Mitralign, Inc. Completes Enrollment In EU Study For Its Novel Catheter-Based Valve Repair Device

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TEWKSBURY, Mass.--(BUSINESS WIRE)--Mitralign Inc., a cardiac device company, announced today it has completed enrollment in a study in Europe investigating its lead device, the Mitralign System, in patients with functional mitral regurgitation (FMR). Pending successful outcomes from the study, the company will seek CE Mark approval in the European Union (EU) as a first step toward commercializing the Mitralign System. Receiving the CE Mark demonstrates that a product has been assessed by the European Commission for Enterprise and Industry and meets EU safety, health and environmental protection requirements.

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