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Abbott Initiates U.S. Study of Absolute Pro(TM) Peripheral Stent System for Iliac Artery Disease
Date:4/1/2009

rtery 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 compa
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