The Sorin Group has launched a clinical trial of its Memo 3D Annuloplasty Ring for mitral valve repair.
The purpose of the open-label, multi-site, treatment study is to evaluate the effectiveness and clinical outcomes of Memo 3D when used to repair a diseased or dysfunctional mitral valve, according to the Milan, Italy-based Sorin.
The study will be recruiting patients and will be conducted at Penn Presbyterian Medical Center in Philadelphia, and several other North American sites.
Secondary outcome measures include survival, lack of further operations and clinical events at 12 months and preoperative and postoperative mitral valve regurgitation, left ventricular dimensions and mass assessed by echocardiography, Sorin said.
The lead principal investigator for the clinical trial is W. Clark Hargrove, III, MD, clinical professor of surgery at the University of Pennsylvania School of Medicine in Philadelphia, and clinical director at division of cardiovascular surgery at Penn Presbyterian.