Aug 28, 2002
Guidant Announces FDA Clearance and CE Mark of Next Generation Heart Failure Lead Delivery System

New System Enhances Physician''s Ability to Navigate Challenging Anatomy

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced U.S. Food and Drug Administration (FDA) clearance and CE Mark of the RAPIDO(tm) dual-catheter system for delivery of the EASYTRAK® lead. This next generation lead delivery system represents the newest innovation for cardiac resynchronization therapy with defibrillator (CRT-D) implants for the treatment of heart failure. The rapid introduction of this next generation product is evidence of Guidant''s commitment to the treatment of heart failure and further demonstrates continued leadership in this important new therapy. The RAPIDO system was market launched worldwide.

"The RAPIDO delivery system was designed using the experience of implanting more than 10,000 over-the-wire left ventricular pacing leads," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "This new system enhances an already exceptional heart failure product family by providing an additional option that allows physicians to help an increased number of people with heart failure."

RAPIDO is the first dual catheter platform specifically designed for lead placement in the difficult to reach left side of the heart. Physicians cite anatomy as the number one challenge associated with CRT-D implants. The RAPIDO system addresses that challenge by enhancing the physician''s ability to access challenging anatomy to obtain selective EASYTRAK lead placement in the left side of the heart. The system is designed to better accommodate lead positioning by increasing maneuverability.

The EASYTRAK lead design was the first to allow a physician to position the electrode in a vein on the left side of the heart using a preferred over-the-wire technique similar to the system used in angioplasty procedures. The EASYTRAK lead has gained wide acceptance since being approved by the FDA in May, exceeding sales and adoption rate projections since launch. The EASYTRAK lead has a strong 99 percent 12-month cumulative survival rate. A lead is a thin, insulated wire that connects an implanted pulse generator to the heart. The lead transmits signals from the heart to the implanted device and, when appropriate, delivers therapy from the device back to the heart.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.