May 2, 2001
Guidant Completes Heart Failure Trial; Study Designed to Determine Benefits of Combined Cardiac Resynchronization and Defibrillation Therapies

Guidant's System Designed to Treat Heart Failure and Prevent Sudden Cardiac Death. Trial Results Suggest a Slowing of Heart Failure Progression, Improvements in Functional Capacity and Quality of Life.

Indianapolis, IN and St. Paul, MN - Results of the CONTAK CD(tm) clinical trial, which will be submitted to the U.S. Food and Drug Administration (FDA) for review, suggest that patients receiving Guidant Corporation's (NYSE and PCX: GDT) new heart failure therapy experience slowing of heart failure progression, increased quality of life and significant improvement in functional capacity. The data will be presented this evening at a symposium held in conjunction with the 22nd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology (NASPE) in Boston.

The data from the CONTAK CD trial forms the basis of Guidant's premarket application (PMA) filing with the FDA for the CONTAK/EASYTRAK product family. The filing was submitted in February 2001. Up to now, Guidant is the only company to apply for FDA approval of a device that combines cardiac resynchronization therapy and ICD therapy. FDA is presently assessing the data contained in the PMA and the agency is responsible for determining whether the data support the safety and effectiveness of the system for market release in the U.S. Guidant's CONTAK/EASYTRAK heart failure device system was market released in Europe in November 1999.

The investigational new heart failure therapy is the CONTAK CD/EASYTRAK® system, a combination cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD) system. It is intended to provide therapy for the two most common modes of heart failure death - progressive pump failure and sudden cardiac death.

"Heart failure may not only affect a patient's quality of life, but it also often takes a patient's life suddenly," said James Coman, M.D., clinical associate professor of medicine, University of Oklahoma College of Medicine, and a lead investigator in the CONTAK CD trial. "This trial suggests that we can treat heart failure patients at risk of sudden, unexpected death by implanting a single device that will enable them to live better and to live longer."

"We are pleased with how the study results complement and deepen what we have seen in our earlier studies," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "We are looking forward to obtaining U.S. regulatory approval to make available to patients the first and only heart failure therapy device with the potential both to enhance patients' lives and to protect against sudden cardiac death."

The CONTAK CD trial, a randomized, parallel, double-blind designed, multi-center trial, followed 581 patients classified as NYHA functional classes II through IV with QRS complexes of greater than 120 milliseconds. These patients were also at risk of sudden cardiac death (SCD) and, therefore, were indicated for ICD therapy. Patients enrolled were distributed across three NYHA classes as follows: 33 percent in Class II, 58 percent in Class III and 9 percent in Class IV. Average follow-up time for these patients in the therapy phase of the study was 4.5 months. Average implant duration was 13 months, with a maximum of three years.

Study suggests that CONTAK CD Saves Lives, Improves Quality of Life

At one year post-implant, twenty-five percent of all patients enrolled in the trial experienced at least one episode of a life-threatening cardiac arrhythmia. These arrhythmias required defibrillation therapy, which was provided by the CONTAK CD device.

Further, the study was designed to demonstrate the benefits of resynchronization therapy that the CONTAK CD device provides. Positive changes in every clinical measurement studied were observed in patients receiving cardiac resynchronization therapy. Additionally, investigators noted that patients with certain common types of more advanced heart failure (NYHA Class III or IV with left bundle branch block or non-specific interventricular conduction delay) received even greater benefit from the therapy.

Key findings from the study include:

• When compared to control patients who did not receive CRT, patients treated with CRT had significant improvement in functional capacity, as evidenced by an increase in peak oxygen consumption, or peak VO2. This metric is viewed as the best non-invasive indicator of a heart failure patient's wellness, because it measures the relative ability of a heart failure patient to increase the supply of oxygen to muscles during daily activities. There was a significant incremental improvement for patients receiving CRT - 0.9ml/kg/min. The incremental improvement for patients with advanced heart failure was even greater - 1.8ml/kg/min, a magnitude that signifies the ability of some patients to resume many activities of daily living with fewer symptoms.

