Healthcare Industry News: Mitral Valve
News Release - February 15, 2008
Sorin Group Announces U.S. Clinical Trial of Memo 3D(TM) Semirigid Annuloplasty RingStudy at Penn Presbyterian Medical Center and other sites will evaluate effectiveness and safety of MEMO 3D(TM) for diseased or dysfunctional Mitral Valve repair
DENVER--(HSMN NewsFeed)--The Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, is supporting a clinical trial of the Sorin MEMO 3DTM Annuloplasty Ring for Mitral Valve repair. 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.
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.”
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,” had 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.”
About MEMO 3D™ Annuloplasty Ring
The first annuloplasty ring with a semirigid cell-structure design capable of mimicking the physiological 3D motion of the native mitral annulus and accommodating the anatomical saddle shape. Its unique design incorporates the latest high-tech biomaterials and manufacturing technologies Shape memory and super-elastic alloy core aimed at restoring the native shape and function Ease of implant due to suture placement guides, a low profile holder and a special configuration of the silicon filler Sorin Group's exclusive CarbofilmTM coating for enhanced hemo-compatibility Indicated for use in the repair of mitral heart valves, the MEMO 3D™ is distributed in the United States by CarboMedics Inc., a Sorin Group Company.
For more information on the MEMO 3D™ clinical trial visit http://clinicaltrials.gov.
About the Sorin Group
The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes these brands: Dideco, CarboMedics, COBE Cardiovascular, Stöckert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Bellco-Soludia. At the Sorin Group 4,500 employees work to serve over 5,000 public and private treatment centers in more than 80 countries throughout the world. For more information, please visit: www.sorin.com
Source: Sorin Group
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