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GUIDANT'S ANCURE BIFURCATED SYSTEM SHOWS DURABILITY AT 5 YEARS.

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 at the 15th International Symposium on Endovascular Therapy.

Guidant Corporation (NYSE:GDT)(PCX:GDT), a world leader in the treatment of cardiac and vascular disease, has reported data from the company's long-term follow-up study evaluating the ANCURE(R) Bifurcated 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 (AAA).

"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 the following:

-- 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 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 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 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 http://www.guidant.com or call 408/845-1660 or 317/971-2031.
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Title Annotation:ANCURE Bifurcated ENDOGRAFT System
Publication:Biotech Equipment Update
Geographic Code:1USA
Date:Mar 1, 2003
Words:573
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