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May 26, 2022  
HEART NEWS: Feature Story

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  • FDA Approves Expanded Indication for ICDs

    FDA Approves Expanded Indication for Guidant Implantable Defibrillators

    July 19, 2002

    INDIANAPOLIS & ST. PAUL, Minn.--(BW HealthWire)--July 18, 2002-- Guidant Corporation (NYSE:GDT)(PCX:GDT), a world leader in the treatment of cardiac and vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has expanded the product labeling for its family of implantable cardioverter defibrillators (ICD).

    The expanded indication now includes the prophylactic use of Guidant ICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is less than or equal to 30%. Ejection fraction is a measure of how efficiently the heart pumps blood. A level of 30% or less is an indication of impaired function that puts heart attack survivors at increased risk for sudden cardiac death.

    The expanded indication is based on results from the landmark Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, which were presented at the 51st Scientific Sessions of the American College of Cardiology in March, and published in the March 21st issue of the New England Journal of Medicine. The trial showed that use of Guidant implantable defibrillators reduced total mortality by 31 percent for heart attack survivors with compromised heart function -- those whose ejection fractions are at or below 30 percent. Guidant is the only implantable defibrillator manufacturer to have approved labeling that includes the patient population defined by MADIT II.

    "Heart attack survivors with impaired heart function are at significant risk for sudden cardiac death," said Arthur J. Moss, M.D., University of Rochester Medical Center, who was the lead investigator for the landmark MADIT II Trial. "Heart attack survivors should know their ejection fraction as well as they know their blood pressure and cholesterol levels."

    "Guidant is very pleased to have sponsored the pioneering work of the MADIT II Trial," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "Now, this expanded FDA indication for Guidant implantable defibrillators provides us an excellent opportunity to serve a much broader group of people at known risk for sudden cardiac death."

    Sudden cardiac death (SCD) is the abrupt loss of heart function, usually due to a potentially fatal electrical rhythm dysfunction called ventricular fibrillation. SCD claims the lives of more than 300,000 Americans annually. More people die in the United States each year from sudden cardiac death than from lung cancer, breast cancer and AIDS combined.

    According to an on-line survey of heart attack survivors, conducted by the North American Society of Pacing and Electrophysiology, 55 percent of respondents did not know their ejection fraction. Guidant is launching several educational outreach programs, directed at both patients and referring physicians, in an effort to increase awareness of this important health indicator.

    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 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 see: http://www.heart1.com/attack/guidant.cfm.

    Last updated: 19-Jul-02

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