Jun 12, 2000
Clinical Data Demonstrates Guidant''s ANCURE Bifurcated Endograft System for Abdominal Aortic Aneurysms as a Safe and Effective Minimally Invasive Treatment

Indianapolis, IN and Menlo Park, CA - Two years of clinical data demonstrate that Guidant Corporation''s (NYSE and PCX: GDT) ANCURE(tm) Bifurcated Endograft System is an effective and safe, minimally invasive treatment for abdominal aortic aneurysms (AAA). Results from clinical trials were presented by Wesley Moore, M.D., professor of vascular surgery at UCLA Medical Center, at the Society for Vascular Surgery''s 54th annual meeting in Toronto, Canada. The data show Guidant''s bifurcated implant to be effective by completely preventing aortic ruptures and decreasing or controlling the size of AAAs in 98 percent of all cases. Approximately two-thirds of patients implanted with the ANCURE device experienced a decrease in aneurysm diameter and nearly one-third of cases resulted in a stabilization of the aneurysm diameter.

Guidant compared its bifurcated endograft to the traditional surgical method of AAA repair. After implanting more than 500 bifurcated endografts since 1995-some with greater than 4 years of follow-up-there were no incidences of ruptures. Additionally, patients who received the minimally invasive treatment lost considerably less blood than recipients of conventional surgery and their respiratory and cardiac complications were reduced by one-half and one-third, respectively. More than 2,000 total bifurcated implants have been performed to date.

Abdominal aortic aneurysm is an enlargement of the aortic artery-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 per year in the United States and more than 45,000 patients require surgery to prevent ruptures of the aneurysm.

The traditional method of preventing aortic ruptures involves an extremely invasive surgical procedure that requires a surgeon to make a large incision in the patient''s abdominal wall. The internal organs are moved aside to provide access to the aorta, which lies deep within the abdominal cavity. The surgeon then incises the aorta and implants a surgical graft to bypass the aneurysm. Recipients of this treatment remain in the hospital one week on average, often with two to three days in the intensive care unit. Patients also must endure several months of home convalescence to fully recuperate.

"The results of Guidant''s latest research on abdominal aortic aneurysms are incredibly encouraging for physicians faced with treating abdominal aortic aneurysms," said Moore. "The data clearly demonstrates the ANCURE System''s position as the best-in-class treatment for this life-threatening disease."

Treatment with the ANCURE System requires significantly shorter recovery periods than surgical procedures because the implant is delivered through small incisions to two arteries in the groin. A delivery catheter containing the implant is inserted into one of these arteries and delivered through the patient''s vasculature to the site of the aneurysm.

Once inside the patient''s body, the ANCURE device''s unique positioning hooks secure the implant to the vessel wall. This attachment mechanism, combined with ANCURE''S woven polyester body, allows the implant to adapt to changes that occur over time in the size and shape of the aorta, while maintaining the implant''s original position within this high-pressure artery.

The U.S. Food and Drug Administration approved the ANCURE System in September of 1999, making this method for endovascular repair available to hospitals throughout the U.S.

A global leader in the medical technology industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant''s products and services, visit the company''s Web site at http://www.guidant.com.