Jun 17 2004
Guidant Corporation has announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) will review Guidant’s submission to expand user labeling, including indications, for its cardiac resynchronization therapy defibrillators on July 28, 2004.
“We look forward to the opportunity for further review and discussion with the FDA panel. Panel review is consistent with expedited review status and our previously stated expectation for approval by year-end,” said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. “We believe the COMPANION data strongly demonstrate the value of cardiac resynchronization therapy defibrillators in a broad group of heart failure patients.”
Guidant’s submission is based on results of the landmark Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial. Results of the COMPANION trial were published in the May 20, 2004 issue of the New England Journal of Medicine.
Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 12,000 employees, Guidant 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.