April 6, 2009 - Evalve Inc. announced today the first enrollment in the ACCESS-Europe study, a post-market observational study of the MitraClip therapy in Europe.
The MitraClip system is the first commercially available treatment option for nonsurgical mitral valve repair for patients suffering from the effects of functional and degenerative mitral regurgitation (MR).
The first patients were enrolled in ACCESS-Europe by a team led by Professor Corrado Tamburino, M.D.. Gian Paolo Ussia, M.D., Salvatore Scandura, M.D., and Sarah Mangiafico, M.D. at Ferrarotto Hospital at Catania University in Sicily, Italy.
"ACCESS-Europe will provide important clinical care and health economic information about the MitraClip therapy," said Professor Tamburino, chair of cardiology, cardiology department, cardiac catheterization and interventional cardiology, Ferrarotto Hospital, University of Catania, Sicily. "This data will allow us to further understand the benefits of the MitraClip 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 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 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.
Percutaneous mitral repair with Evalve's MitraClip 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.
For more information: visit www.evalveinc.com.