Jul 17, 2003
Guidant Announces U.S. Approval of Newest Implantable Defibrillator for the Treatment of Irregular Heart Rhythms

World''s Smallest Dual Chamber System Offers Enhanced Therapies to Patients at Risk of Sudden Cardiac Death

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced it received market approval from the U.S. Food and Drug Administration (FDA) for its VITALITY(tm) DS implantable cardioverter defibrillator (ICD) system, the world''s smallest dual chamber ICD and latest addition to Guidant''s already successful VITALITY ICD product portfolio.

The VITALITY DS system is specifically designed to treat patients with life-threatening rhythms in the lower chambers (ventricles) of the heart, the most common cause of sudden cardiac death. Patients with irregular heart rhythms (cardiac arrhythmia) can experience symptoms such as palpitations, dizziness, lightheadedness or fainting because the heart is beating too fast to circulate blood effectively. This electrical malfunction of the ventricle can result in collapse and sudden cardiac death (SCD) unless medical help is provided immediately. The VITALITY DS ICD, implanted under the skin near the collarbone, continuously monitors the patient's heart rhythm and delivers electrical therapy when needed to protect against sudden cardiac death.

"Guidant is fully committed to developing innovative solutions for treating patients who are at known risk for sudden cardiac death due to irregular heart rhythms," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The VITALITY DS offers physicians another exceptional Guidant ICD therapy option."

Sudden cardiac death is the abrupt loss of heart function, usually due to a potentially fatal electrical rhythm dysfunction in the heart called ventricular fibrillation. Each year, sudden cardiac death claims the lives of as many as 400,000 people in the U.S. alone. More people die from SCD each year than from lung cancer, breast cancer and AIDS combined.

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 11,000 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.
About the VITALITY DS Implantable Defibrillation System

The VITALITY DS ICD is Guidant''s newest implantable defibrillator, and incorporates a complete suite of ventricular therapies in the world''s smallest dual chamber ICD (30cc and 11 mm). The VITALITY DS rounds out Guidant''s VITALITY ICD product portfolio. With up to six plus years of longevity, the VITALITY DS offers physicians the best combination of size and longevity. The new VITALITY DS device also incorporates new capacitor technology, which provides reduced charge time. It is specifically designed to treat patients at risk of sudden cardiac death.

In addition to being the smallest, thinnest and one of the longest lasting ICDs on the market, VITALITY DS provides unmatched cardiac rhythm management solutions, which include:

* Small, thin physiologic shape reduces incision size and increases patient comfort
* AV Search Hysteresis to reduce unnecessary RV pacing
* Shock If Unstable to potentially reduce painful shocks for fast VT
* FullView(tm) three-channel electrograms help identify the origin and progression of arrhythmias

Results from recent trials have suggested that unnecessary pacing in the right ventricle may have a harmful effect on the heart. Guidant remains the only company in the industry to offer AV Search Hysteresis in its ICDs, a feature specifically designed to reduce unnecessary pacing of the right ventricle by periodically searching for the heart's intrinsic rhythm. Guidant offers AV Search Hysteresis in its entire line of dual chamber ICDs, including the VITALITY family of devices.
About Guidant''s Leadership in Tachyarrhythmia Therapy

Lifesaving tachyarrhythmia therapy is available as a result of Guidant''s continued commitment to clinical science and research, which has resulted in expanded implant indications, updated physician guidelines and a national reimbursement coverage decision for patients with prior heart attacks. The decisions were based on data derived from the Guidant sponsored MADIT II study.

MADIT II was a prospective, randomized, multi-center intention-to-treat study that enrolled 1,232 patients at 71 centers in the U.S. and five outside the U.S. The study was designed to determine whether the implantable cardioverter defibrillator (ICD), in combination with optimal drug therapy, prevents more deaths than optimal drug therapy alone in heart attack survivors with moderate impairment of the heart's main pumping chamber, the left ventricle.

An independent Data Safety Monitoring Board halted the MADIT II trial in November 2001 because data showed a 31 percent decrease in mortality for those patients receiving an implantable defibrillator versus those receiving drug therapy alone. Trial results were published in the March 21, 2002 New England Journal of Medicine. On July 18, 2002 the U.S. Food and Drug Administration approved an expanded indication for Guidant implantable defibrillators based on the MADIT II trial results. Guidant is the only implantable defibrillator manufacturer to have approved labeling that specifically includes the patient population defined by MADIT II. Approximately 5 to 10 percent of the one million annual U.S. heart attack survivors meet the MADIT II criteria and would be indicated for an implantable defibrillator.

Recently, the Centers for Medicare and Medicaid Services (CMS) announced its intent to expand national coverage for the use of implantable defibrillators for patients with a previous heart attack, left ventricular ejection fraction ≤30%, and QRS duration greater than 120 milliseconds. This decision increases the number of people who will receive the life-saving benefits of ICDs.