February 15, 2008 - The Sorin Group is launching the Sorin MEMO 3D Annuloplasty Ring for mitral valve repair clinical trial at Penn Presbyterian Medical Center, which is designed to evaluate the effectiveness and safety of MEMO 3D for diseased or dysfunctional mitral valve repair.
The MEMO 3D when used to repair a diseased or dysfunctional mitral valve. The open label, multisite, 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.
The lead principal investigator for the clinical trial is Dr. W. Clark Hargrove, III, M.D., clinical professor of surgery at the University of Pennsylvania School of Medicine and Clinical Director, Division of Cardiovascular Surgery, Penn Presbyterian Medical Center.
“We are looking forward to learning more about how the device’s flexible capabilities will impact its efficacy in functional, ischemic and degenerative Mitral Regurgitation (MR) as well as rheumatic procedures,” said Dr. Hargrove. “The device’s design makes it relatively easy to implant in place, and there is potential that it may be able to be used in many disease processes.”
Researchers hope the ring results in better physiological motion of the mitral annulus after mitral valve repair due to its flexible design and the Carbofilm coating of the ring. This results in decreased inflammatory response due to the introduction of a foreign body into the bloodstream.
For more information: www.clinicaltrials.gov and www.sorin.com