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Percutaneous edge-to-edge mitral valve repair shows favorable preliminary results

. The clip is a product of Evalve Inc., a medical device company, and the sponsor of the trial. Based on these promising results, a larger, Phase II safety and efficacy trial may be initiated later this year.

Dr. Herrmann presented an update of the trial's findings today at the American Heart Association's Scientific Sessions 2004 in New Orleans during a presentation entitled "Percutaneous Edge-to-Edge Mitral Valve Repair: Preliminary Results of the EVEREST- I Study." To be eligible for the investigational procedure, candidates must have moderate-to-severe or severe MR and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle (heart muscle).

Performed in the cardiac catheterization lab, the initial procedures have taken approximately two to four hours. Under full anesthesia, a catheter (a thin, flexible plastic tube) is introduced through the skin in the thigh area and guided through the femoral vein to the affected area of the heart. A smaller delivery catheter that holds the clip is slipped through this tube so that the clip can be guided into place and attached to the leaflets (the "swinging doors") of the mitral valve. Once the clip is attached, the delivery catheter is removed. The entire process is monitored by an echocardiogram. The hospital stay has generally been two nights; and most patients returned to normal activity within one week.

Other investigators contributing to this study are Ted Feldman, MD, Evanston Northwestern Healthcare System; Hal Wasserman, MD, Columbia University Medical Center; William Gray, MD, Swedish Medical Center, Seattle; Peter Block, MD, Emory University Hospital and Patrick Whitlow, MD, The Cleveland Clinic Foundation.


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Contact: Ed Federico
ed.federico@uphs.upenn.edu
215-349-5659
University of Pennsylvania School of Medicine
8-Nov-2004


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