Jun 23, 1999
FDA Advisory Panel Unanimously Recommends Approval of Guidant''s ANCURE(tm) 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 Circulatory System Devices Panel of the Medical Devices Advisory Committee has unanimously recommended FDA approval with conditions of its ANCURE(tm) System for minimally invasive treatment of abdominal aortic aneurysms (AAA). The FDA will now consider the Panel''s recommendation and conditions, together with additional information to be provided by the company, prior to making its final decision.

AAA is an enlargement of the aorta, the main artery of the human body, resulting from a weakness of the vessel wall. If untreated, this enlargement can lead to aortic rupture, which in nearly 80 percent of cases, results in the death of the patient. It is believed that 1.5 million people in the United States have AAA, with most cases being undiagnosed. Each year, 190,000 new cases of AAA are diagnosed, resulting in major surgery for approximately 45,000 of these patients. 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 potentially significant clinical advance over the traditional surgical procedure. Guidant''s data, presented to the Panel today, showed that patients implanted with the ANCURE(tm) System experienced significantly fewer complications than those who underwent conventional surgery. The data also showed that with Guidant''s endovascular approach a patient''s length of hospital stay is reduced to two to three days, versus six days with traditional surgery.

"We are pleased by the Panel''s decision to recommend approval of Guidant''s ANCURE(tm) System," said Jay Watkins, president of Guidant''s Cardiac & Vascular Surgery Group. "Today''s vote is a significant milestone, which moves us closer to our ultimate goal of providing these patients with a minimally invasive alternative to conventional AAA surgery."

"The Panel''s recommendation to the FDA for approval of Guidant''s ANCURE(tm) System marks a significant step in our mission of building a position of unquestioned leadership in cardiovascular and vascular medicine," said Ron Dollens, president and chief executive officer of Guidant Corporation.

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.