Sep 30, 2005
Guidant Announces FDA Approval of New Implantable Defibrillator System

High Energy System Addresses Growing Physician Demand for More Defibrillation Energy

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT) today announced U.S. Food and Drug Administration (FDA) market approval of its VITALITY® HE implantable cardioverter defibrillator. This system combines the small, physiologic profile and exceptional longevity with the capacity to deliver more energy to defibrillate the patient. In addition, the VITALITY HE system provides industry leading diagnostics and fast charge times that physicians have come to expect from Guidant defibrillators. Market launch of VITALITY HE in the United States is planned for early October.

The VITALITY HE is Guidant''s first high-energy product to offer the advanced functionality of the VITALITY family. Recent usage data suggest that more than half of conventional defibrillators implanted in the United States today have higher energy output capability.

"The launch of VITALITY HE, together with the August re-launch of the CONTAK RENEWAL® 3 cardiac resynchronization therapy (CRT) defibrillator and significant other recently announced U.S. product approvals, such as the LATITUDE® Patient Management system, reflect Guidant''s commitment to providing physicians and patients a broad array of therapeutic options for the prevention of sudden cardiac death and the treatment of heart failure," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "With the addition of the VITALITY HE to our product line-up, Guidant now offers a full range of device and therapy options to our physician customers and their patients."

Sudden cardiac death is the abrupt loss of heart function, usually due to an electrical rhythm dysfunction in the lower chambers of the heart, called ventricular fibrillation. Each year, sudden cardiac death claims the lives of as many as 460,000 people in the United States alone. More people die from sudden cardiac death each year than from lung cancer, breast cancer and AIDS combined. Clinical trials, such as the Guidant-sponsored Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, have proven the lifesaving benefits of implantable defibrillator therapy for patients at risk for sudden cardiac death. This evidence was further studied in the National Institutes of Health-supported Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Both trials were published in The New England Journal of Medicine.

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 12,000 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 www.guidant.com.