Sep 28, 1999
Guidant Announces FDA Approval for its ANCURE System for Minimally Invasive Treatment of Abdominal Aortic Aneurysms

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a global leader in cardiovascular and vascular therapy, announced today that the U.S. Food and Drug Administration has approved for market release its minimally invasive treatment of abdominal aortic aneurysms (AAA) in the United States. As a result, Guidant is cleared to begin shipping its ANCURE(tm) System for the minimally invasive treatment of AAA to hospitals throughout the U.S.

This device will provide many of the estimated 1.5 million people afflicted by this life-threatening disease an alternative to the current method of treatment, which is a highly invasive surgical procedure. This FDA approval culminates 10 years of development of a minimally invasive treatment of AAA by Guidant and Endovascular Technologies, which was the first medical device company to successfully perform an endovascular implant in the U.S. in 1993.

AAA is an enlargement of the aorta, the main artery of the human body, resulting from a weakening of the vessel wall. If untreated, this enlargement can lead to aortic rupture, which in nearly 80 percent of cases results in death. It is believed that 1.5 million people in the United States have AAA, with approximately 200,000 new cases diagnosed every year. Many cases of AAA go undetected, as the disease is usually asymptomatic and often diagnosed by coincidence during tests - such as ultrasounds - for other medical conditions. This disease results in major surgery for approximately 45,000 patients per year. The 15,000 deaths attributed to AAA each year make it the nation''s thirteenth-leading cause of death.

Minimally invasive treatment of AAA represents a significant clinical advance over the traditional surgical procedure. Guidant''s clinical data, presented to the FDA, showed that patients implanted with Guidant''s device experienced significantly fewer complications than those experienced by persons who underwent conventional surgery. The data also showed that with Guidant''s minimally invasive approach to AAA repair, a patient''s length of hospital stay was on average only two to three days, compared to six days for persons in the control group who underwent the open surgical procedure.

"Endovascular repair of abdominal aortic aneurysm using the ANCURE System is the most exciting development in the management of patients with AAA since we first developed a way to treat patients with an aneurysm," said Dr. Wesley Moore, professor of vascular surgery at UCLA Medical Center. "It''s made a huge difference in terms of patient discomfort and patient acceptance of aneurysm repair.

"We find that the complication rates are lower with the endovascular repair and provide the same benefit with less discomfort, pain and fewer complications."

Studies of the EGS(tm) System, an earlier generation device that delivers the same implant as the ANCURE System, included 421 EGS patients and 111 who had standard AAA surgery. Blood loss was dramatically lower than in controls, while respiratory and cardiac complications were reduced by approximately one half and one third, respectively. The clinical study of the ANCURE System confirmed that the patient benefits from the earlier EGS study were maintained.

Patients who endure the open surgical repair - which prior to today''s FDA approval was the only treatment for AAA - typically require a week in the hospital, frequently with two to three days in the intensive care unit. Additionally, several months of home convalescence are required for the patient to fully recuperate. The open surgical repair requires a large incision through the abdominal wall. The patient''s internal organs are then moved aside to provide the surgeon access to the aorta, which lies deep within the abdominal cavity. The aorta is then incised, followed by the placement of a surgical graft at the site of the aneurysm.

The ANCURE System differs dramatically from traditional surgical repair due to the fact that it is delivered through the vasculature. The primary components are a delivery catheter and a woven polyester implant. The procedure involves small incisions to two arteries in the groin. The delivery catheter is inserted through one of these arteries, delivering the implant to the site of the aneurysm.

Precisely positioned hooks, a unique feature of the ANCURE System, secure the implant to the vessel wall. This attachment mechanism, combined with ANCURE''S one-piece 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 ANCURE System represents a quantum leap in the treatment of AAA," said Jay Watkins, president of Guidant''s Cardiac & Vascular Surgery Group. "Guidant pioneered the development of this significant alternative to conventional AAA surgery."

"We believe the approval of this device will come as good news to the estimated million and a half people in the United States who have abdominal aortic aneurysm disease. Up until this point, patients with this disease were facing either the prospect of a highly invasive surgical procedure or the unpleasant alternative of taking their chances and waiting for the advent of a better alternative. With the development of the ANCURE System we can offer these patients for the first time, a minimally invasive approach to treating AAA that has fewer complications and requires a shorter hospital stay."

Guidant purchased Endovascular Technologies in 1997 and has continued to develop EVT''s minimally invasive AAA device at its Cardiac & Vascular Surgery Group in Menlo Park, CA.

A global leader in the medical device 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.