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First Patients Enrolled in the Access-Europe Study of The MitraClip(R) Therapy
Date:4/6/2009

therapy for patients with mitral regurgitation and the health economic benefits of a less invasive alternative for patients suffering from MR."

The ACCESS-Europe study will evaluate the MitraClip(R) therapy in the continuum of care available to patients with MR. Patients will be evaluated at baseline through 12 months after enrollment. As many as 20 institutions within Europe will participate and up to 300 patients treated with the MitraClip(R) device will be enrolled. In addition, information will be collected in two comparator groups, one which includes medically managed heart failure patients with MR and another which includes patients who are undergoing mitral valve surgery for MR.

"Initiating enrollment in ACCESS-Europe is another important milestone for Evalve and the MitraClip therapy," said Ferolyn Powell, president and chief executive officer of Evalve. "This study is designed to provide meaningful clinical and health economic information building on the important foundation of data already generated in the US. The early experience in Europe has been primarily the treatment of patients who are either non-surgical candidates, or higher risk surgical patients, with functional MR."

Evalve received CE Mark approval for the MitraClip(R) system last year, and has worked with hospitals across Europe to establish training programs in support of the European roll out. Patients have been treated in Italy, Germany, the United Kingdom, the Netherlands and Switzerland.

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 bre
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SOURCE Evalve, Inc.
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