FDA expands Guidant's implantable defibrillator labeling to include MADIT patients.

INDIANAPOLIS--(HealthWire)--May 16, 1996--Guidant Corp. (NYSE and PSE: GDT), a worldwide leader in implantable defibrillation systems, today announced that it has received U.S. Food and Drug Administration approval to expand the product labeling for its implantable cardioverter defibrillators. This new labeling covers patients identified by the Multicenter Automatic Defibrillator Implantation Trial (MADIT) to be at high risk for sudden cardiac death (SCD).

Currently, CPI, part of Guidant' Cardiac Rhythm Management (CRM) group, is the only manufacturer of implantable cardioverter defibrillators to have approved labeling that includes the patient population identified by the MADIT study.

Guidant's implantable defibrillators approved for expanded labeling include the VENTAK(R) MINI(TM), MINI HC and MINI II family of AICD(TM) Automatic Implantable Cardioverter Defibrillators. The VENTAK MINI II, which received FDA market approval last month, is the world's smallest full-featured implantable defibrillator. "We applaud the FDA's initiative in approving Guidant's devices for use in patients identified by the MADIT trial," said Jay Graf, president of the CRM group and a Guidant vice president.

The announcement of Guidant's expanded labeling came today on the first day of the 17th Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology (NASPE) which featured a presentation of the MADIT study by principal investigator Arthur J. Moss, M.D., professor of medicine and director of the Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, N.Y.

MADIT is the first large, randomized clinical trial comparing implantable defibrillators with conventional antiarrhythmic drug therapy. The study was terminated in March because of the significant improvement in survival of patients with implantable defibrillators.

In the MADIT study, patients with implantable defibrillators had 54 percent fewer deaths and significantly better overall survival than patients who did not receive the device, according to Dr. Moss. Sanjeev Saksena, M.D., chairman of the NASPE Annual Scientific Sessions program and director, arrhythmia and pacemaker service, Eastern Heart Institute, Newark, N.J., commented that MADIT is "the first study that shows treating patients before a cardiac arrest can offer hope for the 90 percent of patients who die before reaching medical help after a cardiac arrest."

Dr. Moss noted that as many as 10 percent or more of all patients who suffer a heart attack are at high risk and may benefit from the implantation of a defibrillator. He estimates that about 800,000 Americans survive a heart attack each year and, of those who survive, approximately 80,000 could benefit from a defibrillator. In contrast, it is estimated that about 22,000 implantable defibrillators were implanted in the U.S. last year.

CPI/Guidant, over the past five years, has provided technical consultation, financial support and all devices used in the MADIT study. The study design, data collection, analysis and evaluation were managed independently by the University of Rochester.

A leader in the medical device industry, Guidant Corp. provides innovative, cost-effective products and services to the global cardiology and minimally invasive surgery marketplaces.

CONTACT: Guidant Corp.

Carol Lindahl, 612/582-4461

Robert E. Allen, 317/971-2031