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Abbott Initiates Clinical Study to Evaluate Use of RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Renal Artery Stenosis
Date:9/25/2007

medications, and must have at least 60 percent stenosis or blockage in a renal artery as measured by visual X-ray angiography.

"We are pleased to begin enrollment in a study to examine the safety and effectiveness of stenting for patients with renal artery disease and uncontrolled high blood pressure," said Chuck Foltz, vice president, Abbott Vascular. "Abbott Vascular has a strong history of innovation and leadership in vascular care, and with the HERCULES trial we can continue to expand our understanding of vascular disease and how to deliver the best treatments for patients."

About the HERCULES Trial

Abbott is conducting the HERCULES trial to seek U.S. Food and Drug Administration approval for use of the RX Herculink Elite Renal Stent System in the treatment of renal artery stenosis.

The HERCULES trial will enroll up to 202 patients at approximately 50 sites across the United States. The primary endpoint of the study is binary restenosis at nine months, a measure of vessel renarrowing. Secondary endpoints in the trial will measure changes in blood pressure and the use of hypertensive medication at nine months. Additional analyses in patient follow-up visits out to 36 months will measure major adverse events in patients such as death, surgical removal of the kidney, or embolic events resulting in kidney damage, as well as target lesion revascularization (TLR), a measure of the need to retreat a diseased vessel that has renarrowed.

About the Investigational RX Herculink Elite Renal Stent System

The RX Herculink Elite Renal Stent System is an .014-inch rapid-exchange (single-operator) renal stent system made of cobalt chromium, a material that is stronger and easier to see under X-ray than stainless steel.

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 pa
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