Healthcare Industry News: Self-Expanding Stent
News Release - April 1, 2009
Abbott Initiates U.S. Study of Absolute Pro(TM) Peripheral Stent System for Iliac Artery DiseaseMOBILITY trial showcases company's leadership in developing innovative endovascular treatment options
ABBOTT PARK, Ill., April 1 (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT) today announced the initiation of MOBILITY, a clinical trial studying the safety and efficacy of the Absolute Pro(TM) 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(TM) Peripheral Stent System; the EMBOSHIELD NAV6(TM) Embolic Protection System for carotid stenting; a fully bioabsorbable drug eluting coronary device; and the XIENCE PRIME(TM) 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.
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 more than 72,000 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 www.abbott.com.
* American Heart Association, Heart Disease and Stroke Statistics - 2009 Update. Chapter 9. pg. 109.
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