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news.Evalve, a developer of devices for the percutaneous repair of cardiac valves, has initiated enrollment in the Access-Europe study, a post-market observational study of the MitraClip therapy in Europe.
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The MitraClip system is reported to be the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of functional and degenerative mitral regurgitation.
The Access-Europe study will evaluate the MitraClip therapy in the continuum of care available to patients with mitral regurgitation (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.
The MitraClip system is currently undergoing clinical evaluation in the US and Canada. The MitraClip system is available for commercial distribution in the EU. MitraClip and Evalve are registered trademarks of Evalve.
Ferolyn Powell, president and CEO of Evalve, said: “Initiating enrollment in Access-Europe is another important milestone for Evalve and the MitraClip therapy. 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.”