DevicePMAs@therightstef:P100009_S028 JSONTXT 11 Projects

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 >= Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) >= 20% and <= 50%, and a left ventricular end systolic dimension (LVESD) <= 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 disease.