| September 15,
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
(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
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
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
The trial is being conducted under an FDA approved
Investigational Device Exemption and is sponsored Evalve,
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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
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.