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The newly approved new indication concerns the treatment of patients with normal mitral valve and developing symptoms of heart failure.
The US Food and Drug Administration has approved a new indication for a heart valve repair device designed to reduce moderate to severe mitral regurgitation, a blood leak backwards through the mitral valve in the left atrium of the heart can cause heart damage symptoms such as shortness of breath, fatigue and swelling of the legs.
When first approved in 2013, the MitraClip clip feed system (MitraClip), manufactured by Abbott Vascular Inc., was indicated to reduce mitral regurgitation in some patients with significant symptoms of mitral regurgitation. heart failure resulted from mitral valve defects primary or degenerative mitral regurgitation) and whose risks of mitral valve surgery are prohibitive.
The newly approved new indication is intended for the treatment of patients with normal mitral valves and with symptoms of heart failure and moderate to severe mitral regurgitation due to a decrease in left cardiac function. (commonly known as secondary or functional mitral regurgitation) despite treatment. with optimal medical treatment. Optimal medical treatment includes a combination of different drugs for heart failure, as well as, in some patients, cardiac resynchronization treatment and implantation of automatic defibrillators.
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