May 29, 2002
Guidant Introduces New Therapy for Treating Postoperative Atrial Fibrillation

New Option Allows Early Intervention of Common Complication

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its SYNCRUS(tm) Internal Cardioversion System to treat postoperative atrial fibrillation following cardiac surgery. The SYNCRUS System has already received CE Mark and Canadian regulatory approval and is currently available in Europe and Canada.

Postoperative atrial fibrillation is one of the most common complications in cardiac surgery, occurring in twenty to fifty percent of all patients within two to four days after heart surgery. The upper chambers of the patient's heart beat in a rapid and disorganized way, compromising the heart's pumping function. Postoperative atrial fibrillation requires treatment before the patient is discharged from the hospital: if left untreated, atrial fibrillation may lead to a variety of medical conditions, including increased risk of hemodynamic instability, stroke, neurocognitive dysfunction, congestive heart failure, and increased need for a permanent pacemaker. The SYNCRUS System is designed to deliver a low energy shock to the atria - the heart's upper chambers - to restore normal heart rhythm immediately.

"Currently, postoperative atrial fibrillation is most commonly treated with drug therapy, which can have potential side-effects, take days to be effective, and increase the patient's hospitalization stay," said Nicky Spaulding, president, Cardiac Surgery, Guidant Corporation. "The other alternative - cardioversion using an external defibrillator - relies on a large transthoracic shock delivered through paddles placed on the patient's chest. The SYNCRUS System is designed to provide physicians with a more immediate, effective and less traumatic therapy for treating postoperative atrial fibrillation than either of the current solutions."

The SYNCRUS System will be used at 16 U.S. centers as part of a multi-center post-marketing study. Ralph Damiano, M.D., of Barnes-Jewish Hospital in St. Louis, Missouri, is serving as principal investigator of this study.

"The introduction of the SYNCRUS System is an important development in the treatment of patients with postoperative atrial arrhythmias," said Dr. Damiano. "The SYNCRUS System provides physicians with a new means of treating post-surgical atrial arrhythmias. This has the potential advantage of both avoiding some of the complications associated with atrial fibrillation and shortening patient length of stay following surgery."

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 10,000 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.

Top