Abbott (NYSE:ABT), Abbott Park, Ill., has enrolled the first
patient in HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial
to Demonstrate Efficacy and Safety), a U.S. clinical trial designed to
evaluate the safety and effectiveness of the investigational RX
Herculink(R) Elite(TM) Renal Stent System to treat patients with renal
artery stenosis (RAS), a condition characterized by fatty plaque buildup
in the kidney arteries that can lead to high blood pressure. The first
implant was performed by Joaquin Martinez de Arraras, M.D., FACC,
president of Amarillo Heart Clinical Research Institute, Inc. in
Amarillo, Texas.
In renal artery stenosis, a buildup of fatty plaque causes
narrowing of the renal arteries that lead to the kidneys, organs that
filter waste from the blood. In patients who have uncontrolled high
blood pressure (hypertension) without apparent cause, renal artery
stenosis is often discovered as the culprit during clinical
investigation. Renal artery stenosis affects approximately 5 million
people in the United States, and occurs most often in men between the
ages of 50 and 70. It can lead to poor kidney function, or even kidney
failure and dialysis, which is a risk factor for cardiovascular disease.
"Many patients with high blood pressure and renal artery
stenosis do not respond as well to medication alone as they may to
medication plus stenting," said Dr. Martinez de Arraras. "The
goal of the HERCULES trial is to evaluate whether renal artery stenting
may reduce vessel renarrowing, thereby potentially reducing other risk
factors for cardiovascular disease, such as high blood pressure."
To qualify for the HERCULES study, patients must have uncontrolled
hypertension that is not responding to treatment with at least two blood
pressure 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 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 and effectiveness in treating patients
with vascular disease.
About Abbott
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.
For more information, visit http://www.abbott.com or call
408/845-3887.
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