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Wake Forest Baptist Announces First Implant in Clinical Trial to Evaluate New Heart Valve Procedure

New Technology Treats Aortic Heart Valve Disease without Surgery

WINSTON-SALEM, N.C. – April 8, 2011– More than 100,000 patients who suffer from severe aortic stenosis, a condition that restricts blood flow from the heart to the body, are ineligible for open-heart valve replacement surgery. Today, Wake Forest Baptist Medical Center announced the enrollment of the first three patients in North Carolina to receive transcatheter aortic-valve implantation (TAVI) as part of the Medtronic CoreValve® U.S. Clinical Trial.

The non-surgical, less-invasive procedure was performed by a multidisciplinary team, led by Neal Kon, M.D., chair of cardiothoracic surgery and Robert Applegate, M.D., professor of cardiology.

During the procedure, physicians channel a catheter (thin tube) with a porcine, prosthetic valve through a small opening in the patient’s femoral artery to reach the heart. The physician guides the CoreValve System to the aortic valve, where it self-expands to replace the diseased aortic valve; the procedure is completed without open-heart surgery or surgical removal of the native valve.

“There is significant need for a new treatment option for patients with aortic stenosis, and it is enormously rewarding that Wake Forest Baptist can be a part of the evaluation process of this remarkable new treatment,” says Applegate.

Aortic stenosis is a heart condition that occurs when the aortic valve narrows, preventing it from properly opening and closing, and diminishing blood flow between the heart and the rest of the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. When aortic stenosis becomes severe and symptoms develop, it is life-threatening.

The most common cause of aortic stenosis is excessive wear on the aortic valve. This usually develops with age, but the process may be expedited in patients who are congenitally predisposed to disease, Applegate says.

"As many as fifty percent of aortic stenosis patients with severe symptoms may die within two years untreated," said Kon. "This new procedure gives us the opportunity to treat those patients who aren't eligible for open-heart surgery."

In the U.S., the CoreValve System is investigational and will not be commercially available until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration (FDA).

Neal Kon, M.D. receives compensation from Medtronic Sofamor Danek for consulting.  His potential conflicts of interest are managed by Wake Forest School of Medicine.

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