Evalve, Inc. has announced the start of enrollment in the ACCESS-Europe study, an observational study of the MitraClip system. The MitraClip system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of mitral regurgitation (MR). The first patients were enrolled in ACCESS-Europe by the team led by Corrado Tamburino, M.D.; Gian Paolo Ussia, M.D.; Salvatore Scandura, M.D.; and Sarah Magiafico, M.D. at Ferrarotto Hospital at Catania University in Sicily, Italy. “ACCESS-Europe will provide valuable information regarding the use of the MitraClip system with respect to health economics and clinical care,” 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 who are not good candidates for surgery.” The ACCESS-Europe study will evaluate the MitraClip therapy in the continuum of care of patients with MR. Patients will be evaluated at baseline through 12 months after enrollment. As many as 20 institutions within the European Union will participate and up to 300 MitraClip therapy patients will be enrolled. In addition, up to 200 patients will be enrolled in two comparator groups, one which includes medically managed heart failure patients with MR and another which includes patients who have undergone mitral valve surgery for MR. “Initiating enrollment in ACCESS-Europe is an important milestone for Evalve,” said Ferolyn Powell, president and chief executive officer of Evalve. “This registry will allow us to gather important information about the MitraClip system as we continue to make the technology available throughout the European Union.” Evalve received CE Mark approval for the MitraClip system last year, and has worked with hospitals across Europe to establish training programs in support of the European roll out. Commercial sales started in September and thus far patients have been treated in Italy, Germany, the UK, the Netherlands and Switzerland.