Navigation Links
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

HERCULES Trial Aims to Treat Renal Artery Obstructions and Lower Blood

Pressure in Patients Not Responding to Medication

ABBOTT PARK, Ill., Sept. 25 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced enrollment of 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.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.


'/>"/>
SOURCE Abbott
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Three Studies Suggest Abbotts Humira (adalimumab) May Improve Work Productivity in Patients with Rheumatoid Arthritis
2. Abbott Announces Positive Nine-Month Results From the Worlds First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
3. Abbott Announces Continued Positive Results with Xience V Everolimus Eluting Coronary Stent in Spirit Clinical Trials
4. New Analysis of Data Shows Treatment With Abbotts Humira (Adalimumab) Significantly Reduced Disease-Related Hospitalization for Patients with Crohns Disease
5. Abbotts Investigational Treatment ABT-874 Shows Positive Results in Phase II Psoriasis Study
6. Abbott Researchers Focus on New Cutting-Edge Approaches in the Fight Against Cancer
7. Two Abbott Studies Reaffirm Carotid Artery Stenting as a Safe and Effective Treatment to Reduce Risk of Stroke
8. Abbott Announces Positive Six-Month Results From the Worlds First Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary Stent
9. Abbotts Xience V Everolimus Eluting Coronary Stent Superior to Taxus Stent in Spirit III U.S. Pivotal Clinical Trial
10. Abbott to Present New Data Across its Vascular Portfolio at the American College of Cardiologys 56th Annual Scientific Session
11. Malvern initiates European user group meetings for chemical imaging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Dublin ... of the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global ... including its applications in various applications. The report deals ... three main industries: pharmaceutical and biotechnology, food and beverage, ...
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American ... function testing company, is now able to perform sophisticated lung assessments ... ndd Medical Technologies , Inc. Patients are no ...  Thanks to ndd,s EasyOne PRO ® , ARL patients like Jeanne ... needed testing done in the comfort of her own home. ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best Buy ... in the United States and Canada wear eyeglasses. Once considered to be a purely ... make a fashion statement. Even celebrities use glasses as a way of creating an ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
Breaking Medicine News(10 mins):