Press Release
Abbott Initiates U.S. Study of Absolute Pro™ Peripheral Stent System for Iliac Artery Disease
MOBILITY trial showcases company's leadership in developing innovative
endovascular treatment options
April 1, 2009
Abbott Park, Illinois (NYSE: ABT)
— Abbott today announced the initiation of MOBILITY, a clinical trial studying
the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent
System in patients with iliac artery disease. Iliac artery disease is a form of
peripheral artery disease (PAD) that affects the lower extremities. The first
patient was enrolled into the MOBILITY trial by John Campbell, M.D., assistant
professor of surgery and medicine, West Virginia University School of Medicine,
Charleston Division, at the Charleston Area Medical Center in Charleston, W.
Va.
"Iliac artery occlusive disease has the potential not only to have a
significant impact on a patient’s ability to carry on daily activities, but it
also can be an early sign of plaque buildup in other parts of the body,"
said Manish Mehta, M.D., M.P.H., FACS, director of Endovascular Services, The
Vascular Institute for Health and Disease, Albany Medical Center in Albany,
N.Y., and co-principal investigator of the MOBILITY trial. "The lower
extremity discomfort and fatigue with walking and exercise caused by this
debilitating disease can tremendously impact a patient's overall quality of
life, making it critical to find effective treatments. Data from the MOBILITY
trial will be an important addition to iliac stenting research."
PAD affects approximately 8 million people in the United States,* and occurs
when the blood vessels in the legs become blocked or narrowed by plaque,
reducing blood flow to the limbs. The most common symptom of PAD is
claudication, a sharp, cramp-like pain in the legs that occurs when walking or
exercising. For patients with iliac artery disease, claudication occurs most
frequently in the thigh or hips. PAD most commonly affects people age 40 and
older,* and can lead to reduced walking capacity, chronic pain and immobility,
disability, and potentially amputation. PAD can be treated with medications,
exercise, angioplasty, stenting or surgery.
"As medical technology has advanced, iliac stenting has become an
excellent first-line interventional treatment option for patients, as it is
less invasive than surgery and has the potential to improve patient
outcomes," said Tony S. Das, M.D., FACC, director, Peripheral Vascular
Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas,
Texas, and co-principal investigator of the MOBILITY trial. "The MOBILITY
trial will provide understanding into how the Absolute Pro peripheral stent
treats the narrowing in the iliac artery to improve blood flow to the leg, with
the ultimate goal of alleviating pain associated with PAD and improving the
patient’s ability to walk and exercise."
The MOBILITY trial is designed to study 150 patients at up to 50 centers in
the United States. The primary endpoint is a composite measure of major adverse
events (MAE) at nine months. MAE is defined as death due to any cause, heart
attack (myocardial infarction), clinically driven target lesion
revascularization and limb loss (amputation only) on the treated side(s).
"With iliac interventions, safety and efficacy are critical when
considering treatment options. The MOBILITY trial will provide valuable
evidence about the performance of the Absolute Pro peripheral stent, and it
will be used as the basis for a peripheral vascular indication filing for the
device," said Charles Simonton, M.D., FACC, FSCAI, divisional vice
president, Medical Affairs, and chief medical officer, Abbott Vascular.
"Abbott is a company with a broad-based vascular business, and the start of
the MOBILITY trial is another example of the company's commitment to
researching and developing advanced products in both the endovascular and
coronary areas to improve patients' overall vascular care."
Abbott's robust vascular research program includes clinical trials in
peripheral artery disease, carotid artery disease, and coronary artery disease.
Key products in the vascular pipeline include: the Omnilink Elite™ Peripheral
Stent System; the EMBOSHIELD NAV6™ Embolic Protection System for carotid
stenting; a fully bioabsorbable drug eluting coronary device; and the XIENCE
PRIME™ Everolimus Eluting Coronary Stent System, which builds on the proven
performance of Abbott's market-leading XIENCE V® Everolimus Eluting Coronary
Stent System.
EMBOSHIELD NAV6 is pending 510(k) clearance by the United States Food and
Drug Administration (FDA) and is not available for sale. Omnilink Elite, the
bioabsorbable drug eluting device, and XIENCE PRIME are in development and are
not available for sale.
About the Absolute Pro Peripheral Stent System
Abbott's Absolute Pro peripheral stent is a self-expanding nitinol stent
with a flexible and conformable design that is intended to keep lesions open
without introducing more metal than necessary to treat a narrowing. The
peripheral stent delivery system is compatible with 0.035" (0.89 mm) guide
wires. The Absolute Pro Peripheral Self-Expanding Stent is currently an
investigational device in the United States for the treatment of iliac artery
disease.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the
United States, Europe and other international markets. XIENCE V is an
investigational device in Japan and is currently under review by Japan's
Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical
Devices Agency.
Additional information about XIENCE V, including important safety and
effectiveness information, is available online at www.xiencev.com.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal
growth in the coronary vessels following stent implantation, due to its
anti-proliferative properties.
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.
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 more than
72,000 people and markets its products in more than 130 countries.
| * |
American Heart Association, Heart Disease and Stroke
Statistics – 2009 Update. Chapter 9. pg. 109. |
Media:
Jonathon Hamilton
Jennie Kim |
(408) 624-0314
(408) 332-4176 |
Financial:
Tina Ventura |
(847) 935-9390
|
