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September 15, 2003

New Endovascular Procedure May Spare Patients Suffering from Mitral Valve Regurgitation the Ordeal of Open-Heart Surgery

The University of Pennsylvania Medical Center Is Among the First to Enroll Patient in the FDA Approved study

(Philadelphia, PA) -- A new catheterization procedure now in Phase I trials at the University of Pennsylvania Medical Center and several other sites across the country may help heart patients with significant mitral valve regurgitation (MR) avoid open-heart surgery.

At present, surgery is the only effective method of treatment for chronic MR, a defect in which the mitral valve fails to close properly, resulting in abnormal flow of blood, weakening the heart, and eventually leading to congestive heart failure.

The new catheterization procedure uses a small implant (manufactured by Evalve Inc. of Redwood City, CA), to bring the leaflets of the valve together, allowing the valve to close properly. In addition to improving blood-flow through the heart, the procedure may relieve the severity of the fatigue and shortness-of-breath that afflicts patients with chronic significant MR.

"We expect that patients' quality of life may be improved, which appears to be the case with the first patient to undergo the procedure. And we hope the procedure will prevent -- or at least delay -- the need for open-heart surgery," said Howard C. Herrmann, MD, Director of Interventional Cardiology at the Medical Center, who is among only a handful of physicians who have implanted the device.

Herrmann served as a moderator for the first public discussion of the new procedure on Monday in Washington, D.C., at the annual national meeting of the Transcatheter Cardiovascular Therapeutics Symposium.

The principal investigator for the U.S. clinical trial is Ted Feldman, MD, of Evanston Northwestern Healthcare in Evanston, IL. Other investigators include Peter Block, MD, Emory University, Atlanta, GA; Patrick Whitlow, MD, the Cleveland Clinic Foundation, Cleveland OH; and William Gray, MD, Swedish Medical Center, Seattle, WA.

Chronic mitral valve regurgitation, is a progressive disorder that affects approximately 4 million people in the United States. In the US about 250,000 develop significant MR annually.

It occurs when the flaps, or "leaflets," of the mitral valve fail to shut completely as the heart pumps blood into the aorta, resulting in a condition in which a portion of the newly-pumped blood flows back ("regurgitates") through the valve during each heart-beat. This condition worsens as the heart weakens over the years. At present, the only way to treat MR is through mitral valve repair or mitral valve replacement, both of which require open-heart surgery with cardiopulmonary bypass.

In the new procedure, a catheter holding the implant is threaded from the groin area through the femoral vein to the heart, and, after positioning over the mid section of the valve, advanced through the mitral valve past the leaflets that open and shut as the heart pumps blood. The implant is closed, forming two openings in the valve, one on either side. Once the implant is securely attached to the valve, the delivery catheter is removed. The entire procedure is monitored by an echocardiogram.

"While we hope this approach may delay and even free many MR patients from the rigors of open-heart surgery, the approach does not preclude future mitral valve surgery if it does become necessary in some cases," Herrmann said.

The trial is being conducted under an FDA approved Investigational Device Exemption and is sponsored Evalve, Inc.

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Editor's note: Dr. Herrmann has no financial interest in the Evalve Corporation.

PENN Medicine is a $2.2 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System (created in 1993 as the nation's first integrated academic health system). Penn's School of Medicine is ranked #2 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S. News & World Report's most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

Penn Health System consists of four hospitals (including its flagship Hospital of the University of Pennsylvania, consistently rated one of the nation's "Honor Roll" hospitals by U.S. News & World Report), a faculty practice plan, a primary-care provider network, three multispecialty satellite facilities, and home health care and hospice.

Evalve, Inc., based in Redwood City, CA, is developing catheter based technology to percutaneously repair heart valves. The company was incorporated in 1999 to design, manufacture and market innovative products that enable the endovascular repair of cardiac valves. The company's initial products are designed to reduce the risks, trauma and costs associated with current open arrested heart surgical options for valve regurgitation.


Release available online at http://www.uphs.upenn.edu/news/News_Releases/sept03/endovascular.htm