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Long-Term Follow-Up Clinical Data on Guidant's ANCURE Bifurcated System Demonstrates Continued Durability at Five Years.


Business Editors/Health/Medical Writers

INDIANAPOLIS, Ind. & MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 22, 2003

More Than 97 Percent of Patients Studied Experienced Stable or

Shrinking Aneurysm aneurysm (ăn`yrĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart.  Size

Guidant Corporation (NYSE NYSE

See: New York Stock Exchange
:GDT GDT Global Descriptor Table
GDT Geographic Data Technology Inc.
GDT Gas Discharge Tube (energy, electrotechinical and electronics)
GDT Getting Things Done
GDT Geometric Dimensioning & Tolerancing
GDT Ground Data Terminal
)(PCX (1) A bitmapped graphics file format that handles monochrome, 2-bit, 4-bit, 8-bit and 24-bit color and uses RLE to achieve compression ratios of approximately 1.1:1 to 1.5:1. Images with large blocks of solid colors compress best under the RLE method. See PC Paintbrush. :GDT), a world leader in the treatment of cardiac and vascular disease, today reported data from the company's long-term follow-up study evaluating the ANCURE(R) Bifurcated bi·fur·cate  
v. bi·fur·cat·ed, bi·fur·cat·ing, bi·fur·cates

v.tr.
To divide into two parts or branches.

v.intr.
To separate into two parts or branches; fork.

adj.
 ENDOGRAFT(R) System in 319 patients for up to five years. The ANCURE Bifurcated ENDOGRAFT System is a minimally invasive treatment for abdominal aortic aneurysm abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105  (AAA AAA: see American Automobile Association.


(Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied.
).

With 147 patients achieving four years of follow-up and 55 patients reaching five years, no long-term follow-up bifurcated study patients have experienced aneurysm rupture. Additionally, the ANCURE Bifurcated ENDOGRAFT System led to a steadily decreasing aneurysm size in a majority of patients. Barry T. Katzen, M.D., founder and director of the Miami Cardiac and Vascular Institute, presented the data today at the 15th International Symposium on Endovascular Therapy The International Symposium on Endovascular Therapy (ISET) is an educational meeting for physicians, scientists, engineers and allied health professionals working in the multidisciplinary field of peripheral and cardiac interventional medicine.  in Miami Beach, Fla.

"The major reason physicians perform AAA surgery using the ANCURE system is to prevent aneurysm rupture and related death," said Dr. Katzen. "The data from this group of patients compare very favorably to the long-term performance of conventional surgical repair of aneurysms, and we were very pleased to note that all long-term follow-up study patients treated with the ANCURE Bifurcated ENDOGRAFT System have been and continue to be free from rupture at five years."

Key findings from the study, in which 55 patients have been followed for five years after treatment with the ANCURE Bifurcated ENDOGRAFT System, show:
-- 100 percent of patients were free from aneurysm rupture. (In Guidant's entire bifurcated clinical study experience, one patient did experience aneurysm rupture.)

-- 78.6 percent of patients had a decrease in aneurysm diameter size between hospital discharge and their five-year follow-up visit. An additional 19 percent of patients had a stable aneurysm size at five years.

-- The cumulative rate of postoperative conversion to open repair of aneurysm remains low, with a 2.8 percent late conversion rate.

-- 99 percent of ANCURE Bifurcated ENDOGRAFT patients were free from graft migration.


"These long-term clinical study results show that endovascular repair with the ANCURE Bifurcated System continues to be a safe and effective tool for physicians who treat abdominal aortic aneurysms," said Beverly A. Huss, president, Endovascular Solutions, Guidant Corporation. "It is gratifying grat·i·fy  
tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies
1. To please or satisfy: His achievement gratified his father. See Synonyms at please.

2.
 to see that after five years, the patients treated with ANCURE are doing well."

Abdominal aortic aneurysm is an enlargement of the aorta - the largest blood vessel blood vessel
n.
An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates.


blood vessel(s),
n the network of muscular tubes that carry blood.
 in the human body - that results from a weakening of the vessel wall. If left untreated, the enlargement can lead to rupture of the aorta, which is fatal in nearly 80 percent of cases. Approximately 200,000 new cases of AAA are diagnosed each year in the United States.

The traditional treatment for AAA is an invasive surgical procedure that requires a deep incision from the breastbone breast·bone
n.
See sternum.
 to the pubic bone through the abdominal cavity. Because the ANCURE ENDOGRAFT can be inserted through incisions in the groin, patients generally spend less time in the hospital and recover more quickly than after a traditional procedure. More than 18,000 patients worldwide have been treated with the ANCURE ENDOGRAFT System.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jan 22, 2003
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