The purpose of the study is to evaluate the effectiveness and clinical outcomes of Memo 3D when used to repair a diseased or dysfunctional mitral valve. The open label, multi-site, treatment study will be recruiting patients and will be conducted at Penn Presbyterian Medical Center and several other North American sites. The primary outcome measure of the study will be the percentage of patients with successful repair at six months. Secondary outcome measures are: freedom from re-operation at 12 months; preoperative and postoperative mitral valve regurgitation, left ventricular dimensions and mass assessed by echocardiography; actuarial survival and freedom from clinical events at 12 months.
Stefano Di Lullo, president of the heart valves business unit, Sorin Group, said: “Memo 3D has been specifically designed to maintain the normal physiological motion of the mitral annulus after mitral valve repair.”