Apr 7, 2004
Guidant Announces U.S. Approval of Next Generation Implantable Defibrillator

World''s Smallest, Thinnest Defibrillator Offers Advanced Rhythm Discrimination and Industry-Leading Longevity

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced it has received market approval from the U.S. Food and Drug Administration (FDA) for its VITALITY®2 implantable cardioverter defibrillator system designed to treat patients at risk for sudden cardiac death due to arrhythmia (irregular heartbeat).

The VITALITY 2 implantable defibrillator system is a next generation device based upon the established VITALITY line of products, and offers distinct advantages for both patients and physicians. The size and physiologic shape of the VITALITY 2, the world''s smallest and thinnest implantable defibrillator at 30cc and 11mm, is designed to facilitate ease of insertion and contribute to patient comfort.

"Guidant is committed to treatment options that enable physicians to provide optimal therapy for their patients at risk for sudden cardiac death," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The launch of the VITALITY 2 represents an important step forward in our ongoing efforts to help these people live longer."

The VITALITY 2 system also incorporates Guidant''s proprietary RHYTHM ID(tm) feature, which utilizes rhythm discrimination technology to help manage complex arrhythmias for people at risk of sudden cardiac death. This easy-to-use feature is designed to distinguish lethal from non-lethal heart rhythms and deliver the appropriate care at the appropriate time.

"The combination of size, longevity and advanced rhythm management options provide great benefits in terms of patient comfort and delivery of appropriate care," said Antonio Curnis, M.D. consultant cardiologist, Spedali Civili, Italy. "In particular, the ability of the VITALITY 2 to distinguish between lethal and non-lethal arrhythmia provides enhanced peace of mind to both the patient and physician."

Full market launch of the VITALITY 2 implantable defibrillator is scheduled for May 2004. This is the fourth implantable defibrillator in the VITALITY family of products. The VITALITY with RHYTHM ID feature received CE Mark approval in Europe in 2002.

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 continually proven the lifesaving benefits of implantable defibrillator therapy in various groups of patients considered 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). The preliminary results of SCD-HeFT were recently presented at the American College of Cardiology conference on March 8th, and provide additional evidence that people receiving defibrillators live longer lives.

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.