Healthcare Industry News: SPIRIT II
News Release - July 19, 2007
Abbott Enrolls First Patient in World's First Clinical Trial Designed to Study Drug Eluting Stent Treatment in WomenXIENCE V SPIRIT WOMEN Trial Designed to Evaluate the XIENCE(TM) V Everolimus Eluting Coronary Stent System in the Treatment of Women with Cardiovascular Disease
ABBOTT PARK, Ill., July 19 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) today announced that the first patient was enrolled in its XIENCE V SPIRIT WOMEN clinical trial, the world's first clinical trial designed to study the safety and effectiveness of drug eluting stent treatment in women. Liliana Grinfeld, M.D., of the Hospital Italiano in Buenos Aires, Argentina, performed the first procedure.
The goal of the XIENCE V SPIRIT WOMEN trial is to increase understanding of how heart disease affects women and to assess the performance of the XIENCE(TM) V Everolimus Eluting Coronary Stent System in women with previously untreated coronary artery lesions from Europe, Asia-Pacific, Canada and Latin America. The trial will focus on specific aspects of women's health in relation to coronary artery disease such as general awareness about the disease, symptoms at time of presentation, referral patterns, and hormonal menopausal status.
"We are honored to have enrolled the first patient in the important XIENCE V SPIRIT WOMEN trial, because it is designed to address issues associated with the under-treatment of women with cardiovascular disease," said Dr. Grinfeld. "The XIENCE V Everolimus Eluting Coronary Stent System performed well, and as with all patients enrolled in the XIENCE V SPIRIT WOMEN trial, the patient will be followed out to 5 years."
Each year, more women than men die of cardiovascular disease (CVD), and 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).
"With more women dying of cardiovascular disease than men, it is tragic that women comprise only 25 percent of participants in all heart-related research studies," said Marie-Claude Morice, M.D., Institute Jacques Cartier, Massy, France, and principal investigator for XIENCE V SPIRIT WOMEN. "As the first trial designed to investigate drug-eluting stent treatment in women, XIENCE V SPIRIT WOMEN has the potential to enhance access to therapy for women by increasing physicians' and women's awareness about cardiovascular disease."
Women with CVD may be under-treated because disease diagnosis is more challenging in women than in men. Women typically exhibit different symptoms than men, and their symptoms often are more gradual and subtle. For example, rather than the more commonly recognized symptoms such as the sudden violent chest pain, or uncomfortable pressure or fullness that are predominant in men, women may experience other warning signs such as shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue, and back, shoulder blade or jaw pain(2). XIENCE V SPIRIT WOMEN will yield specific data on how the disease presents in women.
XIENCE V SPIRIT WOMEN clinical trial is the first large interventional study to study how cardiovascular disease differs in women from men. XIENCE V SPIRIT WOMEN will include approximately 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. The trial will evaluate patient and disease characteristics specific to women such as menopausal status and hormonal profiles, as well as treatment outcomes including death, heart attack, the need for re-treatment (target vessel revascularization, or TVR) and potential risk of stent thrombosis.
"The enrollment of the first patient in this landmark study is important because it has the potential to raise awareness about cardiovascular disease in women and encourage more women with symptoms of the disease to seek treatment," said John M. Capek, Ph.D., president, Abbott Vascular. "XIENCE V SPIRIT WOMEN, and the entire SPIRIT family of clinical trials, demonstrates Abbott's commitment to providing the best technologies for the treatment of cardiovascular disease, and ensuring that these technologies are used safely and effectively in both women and men."
(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
About the XIENCE SPIRIT Family of Trials
XIENCE V 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 10,000. The six studies evaluating the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease are:
-- SPIRIT FIRST, a randomized trial comparing the XIENCE V Everolimus Eluting Coronary Stent System with the MULTI-LINK VISION metallic stent system.
-- SPIRIT II, a randomized clinical trial evaluating XIENCE V versus TAXUS in Europe and Asia Pacific.
-- SPIRIT III, a large-scale randomized pivotal clinical trial comparing XIENCE V to TAXUS in the United States and Japan.
-- SPIRIT IV, a randomized trial currently enrolling patients and will evaluate the safety and efficacy of XIENCE V for the treatment of coronary artery disease in a more complex patient population in the United States.
-- SPIRIT V, an international clinical trial currently enrolling patients that will provide additional data on clinical experience with XIENCE V at 100 clinical sites throughout Europe, Asia Pacific, Canada and Latin America.
-- XIENCE V SPIRIT WOMEN, the world's first drug eluting stent trial to study only women, will evaluate the characteristics of women undergoing stent implantation as well as the performance of XIENCE V in those patients in Europe, Asia-Pacific, Canada and Latin America.
About XIENCE V
XIENCE V was launched in Europe and Asia Pacific in 2006. XIENCE V is currently an investigational device in the United States and Japan. Abbott completed its Premarket Approval (PMA) submission of the XIENCE V system to the United States Food and Drug Administration (FDA) in June 2007.
The XIENCE V system utilizes everolimus, which has been shown to reduce tissue proliferation in coronary vessels following stent implantation, and one of the world's most popular metallic platforms -- the MULTI-LINK VISION Coronary Stent System.
XIENCE V is designed, studied and manufactured by Abbott Vascular. Abbott supplies a private-labeled version of XIENCE V to Boston Scientific, called the PROMUS(TM) Everolimus Eluting Coronary Stent System, as part of a distribution agreement established between the two companies last 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.
Abbott 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.
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