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Abbott to Initiate First Study to Evaluate XIENCE(TM) V Everolimus Eluting Coronary Stent System in Treatment of Women With Cardiovascular Disease

Abbott Park, Illinois (ots/PRNewswire)

- First-of-its-Kind Study Designed to Learn More About
Cardiovascular  Disease in Women
Abbott today announced plans to initiate the world's first
drug-eluting stent clinical trial solely in women. The SPIRIT WOMEN
trial will aim to increase understanding of how heart disease affects
women, and will assess the performance of the XIENCE(TM) V Everolimus
Eluting Coronary Stent System in women with previously untreated
coronary artery lesions.
Each year, more women than men die of cardiovascular disease
(CVD), yet women receive only 33 percent of angioplasties, stents and
bypass surgeries; 28 percent of implantable defibrillators; and 36
percent of open-heart surgeries(1). This may be attributed to the
fact that diagnosis of CVD in women is more challenging than in men,
as women typically exhibit different symptoms than men because their
symptoms are more gradual and subtle. Rather than the more
commonly-recognized symptoms, such as sudden violent chest pain, or
uncomfortable pressure, or fullness, that are predominate in men,
women may experience other warning signs, particularly shortness of
breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue
and back, shoulder blade or jaw pain (2).
"Even though more women than men die from cardiovascular disease
each year, women today comprise only 25 percent of participants in
all heart-related research studies," said Marie-Claude Morice, M.D.,
Institute Jacques Cartier, Massy, France, principal investigator for
SPIRIT WOMEN. "Cardiovascular disease in women is underdiagnosed and
undertreated because the differences between men and women are not
well understood. The SPIRIT WOMEN trial is meant to help improve our
understanding of cardiovascular disease in women, and the best ways
to care for women with CVD."
The SPIRIT WOMEN clinical trial is the first large interventional
study to solely study CVD in women and how it differs from men. The
SPIRIT WOMEN trial will include approximately 2,000 women from 100
sites throughout Europe, Asia-Pacific, Canada and Latin America. The
study will evaluate patient and disease characteristics specific to
women as well as treatment outcomes such as rate of death, heart
attack and target vessel revascularization (TVR) and potential risk
of stent thrombosis. The trial will yield specific data on CVD and
how it is diagnosed in women.
"The SPIRIT WOMEN trial will contribute to therapy access by
increasing awareness and understanding of CVD in women while further
evaluating the performance of our XIENCE V drug-eluting stent in this
patient population," said John M. Capek, Ph.D., president, Abbott
Vascular. "As a leader in vascular care, Abbott believes that it is
our role not only to provide the best technologies, but also to
ensure that they are being used effectively in as broad a patient
population as possible."
Pending requisite approvals from regulatory bodies and clinical
trial sites, patients are expected to begin enrolling in SPIRIT WOMEN
by mid-2007.
About Abbott's SPIRIT Clinical Trial Program
SPIRIT WOMEN represents the sixth study in the SPIRIT Clinical
Trial Program and will increase the number of patients being studied
in the SPIRIT family of trials to approximately 8,000. The six
studies evaluating the XIENCE V Everolimus Eluting Coronary Stent
System for the treatment of coronary artery disease are:
    -- SPIRIT FIRST - First-in-man study showed positive results through two
       years with no major adverse cardiac events between one and two years
       for patients with de novo (previously untreated) native coronary
       artery lesions.
    -- SPIRIT II - Six-month results of the trial conducted in Europe and
       Asia-Pacific demonstrated superiority of the XIENCE V stent system to
       the TAXUS(R) paclitaxel-eluting coronary stent system with respect to
       the study's primary endpoint, which was angiographic in-stent late
       loss at six months.
    -- SPIRIT III - This large-scale pivotal clinical trial compares the
       XIENCE V system to the TAXUS stent system in the United States and
       Japan. The randomized arm of this trial completed patient enrollment
       in March 2006.
    -- SPIRIT IV - This trial, which is currently enrolling patients, will
       evaluate the safety and efficacy of the XIENCE V system for the
       treatment of coronary artery disease in a more complex patient
       population in the United States.
    -- SPIRIT V - This study will provide additional clinical experience with
       the XIENCE V system throughout Europe, Asia-Pacific and Canada in
       real-world patients. One subset of the study is dedicated to diabetic
       patients.
    -- SPIRIT WOMEN - The world's first drug-eluting stent trial to study
       only women will evaluate the characteristics of women undergoing stent
       implantation and performance of XIENCE V in those patients in Europe,
       Asia-Pacific, Canada and Latin America.
The XIENCE V system, which was launched recently in Europe and has
received CE Mark approval, utilizes the drug everolimus and the
highly deliverable and proven MULTI-LINK VISION(R) coronary stent
platform. Everolimus has been shown to reduce tissue proliferation in
coronary vessels following stent implantation. The XIENCE V system is
currently an investigational device in the United States and Japan.
Pending requisite regulatory approvals, Abbott expects to launch
XIENCE V in the United States in the first half of 2008 and in Japan
the following year.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's
leading vascular care businesses. Abbott Vascular is uniquely focused
on advancing the treatment of vascular disease and improving patient
care by combining the latest medical device innovations with
world-class pharmaceuticals, investing in research and development,
and advancing medicine through training and education. Headquartered
in Northern California, Abbott Vascular offers a comprehensive
portfolio of vessel closure, endovascular and coronary products that
are recognized internationally for their safety, effectiveness and
ease of use in treating patients with vascular disease.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices
and diagnostics. The company employs 65,000 people and markets its
products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com .
    (1) National Center on Health Statistics; National Heart, Lung and Blood
        Institute; and American Heart Association's 2002 Heart and Stroke
        Statistical Update
    (2) World Heart Federation
Web site: http://www.abbott.com

Contact:

Media, Karin Bauer Aranaz, +1-408-845-3887, or Financial, Tina
Ventura, +1-847-935-9390, both of Abbott/ Company News On-Call:
http://www.prnewswire.com/comp/110328.html

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