Jan 13, 2003
Guidant Announces FDA Approval of Advanced Heart Failure Technology

CONTAK RENEWAL Includes State-of-the-Art Therapies and Diagnostics for Improved Management of Heart Failure Patients

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced Food and Drug Administration (FDA) approval of its advanced heart failure therapy system'"the CONTAK® RENEWAL(tm) cardiac resynchronization therapy defibrillator (CRT-D). Full commercial launch of the RENEWAL CRT-D in the United States will occur on Monday, January 20, 2003.

The RENEWAL CRT-D was designed specifically for patients and physicians struggling with heart failure. The system contains new diagnostic capabilities that are designed to help physicians better manage their patients' conditions. The RENEWAL CRT-D provides both cardiac resynchronization therapy and implantable defibrillator therapy, to address both of the principal mechanisms by which heart failure patients die'"pump failure and sudden cardiac death (SCD).

"Guidant continues to deliver revolutionary solutions in heart failure therapy," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "During 2002, we introduced both the first and the smallest CRT-D devices in the United States. We continue to pioneer cardiac solutions worldwide with our EASYTRAK® and RAPIDO(tm) families of left ventricular lead and lead introduction systems. In Europe, Guidant has successfully launched the CONTAK RENEWAL 2 CRT-D and the EASYTRAK 2 lead, achieving clear CRT-D market leadership. In addition, Guidant was the sole sponsor of COMPANION, the recently completed landmark clinical trial involving cardiac resynchronization therapy."

"The RENEWAL CRT-D represents a very exciting combination of firsts," said Joseph M. Smith, M.D., Ph.D., F.A.C.C, chief medical officer for Guidant Cardiac Rhythm Management. "As the first and only CRT-D device available in the U.S. to provide independently programmable sensing and pacing in both the right and the left ventricles, the RENEWAL CRT-D greatly facilitates implementation and patient-specific tailoring of CRT therapy."

Included in the array of novel diagnostics and therapeutic features is the incorporation of a left ventricular protection period (LVPP), a unique feature specifically designed to prevent potentially pro-arrhythmic left ventricular pacing, which may occur without adequate left side sensing.

The RENEWAL CRT-D introduces two new heart failure specific diagnostic features. The first enhancement monitors heart rate variability (HRV). This diagnostic tool is designed to baseline, then measure the HRV status of heart failure patients. The second, called Activity Log, uses data from a motion sensor to track trends in the patient''s activity. This capability addresses physicians'' desire to monitor activity levels as an indication of their patients'' ability to perform daily activities. The RENEWAL CRT-D continues to feature Guidant''s signature small size and physiologic shape for ease of implant and increased patient comfort.

"In Europe, physicians have had access to Guidant''s RENEWAL family of cardiac resynchronization therapy defibrillator systems since mid-year 2001. The RENEWAL/EASYTRAK CRT-D system is well-accepted because of its defibrillation capability, advanced patient diagnostics, ease of implant, and therapy flexibility," said Dr. Angelo Auricchio, associate professor of Cardiology, Magdeburg University, Magdeburg, Germany. "Our physician colleagues in the United States now have access to very advanced heart failure therapy with the U.S. availability of the RENEWAL CRT-D."

Nearly 5 million Americans and over 6 million Europeans currently suffer from heart failure. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.

Guidant's RENEWAL CRT-D is the first and only CRT-D device commercially available in the United States that uses independent sensing and independent electrical stimulation to deliver appropriate therapy to both the left and right ventricles. For many heart failure patients, CRT-D therapy has been demonstrated to improve cardiac performance, exercise capability, and quality of life. The RENEWAL CRT-D also includes the capability of an implantable defibrillator, which can automatically restore normal heart rhythm should the patient suffer an episode of SCD.

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.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company''s newsroom at www.guidant.com/newsroom.