Jun 29, 2000
Guidant Announces Completion of Milestone in Heart Failure Clinical Study

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a worldwide leader in implantable medical device systems, today announced that the CONTAK CD heart failure device clinical trial has completed an important milestone. The study is being conducted pursuant to an FDA-approved Investigational Device Exemption (IDE).

"We are pleased to announce that a sufficient number of devices in our CONTAK CD trial have been implanted to ultimately provide the data necessary to support Guidant''s pre-market approval application (PMA)," stated Fred McCoy, president of Guidant''s Cardiac Rhythm Management Group. Progress of these patients will be followed for a minimum of six months before data are available for submission to the FDA.

"This Guidant heart failure device system is intended to relieve heart failure symptoms, positively impact the quality of life of heart failure patients, and save the lives of those patients who suffer an episode of potentially lethal ventricular fibrillation," McCoy added. Guidant''s heart failure device systems were market released in Europe in November 1999.

Products being evaluated in the clinical study include Guidant''s CONTAK(tm) CD pulse generator, which provides heart failure resynchronization therapy with implantable defibrillation backup, and the EASYTRAK(tm) lead, a patented transvenous over-the-wire lead system developed for implantation in the coronary venous system to coordinate stimulation of the left side of the heart with the right side to treat heart failure.

The CONTAK system with an EASYTRAK lead is designed to provide resynchronization therapy that coordinates the beating of the lower chambers of the heart in a way that enhances the heart''s pumping efficiency. The proprietary EASYTRAK lead system, designed in conjunction with Guidant''s Vascular Intervention Group, enables transvenous placement, using an over-the-wire system similar to that used in angioplasty procedures. Since many heart failure patients may also be at risk of life-threatening ventricular arrhythmias, implantable defibrillation backup is also incorporated into this device.

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 and an estimated 6.5 million in Europe. Nearly one million new cases are diagnosed annually, 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. 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. For more information on Guidant''s products and services, visit the company''s web site at www.guidant.com.