DevicePMAs@therightstef:P100009_S028 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P100009_S028","sourcedb":"DevicePMAs@therightstef","sourceid":"P100009_S028","text":"Approval for the MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System for expanding the indication to include secondary mitral regurgitation. The devices, when used with maximally tolerated guideline-directed medical therapy (GDMT), are indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR \u003e= Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) \u003e= 20% and \u003c= 50%, and a left ventricular end systolic dimension (LVESD) \u003c= 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve 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