Feb 28, 2001
Guidant Announces FDA Filing for Heart Failure Treatment

Company First to File for Approval of Cardiac Resynchronization Therapy Defibrillator for Heart Failure Patients

Indianapolis, IN, and St. Paul, MN - Guidant Corporation (NYSE and PCX:GDT), a global leader in heart failure research, today announced that the company has filed a pre-market application with the U.S. Food and Drug Administration for its CONTAK CD? pulse generator and EASYTRAK® lead for the treatment of heart failure.

Today's submission makes Guidant the first company to file for FDA approval of a device that combines cardiac resynchronization therapy and implantable defibrillator therapy to treat both of the principal methods by which heart failure patients die - pump failure and sudden cardiac death, which is often due to dangerously fast heart rhythms.

Guidant's PMA is based on results from Guidant's CONTAK CD trial, a randomized, parallel trial designed to examine the effectiveness of cardiac resynchronization therapy in slowing the progression of heart failure. Preliminary information from this trial will be introduced during the American College of Cardiology's 50th Annual Scientific Sessions in March. Presentation and discussion is scheduled for early May in Boston at the North American Society of Pacing and Electrophysiology's 22nd Annual Scientific Sessions.

"Early experience with cardiac resynchronization therapy for the treatment of heart failure has been very encouraging," said Fred McCoy, president of Guidant's Cardiac Rhythm Management Group. "We are pleased that the CONTAK CD/EASYTRAK system is now entering the FDA review process."

The CONTAK CD pulse generator and EASYTRAK coronary venous lead system is designed to provide cardiac resynchronization therapy that coordinates the beating of the chambers of the heart in a way that enhances the heart's pumping efficiency. The CONTAK CD pulse generator also incorporates implantable defibrillation therapy, which has been proven effective in patients at high risk of SCD. A study published in the Lancet in 1999 showed SCD accounted for 33 to 64 percent of the deaths of heart failure patients with New York Heart Association (NYHA) Class II through IV functional status, which indicates an advanced disease state. These patients were followed for an average of 12 months.

The EASYTRAK coronary venous lead system features a special over-the-wire platform that draws on Guidant's expertise in interventional cardiology to provide physicians with control and precision in navigating the complex anatomy of the left side of the heart.

In January 2001, Guidant announced the completion of the CONTAK Registry, a post-market surveillance study of 1,000 heart failure patients in Europe. The CONTAK Registry collected data about the performance of Guidant's cardiac resynchronization therapy devices for heart failure, the leading cause of hospitalization for persons over the age of 65. In the CONTAK Registry, 60 percent of the Guidant patients improved at least one NYHA functional class at six-month follow-up examination. Ninety-eight percent of patients showed improved or stable NYHA Class scores at six months. Guidant's CONTAK/EASYTRAK heart failure device system was market released in Europe in November 1999.

In the United States, Guidant continues to aggressively enroll patients in the COMPANION study. It is the first controlled study to evaluate the effects of cardiac resynchronization on both mortality and hospitalization rates. This trial will collect and evaluate clinical data on more than 2,000 patients in up to 120 centers across the U.S. to help determine the best therapy for heart failure patients. The three-armed study compares patient experience with drug therapy alone or drug therapy along with either the CONTAK CD system or CONTAK TR system, which provides cardiac resynchronization therapy without defibrillation therapy.

"These trials are a clear indication of Guidant's leadership in and commitment to solutions for heart failure," said McCoy. "We are paving the way through meaningful clinical trials to link medical technology solutions with large, unmet patient needs."

Heart failure is a medical condition in which the heart is unable to pump enough blood to meet the metabolic needs of the body. It affects well over 5 million people in the United States. Nearly one million new cases are diagnosed annually worldwide, making it the only major cardiovascular disorder that is growing in prevalence year after year.

Heart failure is characterized by physical symptoms such as shortness of breath, problems with physical strength and stamina, fatigue, fluid retention and exercise intolerance. Patients often report disruption of their lives and dissatisfaction with their abilities to perform daily activities.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.