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Medical Devices / Submissions and Approvals

FDA Grants New Indication for Valve Repair Device

March 18, 2019
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The FDA approved a new indication for Abbott’s MitraClip, allowing the device to be used to treat moderate-to-severe or severe mitral regurgitation in patients with normal heart valves.

The device’s initial 2013 approval was for treating primary or degenerative mitral regurgitation, which is caused by abnormalities of the mitral valve.

The new indication is for treating patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation due to diminished left heart function.

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