May 23, 2001
Guidant Announces CE Mark Approval and First European Implant of Next-Generation Heart Failure Technology

New Device Includes Diagnostic Capabilities for Better Patient Management

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT) today announced European CE Mark approval of its most advanced heart failure therapy system - CONTAK(tm) RENEWAL(tm) cardiac resynchronization therapy defibrillator (CRT-D). CONTAK RENEWAL CRT-D was specifically designed for heart failure patients and contains new diagnostic capabilities that are designed to help physicians better manage their patients' condition. The CONTAK RENEWAL CRT-D provides cardiac resynchronization therapy and tachycardia therapy, to address both of the principal mechanisms by which heart failure patients die - pump failure and sudden cardiac death (SCD), which is often caused by dangerously fast heart rhythms.

"Guidant is dedicated to creating life-saving technologies that link medical technology solutions to large, unmet patient needs," said Guido J. Neels, president, Guidant Europe, Middle East, Africa and Canada. "As a result, we are proud to be the first company to offer a device specifically designed for heart failure patients that incorporates cardiac resynchronization therapy, tachycardia therapy and diagnostic elements that help to improve patient management."

The CONTAK RENEWAL CRT-D monitors heart rate variability, a tool designed to track and measure the status of heart failure patients. The device also uses data from an accelerometer sensor to track trends in patients' activity levels. This capability addresses physicians' desire to monitor activity levels as an indication of their patients' ability to perform activities of daily living. Additionally, the CONTAK RENEWAL CRT-D features a reduced size and unique patient-friendly physiologic shape for ease of implant and increased patient comfort.

Guidant also announced the first European implant of CONTAK RENEWAL CRT-D, which is part of a Guidant-initiated field following study. The principal investigator of this trial is Dr. Christian Butter, of the German Heart Institute Berlin.

"The CONTAK RENEWAL CRT-D, with its new diagnostic options, mark a significant breakthrough for the treatment of patients with heart failure," said Dr. Butter. "We believe this therapy has the potential to bring added relief and improved quality of life for the millions of patients who suffer from heart failure."

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

The first European implants of the CONTAK RENEWAL CRT-D were completed on May 17 by Dr. Christian Butter (German Heart Institute Berlin), Prof. Hans-Joachim Trappe (Marienhospital, University Bochum, Herne, Germany) and Dr. Derek Connelly (Cardiothoracic Centre - Liverpool, UK).

"The implant of the CONTAK RENEWAL went very smoothly," said Dr. Connelly. "The EASYTRAK® lead and the complete delivery system recently introduced really facilitates the implant procedure and thanks to the separate ventricular channels of the CONTAK RENEWAL device, the therapy can be tailored to each patient's need."

"As a result of Guidant's investment in research, market, and product development, we continue to bring forward product solutions to help people with heart failure," said Fred McCoy, president of Guidant's Cardiac Rhythm Management Group. "Our CONTAK RENEWAL CRT-D, in combination with our EASYTRAK lead and delivery system, has excellent potential to extend and grow the adoption of cardiac resynchronization therapy defibrillators for the treatment of heart failure."

One of the principal causes of death in heart failure patients is mechanical in nature - pump failure, in which the uncoordinated pumping of the heart fails to provide enough blood to the body to sustain life. Guidant's CONTAK RENEWAL CRT-D is the first device to use independent electrical stimulation to the left and right ventricles to address this dyssynchrony in cardiac contractions.

Sudden death accounts for nearly half the deaths from heart failure. The MERIT-HF study, published in the Lancet in 1999, showed that percentages of death from SCD ranged from 33 percent to 64 percent in heart failure patients with Class II to Class IV functional status, a measure of the progression of their disease state. Often sudden death occurs due to extremely fast ventricular arrhythmias. To prevent SCD from arrhythmias, the CONTAK RENEWAL CRT-D incorporates the proven tachycardia therapy of Guidant's VENTAK® PRIZM(tm) implantable defibrillator family.

Heart failure is a widespread, growing condition that robs people of quality and quantity of life. Nearly 5 million Americans and 6.5 million Europeans currently suffer from heart failure. Half of these patients will die within five years of being diagnosed with the disease. It is the leading cause of hospitalization in patients age 65 and up, according to the National Heart Lung and Blood Institute. Nearly 1 million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder. Heart failure is characterized by physical symptoms such as shortness of breath, problems with physical strength and stamina, fatigue, fluid retention and exercise intolerance.

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