Jan 26, 2001
New Study Shows Guidant's Heart Failure Technology Delivers a Marked Improvement for a Solid Majority of Patients

Company's CONTAK Registry Reflects Experience of 1,000 European Heart Failure Patients

Indianapolis, IN, and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a global leader in heart failure research, today 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 death for persons over the age of 65.

The study showed that heart failure patients using Guidant's heart failure technology - including the CONTAK CD(tm) device, the CONTAK TR(tm) device and the EASYTRAK(tm) coronary venous lead system - had marked improvement in their heart failure condition. Patient status was evaluated in terms of the New York Heart Association (NYHA) classification system, which measures the severity of heart disease in terms of symptoms experienced during exercise. NYHA classes range from Class I, in which patients have no symptoms with activity, to Class IV, in which patients experience serious symptoms at rest.

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.

"These findings are compelling. We are enthusiastic about having such a clear indication that Guidant's cardiac resynchronization therapy for the treatment of heart failure so dramatically impacts people's lives," said Fred McCoy, president of Guidant's Cardiac Rhythm Management Group.

"Because cardiac resynchronization therapy for the treatment of heart failure is a therapeutic option that involves new technology, it was important to us to monitor patient experience closely, even after market release," said Guido Neels, president of Guidant Europe.

Carlo Pappone, M.D., of Ospedale San Raffaele in Milan, Italy, said implanting physicians in Europe are encouraged by the changes in patients' status after receiving Guidant's heart failure systems. "The new, special lead introduced through the coronary sinus to stimulate the left ventricular chamber is easy to use," said Dr. Pappone, lead investigator for the CONTAK European Registry.

"We believe this system will have a huge impact not only on patients' quality of life but most probably also on the progression of their disease," he continued. "Based on the results of the CONTAK Registry, cardiac resynchronization therapy is well on its way to gaining acceptance as a treatment for heart failure in Europe."

In the United States, Guidant expects to file results of the CONTAK CD/EASYTRAK IDE clinical study as part of the U.S. FDA PMA submission, still planned for February 2001.

Also in the United States, where Guidant's cardiac resynchronization devices continue to be available for investigational use only, Guidant continues to aggressively enroll patients in the COMPANION study. It is the first controlled study to evaluate the effects of cardiac resynchronization on mortality and hospitalization rates. This trial will collect and evaluate clinical data on more than 2,000 patients in up to 80 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.

"The European CONTAK Registry, the CONTAK CD/EASYTRAK U.S. IDE clinical study, the COMPANION study and other clinical investigations are a clear indication of Guidant's leadership in and commitment to solutions for heart failure," McCoy said.

Heart failure is a medical condition in which the heart is unable to pump enough blood to meet the needs of the body. It affects well over 5 million people in the United States and an estimated 6.5 million in Europe. Nearly one million new cases are diagnosed annually, making it the most rapidly growing cardiovascular disorder. It is the number one cause of hospitalization for patients over the age of 65.

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. See the Guidant website Patient Compass for more information on this condition.

Patients and physicians interested in the COMPANION study can obtain more information by calling 1-866-COMPANION.

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