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Penn Presbyterian Medical Center plans US clinical trial of new semirigid annuloplasty ring

Sorin : 18 February, 2008  (New Product)
The Sorin Group plans to support a clinical trial of the Sorin MEMO 3D Annuloplasty Ring for mitral valve repair, which will 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.

The lead principal investigator for the clinical trial is Dr W Clark Hargrove, III, MD, 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.”

Shortly after Sorin Group announced FDA clearance for the MEMO 3D in September 2007, Dr Hargrove had successfully performed the first procedure at Penn Cardiac Care at Penn Presbyterian Medical Center within the University of Pennsylvania Health System.

“The ring is expected to result in better physiological motion of the mitral annulus after mitral valve repair due to its flexible design and the Carbofilm coating of the ring,” observed Dr Hargrove. “This results in decreased inflammatory response due to the introduction of a foreign body into the bloodstream.”

“We're looking forward to this clinical evaluation further reinforcing the value and efficacy of this innovative device”, said Stefano Di Lullo, president of the heart valves business unit, Sorin Group. “MEMO 3D has been specifically designed to maintain the normal physiological motion of the mitral annulus after mitral valve repair.”

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