Dec 15, 2003
Guidant Announces Clinical Trial for Cardiac Resynchronization Therapy Defibrillator that Combines Treatment for both Heart Failure and Atrial Arrhythmias

Next Generation Device Designed to Address Common Co-morbidity for Heart Failure Patients

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced the launch of a clinical trial in the United States. The CONTAK RENEWAL(tm) 3 AVT Clinical Trial will study the effect of device therapy in patients who suffer from both heart failure and atrial arrhythmias. Atrial arrhythmias affect as many as one-third of the nearly 5 million people in the United States who suffer with heart failure. There are no commercially available cardiac resynchronization therapy devices on the U.S. market today, which are designed to provide therapy for this common co-morbidity.

 

"Cardiac resynchronization therapy defibrillators represent a meaningful step forward in therapy for heart failure. Now we potentially have something further that fills a big unmet need, treating one of the more important co-morbidities in heart failure - atrial fibrillation," said Dr. Leslie Saxon of USC University Hospital, Los Angeles, California and the trial''s national principal investigator. "The ability to use the device to promptly diagnose and treat the atrial arrhythmia has enormous potential for heart failure patients and brings us closer to our goal of treating multiple aspects of this complex condition."

 

Atrial arrhythmias are irregular beats that begin in the heart''s upper chamber. This rapid rate does not allow the atria to effectively pump blood into the ventricles, or lower chambers of the heart. Guidant''s newest investigational cardiac resynchronization therapy defibrillator (CRT-D) is designed to provide physicians with additional options for the management of this complex co-morbidity by treating both the upper and lower chambers of the heart.

 

"Guidant is committed to pioneering treatments for patients with heart failure," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The initiation of this clinical trial of CONTACT RENEWAL 3 AVT tangibly signals our resolve to help more patients live better and live longer."

 

Earlier this year, Guidant introduced the VITALITY(tm) AVT implantable defibrillator, which offers complete atrial and ventricular therapies for patients at risk for sudden cardiac death (SCD). The CONTAK RENEWAL 3 AVT CRT-D demonstrates Guidant''s continued commitment to develop this therapy by pioneering atrial therapies for patients who suffer with heart failure. Guidant expects these pioneering therapies and diagnostics to be available in Europe in 2004 and in the United States pending the successful conclusion of this clinical trial and FDA approval. The first implant of the investigational CONTAK RENEWAL 3 AVT system was completed by Dr. Constantinos A. Costeas at St. Michael''s Medical Center in Newark, New Jersey.

About Guidant''s Leadership in Clinical Science

Guidant has a strong heritage of sponsoring landmark clinical trials designed to answer critical clinical questions about long-term treatment outcomes for cardiovascular disease.

 

  • MADIT: Proved for the first time that prophylactic implantable cardioverter defibrillator (ICD) therapy can dramatically improve survival in high-risk patients. As a result of MADIT, patients no longer have to experience a life-threatening arrhythmia in order to qualify for, and receive the lifesaving benefits of, ICD therapy.
  • MADIT II: Proved heart attack survivors with impaired heart function (EF <30%), without any other risk stratification, benefit from ICD therapy. As a result of MADIT II, patients no longer have to undergo invasive electrophysiological testing to receive the lifesaving benefits of ICD therapy.
  • MADIT-CRT: Designed to test whether cardiac resynchronization therapy defibrillators (CRT-D) will slow the progression of heart failure in heart attack survivors with impaired heart function. Heart failure represents a tremendous burden on both patients and the healthcare system. This trial will evaluate the potential impact of Guidant CRT-D therapy in helping patients live better and live longer.
  • COMPANION: This study compared heart failure patients receiving optimal medical treatment to those receiving implantable cardiac resynchronization therapies plus optimal medical treatment.
  • DECREASE HF: This study is designed to demonstrate the safety and effectiveness of the flexible pacing modes offered in Guidant''s newest heart failure cardiac resynchronization therapy defibrillator (CRT-D) currently available in Europe.

 

Heart failure is a debilitating condition that affects not only a patient''s quality of life, but also life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively. Nearly 22 million people worldwide 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 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 11,000 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.

 

This release includes forward-looking statements concerning the clinical trial and expansion of the therapy. The statements are based on assumptions about many important factors, including regulatory timelines and approvals, continuing clinical and other developments, and other factors identified on Exhibit 99 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.

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