Aug 16, 2004
Guidant Launches Three Innovative Heart Failure Lead Products

Advanced Leads and Lead Delivery System Further Strengthen Company''s Heart Failure Portfolio

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT) today announced U.S. Food and Drug Administration (FDA) approval and market launch of three new products in its heart failure therapy product portfolio -- the RAPIDOÒ ADVANCEä lead delivery system, the EASYTRAKÒ 2 lead and the EASYTRAKÒ 3 lead. These new products are designed to help physicians reach the goal of performing faster and more predictable implants of cardiac resynchronization therapy systems by facilitating access to the left side of the heart.

When used with a RENEWALÒ cardiac resynchronization device, the EASYTRAK 2 and EASYTRAK 3 leads provide physicians with choices of several configurations for stimulating the left side of the heart. In addition, the EASYTRAK 3 lead incorporates a unique shape designed to help physicians optimize lead placement in a broader range of vein sizes.

"Swiftly and accurately positioning the left ventricular lead is one of the most critical aspects of any cardiac resynchronization therapy system implant," said David DeLurgio, M.D., Emory University Hospital, Atlanta, Georgia, who served as principal investigator for the EASYTRAK 2 trial. "The increased flexibility in lead placement when using the RAPIDO ADVANCE delivery system and new EASYTRAK leads is designed to help me navigate challenging anatomy faster."

With the addition of a second electrode, EASYTRAK 2 and EASYTRAK 3 leads are the only over-the-wire bipolar (two electrodes on the lead) left ventricular leads available in the United States. Since Guidant introduced bipolar left ventricular leads in Europe in 2002, physicians have rapidly and overwhelmingly adopted this technology. More than 95 percent of European procedures involving a cardiac resynchronization therapy product from Guidant''s RENEWAL family of devices now also include bipolar leads.

The RAPIDO ADVANCE represents Guidant''s fourth generation in heart failure lead delivery system technology. It is designed to enable physicians to have greater control and stability of lead delivery into the target vein. It is also designed to help physicians navigate difficult anatomy and optimize lead position, which facilitates faster lead placement.

"Guidant has a track record of recognition and response to the needs of physicians and the patients they serve," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "These latest innovative additions to our product portfolio strengthen our capabilities to help physicians and their patients."