FDA Approved Abbott's First-In-Class MitraClip(R)
Posted in the Beaverton Forum
Since: Sep 13
#1 Oct 26, 2013
Abbott reported that its first-in-class, catheter-based MitraClip® therapy has received U.S. Food and Drug Administration (FDA) approval and will launch immediately in the United States, providing physicians with a breakthrough treatment option for patients suffering from mitral regurgitation (MR). The MitraClip device has been approved for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Prohibitive risk is determined by the clinical judgment of a heart team due to the presence of one or more documented surgical risk factors.
MR is a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart. The condition can raise the risk of irregular heartbeats, stroke, and heart failure, which can be deadly.
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