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St. Luke`s Medical Center first in Wisconsin to enroll patient in beating heart mitral valve repair research study

Friday, November 07, 2003

St. Luke’s Medical Center recently became the first hospital in Wisconsin to operate on a patient’s damaged mitral valve during a beating heart procedure. St. Luke’s joins just six other sites nationwide to evaluate the Coapsys™ Annuloplasty System in a FDA regulated research study called the RESTOR-MV.

As part of the RESTOR-MV trial, the Coapsys device is implanted on a beating heart without the use of cardiopulmonary bypass (heart-lung machine) and without needing to make an incision to open the heart for the repair. The device is intended to reduce the amount of blood flowing backwards from the left ventricle (mitral regurgitation). It is also designed to improve cardiac function and potentially reduce overall treatment costs.

“Because of the size of our program and the experience of our staff, our patients have access to cutting edge research and innovation that smaller, specialized heart hospitals cannot offer,” says David Kress, M.D., Chief of Cardiothoracic surgery at St. Luke’s and the primary investigator on the study. “This procedure will likely extend the promise of beating heart surgery to now include patients with mitral valve disease.”

This is a randomized clinical trial that could eventually include up to 25 centers in North America and 250 patients. The first patient to be enrolled in the trial at St. Luke’s is recovering well and is expected to be discharged soon. The incidence of mitral regurgitation continues to be a growing concern for physicians. Ten percent of patients who present for bypass procedures also have valvular disease. In Wisconsin, that means up to 500 patients could potentially benefit from this procedure.

St. Luke’s Medical Center is a part of Aurora Health Care, a not-for-profit Wisconsin health care provider and a nationally recognized leader in efforts to improve the quality of health care. Aurora has care sites in 75 communities throughout eastern Wisconsin. The RESTOR-MV clinical trial is sponsored by Mycor® Inc., a MN based company. # # # Contact: Jennifer Gross 414-385-2363

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