Oct 24, 2000
Three-Year Data On Guidant's ANCURE System Show Control of Abdominal Aortic Aneurysms Following Endovascular Repair

Nearly 75% of Patients Treated with ANCURE Bifurcated System Implant Experience Decreasing Aneurysm Size Over Time

Indianapolis, IN - Three-year follow-up data on Guidant's (NYSE and PCX: GDT) ANCURE(tm) System for the treatment of abdominal aortic aneurysm (AAA) shows that use of the ANCURE system leads to a steadily decreasing aneurysm diameter over time in a majority of patients. The data were presented today at the 86th Annual Clinical Congress of the American College of Surgeons by Dr. Michel S. Makaroun in Chicago.

"Endovascular repair of abdominal aortic aneurysm using the ANCURE system is now a viable option for many patients," said Dr. Makaroun, professor of surgery and chief of the division of vascular surgery, University of Pittsburgh Medical Center. "These clinical results are very encouraging because they show stable aneurysm repair at three years, which bodes well for the long-term."

Key findings show:

Guidant's bifurcated implant completely prevented aortic ruptures and decreased or controlled aneurysm size in 96.2 percent of all cases at three years. 73.7 percent of patients with bifurcated implants had a decrease in aneurysm diameter size between discharge and their third annual visit, as compared to 64.8 percent at their second annual visit, and 53.8 percent at their first annual visit. There were no reports of aneurysm rupture with bifurcated implants. EndoGraft migration was observed in only one patient; demonstrating that bifurcated Endografts remain securely attached following implantation.

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 per year in the United States. This disease results in major surgery for more than 45,000 patients per year. Approximately 15,000 deaths each year are attributed to AAA, making it the nation's 13th leading cause of death. It is one of the leading causes of sudden death in men over the age of 65.

The traditional method of repairing abdominal aortic aneurysms involves an extremely invasive surgical procedure, which requires a long incision from the breastbone to the pubic bone. 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 with sutures to bypass the aneurysm. Recipients of this treatment remain in the hospital for 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. 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.

Guidant compared the ANCURE System to the traditional surgical method of AAA repair. Results from this study contain data from 88 patients implanted with bifurcated ANCURE Grafts who completed three annual follow-up examinations. The diameter of the aneurysm sac was measured by a core laboratory at each follow-up visit to monitor its change in size. Long-term safety data were analyzed using Kaplan-Meier methodology.

After implanting more than 500 bifurcated devices in U.S. clinical trials since 1995, there were no incidences of ruptures. Additionally, patients who were treated with endovascular AAA repair 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 4,000 bifurcated implants have been performed to date.

"The three-year data for the bifurcated system shows zero ruptures and year-to-year improvement over what was presented earlier this year at the Society of Vascular Surgeons conference," said Jay Watkins, president of Guidant's Cardiac & Vascular Surgery Group. "As awareness of AAA grows among physicians and patients, we're confident that endovascular repair with the ANCURE System will be the treatment of choice for this silent, unrecognized killer."

A delivery catheter containing the ANCURE System is inserted into an artery in the groin 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.

Earlier this month, Guidant announced its support of "AAA: Screening for a Silent Threat," a continuing medical education (CME) program on AAA. The program is available exclusively on Medscape, and is designed to raise awareness of AAA among primary care and family physicians, and underscore the importance of early diagnosis.

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

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.