraClip(R) therapy provides a valuable alternative for these patients."

Professor Auricchio, Director of the Heart Failure Clinic commented: "Heart failure is a devastating disease, significantly more common than cancer and has the same poor life-expectancy. Implantable devices such as cardiac resynchronization therapy have improved the quality of life of these patients. Now with percutaneous mitral valve repair, I am confident we can expand our treatment possibilities to many of our Swiss heart failure patients."

Evalve initiated commercial sales of the MitraClip(R) system in Europe under the CE Mark in September 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. The company has worked closely with hospitals to deliver high quality training programs in preparation for the first series of implants. The MitraClip(R) device is now currently being implanted in five countries, including Germany, Italy, the United Kingdom, the Netherlands and now Switzerland.

"We are very pleased to see the successful initial use of the MitraClip device in Switzerland at this important cardiac center," said Ferolyn Powell, president and chief executive officer of Evalve. "The functional MR heart failure patient continues to be the fastest growing segment of the population undergoing treatment with the MitraClip(R) system and the initial commercial results in this population are very encouraging."

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 are registered trademarks of Evalve, Inc.


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SOURCE Evalve, Inc.
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