European approval and first implant of Guidant's next generation heart failure therapy system

Brussels 06 October 2003Guidant Corporation, specialized in the treatment of cardiac and vascular disease, announced European CE Mark and first implant of the newest addition to the RENEWAL family of cardiac resynchronization therapy defibrillators (CRT-D), the CONTAK RENEWAL 4. The RENEWAL 4 represents Guidant's most advanced heart failure therapy offering and delivers industry-leading therapies and diagnostics. In addition, it is the thinnest CRT-D available on the market today, which is intended to make it easier to implant and give added comfort to patients.

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The system contains enhanced patient-focused diagnostic capabilities designed to help the clinician understand the patient's changing condition and customize therapy. Guidant's RENEWAL family uses independent sensing and independent electrical stimulation to deliver appropriate therapy to both the left and right ventricles. For patients who require additional energy to resume normal heart rhythm, the RENEWAL 4 CRT-D family includes a high-energy option.

"This new CRT-D offers our European physician-customers even more flexibility for tailoring therapy to patients", stated Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The RENEWAL 4 system is Guidant's fourth generation CRT-D in Europe and is testament to Guidant's extraordinary commitment to providing innovative solutions for the treatment of heart failure."

First implants of the RENEWAL 4 CRT-D occurred in Italy at the Ospedale Civile di Asti, Asti and at the Ospedale Santa Chiara in Trento, and in Germany at the Klinikum der Friedrich-Schiller-Universität Jena, Jena.

"Often my heart failure patients have larger hearts and may require more energy to restore normal heart rhythm", stated Dr. Mario Bocchiardo, cardiologist at Ospedale Civile di Asti, Asti in Italy. Dr. Maurizio Del Greco, cardiologist at Ospedale Santa Chiara di Trento, Trento in Italy, agreed and added: "The high energy models available in the RENEWAL family offer my patients added security against sudden cardiac death." Drs. Bocchiardo and Del Greco were among the first physicians to implant the new system.

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, including approximately 6,5 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.

The CONTAK RENEWAL 4 CRT-D is specifically designed for heart failure patients and is placed beneath the skin, near the collarbone, to monitor heartbeats and assist as needed. It delivers small electrical impulses that may improve the timing of the heart and its pumping ability. The RENEWAL 4 CRT-D contains all the patient-centred features available in RENEWAL 2 CRT-D, including important programming options to further optimize therapy for patients.

Programming options include resynchronization therapy with a left ventricular offset (LV Offset) in which the ventricles can be paced sequentially or simultaneously, as well as a mode in which only the left ventricle is paced (LV Only). The RENEWAL 4 system includes Guidant's proprietary HRV Monitor Footprint, a unique way to visualize the patient's heart rate and frequency over the previous 24 hours. The Heart Rate Variability (HRV) Monitor Trending feature enables the physician to monitor a heart failure patient's cardiac activity over time.

The RENEWAL 2 CRT-D is currently leading the market in Europe. The RENEWAL 4 CRT-D, with its additional enhancements and flexibility joins Guidant's strong heart failure product portfolio, which includes the CONTAK RENEWAL TR 2, EASYTRAK leads, and the RAPIDO lead delivery system.

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.

Lifesaving therapy, such as the RENEWAL 4 CRT-D, is available today as a result of Guidant's continued commitment to clinical science and research and development in heart failure. More than 13 years and $350 million have been invested to date. Guidant is providing heart failure patients and the physicians who treat them with device-based solutions designed to extend and improve life.

In May 2002, Guidant was the first company to receive approval in the United States to market cardiac resynchronization therapy defibrillators (CRT-D). Guidant is advancing clinical science by sponsoring landmark studies such as the Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. Guidant sponsored clinical research and development in the area of heart failure continues to advance heart failure therapies and provide answers to critical clinical questions about long-term treatment outcomes for cardiovascular disease.


Leslie Versweyveld

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