Jul 18, 2001
Guidant Introduces its New Generation of Heart Failure Therapy

European Market Release of CONTAK RENEWAL, First Human Use Worldwide of CONTAK RENEWAL 2

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT) today announced European market release of its CONTAK? RENEWAL(tm) device for heart failure treatment. The RENEWAL cardiac resynchronization therapy defibrillator (CRT-D) was specifically designed for people struggling with heart failure. It contains new diagnostic capabilities that are designed to help physicians better manage their patients' conditions. The RENEWAL CRT-D provides cardiac resynchronization therapy and defibrillation therapy. RENEWAL CRT-D is designed to address two critical issues faced by physicians who treat heart failure - patients' quality of life and risk of sudden cardiac death.

"As a result of Guidant's investment in research, product, and market development, we continue to bring forward product solutions to help people with heart failure," said Fred McCoy, president of Guidant's Cardiac Rhythm Management Group. "Our RENEWAL CRT-D, in combination with our EASYTRAK® lead and delivery system, has excellent potential to extend and grow the adoption in Europe and elsewhere of cardiac resynchronization therapy defibrillators for the treatment of heart failure."

The RENEWAL CRT-D monitors heart rate variability, a tool designed to track and measure the status of heart failure patients. The device also uses data from an accelerometer sensor to track trends in each patient's activity level. This capability addresses physicians' desire to monitor activity levels as an indication of their patients' ability to perform activities of daily living. Additionally, the RENEWAL CRT-D features reduced size and a patient-friendly physiologic shape for ease of implant and increased patient comfort.

Guidant also announces the first human implants worldwide of the CONTAK(tm) RENEWAL(tm) 2. These initial implants are part of a Guidant-initiated field following study. The principal investigator of this trial is Dr. Christian Butter, of the German Heart Institute, Berlin.

Thus far, there have been 10 implants of the RENEWAL 2 CRT-D as part of the Guidant clinical protocol to evaluate performance via post market studies.

In addition to all the features of RENEWAL CRT-D, the RENEWAL 2 CRT-D offers several new advanced features for the management of heart failure, including:

  • Heart Failure Expert Ease - an automatic feature which assists the physician in optimizing a patient's cardiac resynchronization therapy by providing suggested settings for programming the device

 

  • LV (Left Ventricle) Offset - allows the physician to adjust the timing of the stimulation to optimize ventricular contraction

 

  • Biventricular Trigger - designed to promote synchronous ventricular contractions for patients with atrial arrhythmias

 

A leading European cardiologist, Dr. Jürgen Vogt, Herz-und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany, commented, "The new Expert Ease feature saves us a lot of time, it gives us the additional ability to optimize the AV delay and tailor the therapy to each patient individually by just pressing one button. It greatly facilitates in the follow-up of the patients."

Implanting surgeon Dr. Bert Hansky reported, "The procedure went smoothly. The extended choice of new guiding catheters helped to quickly gain access to the coronary sinus."

"Guidant is dedicated to creating life-saving technologies that link medical technology solutions to large, unmet patient needs," said Guido J. Neels, president, Guidant Europe, Middle East, Africa and Canada. "As a result, we are proud to offer devices specifically designed for heart failure patients that incorporate cardiac resynchronization therapy, defibrillator therapy and valuable diagnostic information. These combine powerfully to help improve patient outcomes."

One of the principal causes of death in heart failure patients is mechanical in nature - pump failure, in which the uncoordinated pumping of the heart fails to provide enough blood to the body to sustain life. Guidant's RENEWAL CRT-D family uses independent electrical stimulation to the left and right ventricles to address this dyssynchrony in cardiac contractions. Sudden cardiac death (SCD) accounts for nearly half the deaths of people in heart failure. Often SCD occurs due to extremely fast ventricular arrhythmias. To prevent SCD from arrhythmias, the RENEWAL CRT-D incorporates the proven defibrillator therapy of Guidant's VENTAK® PRIZM(tm) implantable defibrillator family.

Guidant pioneered the development of device-based systems to treat heart failure through more than 10 years of heart failure research dedicated to understanding mechanisms of the failing heart and the benefits of cardiac resynchronization therapy.

Heart failure is a widespread, growing condition that robs people of quality and quantity of life. Nearly 6.5 million people in Europe, 5 million people in the U.S., and 2.4 million people in Japan 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 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.

 

This release contains forward-looking statements about the company's future financial results, the company's prospects and products in research and development. This information is based upon management's current expectations, but actual results may differ materially from those discussed in the forward-looking statements. Other factors affecting future results include those outlined in Exhibit 99 to the company's Form 10-Q for the quarter ending March 31, 2001.

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