DevicePMAs@therightstef:P100009_S000 JSONTXT 11 Projects

Approval for the mitraclip clip delivery system (mitraclip cds). this device is indicated for the percutaneous reduction ofsignificant symptomatic mitral regurgitation (mr >= 3+) due to primary abnormality of the mitral apparatus [degenerative mr] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.