November 10, 2003
New Stent Graft for Thoracic Aneurysms Offered at Penn
University of Pennsylvania Medical Center serves as regional site for national
trial
(Philadelphia, PA) – In an important step toward
further establishing treatment options for patients
with life-threatening aneurysms or trauma involving
the aorta, the body’s largest artery, the University
of Pennsylvania Medical Center is participating
in an FDA-approved clinical trial of the Talent(TM)
Thoracic Stent Graft System, manufactured by Medtronics,
Inc.
Ronald M. Fairman, MD, Chief of Penn’s
Division of Vascular Surgery is the primary investigator
for the nation-wide “VALOR” trial, which
is taking place at 35 sites across the country with
Penn as the only site in the Philadelphia region. Joseph
E. Bavaria, MD, Director of Penn’s Thoracic
Aorta Surgery and Lung Transplantation Programs, serves
as co-investigator at the Penn site.
“This is an extremely important trial, as we will
be exploring the safety and effectiveness of a device
that could significantly increase the number of treatment
options for thoracic aneurysm patients,” said
Fairman. “In most instances, treatment options
are limited and, as a result, mortality rates high.
I’m hopeful that we can establish that this stent
is both safe and effective, ultimately providing patients
with a new option that could save their lives.”
The procedure involves introducing the stent graft through
a small opening in the femoral artery of the leg, and
advancing it under fluoroscopic guidance to the site
of the thoracic aortic aneurysm or dissection, where
it is then deployed. Once placed, the stent graft expands
to fit the diameter of the aorta, thereby excluding
the aneurysm by providing a new path for blood.
It is estimated that there are more than 21,000 patients
diagnosed with thoracic aortic aneurysms yearly in the
U.S. A number of these patients also have serious co-morbidities
such as coronary artery disease, emphysema, high blood
pressure and diabetes that make it difficult –
if not impossible – for them to survive open surgical
repair, which is the current standard of care. Open
surgery is a risky, taxing procedure that can lead to
death in many frail and elderly patients and can also
be associated with severe complications, such as paraplegia.
For those patients considered ineligible for open surgical
repair, conservative medical management or “watchful
waiting” is often used as a treatment option and
can lead to increased mortality and morbidity in many
elderly patients.
The TalentTM Thoracic Stent Graft System has been approved
for over five years in Europe and has been implanted
more than 6,000 times worldwide. The VALOR study is
a prospective, non-randomized, multi-center, consecutive
trial enrolling patients in three separate study arms:
Patients will be divided into three categories: those
diagnosed with thoracic aortic aneurysms who are considered
candidates for open surgical repair and who are of low-
to-moderate risk of major complications; those patients
with Type B thoracic aortic dissections, aneurysms associated
with dissections, and pseudoaneurysms; and high-risk/non-surgical
candidates: including patients with traumatic thoracic
aortic aneurysms – incurred through emergencies
such as car accidents – who do not have a complete
severing of the aorta.
“The standard operation for thoracic aortic aneurysms
is difficult for the patient, requires a lengthy recovery
period, and can only be done when absolutely necessary,”
said Bavaria. “This new therapy is revolutionary
and allows much greater access to aneurysm repair in
the chest with better outcomes.”
For
a printer friendly version of this release, click
here.
Talent(TM) Thoracic Stent
Graft System. For larger images, click on the pictures.
# # #
Editor’s Note: Drs.
Fairman and Bavaria have no financial interest in Medtronic,
Inc.
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.
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