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Medical Devices / Submissions and Approvals

Abbott's Mitraclip Approved in Japan as Transcatheter Mitral Valve Repair Device

Nov. 8, 2017

Abbott received approval from Japan's Ministry of Health, Labor and Welfare for the company's MitraClip device for treatment of people with mitral regurgitation, a progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart.

The MitraClip system is a catheter-based, minimally-invasive therapy delivered to the heart through a blood vessel in the leg. By securing a portion of the leaflets of the mitral valve with a clip, the heart can pump blood more efficiently throughout the body, relieving symptoms and improving patient quality of life. 

MitraClip was approved by the FDA in 2013, after obtaining CE mark approval in Europe in 2008.

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