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Guidant Announces First U.S. Implant of New Heart Failure Therapy System; New Trial Signifies Continued Leadership in Heart Failure Clinical Science.


Business Editors/Health/Medical Writers

INDIANAPOLIS & ST. PAUL St. Paul

as a missionary he fearlessly confronts the “perils of waters, of robbers, in the city, in the wilderness.” [N.T.: II Cor. 11:26]

See : Bravery
, Minn.--(BUSINESS WIRE)--May 30, 2003

Guidant Corporation (NYSE NYSE

See: New York Stock Exchange
:GDT GDT Global Descriptor Table
GDT Geographic Data Technology Inc.
GDT Gas Discharge Tube (energy, electrotechinical and electronics)
GDT Getting Things Done
GDT Geometric Dimensioning & Tolerancing
GDT Ground Data Terminal
), a world leader in the treatment of cardiac and vascular disease, announced the first implant in its latest heart failure clinical trial. The U.S. trial is designed to determine the safety and efficacy of the EASYTRAK(R) 3 lead's new features, including the lead's unique spiral shape. During the trial, the lead will be implanted in conjunction with the CONTAK(R) RENEWAL(TM) 3 cardiac resynchronization therapy defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a  (CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators ). The RENEWAL 3 CRT-D builds on the success of the RENEWAL family and offers a wide range of diagnostics and therapies in a new smaller physiologic shape.

"The EASYTRAK 3 trial is another example of Guidant's commitment to research, development and clinical science designed to advance new treatment options for patients who struggle with heart failure," said Fred McCoy, president, Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. , Guidant Corporation. "Our pioneering work in device-based solutions for heart failure spans over 13 years. Along the way we have invested more than $350 million to provide heart failure patients and the physicians who treat them with innovative, effective therapies to battle this debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 condition."

Dr. Ronald Berger, Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. , is the trial's principal investigator. The first implant of the EASYTRAK 3/RENEWAL 3 system occurred at the University of Massachusetts The system includes UMass Amherst, UMass Boston, UMass Dartmouth (affiliated with Cape Cod Community College), UMass Lowell, and the UMass Medical School. It also has an online school called UMassOnline.  Medical Center and was performed by Dr. Larry Rosenthal. "This system offers patients a small full-featured device and gives physicians greater flexibility in lead placement, which is especially important when navigating difficult anatomy," said Dr. Rosenthal. "Today's implant went remarkably well thanks to the handling characteristics of the EASYTRAK 3 and the entire complement of tools that Guidant has pioneered to facilitate a predictable implant."

The EASYTRAK 3 lead is Guidant's newest heart failure therapy lead using its proprietary over-the-wire design. The EASYTRAK lead, in conjunction with leads implanted in the right side of the heart, allows the device to sense and stimulate both the left and right sides of the heart. Guidant's EASYTRAK lead design was the first to allow the physician to position the electrode in a coronary vein coronary vein
n.
Any of the veins that drain blood from the muscular tissue of the heart and empty into the coronary sinus.
 on the left side of the heart using a convenient over-the-wire technique similar to the system used in angioplasty procedures.

Guidant was the first company to receive approval to market a CRT-D system for the treatment of heart failure in the United States, the first to offer a CRT-D device with independent channels, and the first to offer a fourth-generation CRT-D device. Guidant remains the only company with a market-released CRT-D device with independent channels. These independent channels enable independent pacing and sensing in the left and right ventricles, and are intended to assist the physician in tailoring therapy for individual patients.

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.

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

About the EASYTRAK 3 Lead

The EASYTRAK 3 coronary venous lead features a novel fixation spiral tip designed to help physicians optimize lead placement by allowing access to a broader range of vein sizes. Access to a broader range of vein sizes is important because it allows physicians to select a lead position that best adjusts to individual patient anatomies. The availability of dual electrodes and dual steroid collars with the EASYTRAK 3 create bipolar sensing and pacing capabilities. These features offer clinicians additional programming options, both during and post implant. The EASYTRAK lead was approved for use in the United States in May 2002. The EASYTRAK lead family represents a key component in Guidant's industry-leading heart failure product line.

For more information about Guidant's cardiac resynchronization therapy products for the treatment of heart failure, please visit www.guidant.com/products/crtd_us.shtml.

About Guidant's Leadership in Heart Failure Therapy

As a leader in technical innovation, 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 Defibrillation Definition

Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm.
 in Chronic Heart Failure (COMPANION) trial. Preliminary results of the COMPANION trial were presented at the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S.  52nd Annual Scientific Session in March 2003. 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 Cardiovascular disease
Disease that affects the heart and blood vessels.

Mentioned in: Lipoproteins Test

cardiovascular disease 
. Guidant continually works with government agencies, elected officials, physicians and patient advocacy groups to help ensure timely access to new technologies for the patients who will benefit from these medical innovations.

Heart failure is a debilitating condition that affects not only a patient's quality of life, but also life expectancy Life Expectancy

1. The age until which a person is expected to live.

2. The remaining number of years an individual is expected to live, based on IRS issued life expectancy tables.
. It is a disease in which the heart weakens and gradually loses the ability to pump blood effectively. Heart failure currently affects nearly five million Americans and is increasing each year in both prevalence and incidence. It is the leading cause of hospitalizations for people age 65 and older. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder. Heart failure is a progressive cardiac illness in which the heart cannot pump enough oxygenated blood Oxygenated blood
Blood carrying oxygen through the body.

Mentioned in: Patent Ductus Arteriosus
 to meet the body's needs. In many cases, this inefficient pumping occurs because the four chambers of the heart are not working as a team. The timing, or synchrony synchrony /syn·chro·ny/ (-krah-ne) the occurrence of two events simultaneously or with a fixed time interval between them.

atrioventricular (AV) synchrony
, between the chambers is often poor. Consequently, the chambers do not fill and empty normally, so the heart's pumping efficiency is compromised.
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Date:May 30, 2003
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