• Patients treated with CRT also improved their six-minute walk distance. The improvement in walk distance for these patients averaged 35 meters, when compared to baseline. In patients with more advanced heart failure, the benefit was even greater (47 meters).

• Patients treated with CRT improved in quality of life as measured by the Minnesota Living With Heart Failure Questionnaire(tm). Quality of life for these patients increased 16 percent compared to baseline. Improvement in quality of life for patients with more advanced heart failure was even greater (23 percent). The CRT-treated patients in this group experienced an incrementally greater improvement in quality of life through six months when compared to patients not receiving CRT.

Encouraging Trend: Slowing of Heart Failure Progression

The study also found that patients receiving CRT therapy had a 21 percent slowing in the progression of heart failure, as measured by a composite index that included death, heart failure hospitalization, worsening of heart failure requiring other interventions, and the occurrence of malignant arrhythmias requiring intervention from the CONTAK CD device.

"The trend observed showing a slowing of the progression of the disease in less than five months is encouraging," said Paul L. Ludmer, M.D., founder, San Francisco East Bay Arrhythmia and Electrophysiology Center. "Drug trials demonstrating a significant slowing of heart failure progression have usually required 18 to 24 months. Since patients in this trial also received drug therapy for heart failure, the finding suggests that CRT may provide benefits that are additive to the drugs commonly used in the treatment of heart failure patients."

Trial Results Consistent with European Experience

The trial also tracked physicians' success in implanting the EASYTRAK lead system. First-attempt implant success rate is a more stringent performance indicator than an overall implant success rate. Using this metric, the study showed strong device performance results, including a first-attempt implant success rate of 87 percent. That rate rose to 91 percent as physician experience with the CONTAK CD system increased.

In addition, all adverse events reported in the trial were within the expected range.

Results of the trial are consistent with performance data collected in Europe, where the device has been in use since November 1999. Data regarding the performance of the CONTAK/EASYTRAK heart failure device system were collected as part of the CONTAK Registry, a post-market surveillance study of 1,000 heart failure patients in Europe. Registry results, which were announced in January 2001, showed that 60 percent of patients improved at least one NYHA functional class at six-month follow-up examination. Further, this registry showed 98 percent of patients had improved or stable NYHA Class scores at six months.

"With these scientific studies of the CONTAK CD/EASYTRAK system, we believe a new and viable device solution for heart failure patients will be established," said Ronald W. Dollens, president and CEO, Guidant Corporation. "Pending U.S. regulatory review and approval, we look forward to providing this innovative product designed to improve and save lives. Moreover, we are committed to continuing our efforts to use solid clinical science for the evaluation and advancement of devices that provide cardiac resynchronization therapy and defibrillation."

About Heart Failure and Sudden Cardiac Death

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 five million people in the United States. Nearly one million new cases are diagnosed annually worldwide, and it is growing in prevalence year after year. In the United States, heart failure is the leading reason for hospital admissions in people over the age of 65, and the costs of treatment exceed $40 billion annually.

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.

Heart failure patients die commonly from two primary causes - unheralded sudden cardiac death or insidious progression of pump failure.

Sudden cardiac death is the abrupt loss of heart function (i.e., cardiac arrest) in a person who may or may not have diagnosed heart disease. The time and mode of death are unexpected. It occurs instantly or shortly after symptoms appear. The CONTAK CD device, which combines heart failure therapy with defibrillation, is the first CRT device to address both of the principal causes by which heart failure patients die.

About Guidant's Leadership in Heart Failure

Guidant has pioneered the development of device-based systems to treat heart failure through 10 years of heart failure research dedicated to the understanding of the mechanisms of the failing heart and mechanisms of cardiac resynchronization therapy. This research and development has resulted in approximately 40 patents and more than 220 peer-reviewed papers and abstracts.

In the United States, Guidant continues to aggressively enroll patients in the COMPANION study, 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 up to 2,200 patients in up to 120 centers across the U.S. to advance the treatment of 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.

"COMPANION and other trials we are conducting are an indication of Guidant's leadership in and commitment to solutions for heart failure," McCoy said. "Guidant is committed to conducting meaningful clinical trials that link medical technology solutions with large, unmet patient needs."

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.