Evalve Initiates Postmarket Study of MitraClip

April 6, 2009—Evalve, Inc. (Menlo Park, CA) announced the commencement of enrollment in the ACCESS-Europe postmarket observational study of the company's MitraClip therapy in Europe. The MitraClip system is a treatment option for nonsurgical mitral valve repair for patients experiencing the effects of functional and degenerative mitral regurgitation (MR). The first patients were enrolled in ACCESS-Europe by Professor Corrado Tamburino, MD, and colleagues at Ferrarotto Hospital at Catania University in Sicily, Italy.

According to the company, the ACCESS-Europe study will evaluate the MitraClip 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 in Europe will participate and up to 300 patients treated with the MitraClip device will be enrolled. In addition, information will be collected in two comparator groups: one that includes medically managed heart failure patients with MR, and another that includes patients undergoing mitral valve surgery for MR.

Evalve received CE Mark approval for the MitraClip system in 2008. The company established training programs with European hospitals in support of the market introduction. The MitraClip system is available for commercial distribution in the European Union. It is currently undergoing clinical evaluation in the United States and Canada, the company stated.